Sara Freeman

BARCELONA – Patients with early-stage, “favorable” Hodgkin’s lymphoma can be safety and effectively treated with a reduced intensity chemoradiotherapy regimen, according to final results from the German Hodgkin Study Group Trial HD10.

“The radiation dose can be reduced dramatically, by 33%, from 30 to 20 Gy, which of course is very good for our patients, and I hope it will be very good for [decreasing] late toxicities,” Dr. Hans Theodor Eich of the University of Cologne (Germany), said during an interview.

In addition, he noted that two cycles of the regimen, abbreviated as ABVD (doxorubicin [Adriamycin], bleomycin, vinblastine, and dacarbazine), proved to be just as effective as four cycles, but with significantly less acute toxicity observed in patients who were given the lower number of chemotherapy cycles.

Dr. Eich presented the final findings of the German Hodgkin Study Group (GHSG) Trial HD10 at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29). Data were also reported in the New England Journal of Medicine (2010;363:640-2).

During the trial, 1,370 patients with stage I/II Hodgkin’s lymphoma who had an overall favorable prognosis were randomized to treatment with two or four cycles of ABVD in combination with either 20 or 30 Gy of involved-field radiation therapy (IFRT). In total, 346 patients were treated with four cycles of ABVD followed by 30-Gy IFRT; 340 received four cycles of ABVD followed by 20-Gy IFRT; 341 had two cycles of ABVD, then 20 Gy IFRT; and 343 had two cycles of ABVD and then 20-Gy IFRT.

Dr. Eich reported that two cycles of ABVD plus IFRT was associated with a 5-year, progression-free survival rate of 91%. The regimen was found to be noninferior to four cycles of ABVD plus IFRT, with a –2.3% difference in progression-free survival between the two chemotherapy arms.

Chemotherapy, followed by 20 Gy of IFRT, was also associated with a 5-year, progression-free survival rate of 93%. The lower radiotherapy dose was noninferior to 30 Gy, with a between-arm difference of –0.6% in progression-free survival.

“We come from using very large fields of radiation with extended-field radiotherapy to involved-field radiotherapy,” Dr. Eich said. Previous research by his group has shown that IFRT is equally as effective as extended-field radiotherapy, he added, but with less acute toxicity (J. Clin. Oncol. 2003;21:3601-8).

In the current trial, the switch from using extended- to involved-field radiotherapy not only works, he said, but it also enables a much lower radiation dose to be delivered. By itself, this “is an achievement for radiation oncology.”

Patient characteristics and histopathology were similar among the groups. The median age was 36 years, 39% of patients were female, and the majority (62%) had stage IIA disease, with 30% having stage IA, 6% stage IIB, and 2% stage IB Hodgkin’s lymphoma. Most (74%) had a performance status of 0 or 1.

The effects of two vs. four cycles of ABVD could be assessed in 1,190 patients. Two cycles of the chemotherapy were associated with significantly less World Health Organization grade 3/4 toxicities than were four cycles (33% vs. 52% of patients; P less than .0001).

The effects of 20 vs. 30 Gy of IFRT could be assessed in 1,163 patients. Both doses of IFRT were associated with low rates of acute toxicity (3% and 9% for CTC grade 3/4 toxicity, respectively). At a median follow-up of 79 months, no significant reduction of late toxicities has been demonstrated, Dr. Eich said.

Overall survival also was virtually identical in the chemotherapy and radiotherapy comparisons.

“Chemotherapy followed by 30-Gy IFRT is an effective treatment for early-stage, favorable Hodgkin’s lymphoma, and 20-Gy IFRT is not inferior to 30-Gy IFRT as consolidation therapy after chemotherapy,” he said.

Taken together, “two cycles of ABVD with only 20-Gy IFRT is regarded as a new international standard for early-stage, favorable Hodgkin’s lymphoma,” Dr. Eich concluded.

As the official commentator on the trial at ESTRO 29, Dr. Theodore Girinsky of the Institut Gustave-Roussy in Villejuif, France, said that although the conclusions are very clear, there are were some caveats. “This was a very highly selected patient population, and this type of treatment cannot be applied to all patients,” he asserted.

However, Dr. Andrew McCann, a radiation oncologist at Auckland (New Zealand) Hospital, who was in the audience and was not involved the trial, said in an interview that he thought “this trial is clearly going to change practice.”

In this select group of patients with early Hodgkin’s disease, he said, it shows that “we can reduce the intensity of treatment,” with fewer cycles of chemotherapy and a lesser dose of radiation, and “still have a good outcome.”

Dr. McCann added, “We would hope that this would lead to less long-term side effects without reducing the efficacy of the treatment.”

The GHSG Trial HD10 was funded by Deutsche Krebshilfe and the Swiss Federal Government. Dr. Eich had no personal financial disclosures. Dr. Girinsky and Dr. McCann were not involved in the study.

BARCELONA – Patients with early-stage, “favorable” Hodgkin’s lymphoma can be safety and effectively treated with a reduced intensity chemoradiotherapy regimen, according to final results from the German Hodgkin Study Group Trial HD10.

“The radiation dose can be reduced dramatically, by 33%, from 30 to 20 Gy, which of course is very good for our patients, and I hope it will be very good for [decreasing] late toxicities,” Dr. Hans Theodor Eich of the University of Cologne (Germany), said during an interview.

In addition, he noted that two cycles of the regimen, abbreviated as ABVD (doxorubicin [Adriamycin], bleomycin, vinblastine, and dacarbazine), proved to be just as effective as four cycles, but with significantly less acute toxicity observed in patients who were given the lower number of chemotherapy cycles.

Dr. Eich presented the final findings of the German Hodgkin Study Group (GHSG) Trial HD10 at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29). Data were also reported in the New England Journal of Medicine (2010;363:640-2).

During the trial, 1,370 patients with stage I/II Hodgkin’s lymphoma who had an overall favorable prognosis were randomized to treatment with two or four cycles of ABVD in combination with either 20 or 30 Gy of involved-field radiation therapy (IFRT). In total, 346 patients were treated with four cycles of ABVD followed by 30-Gy IFRT; 340 received four cycles of ABVD followed by 20-Gy IFRT; 341 had two cycles of ABVD, then 20 Gy IFRT; and 343 had two cycles of ABVD and then 20-Gy IFRT.

Dr. Eich reported that two cycles of ABVD plus IFRT was associated with a 5-year, progression-free survival rate of 91%. The regimen was found to be noninferior to four cycles of ABVD plus IFRT, with a –2.3% difference in progression-free survival between the two chemotherapy arms.

Chemotherapy, followed by 20 Gy of IFRT, was also associated with a 5-year, progression-free survival rate of 93%. The lower radiotherapy dose was noninferior to 30 Gy, with a between-arm difference of –0.6% in progression-free survival.

“We come from using very large fields of radiation with extended-field radiotherapy to involved-field radiotherapy,” Dr. Eich said. Previous research by his group has shown that IFRT is equally as effective as extended-field radiotherapy, he added, but with less acute toxicity (J. Clin. Oncol. 2003;21:3601-8).

In the current trial, the switch from using extended- to involved-field radiotherapy not only works, he said, but it also enables a much lower radiation dose to be delivered. By itself, this “is an achievement for radiation oncology.”

Patient characteristics and histopathology were similar among the groups. The median age was 36 years, 39% of patients were female, and the majority (62%) had stage IIA disease, with 30% having stage IA, 6% stage IIB, and 2% stage IB Hodgkin’s lymphoma. Most (74%) had a performance status of 0 or 1.

The effects of two vs. four cycles of ABVD could be assessed in 1,190 patients. Two cycles of the chemotherapy were associated with significantly less World Health Organization grade 3/4 toxicities than were four cycles (33% vs. 52% of patients; P less than .0001).

The effects of 20 vs. 30 Gy of IFRT could be assessed in 1,163 patients. Both doses of IFRT were associated with low rates of acute toxicity (3% and 9% for CTC grade 3/4 toxicity, respectively). At a median follow-up of 79 months, no significant reduction of late toxicities has been demonstrated, Dr. Eich said.

Overall survival also was virtually identical in the chemotherapy and radiotherapy comparisons.

“Chemotherapy followed by 30-Gy IFRT is an effective treatment for early-stage, favorable Hodgkin’s lymphoma, and 20-Gy IFRT is not inferior to 30-Gy IFRT as consolidation therapy after chemotherapy,” he said.

Taken together, “two cycles of ABVD with only 20-Gy IFRT is regarded as a new international standard for early-stage, favorable Hodgkin’s lymphoma,” Dr. Eich concluded.

As the official commentator on the trial at ESTRO 29, Dr. Theodore Girinsky of the Institut Gustave-Roussy in Villejuif, France, said that although the conclusions are very clear, there are were some caveats. “This was a very highly selected patient population, and this type of treatment cannot be applied to all patients,” he asserted.

However, Dr. Andrew McCann, a radiation oncologist at Auckland (New Zealand) Hospital, who was in the audience and was not involved the trial, said in an interview that he thought “this trial is clearly going to change practice.”

In this select group of patients with early Hodgkin’s disease, he said, it shows that “we can reduce the intensity of treatment,” with fewer cycles of chemotherapy and a lesser dose of radiation, and “still have a good outcome.”

Dr. McCann added, “We would hope that this would lead to less long-term side effects without reducing the efficacy of the treatment.”

The GHSG Trial HD10 was funded by Deutsche Krebshilfe and the Swiss Federal Government. Dr. Eich had no personal financial disclosures. Dr. Girinsky and Dr. McCann were not involved in the study.

BARCELONA – Patients with early-stage, “favorable” Hodgkin’s lymphoma can be safety and effectively treated with a reduced intensity chemoradiotherapy regimen, according to final results from the German Hodgkin Study Group Trial HD10.

“The radiation dose can be reduced dramatically, by 33%, from 30 to 20 Gy, which of course is very good for our patients, and I hope it will be very good for [decreasing] late toxicities,” Dr. Hans Theodor Eich of the University of Cologne (Germany), said during an interview.

In addition, he noted that two cycles of the regimen, abbreviated as ABVD (doxorubicin [Adriamycin], bleomycin, vinblastine, and dacarbazine), proved to be just as effective as four cycles, but with significantly less acute toxicity observed in patients who were given the lower number of chemotherapy cycles.

Dr. Eich presented the final findings of the German Hodgkin Study Group (GHSG) Trial HD10 at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29). Data were also reported in the New England Journal of Medicine (2010;363:640-2).

During the trial, 1,370 patients with stage I/II Hodgkin’s lymphoma who had an overall favorable prognosis were randomized to treatment with two or four cycles of ABVD in combination with either 20 or 30 Gy of involved-field radiation therapy (IFRT). In total, 346 patients were treated with four cycles of ABVD followed by 30-Gy IFRT; 340 received four cycles of ABVD followed by 20-Gy IFRT; 341 had two cycles of ABVD, then 20 Gy IFRT; and 343 had two cycles of ABVD and then 20-Gy IFRT.

Dr. Eich reported that two cycles of ABVD plus IFRT was associated with a 5-year, progression-free survival rate of 91%. The regimen was found to be noninferior to four cycles of ABVD plus IFRT, with a –2.3% difference in progression-free survival between the two chemotherapy arms.

Chemotherapy, followed by 20 Gy of IFRT, was also associated with a 5-year, progression-free survival rate of 93%. The lower radiotherapy dose was noninferior to 30 Gy, with a between-arm difference of –0.6% in progression-free survival.

“We come from using very large fields of radiation with extended-field radiotherapy to involved-field radiotherapy,” Dr. Eich said. Previous research by his group has shown that IFRT is equally as effective as extended-field radiotherapy, he added, but with less acute toxicity (J. Clin. Oncol. 2003;21:3601-8).

In the current trial, the switch from using extended- to involved-field radiotherapy not only works, he said, but it also enables a much lower radiation dose to be delivered. By itself, this “is an achievement for radiation oncology.”

Patient characteristics and histopathology were similar among the groups. The median age was 36 years, 39% of patients were female, and the majority (62%) had stage IIA disease, with 30% having stage IA, 6% stage IIB, and 2% stage IB Hodgkin’s lymphoma. Most (74%) had a performance status of 0 or 1.

The effects of two vs. four cycles of ABVD could be assessed in 1,190 patients. Two cycles of the chemotherapy were associated with significantly less World Health Organization grade 3/4 toxicities than were four cycles (33% vs. 52% of patients; P less than .0001).

The effects of 20 vs. 30 Gy of IFRT could be assessed in 1,163 patients. Both doses of IFRT were associated with low rates of acute toxicity (3% and 9% for CTC grade 3/4 toxicity, respectively). At a median follow-up of 79 months, no significant reduction of late toxicities has been demonstrated, Dr. Eich said.

Overall survival also was virtually identical in the chemotherapy and radiotherapy comparisons.

“Chemotherapy followed by 30-Gy IFRT is an effective treatment for early-stage, favorable Hodgkin’s lymphoma, and 20-Gy IFRT is not inferior to 30-Gy IFRT as consolidation therapy after chemotherapy,” he said.

Taken together, “two cycles of ABVD with only 20-Gy IFRT is regarded as a new international standard for early-stage, favorable Hodgkin’s lymphoma,” Dr. Eich concluded.

As the official commentator on the trial at ESTRO 29, Dr. Theodore Girinsky of the Institut Gustave-Roussy in Villejuif, France, said that although the conclusions are very clear, there are were some caveats. “This was a very highly selected patient population, and this type of treatment cannot be applied to all patients,” he asserted.

However, Dr. Andrew McCann, a radiation oncologist at Auckland (New Zealand) Hospital, who was in the audience and was not involved the trial, said in an interview that he thought “this trial is clearly going to change practice.”

In this select group of patients with early Hodgkin’s disease, he said, it shows that “we can reduce the intensity of treatment,” with fewer cycles of chemotherapy and a lesser dose of radiation, and “still have a good outcome.”

Dr. McCann added, “We would hope that this would lead to less long-term side effects without reducing the efficacy of the treatment.”

The GHSG Trial HD10 was funded by Deutsche Krebshilfe and the Swiss Federal Government. Dr. Eich had no personal financial disclosures. Dr. Girinsky and Dr. McCann were not involved in the study.

BARCELONA – Vaginal brachytherapy for high-intermediate risk endometrial cancer is associated with significantly less diarrhea and fewer bowel symptoms that limit patients’ daily activities, compared with pelvic external beam radiation therapy, according to 5-year follow-up data from a phase III trial.

The latest findings from the open-label, randomized PORTEC-2 (Postoperative Radiation Therapy for Endometrial Carcinoma–2) trial also show that, compared with standard pelvic radiotherapy, vaginal brachytherapy results in better overall social functioning and does not significantly affect sexual activity.

These data further support vaginal brachytherapy as the preferred form of adjuvant radiotherapy for high-intermediate risk endometrial cancer, said Dr. Remi A. Nout, a radiation oncologist at Leiden (the Netherlands) University Medical Center. He presented the updated quality of life findings Sept. 15th at the biennial meeting of the European Society for Therapeutic Radiation and Oncology (ESTRO 29).

“From the first PORTEC trial [Lancet 2000;355:1404-11], we learned that high-intermediate risk patients showed the largest benefit in terms of locoregional control” from the addition of EBRT after surgery, Dr. Nout explained. “The locoregional recurrence risk dropped from approximately 20% in the nonirradiated group to 5% in the patients who received external beam radiotherapy, and the major decrease was seen in vaginal recurrences which accounted for approximately 75% of the locoregional recurrences.”

The use of postoperative EBRT was associated with increased treatment morbidity, however, and the aim of PORTEC-2 was to determine whether vaginal brachytherapy could achieve similarly good efficacy results, but with less overall toxicity, and perhaps beneficial effects on quality of life. The primary outcome data of the trial were reported recently, and showed similar rates of vaginal recurrence (1.8% with EBRT vs. 1.6% with brachytherapy), locoregional relapse (2.1% vs. 5.1%, respectively), and overall survival (79.6% vs. 84.8%, respectively) at a median follow-up of 3.75 years (Lancet 2010;375:816-23).

Quality of life during the trial was assessed before and after radiotherapy, and then every 6 months for the first 2 years and thereafter annually until 5 years’ follow-up had been achieved. Several instruments were used to assess both cancer-specific and symptom-related quality of life. Of the 427 women in the PORTEC-2 trial, 349 completed the quality of life questionnaires, giving an overall initial response rate of 82%.

The 2-year quality of life findings from the study have been previously reported (J. Clin. Oncol. 2009;27:3547-56), and Dr. Nout presented an updated quality of life analysis after a median follow-up of 4.4 years. The results showed significantly higher rates of diarrhea following EBRT than vaginal brachytherapy at all assessment points (P less than .001). The greatest difference in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C330) diarrhea scores occurred after radiotherapy. Diarrhea scores following vaginal brachytherapy were comparable with those from the age-matched Dutch general population, whereas those for EBRT were substantially worse.

“In addition to this increased rate of diarrhea, we also saw an increased rate of fecal leakage and a need to remain close to the toilet” in the EBRT vs. the brachytherapy groups, Dr. Nout observed. He added, “If we look at the limitation in daily activities due to bowel problems, we can also see a clear increase which persists over time until 5 years, which is highly significant [P less than .001] in favor of brachytherapy.”

Social functioning scores were lowest at baseline and rose after both EBRT and brachytherapy, although scores were significantly higher (P less than .001) in women who underwent brachytherapy, and were again in line with the age-matched general population data.

With regard to sexual activity, there was no difference between the two types of radiotherapy, and an overall increase from baseline values. The sexual activity decreased over time, which reflected changes in sexual activity of the age-matched general population.

Considering these long-term quality of life data together with the prior efficacy findings, “vaginal brachytherapy is the adjuvant treatment of choice for women with high-intermediate risk endometrial carcinoma,” Dr. Nout said.

A grant from the Dutch Cancer Society supported PORTEC-2 trial. Dr. Nout had no conflicts of interest.

BARCELONA – Vaginal brachytherapy for high-intermediate risk endometrial cancer is associated with significantly less diarrhea and fewer bowel symptoms that limit patients’ daily activities, compared with pelvic external beam radiation therapy, according to 5-year follow-up data from a phase III trial.

The latest findings from the open-label, randomized PORTEC-2 (Postoperative Radiation Therapy for Endometrial Carcinoma–2) trial also show that, compared with standard pelvic radiotherapy, vaginal brachytherapy results in better overall social functioning and does not significantly affect sexual activity.

These data further support vaginal brachytherapy as the preferred form of adjuvant radiotherapy for high-intermediate risk endometrial cancer, said Dr. Remi A. Nout, a radiation oncologist at Leiden (the Netherlands) University Medical Center. He presented the updated quality of life findings Sept. 15th at the biennial meeting of the European Society for Therapeutic Radiation and Oncology (ESTRO 29).

“From the first PORTEC trial [Lancet 2000;355:1404-11], we learned that high-intermediate risk patients showed the largest benefit in terms of locoregional control” from the addition of EBRT after surgery, Dr. Nout explained. “The locoregional recurrence risk dropped from approximately 20% in the nonirradiated group to 5% in the patients who received external beam radiotherapy, and the major decrease was seen in vaginal recurrences which accounted for approximately 75% of the locoregional recurrences.”

The use of postoperative EBRT was associated with increased treatment morbidity, however, and the aim of PORTEC-2 was to determine whether vaginal brachytherapy could achieve similarly good efficacy results, but with less overall toxicity, and perhaps beneficial effects on quality of life. The primary outcome data of the trial were reported recently, and showed similar rates of vaginal recurrence (1.8% with EBRT vs. 1.6% with brachytherapy), locoregional relapse (2.1% vs. 5.1%, respectively), and overall survival (79.6% vs. 84.8%, respectively) at a median follow-up of 3.75 years (Lancet 2010;375:816-23).

Quality of life during the trial was assessed before and after radiotherapy, and then every 6 months for the first 2 years and thereafter annually until 5 years’ follow-up had been achieved. Several instruments were used to assess both cancer-specific and symptom-related quality of life. Of the 427 women in the PORTEC-2 trial, 349 completed the quality of life questionnaires, giving an overall initial response rate of 82%.

The 2-year quality of life findings from the study have been previously reported (J. Clin. Oncol. 2009;27:3547-56), and Dr. Nout presented an updated quality of life analysis after a median follow-up of 4.4 years. The results showed significantly higher rates of diarrhea following EBRT than vaginal brachytherapy at all assessment points (P less than .001). The greatest difference in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C330) diarrhea scores occurred after radiotherapy. Diarrhea scores following vaginal brachytherapy were comparable with those from the age-matched Dutch general population, whereas those for EBRT were substantially worse.

“In addition to this increased rate of diarrhea, we also saw an increased rate of fecal leakage and a need to remain close to the toilet” in the EBRT vs. the brachytherapy groups, Dr. Nout observed. He added, “If we look at the limitation in daily activities due to bowel problems, we can also see a clear increase which persists over time until 5 years, which is highly significant [P less than .001] in favor of brachytherapy.”

Social functioning scores were lowest at baseline and rose after both EBRT and brachytherapy, although scores were significantly higher (P less than .001) in women who underwent brachytherapy, and were again in line with the age-matched general population data.

With regard to sexual activity, there was no difference between the two types of radiotherapy, and an overall increase from baseline values. The sexual activity decreased over time, which reflected changes in sexual activity of the age-matched general population.

Considering these long-term quality of life data together with the prior efficacy findings, “vaginal brachytherapy is the adjuvant treatment of choice for women with high-intermediate risk endometrial carcinoma,” Dr. Nout said.

A grant from the Dutch Cancer Society supported PORTEC-2 trial. Dr. Nout had no conflicts of interest.

BARCELONA – Vaginal brachytherapy for high-intermediate risk endometrial cancer is associated with significantly less diarrhea and fewer bowel symptoms that limit patients’ daily activities, compared with pelvic external beam radiation therapy, according to 5-year follow-up data from a phase III trial.

The latest findings from the open-label, randomized PORTEC-2 (Postoperative Radiation Therapy for Endometrial Carcinoma–2) trial also show that, compared with standard pelvic radiotherapy, vaginal brachytherapy results in better overall social functioning and does not significantly affect sexual activity.

These data further support vaginal brachytherapy as the preferred form of adjuvant radiotherapy for high-intermediate risk endometrial cancer, said Dr. Remi A. Nout, a radiation oncologist at Leiden (the Netherlands) University Medical Center. He presented the updated quality of life findings Sept. 15th at the biennial meeting of the European Society for Therapeutic Radiation and Oncology (ESTRO 29).

“From the first PORTEC trial [Lancet 2000;355:1404-11], we learned that high-intermediate risk patients showed the largest benefit in terms of locoregional control” from the addition of EBRT after surgery, Dr. Nout explained. “The locoregional recurrence risk dropped from approximately 20% in the nonirradiated group to 5% in the patients who received external beam radiotherapy, and the major decrease was seen in vaginal recurrences which accounted for approximately 75% of the locoregional recurrences.”

The use of postoperative EBRT was associated with increased treatment morbidity, however, and the aim of PORTEC-2 was to determine whether vaginal brachytherapy could achieve similarly good efficacy results, but with less overall toxicity, and perhaps beneficial effects on quality of life. The primary outcome data of the trial were reported recently, and showed similar rates of vaginal recurrence (1.8% with EBRT vs. 1.6% with brachytherapy), locoregional relapse (2.1% vs. 5.1%, respectively), and overall survival (79.6% vs. 84.8%, respectively) at a median follow-up of 3.75 years (Lancet 2010;375:816-23).

Quality of life during the trial was assessed before and after radiotherapy, and then every 6 months for the first 2 years and thereafter annually until 5 years’ follow-up had been achieved. Several instruments were used to assess both cancer-specific and symptom-related quality of life. Of the 427 women in the PORTEC-2 trial, 349 completed the quality of life questionnaires, giving an overall initial response rate of 82%.

The 2-year quality of life findings from the study have been previously reported (J. Clin. Oncol. 2009;27:3547-56), and Dr. Nout presented an updated quality of life analysis after a median follow-up of 4.4 years. The results showed significantly higher rates of diarrhea following EBRT than vaginal brachytherapy at all assessment points (P less than .001). The greatest difference in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C330) diarrhea scores occurred after radiotherapy. Diarrhea scores following vaginal brachytherapy were comparable with those from the age-matched Dutch general population, whereas those for EBRT were substantially worse.

“In addition to this increased rate of diarrhea, we also saw an increased rate of fecal leakage and a need to remain close to the toilet” in the EBRT vs. the brachytherapy groups, Dr. Nout observed. He added, “If we look at the limitation in daily activities due to bowel problems, we can also see a clear increase which persists over time until 5 years, which is highly significant [P less than .001] in favor of brachytherapy.”

Social functioning scores were lowest at baseline and rose after both EBRT and brachytherapy, although scores were significantly higher (P less than .001) in women who underwent brachytherapy, and were again in line with the age-matched general population data.

With regard to sexual activity, there was no difference between the two types of radiotherapy, and an overall increase from baseline values. The sexual activity decreased over time, which reflected changes in sexual activity of the age-matched general population.

Considering these long-term quality of life data together with the prior efficacy findings, “vaginal brachytherapy is the adjuvant treatment of choice for women with high-intermediate risk endometrial carcinoma,” Dr. Nout said.

A grant from the Dutch Cancer Society supported PORTEC-2 trial. Dr. Nout had no conflicts of interest.

BARCELONA – The erythropoiesis-stimulating agent darbepoetin alfa should not be used in combination with radiotherapy in patients with potentially curable head and neck cancer, late results of the halted Danish Head and Neck Cancer Study Group 10 trial indicate.

Although darbepoetin alfa (Aranesp), given at a weekly subcutaneous dose of 150 mcg, successfully raised low hemoglobin (Hb) levels, its use with accelerated radiotherapy was associated with significantly worse clinical outcomes, including locoregional tumor control and overall survival at 5 years, than was radiotherapy alone.

This is in agreement with other similar trials, said study investigator Dr. Jens Overgaard, professor and head of the department of experimental clinical oncology at Aarhus (Denmark) University Hospital. “What is interesting is that all these trials began with the belief that at least we will do no harm – we might do good – and then it turned out that it is the opposite: You actually are doing harm,” Dr. Overgaard said in an interview, Sept. 16 at the biennial meeting of the European Society of Therapeutic Radiation and Oncology, where he presented the new data.

The DAHANCA 10 trial started in June 2002 to test the hypothesis that raising low Hb (defined as less than or equal to 14.5 g/dL) with darbepoetin during curative radiotherapy for squamous cell carcinoma of the head and neck would improve patient outcomes vs. radiotherapy alone. However, the study was stopped early in November 2006, when 522 of the originally anticipated 600 patients had been randomized, because of worse outcomes in the Aranesp-treated patients.

In all, data on 254 evaluable patients who were treated with darbepoetin plus radiotherapy (66-68 Gy given in 33-34 fractions, at 6 fractions per week) and 259 evaluable patients who were given radiotherapy alone were available for the 5-year follow-up analysis. Results showed that the addition of darbepoetin was associated with significantly worse rates of locoregional tumor control (50% vs. 63%; P = .003), death from cancer (53% vs. 65%; P = .02), disease-free survival (33% vs. 46%; P =.003), and overall survival (40% vs. 51%; P = .03).

There were no statistically significant differences in tumor characteristics between the two treatment arms that could perhaps help explain the findings, nor was there any difference in the rate of deaths that were not from cancer.

Hazard ratios for locoregional failure, overall death, and disease-specific death were 1.54, 1.29, and 1.41, respectively, for darbepoetin vs. no ESA use. Higher tumor grade, nodal involvement, male sex, and World Health Organization performance status were also significant predictors of worse outcome.

“The cause of the poorer outcome in the Aranesp group is not quite obvious, but of course it is tempting to guess that it is a potential tumor- or growth-stimulating effect of the agent,” which is currently being further explored, Dr. Overgaard said during his presentation.

He concluded, “The idea of using ESAs in this patient cohort is not something one should continue to do.”

Dr. Camilla Hoff, also of the department of experimental clinical oncology at Aarhus University Hospital, presented findings from the DAHANCA 5 trial. The 414-patient study demonstrated that raising Hb via blood transfusion around the time of radiotherapy also was unable to significantly improve patients’ outcomes vs. no transfusion.

“We know that with a lower hemoglobin level patients do worse, but the point is that you cannot just correct it,” Dr. Overgaard observed.

The Danish Cancer Society supported the DAHANCA 5 and DAHANCA 10 trials. Amgen provided additional support for the DAHANCA 10 trial. Dr. Overgaard and Dr. Hoff had no personal financial disclosures.

BARCELONA – The erythropoiesis-stimulating agent darbepoetin alfa should not be used in combination with radiotherapy in patients with potentially curable head and neck cancer, late results of the halted Danish Head and Neck Cancer Study Group 10 trial indicate.

Although darbepoetin alfa (Aranesp), given at a weekly subcutaneous dose of 150 mcg, successfully raised low hemoglobin (Hb) levels, its use with accelerated radiotherapy was associated with significantly worse clinical outcomes, including locoregional tumor control and overall survival at 5 years, than was radiotherapy alone.

This is in agreement with other similar trials, said study investigator Dr. Jens Overgaard, professor and head of the department of experimental clinical oncology at Aarhus (Denmark) University Hospital. “What is interesting is that all these trials began with the belief that at least we will do no harm – we might do good – and then it turned out that it is the opposite: You actually are doing harm,” Dr. Overgaard said in an interview, Sept. 16 at the biennial meeting of the European Society of Therapeutic Radiation and Oncology, where he presented the new data.

The DAHANCA 10 trial started in June 2002 to test the hypothesis that raising low Hb (defined as less than or equal to 14.5 g/dL) with darbepoetin during curative radiotherapy for squamous cell carcinoma of the head and neck would improve patient outcomes vs. radiotherapy alone. However, the study was stopped early in November 2006, when 522 of the originally anticipated 600 patients had been randomized, because of worse outcomes in the Aranesp-treated patients.

In all, data on 254 evaluable patients who were treated with darbepoetin plus radiotherapy (66-68 Gy given in 33-34 fractions, at 6 fractions per week) and 259 evaluable patients who were given radiotherapy alone were available for the 5-year follow-up analysis. Results showed that the addition of darbepoetin was associated with significantly worse rates of locoregional tumor control (50% vs. 63%; P = .003), death from cancer (53% vs. 65%; P = .02), disease-free survival (33% vs. 46%; P =.003), and overall survival (40% vs. 51%; P = .03).

There were no statistically significant differences in tumor characteristics between the two treatment arms that could perhaps help explain the findings, nor was there any difference in the rate of deaths that were not from cancer.

Hazard ratios for locoregional failure, overall death, and disease-specific death were 1.54, 1.29, and 1.41, respectively, for darbepoetin vs. no ESA use. Higher tumor grade, nodal involvement, male sex, and World Health Organization performance status were also significant predictors of worse outcome.

“The cause of the poorer outcome in the Aranesp group is not quite obvious, but of course it is tempting to guess that it is a potential tumor- or growth-stimulating effect of the agent,” which is currently being further explored, Dr. Overgaard said during his presentation.

He concluded, “The idea of using ESAs in this patient cohort is not something one should continue to do.”

Dr. Camilla Hoff, also of the department of experimental clinical oncology at Aarhus University Hospital, presented findings from the DAHANCA 5 trial. The 414-patient study demonstrated that raising Hb via blood transfusion around the time of radiotherapy also was unable to significantly improve patients’ outcomes vs. no transfusion.

“We know that with a lower hemoglobin level patients do worse, but the point is that you cannot just correct it,” Dr. Overgaard observed.

The Danish Cancer Society supported the DAHANCA 5 and DAHANCA 10 trials. Amgen provided additional support for the DAHANCA 10 trial. Dr. Overgaard and Dr. Hoff had no personal financial disclosures.

BARCELONA – The erythropoiesis-stimulating agent darbepoetin alfa should not be used in combination with radiotherapy in patients with potentially curable head and neck cancer, late results of the halted Danish Head and Neck Cancer Study Group 10 trial indicate.

Although darbepoetin alfa (Aranesp), given at a weekly subcutaneous dose of 150 mcg, successfully raised low hemoglobin (Hb) levels, its use with accelerated radiotherapy was associated with significantly worse clinical outcomes, including locoregional tumor control and overall survival at 5 years, than was radiotherapy alone.

This is in agreement with other similar trials, said study investigator Dr. Jens Overgaard, professor and head of the department of experimental clinical oncology at Aarhus (Denmark) University Hospital. “What is interesting is that all these trials began with the belief that at least we will do no harm – we might do good – and then it turned out that it is the opposite: You actually are doing harm,” Dr. Overgaard said in an interview, Sept. 16 at the biennial meeting of the European Society of Therapeutic Radiation and Oncology, where he presented the new data.

The DAHANCA 10 trial started in June 2002 to test the hypothesis that raising low Hb (defined as less than or equal to 14.5 g/dL) with darbepoetin during curative radiotherapy for squamous cell carcinoma of the head and neck would improve patient outcomes vs. radiotherapy alone. However, the study was stopped early in November 2006, when 522 of the originally anticipated 600 patients had been randomized, because of worse outcomes in the Aranesp-treated patients.

In all, data on 254 evaluable patients who were treated with darbepoetin plus radiotherapy (66-68 Gy given in 33-34 fractions, at 6 fractions per week) and 259 evaluable patients who were given radiotherapy alone were available for the 5-year follow-up analysis. Results showed that the addition of darbepoetin was associated with significantly worse rates of locoregional tumor control (50% vs. 63%; P = .003), death from cancer (53% vs. 65%; P = .02), disease-free survival (33% vs. 46%; P =.003), and overall survival (40% vs. 51%; P = .03).

There were no statistically significant differences in tumor characteristics between the two treatment arms that could perhaps help explain the findings, nor was there any difference in the rate of deaths that were not from cancer.

Hazard ratios for locoregional failure, overall death, and disease-specific death were 1.54, 1.29, and 1.41, respectively, for darbepoetin vs. no ESA use. Higher tumor grade, nodal involvement, male sex, and World Health Organization performance status were also significant predictors of worse outcome.

“The cause of the poorer outcome in the Aranesp group is not quite obvious, but of course it is tempting to guess that it is a potential tumor- or growth-stimulating effect of the agent,” which is currently being further explored, Dr. Overgaard said during his presentation.

He concluded, “The idea of using ESAs in this patient cohort is not something one should continue to do.”

Dr. Camilla Hoff, also of the department of experimental clinical oncology at Aarhus University Hospital, presented findings from the DAHANCA 5 trial. The 414-patient study demonstrated that raising Hb via blood transfusion around the time of radiotherapy also was unable to significantly improve patients’ outcomes vs. no transfusion.

“We know that with a lower hemoglobin level patients do worse, but the point is that you cannot just correct it,” Dr. Overgaard observed.

The Danish Cancer Society supported the DAHANCA 5 and DAHANCA 10 trials. Amgen provided additional support for the DAHANCA 10 trial. Dr. Overgaard and Dr. Hoff had no personal financial disclosures.

BARCELONA – One-fifth of rectal cancer patients can avoid the need to have their rectum removed by the addition of high-dose, contact irradiation to external beam radiation therapy, data from a 10-year follow-up of a randomized, controlled trial have demonstrated.

As reported at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29), the findings from the LYON R96-02 trial show clear, long-term benefits for patients with cancer of the lower rectum by the addition of contact irradiation (CXRT) to external beam radiation therapy (EBRT).

“When we add the technique of contact radiation therapy to conventional radiotherapy in the preoperative treatment of patients with rectal cancer, we improve the chances of conserving the sphincter of these patients,” said study investigator Dr. C?cile Ortholan in an interview.

Dr. Ortholan of the department of radiation oncology at the Centre Antoine-Lacassagne in Nice, France, added that “preserving the sphincter is very important for patients in terms of their quality of life.” She noted that the technique is very easy and takes about 3 minutes to perform, requires local anesthesia only, and there were no real side effects. Perhaps most important, however, is that there was a significantly decreased rate of permanent colostomy in the patients who received CXRT-EBRT vs. EBRT alone.

Between 1996 and 2001, a total of 88 patients with a median age of 68 years were enrolled into the LYON R96-02 study. Of these patients, 43 were randomized to receive EBRT, given at a total dose of 39 Gy in 13 fractions, while 45 were randomized to receive a high (85 Gy) CXRT dose in addition to EBRT. Between 1996 and 2001, CXRT was administered on days 1, 8, and 21 in decreasing dose fractions (35 Gy, 30 Gy, and 20 Gy, respectively). Median follow-up was 132 months.

While no patient who had EBRT before surgery was able to keep their rectum, nine (20%) of those who had additional CXRT were able to avoid the muscle’s removal, and a higher percentage given CXRT-EBRT avoided the need for a permanent colostomy. Indeed, the cumulative rate of permanent colostomy at 10 years in this group was 29% vs. 63% for radiotherapy alone (P less than .001).

These benefits came at no extra cost in terms of local disease control, disease-free survival, or overall survival at 10 years. Although the difference was not significant, the local recurrence rate was lower in the CXBT-EBRT-treated patients (10% vs. 15%). The clinical complete response rate was significantly better at 24% with the added radiation vs. 2% with EBRT alone (P = .006).

“My take-home message is that, with the addition of contact radiotherapy, we avoid definitive colostomy for the patient,” said Dr. Ortholan, who plans to study the use of CXRT in combination with chemoradiotherapy in the treatment of patients with small rectal tumors and in very elderly patients, with the hope of avoiding the need for surgery altogether.

“These findings are important because they highlight that it is not only important to cure a patients’ cancer, but it is also important to maintain their long-term quality of life,” commented Dr. Jean Bourhis, chairman of the radiation and oncology department at the Institut Gustave Roussy in Villejuif, France.

Dr. Bourhis, who is the president of ESTRO and cochair of ESTRO 29, added: “If you can preserve the sphincter, then patients’ long-term quality of life is completely different as compared to surgical removal and permanent colostomy.”

Dr. Ortholan had no financial disclosures. Dr. Bourhis was not involved in the study.

BARCELONA – One-fifth of rectal cancer patients can avoid the need to have their rectum removed by the addition of high-dose, contact irradiation to external beam radiation therapy, data from a 10-year follow-up of a randomized, controlled trial have demonstrated.

As reported at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29), the findings from the LYON R96-02 trial show clear, long-term benefits for patients with cancer of the lower rectum by the addition of contact irradiation (CXRT) to external beam radiation therapy (EBRT).

“When we add the technique of contact radiation therapy to conventional radiotherapy in the preoperative treatment of patients with rectal cancer, we improve the chances of conserving the sphincter of these patients,” said study investigator Dr. C?cile Ortholan in an interview.

Dr. Ortholan of the department of radiation oncology at the Centre Antoine-Lacassagne in Nice, France, added that “preserving the sphincter is very important for patients in terms of their quality of life.” She noted that the technique is very easy and takes about 3 minutes to perform, requires local anesthesia only, and there were no real side effects. Perhaps most important, however, is that there was a significantly decreased rate of permanent colostomy in the patients who received CXRT-EBRT vs. EBRT alone.

Between 1996 and 2001, a total of 88 patients with a median age of 68 years were enrolled into the LYON R96-02 study. Of these patients, 43 were randomized to receive EBRT, given at a total dose of 39 Gy in 13 fractions, while 45 were randomized to receive a high (85 Gy) CXRT dose in addition to EBRT. Between 1996 and 2001, CXRT was administered on days 1, 8, and 21 in decreasing dose fractions (35 Gy, 30 Gy, and 20 Gy, respectively). Median follow-up was 132 months.

While no patient who had EBRT before surgery was able to keep their rectum, nine (20%) of those who had additional CXRT were able to avoid the muscle’s removal, and a higher percentage given CXRT-EBRT avoided the need for a permanent colostomy. Indeed, the cumulative rate of permanent colostomy at 10 years in this group was 29% vs. 63% for radiotherapy alone (P less than .001).

These benefits came at no extra cost in terms of local disease control, disease-free survival, or overall survival at 10 years. Although the difference was not significant, the local recurrence rate was lower in the CXBT-EBRT-treated patients (10% vs. 15%). The clinical complete response rate was significantly better at 24% with the added radiation vs. 2% with EBRT alone (P = .006).

“My take-home message is that, with the addition of contact radiotherapy, we avoid definitive colostomy for the patient,” said Dr. Ortholan, who plans to study the use of CXRT in combination with chemoradiotherapy in the treatment of patients with small rectal tumors and in very elderly patients, with the hope of avoiding the need for surgery altogether.

“These findings are important because they highlight that it is not only important to cure a patients’ cancer, but it is also important to maintain their long-term quality of life,” commented Dr. Jean Bourhis, chairman of the radiation and oncology department at the Institut Gustave Roussy in Villejuif, France.

Dr. Bourhis, who is the president of ESTRO and cochair of ESTRO 29, added: “If you can preserve the sphincter, then patients’ long-term quality of life is completely different as compared to surgical removal and permanent colostomy.”

Dr. Ortholan had no financial disclosures. Dr. Bourhis was not involved in the study.

BARCELONA – One-fifth of rectal cancer patients can avoid the need to have their rectum removed by the addition of high-dose, contact irradiation to external beam radiation therapy, data from a 10-year follow-up of a randomized, controlled trial have demonstrated.

As reported at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29), the findings from the LYON R96-02 trial show clear, long-term benefits for patients with cancer of the lower rectum by the addition of contact irradiation (CXRT) to external beam radiation therapy (EBRT).

“When we add the technique of contact radiation therapy to conventional radiotherapy in the preoperative treatment of patients with rectal cancer, we improve the chances of conserving the sphincter of these patients,” said study investigator Dr. C?cile Ortholan in an interview.

Dr. Ortholan of the department of radiation oncology at the Centre Antoine-Lacassagne in Nice, France, added that “preserving the sphincter is very important for patients in terms of their quality of life.” She noted that the technique is very easy and takes about 3 minutes to perform, requires local anesthesia only, and there were no real side effects. Perhaps most important, however, is that there was a significantly decreased rate of permanent colostomy in the patients who received CXRT-EBRT vs. EBRT alone.

Between 1996 and 2001, a total of 88 patients with a median age of 68 years were enrolled into the LYON R96-02 study. Of these patients, 43 were randomized to receive EBRT, given at a total dose of 39 Gy in 13 fractions, while 45 were randomized to receive a high (85 Gy) CXRT dose in addition to EBRT. Between 1996 and 2001, CXRT was administered on days 1, 8, and 21 in decreasing dose fractions (35 Gy, 30 Gy, and 20 Gy, respectively). Median follow-up was 132 months.

While no patient who had EBRT before surgery was able to keep their rectum, nine (20%) of those who had additional CXRT were able to avoid the muscle’s removal, and a higher percentage given CXRT-EBRT avoided the need for a permanent colostomy. Indeed, the cumulative rate of permanent colostomy at 10 years in this group was 29% vs. 63% for radiotherapy alone (P less than .001).

These benefits came at no extra cost in terms of local disease control, disease-free survival, or overall survival at 10 years. Although the difference was not significant, the local recurrence rate was lower in the CXBT-EBRT-treated patients (10% vs. 15%). The clinical complete response rate was significantly better at 24% with the added radiation vs. 2% with EBRT alone (P = .006).

“My take-home message is that, with the addition of contact radiotherapy, we avoid definitive colostomy for the patient,” said Dr. Ortholan, who plans to study the use of CXRT in combination with chemoradiotherapy in the treatment of patients with small rectal tumors and in very elderly patients, with the hope of avoiding the need for surgery altogether.

“These findings are important because they highlight that it is not only important to cure a patients’ cancer, but it is also important to maintain their long-term quality of life,” commented Dr. Jean Bourhis, chairman of the radiation and oncology department at the Institut Gustave Roussy in Villejuif, France.

Dr. Bourhis, who is the president of ESTRO and cochair of ESTRO 29, added: “If you can preserve the sphincter, then patients’ long-term quality of life is completely different as compared to surgical removal and permanent colostomy.”

Dr. Ortholan had no financial disclosures. Dr. Bourhis was not involved in the study.

BARCELONA – One-fifth of rectal cancer patients can avoid the need to have their rectum removed by the addition of high-dose, contact irradiation to external beam radiation therapy, data from a 10-year follow-up of a randomized, controlled trial have demonstrated.

As reported at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29), the findings from the LYON R96-02 trial show clear, long-term benefits for patients with cancer of the lower rectum by the addition of contact irradiation (CXRT) to external beam radiation therapy (EBRT).

“When we add the technique of contact radiation therapy to conventional radiotherapy in the preoperative treatment of patients with rectal cancer, we improve the chances of conserving the sphincter of these patients,” said study investigator Dr. C?cile Ortholan in an interview.

Dr. Ortholan of the department of radiation oncology at the Centre Antoine-Lacassagne in Nice, France, added that “preserving the sphincter is very important for patients in terms of their quality of life.” She noted that the technique is very easy and takes about 3 minutes to perform, requires local anesthesia only, and there were no real side effects. Perhaps most important, however, is that there was a significantly decreased rate of permanent colostomy in the patients who received CXRT-EBRT vs. EBRT alone.

Between 1996 and 2001, a total of 88 patients with a median age of 68 years were enrolled into the LYON R96-02 study. Of these patients, 43 were randomized to receive EBRT, given at a total dose of 39 Gy in 13 fractions, while 45 were randomized to receive a high (85 Gy) CXRT dose in addition to EBRT. Between 1996 and 2001, CXRT was administered on days 1, 8, and 21 in decreasing dose fractions (35 Gy, 30 Gy, and 20 Gy, respectively). Median follow-up was 132 months.

While no patient who had EBRT before surgery was able to keep their rectum, nine (20%) of those who had additional CXRT were able to avoid the muscle’s removal, and a higher percentage given CXRT-EBRT avoided the need for a permanent colostomy. Indeed, the cumulative rate of permanent colostomy at 10 years in this group was 29% vs. 63% for radiotherapy alone (P less than .001).

These benefits came at no extra cost in terms of local disease control, disease-free survival, or overall survival at 10 years. Although the difference was not significant, the local recurrence rate was lower in the CXBT-EBRT-treated patients (10% vs. 15%). The clinical complete response rate was significantly better at 24% with the added radiation vs. 2% with EBRT alone (P = .006).

“My take-home message is that, with the addition of contact radiotherapy, we avoid definitive colostomy for the patient,” said Dr. Ortholan, who plans to study the use of CXRT in combination with chemoradiotherapy in the treatment of patients with small rectal tumors and in very elderly patients, with the hope of avoiding the need for surgery altogether.

“These findings are important because they highlight that it is not only important to cure a patients’ cancer, but it is also important to maintain their long-term quality of life,” commented Dr. Jean Bourhis, chairman of the radiation and oncology department at the Institut Gustave Roussy in Villejuif, France.

Dr. Bourhis, who is the president of ESTRO and cochair of ESTRO 29, added: “If you can preserve the sphincter, then patients’ long-term quality of life is completely different as compared to surgical removal and permanent colostomy.”

Dr. Ortholan had no financial disclosures. Dr. Bourhis was not involved in the study.

BARCELONA – One-fifth of rectal cancer patients can avoid the need to have their rectum removed by the addition of high-dose, contact irradiation to external beam radiation therapy, data from a 10-year follow-up of a randomized, controlled trial have demonstrated.

As reported at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29), the findings from the LYON R96-02 trial show clear, long-term benefits for patients with cancer of the lower rectum by the addition of contact irradiation (CXRT) to external beam radiation therapy (EBRT).

“When we add the technique of contact radiation therapy to conventional radiotherapy in the preoperative treatment of patients with rectal cancer, we improve the chances of conserving the sphincter of these patients,” said study investigator Dr. C?cile Ortholan in an interview.

Dr. Ortholan of the department of radiation oncology at the Centre Antoine-Lacassagne in Nice, France, added that “preserving the sphincter is very important for patients in terms of their quality of life.” She noted that the technique is very easy and takes about 3 minutes to perform, requires local anesthesia only, and there were no real side effects. Perhaps most important, however, is that there was a significantly decreased rate of permanent colostomy in the patients who received CXRT-EBRT vs. EBRT alone.

Between 1996 and 2001, a total of 88 patients with a median age of 68 years were enrolled into the LYON R96-02 study. Of these patients, 43 were randomized to receive EBRT, given at a total dose of 39 Gy in 13 fractions, while 45 were randomized to receive a high (85 Gy) CXRT dose in addition to EBRT. Between 1996 and 2001, CXRT was administered on days 1, 8, and 21 in decreasing dose fractions (35 Gy, 30 Gy, and 20 Gy, respectively). Median follow-up was 132 months.

While no patient who had EBRT before surgery was able to keep their rectum, nine (20%) of those who had additional CXRT were able to avoid the muscle’s removal, and a higher percentage given CXRT-EBRT avoided the need for a permanent colostomy. Indeed, the cumulative rate of permanent colostomy at 10 years in this group was 29% vs. 63% for radiotherapy alone (P less than .001).

These benefits came at no extra cost in terms of local disease control, disease-free survival, or overall survival at 10 years. Although the difference was not significant, the local recurrence rate was lower in the CXBT-EBRT-treated patients (10% vs. 15%). The clinical complete response rate was significantly better at 24% with the added radiation vs. 2% with EBRT alone (P = .006).

“My take-home message is that, with the addition of contact radiotherapy, we avoid definitive colostomy for the patient,” said Dr. Ortholan, who plans to study the use of CXRT in combination with chemoradiotherapy in the treatment of patients with small rectal tumors and in very elderly patients, with the hope of avoiding the need for surgery altogether.

“These findings are important because they highlight that it is not only important to cure a patients’ cancer, but it is also important to maintain their long-term quality of life,” commented Dr. Jean Bourhis, chairman of the radiation and oncology department at the Institut Gustave Roussy in Villejuif, France.

Dr. Bourhis, who is the president of ESTRO and cochair of ESTRO 29, added: “If you can preserve the sphincter, then patients’ long-term quality of life is completely different as compared to surgical removal and permanent colostomy.”

Dr. Ortholan had no financial disclosures. Dr. Bourhis was not involved in the study.

BARCELONA – One-fifth of rectal cancer patients can avoid the need to have their rectum removed by the addition of high-dose, contact irradiation to external beam radiation therapy, data from a 10-year follow-up of a randomized, controlled trial have demonstrated.

As reported at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29), the findings from the LYON R96-02 trial show clear, long-term benefits for patients with cancer of the lower rectum by the addition of contact irradiation (CXRT) to external beam radiation therapy (EBRT).

“When we add the technique of contact radiation therapy to conventional radiotherapy in the preoperative treatment of patients with rectal cancer, we improve the chances of conserving the sphincter of these patients,” said study investigator Dr. C?cile Ortholan in an interview.

Dr. Ortholan of the department of radiation oncology at the Centre Antoine-Lacassagne in Nice, France, added that “preserving the sphincter is very important for patients in terms of their quality of life.” She noted that the technique is very easy and takes about 3 minutes to perform, requires local anesthesia only, and there were no real side effects. Perhaps most important, however, is that there was a significantly decreased rate of permanent colostomy in the patients who received CXRT-EBRT vs. EBRT alone.

Between 1996 and 2001, a total of 88 patients with a median age of 68 years were enrolled into the LYON R96-02 study. Of these patients, 43 were randomized to receive EBRT, given at a total dose of 39 Gy in 13 fractions, while 45 were randomized to receive a high (85 Gy) CXRT dose in addition to EBRT. Between 1996 and 2001, CXRT was administered on days 1, 8, and 21 in decreasing dose fractions (35 Gy, 30 Gy, and 20 Gy, respectively). Median follow-up was 132 months.

While no patient who had EBRT before surgery was able to keep their rectum, nine (20%) of those who had additional CXRT were able to avoid the muscle’s removal, and a higher percentage given CXRT-EBRT avoided the need for a permanent colostomy. Indeed, the cumulative rate of permanent colostomy at 10 years in this group was 29% vs. 63% for radiotherapy alone (P less than .001).

These benefits came at no extra cost in terms of local disease control, disease-free survival, or overall survival at 10 years. Although the difference was not significant, the local recurrence rate was lower in the CXBT-EBRT-treated patients (10% vs. 15%). The clinical complete response rate was significantly better at 24% with the added radiation vs. 2% with EBRT alone (P = .006).

“My take-home message is that, with the addition of contact radiotherapy, we avoid definitive colostomy for the patient,” said Dr. Ortholan, who plans to study the use of CXRT in combination with chemoradiotherapy in the treatment of patients with small rectal tumors and in very elderly patients, with the hope of avoiding the need for surgery altogether.

“These findings are important because they highlight that it is not only important to cure a patients’ cancer, but it is also important to maintain their long-term quality of life,” commented Dr. Jean Bourhis, chairman of the radiation and oncology department at the Institut Gustave Roussy in Villejuif, France.

Dr. Bourhis, who is the president of ESTRO and cochair of ESTRO 29, added: “If you can preserve the sphincter, then patients’ long-term quality of life is completely different as compared to surgical removal and permanent colostomy.”

Dr. Ortholan had no financial disclosures. Dr. Bourhis was not involved in the study.

Major Finding: Validation of the Carisome platform, in more than 900 clinically relevant plasma samples, showed that the test had an overall accuracy of 85% to detect prostate cancer.

Data Source: Lecture at Worldwide Innovative Networking in Personalized Cancer Medicine Symposium.

Disclosures: Dr. Knowles is vice chair and chief scientific officer of Caris Life Sciences Inc., the developer of the Carisome platform.

PARIS — An assay that measures the number of exosomes in the blood may provide a novel means of diagnosing prostate and other cancers in the near future while avoiding the need for repeated biopsies.

Validation of the Carisome platform in more than 900 clinically relevant plasma samples showed that the test had an overall accuracy of 85% to detect prostate cancer. The test is in the late stages of validation, and Caris Life Sciences Inc. hopes to offer the test to U.S. urologists later this year.

“If you are diagnosed with high or accelerating [prostate specific antigen], this avoids or delays the next step of biopsy, which is painful or very unpleasant. This test should allow the detection of and differentiation between real cancer and benign prostatic hypertrophy” said Dr. Jonathan Knowles.

“All cells have three main ways in which they communicate,” said Dr. Knowles, chief scientific officer of Caris. “They send out hormones, such as estrogen, or other small molecules, such as acetylcholine, or interleukin-6. They communicate via cell-to-cell contact. And they send out exosomes.”

Exosomes are released from various cell types, and are found under both normal and pathological conditions, including cancer. “They are constructed in the endoplasmic reticulum, and they are specifically used by cells to communicate with other cells,” said Dr. Knowles, who is also a professor of translational medicine at the École Polytechnique Fédérale de Lausanne (Switzerland) and holds a distinguished professorship in personalized health care at the Finnish Institute for Molecular Medicine in Helsinki.

He noted that exosomes are involved in the process whereby antigens are presented by dendritic cells to other cells in the immune system, and that they contain both micro and messenger RNA and are possibly used by cancer cells to “reprogram” other cells.

The Carisome platform is able to detect the almost 10-fold excess levels of exosomes in the plasma of patients with prostate cancer, compared with controls, and it has been shown to have 85% sensitivity and 86% specificity, based on 933 samples.

“From about 0.5 mL of blood, this particular assay can detect tumors of around 1 cm in size.” Dr. Knowles said, adding that early indications suggest that variations of the test will be of value in the detection of other tumor types, such as colorectal, breast, lung, and ovarian cancers.

“Not only can you say that somebody's got cancer; you can also say what kind of cancer they have got,” he said.

Although the price of the test is still to be determined, Caris hopes to introduce the Carisome platform in the United States as a CLIA (Clinical Laboratory Improvement Amendments) lab-developed test. In parallel, the company is preparing to submit the test for Food and Drug Administration and European Medicines Agency approval. The first test will be for prostate cancer, with assays for other tumor types to follow.

'If you are diagnosed with high or accelerating PSA, this avoids or delays the next step of biopsy.'

Source DR. KNOWLES

Major Finding: Validation of the Carisome platform, in more than 900 clinically relevant plasma samples, showed that the test had an overall accuracy of 85% to detect prostate cancer.

Data Source: Lecture at Worldwide Innovative Networking in Personalized Cancer Medicine Symposium.

Disclosures: Dr. Knowles is vice chair and chief scientific officer of Caris Life Sciences Inc., the developer of the Carisome platform.

PARIS — An assay that measures the number of exosomes in the blood may provide a novel means of diagnosing prostate and other cancers in the near future while avoiding the need for repeated biopsies.

Validation of the Carisome platform in more than 900 clinically relevant plasma samples showed that the test had an overall accuracy of 85% to detect prostate cancer. The test is in the late stages of validation, and Caris Life Sciences Inc. hopes to offer the test to U.S. urologists later this year.

“If you are diagnosed with high or accelerating [prostate specific antigen], this avoids or delays the next step of biopsy, which is painful or very unpleasant. This test should allow the detection of and differentiation between real cancer and benign prostatic hypertrophy” said Dr. Jonathan Knowles.

“All cells have three main ways in which they communicate,” said Dr. Knowles, chief scientific officer of Caris. “They send out hormones, such as estrogen, or other small molecules, such as acetylcholine, or interleukin-6. They communicate via cell-to-cell contact. And they send out exosomes.”

Exosomes are released from various cell types, and are found under both normal and pathological conditions, including cancer. “They are constructed in the endoplasmic reticulum, and they are specifically used by cells to communicate with other cells,” said Dr. Knowles, who is also a professor of translational medicine at the École Polytechnique Fédérale de Lausanne (Switzerland) and holds a distinguished professorship in personalized health care at the Finnish Institute for Molecular Medicine in Helsinki.

He noted that exosomes are involved in the process whereby antigens are presented by dendritic cells to other cells in the immune system, and that they contain both micro and messenger RNA and are possibly used by cancer cells to “reprogram” other cells.

The Carisome platform is able to detect the almost 10-fold excess levels of exosomes in the plasma of patients with prostate cancer, compared with controls, and it has been shown to have 85% sensitivity and 86% specificity, based on 933 samples.

“From about 0.5 mL of blood, this particular assay can detect tumors of around 1 cm in size.” Dr. Knowles said, adding that early indications suggest that variations of the test will be of value in the detection of other tumor types, such as colorectal, breast, lung, and ovarian cancers.

“Not only can you say that somebody's got cancer; you can also say what kind of cancer they have got,” he said.

Although the price of the test is still to be determined, Caris hopes to introduce the Carisome platform in the United States as a CLIA (Clinical Laboratory Improvement Amendments) lab-developed test. In parallel, the company is preparing to submit the test for Food and Drug Administration and European Medicines Agency approval. The first test will be for prostate cancer, with assays for other tumor types to follow.

'If you are diagnosed with high or accelerating PSA, this avoids or delays the next step of biopsy.'

Source DR. KNOWLES

Major Finding: Validation of the Carisome platform, in more than 900 clinically relevant plasma samples, showed that the test had an overall accuracy of 85% to detect prostate cancer.

Data Source: Lecture at Worldwide Innovative Networking in Personalized Cancer Medicine Symposium.

Disclosures: Dr. Knowles is vice chair and chief scientific officer of Caris Life Sciences Inc., the developer of the Carisome platform.

PARIS — An assay that measures the number of exosomes in the blood may provide a novel means of diagnosing prostate and other cancers in the near future while avoiding the need for repeated biopsies.

Validation of the Carisome platform in more than 900 clinically relevant plasma samples showed that the test had an overall accuracy of 85% to detect prostate cancer. The test is in the late stages of validation, and Caris Life Sciences Inc. hopes to offer the test to U.S. urologists later this year.

“If you are diagnosed with high or accelerating [prostate specific antigen], this avoids or delays the next step of biopsy, which is painful or very unpleasant. This test should allow the detection of and differentiation between real cancer and benign prostatic hypertrophy” said Dr. Jonathan Knowles.

“All cells have three main ways in which they communicate,” said Dr. Knowles, chief scientific officer of Caris. “They send out hormones, such as estrogen, or other small molecules, such as acetylcholine, or interleukin-6. They communicate via cell-to-cell contact. And they send out exosomes.”

Exosomes are released from various cell types, and are found under both normal and pathological conditions, including cancer. “They are constructed in the endoplasmic reticulum, and they are specifically used by cells to communicate with other cells,” said Dr. Knowles, who is also a professor of translational medicine at the École Polytechnique Fédérale de Lausanne (Switzerland) and holds a distinguished professorship in personalized health care at the Finnish Institute for Molecular Medicine in Helsinki.

He noted that exosomes are involved in the process whereby antigens are presented by dendritic cells to other cells in the immune system, and that they contain both micro and messenger RNA and are possibly used by cancer cells to “reprogram” other cells.

The Carisome platform is able to detect the almost 10-fold excess levels of exosomes in the plasma of patients with prostate cancer, compared with controls, and it has been shown to have 85% sensitivity and 86% specificity, based on 933 samples.

“From about 0.5 mL of blood, this particular assay can detect tumors of around 1 cm in size.” Dr. Knowles said, adding that early indications suggest that variations of the test will be of value in the detection of other tumor types, such as colorectal, breast, lung, and ovarian cancers.

“Not only can you say that somebody's got cancer; you can also say what kind of cancer they have got,” he said.

Although the price of the test is still to be determined, Caris hopes to introduce the Carisome platform in the United States as a CLIA (Clinical Laboratory Improvement Amendments) lab-developed test. In parallel, the company is preparing to submit the test for Food and Drug Administration and European Medicines Agency approval. The first test will be for prostate cancer, with assays for other tumor types to follow.

'If you are diagnosed with high or accelerating PSA, this avoids or delays the next step of biopsy.'

Source DR. KNOWLES

BIRMINGHAM, ENGLAND — The use of complementary or alterative medicines in rheumatoid arthritis, osteoarthritis, and fibromyalgia is not supported by credible evidence, according to an expert review of available data.

The review, commissioned by Arthritis Research UK for patients, shows that although there is some consistent suggestion of a benefit of fish oil in RA and capsaicin gel in OA, there is no such support for the use of any oral or topical complementary or alterative medicines (CAMs) in fibromyalgia.

“Complementary medicines are popular, but considering particularly those taken orally or applied topically, we have relatively little information for most compounds on efficacy,” Dr. Gary J. MacFarlane said at the meeting.

“Both positive and negative conclusions are based upon relatively little amounts of evidence,” added Dr. MacFarlane, professor of epidemiology at the University of Aberdeen (Scotland) and head of the Arthritis Research UK working group on complementary and alternative medicines.

The working group consisted of eight expert advisers who looked at the available evidence on 41 CAMs for which there was some evidence from randomized controlled trials. There were a further 38 compounds commonly used by patients for which no suitable trial evidence could be found.

The aim of the review was to determine both the efficacy and safety of the compounds to give patients some idea of which CAMs worked and which probably did not, Dr. MacFarlane said. If a rigid Cochrane Review had been performed, he conceded, most of the studies that were assessed would probably have been excluded. “However, patients were saying to us, actually we want you to say something, not just that there is not enough evidence,” Dr. MacFarlane explained.

Efficacy was graded on a 5-level scale, with level 1 signifying that there is no overall evidence that the compound worked, and level 5 meaning there was some consistent evidence across several studies.

The only compounds at level 5 were fish oil for RA and capsaicin gel for OA.

Glucosamine sulfate for OA was graded at level 3, meaning that there was some promising evidence, despite its not being recommended for the treatment of OA in the 2008 OA clinical guidelines of the U.K. National Institute for Health and Clinical Excellence.

Out of four CAMs used for fibromyalgia, none was graded higher than a level 2.

Dr. MacFarlane said that in his view, “fibromyalgia is a condition that really doesn't have any very effective therapy.” Although there have been a small number of positive CAM studies in fibromyalgia, he added, their lack of replication means that further, higher-quality trials are necessary to determine whether these initial findings can be supported by a larger evidence base.

The working group's findings on the use of CAM in fibromyalgia have recently been published (Rheumatology 2010;49:1063-8), and publications on the use of CAM in OA and RA will be forthcoming in the coming months.

“Most patients consider complementary medicines as safe,” Dr. MacFarlane observed, adding that there are important safety issues to consider, such as the quality of the preparation, contraindications, and interactions with conventionally prescribed medicines.

BIRMINGHAM, ENGLAND — The use of complementary or alterative medicines in rheumatoid arthritis, osteoarthritis, and fibromyalgia is not supported by credible evidence, according to an expert review of available data.

The review, commissioned by Arthritis Research UK for patients, shows that although there is some consistent suggestion of a benefit of fish oil in RA and capsaicin gel in OA, there is no such support for the use of any oral or topical complementary or alterative medicines (CAMs) in fibromyalgia.

“Complementary medicines are popular, but considering particularly those taken orally or applied topically, we have relatively little information for most compounds on efficacy,” Dr. Gary J. MacFarlane said at the meeting.

“Both positive and negative conclusions are based upon relatively little amounts of evidence,” added Dr. MacFarlane, professor of epidemiology at the University of Aberdeen (Scotland) and head of the Arthritis Research UK working group on complementary and alternative medicines.

The working group consisted of eight expert advisers who looked at the available evidence on 41 CAMs for which there was some evidence from randomized controlled trials. There were a further 38 compounds commonly used by patients for which no suitable trial evidence could be found.

The aim of the review was to determine both the efficacy and safety of the compounds to give patients some idea of which CAMs worked and which probably did not, Dr. MacFarlane said. If a rigid Cochrane Review had been performed, he conceded, most of the studies that were assessed would probably have been excluded. “However, patients were saying to us, actually we want you to say something, not just that there is not enough evidence,” Dr. MacFarlane explained.

Efficacy was graded on a 5-level scale, with level 1 signifying that there is no overall evidence that the compound worked, and level 5 meaning there was some consistent evidence across several studies.

The only compounds at level 5 were fish oil for RA and capsaicin gel for OA.

Glucosamine sulfate for OA was graded at level 3, meaning that there was some promising evidence, despite its not being recommended for the treatment of OA in the 2008 OA clinical guidelines of the U.K. National Institute for Health and Clinical Excellence.

Out of four CAMs used for fibromyalgia, none was graded higher than a level 2.

Dr. MacFarlane said that in his view, “fibromyalgia is a condition that really doesn't have any very effective therapy.” Although there have been a small number of positive CAM studies in fibromyalgia, he added, their lack of replication means that further, higher-quality trials are necessary to determine whether these initial findings can be supported by a larger evidence base.

The working group's findings on the use of CAM in fibromyalgia have recently been published (Rheumatology 2010;49:1063-8), and publications on the use of CAM in OA and RA will be forthcoming in the coming months.

“Most patients consider complementary medicines as safe,” Dr. MacFarlane observed, adding that there are important safety issues to consider, such as the quality of the preparation, contraindications, and interactions with conventionally prescribed medicines.

BIRMINGHAM, ENGLAND — The use of complementary or alterative medicines in rheumatoid arthritis, osteoarthritis, and fibromyalgia is not supported by credible evidence, according to an expert review of available data.

The review, commissioned by Arthritis Research UK for patients, shows that although there is some consistent suggestion of a benefit of fish oil in RA and capsaicin gel in OA, there is no such support for the use of any oral or topical complementary or alterative medicines (CAMs) in fibromyalgia.

“Complementary medicines are popular, but considering particularly those taken orally or applied topically, we have relatively little information for most compounds on efficacy,” Dr. Gary J. MacFarlane said at the meeting.

“Both positive and negative conclusions are based upon relatively little amounts of evidence,” added Dr. MacFarlane, professor of epidemiology at the University of Aberdeen (Scotland) and head of the Arthritis Research UK working group on complementary and alternative medicines.

The working group consisted of eight expert advisers who looked at the available evidence on 41 CAMs for which there was some evidence from randomized controlled trials. There were a further 38 compounds commonly used by patients for which no suitable trial evidence could be found.

The aim of the review was to determine both the efficacy and safety of the compounds to give patients some idea of which CAMs worked and which probably did not, Dr. MacFarlane said. If a rigid Cochrane Review had been performed, he conceded, most of the studies that were assessed would probably have been excluded. “However, patients were saying to us, actually we want you to say something, not just that there is not enough evidence,” Dr. MacFarlane explained.

Efficacy was graded on a 5-level scale, with level 1 signifying that there is no overall evidence that the compound worked, and level 5 meaning there was some consistent evidence across several studies.

The only compounds at level 5 were fish oil for RA and capsaicin gel for OA.

Glucosamine sulfate for OA was graded at level 3, meaning that there was some promising evidence, despite its not being recommended for the treatment of OA in the 2008 OA clinical guidelines of the U.K. National Institute for Health and Clinical Excellence.

Out of four CAMs used for fibromyalgia, none was graded higher than a level 2.

Dr. MacFarlane said that in his view, “fibromyalgia is a condition that really doesn't have any very effective therapy.” Although there have been a small number of positive CAM studies in fibromyalgia, he added, their lack of replication means that further, higher-quality trials are necessary to determine whether these initial findings can be supported by a larger evidence base.

The working group's findings on the use of CAM in fibromyalgia have recently been published (Rheumatology 2010;49:1063-8), and publications on the use of CAM in OA and RA will be forthcoming in the coming months.

“Most patients consider complementary medicines as safe,” Dr. MacFarlane observed, adding that there are important safety issues to consider, such as the quality of the preparation, contraindications, and interactions with conventionally prescribed medicines.

Major Finding: Musculoskeletal ultrasound of the wrist, as well as the metacarpophalangeal and metatarsophalangeal regions, showed the highest predictive value in very early arthritis patients.

Data Source: A prospective study of 58 patients with very early arthritis.

Disclosures: Dr. Filer had no conflicts of interest in relation to the study. The study was funded by Arthritis Research UK and the AutoCure Consortium.

BIRMINGHAM, ENGLAND — Musculoskeletal ultrasound of multiple small joints is more accurate than traditional clinical assessment at predicting patient outcomes in very early arthritis, judging from the results of a pilot investigation.

“Musculoskeletal ultrasound is not routinely used for diagnosing arthritis [in the United Kingdom],” according to Dr. Andrew Filer, who noted that there have been few studies of the technique for the prediction of patient outcome.

“We know that if we treat patients early they do better, not only in the short term but also in the long term,” he added. “The trouble is, not all patients come through the door with a confirmed diagnosis of rheumatoid or psoriatic arthritis,” said Dr. Filer, who is senior lecturer at the University of Birmingham and consultant rheumatologist at Sandwell and West Birmingham Hospitals NHS Trust. He is also a member of the Rheumatology Research Group at the University of Birmingham.

At the meeting, Dr. Filer reported the preliminary results of an ongoing study designed to determine if musculoskeletal ultrasound can help predict which patients with very early arthritis actually develop rheumatoid arthritis (RA) or related conditions.

The researchers recruited 58 patients who had inflammatory joint symptoms of 3 months or less duration and clinically apparent inflammation of at least one joint. Half of the cohort (50%, 29) had RA, with 48% (14) having detectable anti-citrullinated peptide antibodies. Sixteen (27.6%) patients had resolving arthritis, which was mostly unclassified, and 13 (22.4%) patients had persistent conditions other than RA.

The non-RA group included five patients with psoriatic arthritis, one with reactive arthritis, and two with systemic lupus erythematous. Disease could not be classified in 5 patients.

Patients were assessed clinically before undergoing musculoskeletal ultrasound within 24 hours, and followed up prospectively for 18 months. Baseline and follow-up clinical assessments included 68 tender and 66 swollen joint counts; 28-joint disease activity score; serological data; and conventional radiography of the hands and feet.

An ultrasonographer, who was unaware of the clinical findings, systematically assessed a total of 50 joints using four-point semi-quantitative scales to note the presence of erosions.

Musculoskeletal ultrasound detected significantly more joint involvement than did clinical examination. It also detected more clinically silent involvement of the wrist, elbow, knee, ankle, and metatarsophalangeal (MTP) region.

Sensitivity and specificity analyses showed that ultrasound images of the wrist, metacarpophalangeal (MCP) region, and MTP region were the best predictors of joint involvement, improving upon clinical predictive models for RA. In contrast, imaging of the large joints was not useful for predicting joint involvement.

Dr. Andrew Filer demonstrates ultrasound assessment of the wrist and metacarpophalangeal region.

Source Courtesy Dr. Andrew Filer

My Take

Patterns of Very Early Changes Must Be Confirmed

The study provides an indication that systematic evaluation of joints by ultrasound in patients presenting with very early undifferentiated arthritis may be a useful predictor of future diagnosis of rheumatoid arthritis. Ultrasound may detect involvement in more joints than are detected on clinical examination, and it may detect early erosions with greater sensitivity than conventional radiography. Especially in patients who do not have anti-citrullinated peptide antibodies, the presence of polyarthritis and erosions on ultrasound appears to herald an eventual diagnosis of RA even when patients who do not appear to have polyarthritis on clinical examination.

This approach has promise, but examination of 50 joints is not likely to be efficiently done or reimbursable in routine clinical practice. Further work may yield a profile of specific target joints that may have highest sensitivity and predictability for eventual development of RA when examined by ultrasound, or determine whether all joints would need to be evaluated. Studies of conventional radiography have failed to reveal a consistent pattern or joints that could be consistently excluded. MRI studies of the hands have suggested that involvement of specific joints in the wrists, for example, might best discriminate the eventual diagnosis of RA early in the disease Such studies are needed to better define the role of ultrasound in assessing patients with early undifferentiated inflammatory arthritis.

ERIC L. MATTESON, M.D., is professor of medicine and chief of the division of rheumatology at the Mayo Clinic, Rochester, Minn. He has no relevant financial disclosures.

Major Finding: Musculoskeletal ultrasound of the wrist, as well as the metacarpophalangeal and metatarsophalangeal regions, showed the highest predictive value in very early arthritis patients.

Data Source: A prospective study of 58 patients with very early arthritis.

Disclosures: Dr. Filer had no conflicts of interest in relation to the study. The study was funded by Arthritis Research UK and the AutoCure Consortium.

BIRMINGHAM, ENGLAND — Musculoskeletal ultrasound of multiple small joints is more accurate than traditional clinical assessment at predicting patient outcomes in very early arthritis, judging from the results of a pilot investigation.

“Musculoskeletal ultrasound is not routinely used for diagnosing arthritis [in the United Kingdom],” according to Dr. Andrew Filer, who noted that there have been few studies of the technique for the prediction of patient outcome.

“We know that if we treat patients early they do better, not only in the short term but also in the long term,” he added. “The trouble is, not all patients come through the door with a confirmed diagnosis of rheumatoid or psoriatic arthritis,” said Dr. Filer, who is senior lecturer at the University of Birmingham and consultant rheumatologist at Sandwell and West Birmingham Hospitals NHS Trust. He is also a member of the Rheumatology Research Group at the University of Birmingham.

At the meeting, Dr. Filer reported the preliminary results of an ongoing study designed to determine if musculoskeletal ultrasound can help predict which patients with very early arthritis actually develop rheumatoid arthritis (RA) or related conditions.

The researchers recruited 58 patients who had inflammatory joint symptoms of 3 months or less duration and clinically apparent inflammation of at least one joint. Half of the cohort (50%, 29) had RA, with 48% (14) having detectable anti-citrullinated peptide antibodies. Sixteen (27.6%) patients had resolving arthritis, which was mostly unclassified, and 13 (22.4%) patients had persistent conditions other than RA.

The non-RA group included five patients with psoriatic arthritis, one with reactive arthritis, and two with systemic lupus erythematous. Disease could not be classified in 5 patients.

Patients were assessed clinically before undergoing musculoskeletal ultrasound within 24 hours, and followed up prospectively for 18 months. Baseline and follow-up clinical assessments included 68 tender and 66 swollen joint counts; 28-joint disease activity score; serological data; and conventional radiography of the hands and feet.

An ultrasonographer, who was unaware of the clinical findings, systematically assessed a total of 50 joints using four-point semi-quantitative scales to note the presence of erosions.

Musculoskeletal ultrasound detected significantly more joint involvement than did clinical examination. It also detected more clinically silent involvement of the wrist, elbow, knee, ankle, and metatarsophalangeal (MTP) region.

Sensitivity and specificity analyses showed that ultrasound images of the wrist, metacarpophalangeal (MCP) region, and MTP region were the best predictors of joint involvement, improving upon clinical predictive models for RA. In contrast, imaging of the large joints was not useful for predicting joint involvement.

Dr. Andrew Filer demonstrates ultrasound assessment of the wrist and metacarpophalangeal region.

Source Courtesy Dr. Andrew Filer

My Take

Patterns of Very Early Changes Must Be Confirmed

The study provides an indication that systematic evaluation of joints by ultrasound in patients presenting with very early undifferentiated arthritis may be a useful predictor of future diagnosis of rheumatoid arthritis. Ultrasound may detect involvement in more joints than are detected on clinical examination, and it may detect early erosions with greater sensitivity than conventional radiography. Especially in patients who do not have anti-citrullinated peptide antibodies, the presence of polyarthritis and erosions on ultrasound appears to herald an eventual diagnosis of RA even when patients who do not appear to have polyarthritis on clinical examination.

This approach has promise, but examination of 50 joints is not likely to be efficiently done or reimbursable in routine clinical practice. Further work may yield a profile of specific target joints that may have highest sensitivity and predictability for eventual development of RA when examined by ultrasound, or determine whether all joints would need to be evaluated. Studies of conventional radiography have failed to reveal a consistent pattern or joints that could be consistently excluded. MRI studies of the hands have suggested that involvement of specific joints in the wrists, for example, might best discriminate the eventual diagnosis of RA early in the disease Such studies are needed to better define the role of ultrasound in assessing patients with early undifferentiated inflammatory arthritis.

ERIC L. MATTESON, M.D., is professor of medicine and chief of the division of rheumatology at the Mayo Clinic, Rochester, Minn. He has no relevant financial disclosures.

Major Finding: Musculoskeletal ultrasound of the wrist, as well as the metacarpophalangeal and metatarsophalangeal regions, showed the highest predictive value in very early arthritis patients.

Data Source: A prospective study of 58 patients with very early arthritis.

Disclosures: Dr. Filer had no conflicts of interest in relation to the study. The study was funded by Arthritis Research UK and the AutoCure Consortium.

BIRMINGHAM, ENGLAND — Musculoskeletal ultrasound of multiple small joints is more accurate than traditional clinical assessment at predicting patient outcomes in very early arthritis, judging from the results of a pilot investigation.

“Musculoskeletal ultrasound is not routinely used for diagnosing arthritis [in the United Kingdom],” according to Dr. Andrew Filer, who noted that there have been few studies of the technique for the prediction of patient outcome.

“We know that if we treat patients early they do better, not only in the short term but also in the long term,” he added. “The trouble is, not all patients come through the door with a confirmed diagnosis of rheumatoid or psoriatic arthritis,” said Dr. Filer, who is senior lecturer at the University of Birmingham and consultant rheumatologist at Sandwell and West Birmingham Hospitals NHS Trust. He is also a member of the Rheumatology Research Group at the University of Birmingham.

At the meeting, Dr. Filer reported the preliminary results of an ongoing study designed to determine if musculoskeletal ultrasound can help predict which patients with very early arthritis actually develop rheumatoid arthritis (RA) or related conditions.

The researchers recruited 58 patients who had inflammatory joint symptoms of 3 months or less duration and clinically apparent inflammation of at least one joint. Half of the cohort (50%, 29) had RA, with 48% (14) having detectable anti-citrullinated peptide antibodies. Sixteen (27.6%) patients had resolving arthritis, which was mostly unclassified, and 13 (22.4%) patients had persistent conditions other than RA.

The non-RA group included five patients with psoriatic arthritis, one with reactive arthritis, and two with systemic lupus erythematous. Disease could not be classified in 5 patients.

Patients were assessed clinically before undergoing musculoskeletal ultrasound within 24 hours, and followed up prospectively for 18 months. Baseline and follow-up clinical assessments included 68 tender and 66 swollen joint counts; 28-joint disease activity score; serological data; and conventional radiography of the hands and feet.

An ultrasonographer, who was unaware of the clinical findings, systematically assessed a total of 50 joints using four-point semi-quantitative scales to note the presence of erosions.

Musculoskeletal ultrasound detected significantly more joint involvement than did clinical examination. It also detected more clinically silent involvement of the wrist, elbow, knee, ankle, and metatarsophalangeal (MTP) region.

Sensitivity and specificity analyses showed that ultrasound images of the wrist, metacarpophalangeal (MCP) region, and MTP region were the best predictors of joint involvement, improving upon clinical predictive models for RA. In contrast, imaging of the large joints was not useful for predicting joint involvement.

Dr. Andrew Filer demonstrates ultrasound assessment of the wrist and metacarpophalangeal region.

Source Courtesy Dr. Andrew Filer

My Take

Patterns of Very Early Changes Must Be Confirmed

The study provides an indication that systematic evaluation of joints by ultrasound in patients presenting with very early undifferentiated arthritis may be a useful predictor of future diagnosis of rheumatoid arthritis. Ultrasound may detect involvement in more joints than are detected on clinical examination, and it may detect early erosions with greater sensitivity than conventional radiography. Especially in patients who do not have anti-citrullinated peptide antibodies, the presence of polyarthritis and erosions on ultrasound appears to herald an eventual diagnosis of RA even when patients who do not appear to have polyarthritis on clinical examination.

This approach has promise, but examination of 50 joints is not likely to be efficiently done or reimbursable in routine clinical practice. Further work may yield a profile of specific target joints that may have highest sensitivity and predictability for eventual development of RA when examined by ultrasound, or determine whether all joints would need to be evaluated. Studies of conventional radiography have failed to reveal a consistent pattern or joints that could be consistently excluded. MRI studies of the hands have suggested that involvement of specific joints in the wrists, for example, might best discriminate the eventual diagnosis of RA early in the disease Such studies are needed to better define the role of ultrasound in assessing patients with early undifferentiated inflammatory arthritis.

ERIC L. MATTESON, M.D., is professor of medicine and chief of the division of rheumatology at the Mayo Clinic, Rochester, Minn. He has no relevant financial disclosures.

Major Finding: This study showed that 20% of RA cases had pericardial disease at the time of death, compared with 9.5% of controls.

Data Source: Case-control study of 84 patients with RA diagnosed in 1981–1996.

Disclosures: Dr. Goodson had no conflicts of interest. The study was funded by a Clinical Fellowship awarded by the Devonshire Royal Hospital Endowment Fund.

BIRMINGHAM, ENGLAND — Pericardial disease remains a common cardiovascular complication of rheumatoid arthritis, judging from findings from a recent study.

Findings from the case-control study showed that 20% of patients with RA had pericardial disease at the time of their death, compared with 9.5% of controls. Patients who were rheumatoid factor positive were more likely than RF-negative cases to have pericardial disease.

“This rate is lower than that reported in previous autopsy studies. And it may reflect more recent and more effective disease suppression of rheumatoid arthritis,” said Dr. Nicola J. Goodson, a clinical research fellow at the Arthritis Research U.K. Epidemiology Unit of the University of Manchester (England).

Previous research has found that at the time of their death, 50% of RA patients had pericardial disease (Arch. Intern. Med. 1969;124:714–9). However, the population of patients studied was diagnosed in the 1950s, rather than in the 1980–1990s as in the current review, Dr. Goodson said.

Dr. Goodson reported the results of a study that looked at the presence of cardiovascular disease detected at autopsy in patients with RA who were part of an inception cohort. Of 1,010 RA patients recruited between 1981 and 1996, 565 (56%) had died, and 145 of those had postmortem examinations. Of these, 84 autopsy records were obtained and compared with 84 postmortem reports from the general population that were matched for age, sex, and date of autopsy.

The mean age of the cohort at the time of death was 73.3 years for both cases and controls, and 71% were female. The median duration of arthritis was 8 years, and 80% of patients were RF positive.

According to the death certificates, two-thirds of cases and two-thirds of controls had most likely died as a result of cardiovascular disease. Similar proportions of cases and controls had died as a result of respiratory, malignant, traumatic, or gastrointestinal causes.

Similar cardiovascular causes of death were identified on the death certificates in both cases and controls, with ischemic heart disease, MI, and atherosclerotic disease noted as the most common findings.

RA was listed as a possible contributing cause of death in only 8 (9.5%) of the 84 RA death certificates, although it was cited in the history or examination sections of the autopsy reports in 49 cases.

A consultant histopathologist reviewed the autopsy reports and identified a similar rate of cardiovascular diseases in cases and controls, with the exception of pericardial disease.

Pericardial disease occurred in 22% of patients who were RF positive and in 11% of those who were RF negative.

“Pericardial thickening was the predominant finding,” Dr. Goodson observed, adding that the presence of pericardial disease did not appear to contribute to the overall cause of death.

Because the study was conducted in a contemporary RA population, perhaps a similar prevalence of atherosclerosis in cases and controls was due to the improved overall treatment of RA and cardiovascular risk factors in recent years, she said.

Vitals

Source Elsevier Global Medical News

Major Finding: This study showed that 20% of RA cases had pericardial disease at the time of death, compared with 9.5% of controls.

Data Source: Case-control study of 84 patients with RA diagnosed in 1981–1996.

Disclosures: Dr. Goodson had no conflicts of interest. The study was funded by a Clinical Fellowship awarded by the Devonshire Royal Hospital Endowment Fund.

BIRMINGHAM, ENGLAND — Pericardial disease remains a common cardiovascular complication of rheumatoid arthritis, judging from findings from a recent study.

Findings from the case-control study showed that 20% of patients with RA had pericardial disease at the time of their death, compared with 9.5% of controls. Patients who were rheumatoid factor positive were more likely than RF-negative cases to have pericardial disease.

“This rate is lower than that reported in previous autopsy studies. And it may reflect more recent and more effective disease suppression of rheumatoid arthritis,” said Dr. Nicola J. Goodson, a clinical research fellow at the Arthritis Research U.K. Epidemiology Unit of the University of Manchester (England).

Previous research has found that at the time of their death, 50% of RA patients had pericardial disease (Arch. Intern. Med. 1969;124:714–9). However, the population of patients studied was diagnosed in the 1950s, rather than in the 1980–1990s as in the current review, Dr. Goodson said.

Dr. Goodson reported the results of a study that looked at the presence of cardiovascular disease detected at autopsy in patients with RA who were part of an inception cohort. Of 1,010 RA patients recruited between 1981 and 1996, 565 (56%) had died, and 145 of those had postmortem examinations. Of these, 84 autopsy records were obtained and compared with 84 postmortem reports from the general population that were matched for age, sex, and date of autopsy.

The mean age of the cohort at the time of death was 73.3 years for both cases and controls, and 71% were female. The median duration of arthritis was 8 years, and 80% of patients were RF positive.

According to the death certificates, two-thirds of cases and two-thirds of controls had most likely died as a result of cardiovascular disease. Similar proportions of cases and controls had died as a result of respiratory, malignant, traumatic, or gastrointestinal causes.

Similar cardiovascular causes of death were identified on the death certificates in both cases and controls, with ischemic heart disease, MI, and atherosclerotic disease noted as the most common findings.

RA was listed as a possible contributing cause of death in only 8 (9.5%) of the 84 RA death certificates, although it was cited in the history or examination sections of the autopsy reports in 49 cases.

A consultant histopathologist reviewed the autopsy reports and identified a similar rate of cardiovascular diseases in cases and controls, with the exception of pericardial disease.

Pericardial disease occurred in 22% of patients who were RF positive and in 11% of those who were RF negative.

“Pericardial thickening was the predominant finding,” Dr. Goodson observed, adding that the presence of pericardial disease did not appear to contribute to the overall cause of death.

Because the study was conducted in a contemporary RA population, perhaps a similar prevalence of atherosclerosis in cases and controls was due to the improved overall treatment of RA and cardiovascular risk factors in recent years, she said.

Vitals

Source Elsevier Global Medical News

Major Finding: This study showed that 20% of RA cases had pericardial disease at the time of death, compared with 9.5% of controls.

Data Source: Case-control study of 84 patients with RA diagnosed in 1981–1996.

Disclosures: Dr. Goodson had no conflicts of interest. The study was funded by a Clinical Fellowship awarded by the Devonshire Royal Hospital Endowment Fund.

BIRMINGHAM, ENGLAND — Pericardial disease remains a common cardiovascular complication of rheumatoid arthritis, judging from findings from a recent study.

Findings from the case-control study showed that 20% of patients with RA had pericardial disease at the time of their death, compared with 9.5% of controls. Patients who were rheumatoid factor positive were more likely than RF-negative cases to have pericardial disease.

“This rate is lower than that reported in previous autopsy studies. And it may reflect more recent and more effective disease suppression of rheumatoid arthritis,” said Dr. Nicola J. Goodson, a clinical research fellow at the Arthritis Research U.K. Epidemiology Unit of the University of Manchester (England).

Previous research has found that at the time of their death, 50% of RA patients had pericardial disease (Arch. Intern. Med. 1969;124:714–9). However, the population of patients studied was diagnosed in the 1950s, rather than in the 1980–1990s as in the current review, Dr. Goodson said.

Dr. Goodson reported the results of a study that looked at the presence of cardiovascular disease detected at autopsy in patients with RA who were part of an inception cohort. Of 1,010 RA patients recruited between 1981 and 1996, 565 (56%) had died, and 145 of those had postmortem examinations. Of these, 84 autopsy records were obtained and compared with 84 postmortem reports from the general population that were matched for age, sex, and date of autopsy.

The mean age of the cohort at the time of death was 73.3 years for both cases and controls, and 71% were female. The median duration of arthritis was 8 years, and 80% of patients were RF positive.

According to the death certificates, two-thirds of cases and two-thirds of controls had most likely died as a result of cardiovascular disease. Similar proportions of cases and controls had died as a result of respiratory, malignant, traumatic, or gastrointestinal causes.

Similar cardiovascular causes of death were identified on the death certificates in both cases and controls, with ischemic heart disease, MI, and atherosclerotic disease noted as the most common findings.

RA was listed as a possible contributing cause of death in only 8 (9.5%) of the 84 RA death certificates, although it was cited in the history or examination sections of the autopsy reports in 49 cases.

A consultant histopathologist reviewed the autopsy reports and identified a similar rate of cardiovascular diseases in cases and controls, with the exception of pericardial disease.

Pericardial disease occurred in 22% of patients who were RF positive and in 11% of those who were RF negative.

“Pericardial thickening was the predominant finding,” Dr. Goodson observed, adding that the presence of pericardial disease did not appear to contribute to the overall cause of death.

Because the study was conducted in a contemporary RA population, perhaps a similar prevalence of atherosclerosis in cases and controls was due to the improved overall treatment of RA and cardiovascular risk factors in recent years, she said.

Vitals

Source Elsevier Global Medical News

Major Finding: For every 10-year increase in age, the chance of a patient with RA receiving more intensive treatment reduces by approximately 22%.

Data Source: Repeat cross-sectional study of 290 patients with RA.

Disclosures: Dr. Ma and Dr. Deighton had no conflicts of interest to declare.

BIRMINGHAM, ENGLAND — Elderly patients with rheumatoid arthritis are treated less intensively than their younger counterparts, despite experiencing similar levels of disease activity.

Data from a cross-sectional study that was conducted at two centers in the United Kingdom show that for every 10-year increase in age, the chance of an RA patient's receiving more intensive treatment is reduced by approximately 22%.

“Unfortunately, the elderly population is not well represented in clinical studies,” said Dr. Margaret H.Y. Ma, a clinical research fellow at King's College Hospital in London.

“In routine clinical practice, we see a much larger proportion of elderly patients, and it is unclear currently how well we treat this population,” Dr. Ma said.

The incidence and prevalence of RA increases with age, and it is in the elderly (aged 65 years and older) that disease-related disabilities usually have the greatest impact. Therefore, the aim of the study was to examine the effects of age and other variables on the treatment of RA.

Dr. Ma reported that the study, performed in 2009–2010 and involving 290 participants, was a repeat of a similar investigation that was performed in 2007–2008 and involved 236 people. The original and repeat cohorts of patients were similar in terms of age (58 and 59 years, respectively), sex (79% vs. 81% female), and ethnicity (70% vs. 72% white; 20% vs. 19% Afro-Caribbean). Treatment plans also were similar between the cohorts (80% vs. 81% taking disease-modifying antirheumatic drugs [DMARDs]; 11% vs. 11% taking steroids; 15% vs. 17% taking biologics).

Patients in the repeat study, however, were more likely to have longer disease duration (10 years vs. 8.3 years), as well as a lower 28-joint disease activity score, or DAS28 (4.1 vs. 3.78), than did those who took part in the original study.

Both studies showed that there was a significant effect of age and disease activity on the chances that patients would be given more intensive therapy. While older patients were less likely to receive treatment increases (odds ratio, 0.83 in the original study and 0.82 in the repeat study), higher disease activity was associated with more intensive therapy (OR, 2.15 and 2.39, respectively).

Adjustment for possible confounding factors revealed that age and disease activity were the only determinants of treatment changes.

In the 2009–2010 cohort, the percentage of patients aged 65 years and older on DMARDs, steroids, and biologics was 77%, 11%, and 11%, whereas the percentage of those younger than 65 years who took these drugs was 83%, 19%, and 19%.

“What stuck us the most was the comparison of disease activity,” Dr. Ma said. When they compared patients aged 65 years or older vs. those younger than 65 years, they found that there were no differences in disease activity, with both age groups exhibiting a similar spectrum of disease activity in both the original and repeat studies. However, for the same DAS28, elderly patients were less likely than younger patients to receive an increase in therapy if they had more moderate disease, Dr. Ma reported.

“It is interesting because in patients that have got very active disease, then it seems that, irrespective of their age, we are more likely to try to treat their disease more aggressively,” Dr. Chris Deighton, consultant rheumatologist at the Derbyshire Royal Infirmary, Derby, England, commented.

“If they have got moderate disease, then there is probably more of a negotiation that takes place” between the patient and physician, Dr. Deighton added.

Major Finding: For every 10-year increase in age, the chance of a patient with RA receiving more intensive treatment reduces by approximately 22%.

Data Source: Repeat cross-sectional study of 290 patients with RA.

Disclosures: Dr. Ma and Dr. Deighton had no conflicts of interest to declare.

BIRMINGHAM, ENGLAND — Elderly patients with rheumatoid arthritis are treated less intensively than their younger counterparts, despite experiencing similar levels of disease activity.

Data from a cross-sectional study that was conducted at two centers in the United Kingdom show that for every 10-year increase in age, the chance of an RA patient's receiving more intensive treatment is reduced by approximately 22%.

“Unfortunately, the elderly population is not well represented in clinical studies,” said Dr. Margaret H.Y. Ma, a clinical research fellow at King's College Hospital in London.

“In routine clinical practice, we see a much larger proportion of elderly patients, and it is unclear currently how well we treat this population,” Dr. Ma said.

The incidence and prevalence of RA increases with age, and it is in the elderly (aged 65 years and older) that disease-related disabilities usually have the greatest impact. Therefore, the aim of the study was to examine the effects of age and other variables on the treatment of RA.

Dr. Ma reported that the study, performed in 2009–2010 and involving 290 participants, was a repeat of a similar investigation that was performed in 2007–2008 and involved 236 people. The original and repeat cohorts of patients were similar in terms of age (58 and 59 years, respectively), sex (79% vs. 81% female), and ethnicity (70% vs. 72% white; 20% vs. 19% Afro-Caribbean). Treatment plans also were similar between the cohorts (80% vs. 81% taking disease-modifying antirheumatic drugs [DMARDs]; 11% vs. 11% taking steroids; 15% vs. 17% taking biologics).

Patients in the repeat study, however, were more likely to have longer disease duration (10 years vs. 8.3 years), as well as a lower 28-joint disease activity score, or DAS28 (4.1 vs. 3.78), than did those who took part in the original study.

Both studies showed that there was a significant effect of age and disease activity on the chances that patients would be given more intensive therapy. While older patients were less likely to receive treatment increases (odds ratio, 0.83 in the original study and 0.82 in the repeat study), higher disease activity was associated with more intensive therapy (OR, 2.15 and 2.39, respectively).

Adjustment for possible confounding factors revealed that age and disease activity were the only determinants of treatment changes.

In the 2009–2010 cohort, the percentage of patients aged 65 years and older on DMARDs, steroids, and biologics was 77%, 11%, and 11%, whereas the percentage of those younger than 65 years who took these drugs was 83%, 19%, and 19%.

“What stuck us the most was the comparison of disease activity,” Dr. Ma said. When they compared patients aged 65 years or older vs. those younger than 65 years, they found that there were no differences in disease activity, with both age groups exhibiting a similar spectrum of disease activity in both the original and repeat studies. However, for the same DAS28, elderly patients were less likely than younger patients to receive an increase in therapy if they had more moderate disease, Dr. Ma reported.

“It is interesting because in patients that have got very active disease, then it seems that, irrespective of their age, we are more likely to try to treat their disease more aggressively,” Dr. Chris Deighton, consultant rheumatologist at the Derbyshire Royal Infirmary, Derby, England, commented.

“If they have got moderate disease, then there is probably more of a negotiation that takes place” between the patient and physician, Dr. Deighton added.

Major Finding: For every 10-year increase in age, the chance of a patient with RA receiving more intensive treatment reduces by approximately 22%.

Data Source: Repeat cross-sectional study of 290 patients with RA.

Disclosures: Dr. Ma and Dr. Deighton had no conflicts of interest to declare.

BIRMINGHAM, ENGLAND — Elderly patients with rheumatoid arthritis are treated less intensively than their younger counterparts, despite experiencing similar levels of disease activity.

Data from a cross-sectional study that was conducted at two centers in the United Kingdom show that for every 10-year increase in age, the chance of an RA patient's receiving more intensive treatment is reduced by approximately 22%.

“Unfortunately, the elderly population is not well represented in clinical studies,” said Dr. Margaret H.Y. Ma, a clinical research fellow at King's College Hospital in London.

“In routine clinical practice, we see a much larger proportion of elderly patients, and it is unclear currently how well we treat this population,” Dr. Ma said.

The incidence and prevalence of RA increases with age, and it is in the elderly (aged 65 years and older) that disease-related disabilities usually have the greatest impact. Therefore, the aim of the study was to examine the effects of age and other variables on the treatment of RA.

Dr. Ma reported that the study, performed in 2009–2010 and involving 290 participants, was a repeat of a similar investigation that was performed in 2007–2008 and involved 236 people. The original and repeat cohorts of patients were similar in terms of age (58 and 59 years, respectively), sex (79% vs. 81% female), and ethnicity (70% vs. 72% white; 20% vs. 19% Afro-Caribbean). Treatment plans also were similar between the cohorts (80% vs. 81% taking disease-modifying antirheumatic drugs [DMARDs]; 11% vs. 11% taking steroids; 15% vs. 17% taking biologics).

Patients in the repeat study, however, were more likely to have longer disease duration (10 years vs. 8.3 years), as well as a lower 28-joint disease activity score, or DAS28 (4.1 vs. 3.78), than did those who took part in the original study.

Both studies showed that there was a significant effect of age and disease activity on the chances that patients would be given more intensive therapy. While older patients were less likely to receive treatment increases (odds ratio, 0.83 in the original study and 0.82 in the repeat study), higher disease activity was associated with more intensive therapy (OR, 2.15 and 2.39, respectively).

Adjustment for possible confounding factors revealed that age and disease activity were the only determinants of treatment changes.

In the 2009–2010 cohort, the percentage of patients aged 65 years and older on DMARDs, steroids, and biologics was 77%, 11%, and 11%, whereas the percentage of those younger than 65 years who took these drugs was 83%, 19%, and 19%.

“What stuck us the most was the comparison of disease activity,” Dr. Ma said. When they compared patients aged 65 years or older vs. those younger than 65 years, they found that there were no differences in disease activity, with both age groups exhibiting a similar spectrum of disease activity in both the original and repeat studies. However, for the same DAS28, elderly patients were less likely than younger patients to receive an increase in therapy if they had more moderate disease, Dr. Ma reported.

“It is interesting because in patients that have got very active disease, then it seems that, irrespective of their age, we are more likely to try to treat their disease more aggressively,” Dr. Chris Deighton, consultant rheumatologist at the Derbyshire Royal Infirmary, Derby, England, commented.

“If they have got moderate disease, then there is probably more of a negotiation that takes place” between the patient and physician, Dr. Deighton added.