Breast Cancer

SAN ANTONIO – Accelerated partial-breast brachytherapy, delivered as part of breast-conserving therapy for early breast cancer, was associated with twice the mastectomy rate when compared with standard whole-breast irradiation in a large study.

Moreover, accelerated partial-breast brachytherapy entailed substantially higher rates of both acute and late complications, Dr. Benjamin D. Smith said in a presentation of the study findings at the San Antonio Breast Cancer Symposium.

Investigators reviewed Medicare claims data for all 130,535 beneficiaries whose early breast cancer was treated with lumpectomy followed by adjuvant radiation during 2000-2007. The use of accelerated partial-breast brachytherapy in this population rose from less than 1% in 2000 to 13% in 2007.

The incidence of mastectomy during 5 years of follow-up was 4% in 7,291 brachytherapy recipients, compared with 2% after whole breast irradiation (P less than .001). Upon adjustment for the brachytherapy recipients’ older average age, more comorbid conditions, and lesser rate of positive axillary lymph nodes, brachytherapy was associated with a 2.2-fold increased risk of losing the treated breast within 5 years, reported Dr. Smith, a radiation oncologist at the University of Texas M.D. Anderson Cancer Center, Houston.

"When we adjusted for various clinical and sociodemographic factors, to our surprise brachytherapy was the variable that had the strongest correlation with the risk of subsequent mastectomy," he noted.

Partial-breast brachytherapy was also associated with significantly higher rates of postoperative wound infection and acute noninfectious complications as well as increased 5-year rates of fat necrosis and breast pain. Fat necrosis is considered a marker of tissue injury caused by surgery and/or radiotherapy.

Within 1 year of breast cancer diagnosis, infectious complications involving breast or surrounding skin or soft tissues occurred in 16% of women treated with brachytherapy vs. 10% of those who received standard whole breast radiation.

Noninfectious complications including surgical wound breakdown, postoperative bleeding, or seroma formation were twice as common with brachytherapy at 16% and 8%, respectively.

Five-year rates of fat necrosis (9% vs. 4%) and breast pain (15% vs. 12%) also were higher with brachytherapy.

Accelerated partial-breast brachytherapy was developed to address the shortcomings of whole-breast irradiation, the historic standard of care, which entails up to 7 weeks of daily Monday-through-Friday treatment. Whole-breast irradiation is inconvenient. Indeed, it’s such a hardship, especially for patients in rural areas distant from a radiotherapy center, that some women opt for mastectomy as a matter of convenience. Moreover, 15%-30% of women who undergo lumpectomy forgo prescribed radiation therapy, placing themselves at increased risk of local recurrence.

Accelerated partial-breast brachytherapy may improve patient compliance with radiotherapy. It shortens the treatment course to 1 week. It entails temporary placement of radioactive beads within the breast via a catheter system. This method delivers radiation only to breast tissue immediately adjacent to the lumpectomy. This technique is but one of several forms of partial breast irradiation, however; the new findings don’t apply to 3-D external beam radiation, for example.

Accelerated partial breast brachytherapy has boomed in popularity in recent years, especially in community practice. But these new data may put the brakes on that trend.

"This study has changed the way that I think about these two different treatment options, and it’s changed the way I practice," Dr. Smith said in an interview.

Dr. Jennifer A. Ligibel, who chaired a press conference where Dr. Smith presented his findings, said the study carries an important message: "Although observational data using a claims database are no substitute for a randomized trial with long-term follow-up, what we see in this study is that this technique was not as effective and it was also associated with a lot more complications. So if your argument in using this is that it’s sparing patients from additional problems, we’re not seeing that in this study.

"I think this study really does give pause to the incorporation of accelerated partial-breast brachytherapy into routine clinical practice. These results should make people wait for the results of the ongoing randomized trials before they offer this as a standard procedure for their patients," added Dr. Ligibel of Dana-Farber Cancer Center, Boston.

The major randomized trial underway is the National Surgical Breast and Bowel Project B-39/Radiation Therapy Oncology Group 0413 study. The NSABP B-39/RTOG 0413 trial has enrolled 4,000 of a planned 4,500 patients with early breast cancer. The emphasis is on patients under age 50, since they have a higher local recurrence risk than older women. Participants are randomized to whole-breast radiation or various forms of partial breast irradiation after lumpectomy. Mature results aren’t expected until mid-decade.

Dr. Smith and Dr. Ligibel declared having no relevant financial interests.

SAN ANTONIO – Accelerated partial-breast brachytherapy, delivered as part of breast-conserving therapy for early breast cancer, was associated with twice the mastectomy rate when compared with standard whole-breast irradiation in a large study.

Moreover, accelerated partial-breast brachytherapy entailed substantially higher rates of both acute and late complications, Dr. Benjamin D. Smith said in a presentation of the study findings at the San Antonio Breast Cancer Symposium.

Investigators reviewed Medicare claims data for all 130,535 beneficiaries whose early breast cancer was treated with lumpectomy followed by adjuvant radiation during 2000-2007. The use of accelerated partial-breast brachytherapy in this population rose from less than 1% in 2000 to 13% in 2007.

The incidence of mastectomy during 5 years of follow-up was 4% in 7,291 brachytherapy recipients, compared with 2% after whole breast irradiation (P less than .001). Upon adjustment for the brachytherapy recipients’ older average age, more comorbid conditions, and lesser rate of positive axillary lymph nodes, brachytherapy was associated with a 2.2-fold increased risk of losing the treated breast within 5 years, reported Dr. Smith, a radiation oncologist at the University of Texas M.D. Anderson Cancer Center, Houston.

"When we adjusted for various clinical and sociodemographic factors, to our surprise brachytherapy was the variable that had the strongest correlation with the risk of subsequent mastectomy," he noted.

Partial-breast brachytherapy was also associated with significantly higher rates of postoperative wound infection and acute noninfectious complications as well as increased 5-year rates of fat necrosis and breast pain. Fat necrosis is considered a marker of tissue injury caused by surgery and/or radiotherapy.

Within 1 year of breast cancer diagnosis, infectious complications involving breast or surrounding skin or soft tissues occurred in 16% of women treated with brachytherapy vs. 10% of those who received standard whole breast radiation.

Noninfectious complications including surgical wound breakdown, postoperative bleeding, or seroma formation were twice as common with brachytherapy at 16% and 8%, respectively.

Five-year rates of fat necrosis (9% vs. 4%) and breast pain (15% vs. 12%) also were higher with brachytherapy.

Accelerated partial-breast brachytherapy was developed to address the shortcomings of whole-breast irradiation, the historic standard of care, which entails up to 7 weeks of daily Monday-through-Friday treatment. Whole-breast irradiation is inconvenient. Indeed, it’s such a hardship, especially for patients in rural areas distant from a radiotherapy center, that some women opt for mastectomy as a matter of convenience. Moreover, 15%-30% of women who undergo lumpectomy forgo prescribed radiation therapy, placing themselves at increased risk of local recurrence.

Accelerated partial-breast brachytherapy may improve patient compliance with radiotherapy. It shortens the treatment course to 1 week. It entails temporary placement of radioactive beads within the breast via a catheter system. This method delivers radiation only to breast tissue immediately adjacent to the lumpectomy. This technique is but one of several forms of partial breast irradiation, however; the new findings don’t apply to 3-D external beam radiation, for example.

Accelerated partial breast brachytherapy has boomed in popularity in recent years, especially in community practice. But these new data may put the brakes on that trend.

"This study has changed the way that I think about these two different treatment options, and it’s changed the way I practice," Dr. Smith said in an interview.

Dr. Jennifer A. Ligibel, who chaired a press conference where Dr. Smith presented his findings, said the study carries an important message: "Although observational data using a claims database are no substitute for a randomized trial with long-term follow-up, what we see in this study is that this technique was not as effective and it was also associated with a lot more complications. So if your argument in using this is that it’s sparing patients from additional problems, we’re not seeing that in this study.

"I think this study really does give pause to the incorporation of accelerated partial-breast brachytherapy into routine clinical practice. These results should make people wait for the results of the ongoing randomized trials before they offer this as a standard procedure for their patients," added Dr. Ligibel of Dana-Farber Cancer Center, Boston.

The major randomized trial underway is the National Surgical Breast and Bowel Project B-39/Radiation Therapy Oncology Group 0413 study. The NSABP B-39/RTOG 0413 trial has enrolled 4,000 of a planned 4,500 patients with early breast cancer. The emphasis is on patients under age 50, since they have a higher local recurrence risk than older women. Participants are randomized to whole-breast radiation or various forms of partial breast irradiation after lumpectomy. Mature results aren’t expected until mid-decade.

Dr. Smith and Dr. Ligibel declared having no relevant financial interests.

SAN ANTONIO – Accelerated partial-breast brachytherapy, delivered as part of breast-conserving therapy for early breast cancer, was associated with twice the mastectomy rate when compared with standard whole-breast irradiation in a large study.

Moreover, accelerated partial-breast brachytherapy entailed substantially higher rates of both acute and late complications, Dr. Benjamin D. Smith said in a presentation of the study findings at the San Antonio Breast Cancer Symposium.

Investigators reviewed Medicare claims data for all 130,535 beneficiaries whose early breast cancer was treated with lumpectomy followed by adjuvant radiation during 2000-2007. The use of accelerated partial-breast brachytherapy in this population rose from less than 1% in 2000 to 13% in 2007.

The incidence of mastectomy during 5 years of follow-up was 4% in 7,291 brachytherapy recipients, compared with 2% after whole breast irradiation (P less than .001). Upon adjustment for the brachytherapy recipients’ older average age, more comorbid conditions, and lesser rate of positive axillary lymph nodes, brachytherapy was associated with a 2.2-fold increased risk of losing the treated breast within 5 years, reported Dr. Smith, a radiation oncologist at the University of Texas M.D. Anderson Cancer Center, Houston.

"When we adjusted for various clinical and sociodemographic factors, to our surprise brachytherapy was the variable that had the strongest correlation with the risk of subsequent mastectomy," he noted.

Partial-breast brachytherapy was also associated with significantly higher rates of postoperative wound infection and acute noninfectious complications as well as increased 5-year rates of fat necrosis and breast pain. Fat necrosis is considered a marker of tissue injury caused by surgery and/or radiotherapy.

Within 1 year of breast cancer diagnosis, infectious complications involving breast or surrounding skin or soft tissues occurred in 16% of women treated with brachytherapy vs. 10% of those who received standard whole breast radiation.

Noninfectious complications including surgical wound breakdown, postoperative bleeding, or seroma formation were twice as common with brachytherapy at 16% and 8%, respectively.

Five-year rates of fat necrosis (9% vs. 4%) and breast pain (15% vs. 12%) also were higher with brachytherapy.

Accelerated partial-breast brachytherapy was developed to address the shortcomings of whole-breast irradiation, the historic standard of care, which entails up to 7 weeks of daily Monday-through-Friday treatment. Whole-breast irradiation is inconvenient. Indeed, it’s such a hardship, especially for patients in rural areas distant from a radiotherapy center, that some women opt for mastectomy as a matter of convenience. Moreover, 15%-30% of women who undergo lumpectomy forgo prescribed radiation therapy, placing themselves at increased risk of local recurrence.

Accelerated partial-breast brachytherapy may improve patient compliance with radiotherapy. It shortens the treatment course to 1 week. It entails temporary placement of radioactive beads within the breast via a catheter system. This method delivers radiation only to breast tissue immediately adjacent to the lumpectomy. This technique is but one of several forms of partial breast irradiation, however; the new findings don’t apply to 3-D external beam radiation, for example.

Accelerated partial breast brachytherapy has boomed in popularity in recent years, especially in community practice. But these new data may put the brakes on that trend.

"This study has changed the way that I think about these two different treatment options, and it’s changed the way I practice," Dr. Smith said in an interview.

Dr. Jennifer A. Ligibel, who chaired a press conference where Dr. Smith presented his findings, said the study carries an important message: "Although observational data using a claims database are no substitute for a randomized trial with long-term follow-up, what we see in this study is that this technique was not as effective and it was also associated with a lot more complications. So if your argument in using this is that it’s sparing patients from additional problems, we’re not seeing that in this study.

"I think this study really does give pause to the incorporation of accelerated partial-breast brachytherapy into routine clinical practice. These results should make people wait for the results of the ongoing randomized trials before they offer this as a standard procedure for their patients," added Dr. Ligibel of Dana-Farber Cancer Center, Boston.

The major randomized trial underway is the National Surgical Breast and Bowel Project B-39/Radiation Therapy Oncology Group 0413 study. The NSABP B-39/RTOG 0413 trial has enrolled 4,000 of a planned 4,500 patients with early breast cancer. The emphasis is on patients under age 50, since they have a higher local recurrence risk than older women. Participants are randomized to whole-breast radiation or various forms of partial breast irradiation after lumpectomy. Mature results aren’t expected until mid-decade.

Dr. Smith and Dr. Ligibel declared having no relevant financial interests.

Adding the monoclonal antibody pertuzumab to standard neoadjuvant therapy with trastuzumab plus docetaxel increased the rate of complete tumor response in the proof-of-concept NeoSphere study of women with locally advanced, inflammatory, or early HER2-positive breast cancer, as published online Dec. 6 in Lancet Oncology.

The addition of pertuzumab, which has a different binding site and a complementary mechanism of action to trastuzumab (Herceptin), did not appear to increase the number or severity of treatment-related adverse events in the industry-sponsored, open-label, phase II study, said Dr. Luca Gianni of San Raffaele Cancer Centre in Milan (Italy), and his associates.

"The tumor response to this new triplet combination is one of the highest reported to date, despite just a short treatment time, and could be a big advance for women with HER2-positive disease," Dr. Gianni noted in a press statement accompanying the report.

In the international study, 417 treatment-naive patients at 59 medical centers were randomly assigned to receive 12 weeks of conventional therapy with neoadjuvant trastuzumab plus docetaxel (Taxotere), or pertuzumab and trastuzumab plus docetaxel, or pertuzumab and trastuzumab with no chemotherapy, or pertuzumab plus docetaxel before undergoing surgery. In all, 25 patients, "mostly in the chemotherapy-free group," did not complete surgery as planned. Following surgery, patients in all groups received adjuvant conventional treatment including anthracyclines and trastuzumab for 1 year.

The primary efficacy end point was complete pathologic response within the breast, defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor at surgery. This was achieved in 46% of women given the triplet, compared with only 29% of those given conventional therapy, 17% of those given both monoclonal antibodies but no chemotherapy, and 24% of those given pertuzumab plus chemotherapy.

Thus, the triplet was more effective than was conventional treatment, as well as being more effective than chemotherapy plus either monoclonal antibody alone, Dr. Gianni and his colleagues said (Lancet Oncol. 2011 Dec. 6 [doi:10.1016/S1470-2045(11)70336-9]).

The triplet was particularly effective in the subgroup of women with hormone receptor–negative tumors, with a complete response rate of 63%, they noted. In addition, dual HER2 blockade by pertuzumab and trastuzumab completely eradicated breast tumors in 27% of patients who did not receive docetaxel for these tumors.

The 17% complete response rate among all patients given both monoclonal antibodies without chemotherapy was notable. It suggests that a proportion of HER2-positive tumors can be eradicated without any chemotherapy, "which might have immediate use for women who cannot receive cytotoxic drugs," the investigators added.

Approximately one-third of this subgroup of patients did not respond to the dual-antibody regimen, and that may be attributable to the short duration of neoadjuvant treatment. This possibility will be assessed in clinical trials with longer-term therapy, the researchers said.

As expected with docetaxel, the most common adverse events of grade 3 or higher were neutropenia, febrile neutropenia, and leukopenia. The rates of adverse events (12%-14%) and serious adverse events (10%-17%) were similar across the three groups that received docetaxel, and were markedly lower in the group that didn’t receive it (2% and 4%, respectively).

In particular, cardiac toxicity was considered "good," but a longer observation period will be necessary to rule out the possibility that adding pertuzumab may increase cardiotoxicity. The mean maximal decrease in left ventricular ejection fraction (LVEF) was 4%-5% and was similar across all treatment groups. "No significant change was detected when pertuzumab was added to trastuzumab, and no patient had an LVEF decrease to less than 40% at any time during the study. Four patients [three receiving conventional therapy and one receiving triple-combination therapy] showed LVEF declines of 10%-15% from baseline and to less than 50% during the neoadjuvant period," Dr. Gianni and his associates said.

In July, Roche announced that it plans to see Food and Drug Administration approval based on a survival advantage for the triplet in the phase III CLEOPATRA trial. Data from that study will be presented this week at the San Antonio Breast Cancer Symposium.

This NeoSphere study was funded by Hoffmann-La Roche, maker of pertuzumab; the company provided the study drugs and was involved in the study design, safety monitoring and reporting, and data management and anaylsis. Fondazione Michelangelo also provided support. Dr. Gianni is an advisory board member for Roche, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Wyeth, and Novartis. Three coauthors are Roche employees; two disclosed Roche stock ownership.

Adding the monoclonal antibody pertuzumab to standard neoadjuvant therapy with trastuzumab plus docetaxel increased the rate of complete tumor response in the proof-of-concept NeoSphere study of women with locally advanced, inflammatory, or early HER2-positive breast cancer, as published online Dec. 6 in Lancet Oncology.

The addition of pertuzumab, which has a different binding site and a complementary mechanism of action to trastuzumab (Herceptin), did not appear to increase the number or severity of treatment-related adverse events in the industry-sponsored, open-label, phase II study, said Dr. Luca Gianni of San Raffaele Cancer Centre in Milan (Italy), and his associates.

"The tumor response to this new triplet combination is one of the highest reported to date, despite just a short treatment time, and could be a big advance for women with HER2-positive disease," Dr. Gianni noted in a press statement accompanying the report.

In the international study, 417 treatment-naive patients at 59 medical centers were randomly assigned to receive 12 weeks of conventional therapy with neoadjuvant trastuzumab plus docetaxel (Taxotere), or pertuzumab and trastuzumab plus docetaxel, or pertuzumab and trastuzumab with no chemotherapy, or pertuzumab plus docetaxel before undergoing surgery. In all, 25 patients, "mostly in the chemotherapy-free group," did not complete surgery as planned. Following surgery, patients in all groups received adjuvant conventional treatment including anthracyclines and trastuzumab for 1 year.

The primary efficacy end point was complete pathologic response within the breast, defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor at surgery. This was achieved in 46% of women given the triplet, compared with only 29% of those given conventional therapy, 17% of those given both monoclonal antibodies but no chemotherapy, and 24% of those given pertuzumab plus chemotherapy.

Thus, the triplet was more effective than was conventional treatment, as well as being more effective than chemotherapy plus either monoclonal antibody alone, Dr. Gianni and his colleagues said (Lancet Oncol. 2011 Dec. 6 [doi:10.1016/S1470-2045(11)70336-9]).

The triplet was particularly effective in the subgroup of women with hormone receptor–negative tumors, with a complete response rate of 63%, they noted. In addition, dual HER2 blockade by pertuzumab and trastuzumab completely eradicated breast tumors in 27% of patients who did not receive docetaxel for these tumors.

The 17% complete response rate among all patients given both monoclonal antibodies without chemotherapy was notable. It suggests that a proportion of HER2-positive tumors can be eradicated without any chemotherapy, "which might have immediate use for women who cannot receive cytotoxic drugs," the investigators added.

Approximately one-third of this subgroup of patients did not respond to the dual-antibody regimen, and that may be attributable to the short duration of neoadjuvant treatment. This possibility will be assessed in clinical trials with longer-term therapy, the researchers said.

As expected with docetaxel, the most common adverse events of grade 3 or higher were neutropenia, febrile neutropenia, and leukopenia. The rates of adverse events (12%-14%) and serious adverse events (10%-17%) were similar across the three groups that received docetaxel, and were markedly lower in the group that didn’t receive it (2% and 4%, respectively).

In particular, cardiac toxicity was considered "good," but a longer observation period will be necessary to rule out the possibility that adding pertuzumab may increase cardiotoxicity. The mean maximal decrease in left ventricular ejection fraction (LVEF) was 4%-5% and was similar across all treatment groups. "No significant change was detected when pertuzumab was added to trastuzumab, and no patient had an LVEF decrease to less than 40% at any time during the study. Four patients [three receiving conventional therapy and one receiving triple-combination therapy] showed LVEF declines of 10%-15% from baseline and to less than 50% during the neoadjuvant period," Dr. Gianni and his associates said.

In July, Roche announced that it plans to see Food and Drug Administration approval based on a survival advantage for the triplet in the phase III CLEOPATRA trial. Data from that study will be presented this week at the San Antonio Breast Cancer Symposium.

This NeoSphere study was funded by Hoffmann-La Roche, maker of pertuzumab; the company provided the study drugs and was involved in the study design, safety monitoring and reporting, and data management and anaylsis. Fondazione Michelangelo also provided support. Dr. Gianni is an advisory board member for Roche, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Wyeth, and Novartis. Three coauthors are Roche employees; two disclosed Roche stock ownership.

Adding the monoclonal antibody pertuzumab to standard neoadjuvant therapy with trastuzumab plus docetaxel increased the rate of complete tumor response in the proof-of-concept NeoSphere study of women with locally advanced, inflammatory, or early HER2-positive breast cancer, as published online Dec. 6 in Lancet Oncology.

The addition of pertuzumab, which has a different binding site and a complementary mechanism of action to trastuzumab (Herceptin), did not appear to increase the number or severity of treatment-related adverse events in the industry-sponsored, open-label, phase II study, said Dr. Luca Gianni of San Raffaele Cancer Centre in Milan (Italy), and his associates.

"The tumor response to this new triplet combination is one of the highest reported to date, despite just a short treatment time, and could be a big advance for women with HER2-positive disease," Dr. Gianni noted in a press statement accompanying the report.

In the international study, 417 treatment-naive patients at 59 medical centers were randomly assigned to receive 12 weeks of conventional therapy with neoadjuvant trastuzumab plus docetaxel (Taxotere), or pertuzumab and trastuzumab plus docetaxel, or pertuzumab and trastuzumab with no chemotherapy, or pertuzumab plus docetaxel before undergoing surgery. In all, 25 patients, "mostly in the chemotherapy-free group," did not complete surgery as planned. Following surgery, patients in all groups received adjuvant conventional treatment including anthracyclines and trastuzumab for 1 year.

The primary efficacy end point was complete pathologic response within the breast, defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor at surgery. This was achieved in 46% of women given the triplet, compared with only 29% of those given conventional therapy, 17% of those given both monoclonal antibodies but no chemotherapy, and 24% of those given pertuzumab plus chemotherapy.

Thus, the triplet was more effective than was conventional treatment, as well as being more effective than chemotherapy plus either monoclonal antibody alone, Dr. Gianni and his colleagues said (Lancet Oncol. 2011 Dec. 6 [doi:10.1016/S1470-2045(11)70336-9]).

The triplet was particularly effective in the subgroup of women with hormone receptor–negative tumors, with a complete response rate of 63%, they noted. In addition, dual HER2 blockade by pertuzumab and trastuzumab completely eradicated breast tumors in 27% of patients who did not receive docetaxel for these tumors.

The 17% complete response rate among all patients given both monoclonal antibodies without chemotherapy was notable. It suggests that a proportion of HER2-positive tumors can be eradicated without any chemotherapy, "which might have immediate use for women who cannot receive cytotoxic drugs," the investigators added.

Approximately one-third of this subgroup of patients did not respond to the dual-antibody regimen, and that may be attributable to the short duration of neoadjuvant treatment. This possibility will be assessed in clinical trials with longer-term therapy, the researchers said.

As expected with docetaxel, the most common adverse events of grade 3 or higher were neutropenia, febrile neutropenia, and leukopenia. The rates of adverse events (12%-14%) and serious adverse events (10%-17%) were similar across the three groups that received docetaxel, and were markedly lower in the group that didn’t receive it (2% and 4%, respectively).

In particular, cardiac toxicity was considered "good," but a longer observation period will be necessary to rule out the possibility that adding pertuzumab may increase cardiotoxicity. The mean maximal decrease in left ventricular ejection fraction (LVEF) was 4%-5% and was similar across all treatment groups. "No significant change was detected when pertuzumab was added to trastuzumab, and no patient had an LVEF decrease to less than 40% at any time during the study. Four patients [three receiving conventional therapy and one receiving triple-combination therapy] showed LVEF declines of 10%-15% from baseline and to less than 50% during the neoadjuvant period," Dr. Gianni and his associates said.

In July, Roche announced that it plans to see Food and Drug Administration approval based on a survival advantage for the triplet in the phase III CLEOPATRA trial. Data from that study will be presented this week at the San Antonio Breast Cancer Symposium.

This NeoSphere study was funded by Hoffmann-La Roche, maker of pertuzumab; the company provided the study drugs and was involved in the study design, safety monitoring and reporting, and data management and anaylsis. Fondazione Michelangelo also provided support. Dr. Gianni is an advisory board member for Roche, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Wyeth, and Novartis. Three coauthors are Roche employees; two disclosed Roche stock ownership.

The 2011 San Antonio Breast Cancer Symposium that opened Dec. 6 features a hefty number of studies that could change clinical practice in the treatment of breast cancer.

Oncologists have been eagerly awaiting data from the phase III BOLERO-2 and CLEOPATRA trials, which are to be presented Dec. 8 and 9, respectively.

– BOLERO-2 investigators reported that pairing everolimus (Afinitor) with exemestane (Aromasin) increased median progression-free survival by 4.1 months in an interim analysis presented this fall at the European Multidisciplinary Cancer Congress in Stockholm. Women in this study had estrogen receptor-positive disease that was resistant to hormone therapy.

– Genentech announced last summer that dual HER2 blockade with pertuzumab* and trastuzumab (Herceptin) improved progression-free survival for women with HER2-positive disease who also received docetaxel (Taxotere) in CLEOPATRA. The pairing has also produced good results in the NeoSphere trial, and early reports from studies pairing lapatinib (Tykerb) with trastuzumab have been encouraging.

On Dec. 7, an early-morning press briefing has been scheduled for investigators to outline findings of four noteworthy studies.

– Swedish researchers will report that diabetes and obesity after age 60 are risk factors for breast cancer. Low lipids also increased risk, but high lipids did not in their study comparing medical records of more than 23,000 women. Similarly, risk went up with use of the diabetes drug glargine but down with metformin.

– Gene expression patterns at diagnosis of hormone receptor–positive breast cancer can predict which women will have recurrences late, early, or not at all, according to researchers from the United States.

– Women treated with brachytherapy were about twice as likely to undergo subsequent mastectomy when compared with those treated by whole breast irradiation in a study of more than 150,000 Medicare claims.

– A ductal carcinoma in situ (DCIS) risk score based on the multigene Oncotype DX assay has been validated for prediction of breast cancer recurrence in DCIS patients.

Other Dec. 7 highlights will include presentations from four studies of bisphosphonate use in breast cancer patients and an Institute of Medicine report on "Breast Cancer and the Environment."

For ongoing coverage of these and other presentations at the San Antonio Breast Cancer Symposium, visit http://www.oncologyreport.com.

*Correction, Dec. 8, 2011: An earlier version of this story referred to pertuzumab by the trade name Omnitarg. That trade name was discontinued by Genentech in 2007 and currently the drug goes by pertuzumab.

The 2011 San Antonio Breast Cancer Symposium that opened Dec. 6 features a hefty number of studies that could change clinical practice in the treatment of breast cancer.

Oncologists have been eagerly awaiting data from the phase III BOLERO-2 and CLEOPATRA trials, which are to be presented Dec. 8 and 9, respectively.

– BOLERO-2 investigators reported that pairing everolimus (Afinitor) with exemestane (Aromasin) increased median progression-free survival by 4.1 months in an interim analysis presented this fall at the European Multidisciplinary Cancer Congress in Stockholm. Women in this study had estrogen receptor-positive disease that was resistant to hormone therapy.

– Genentech announced last summer that dual HER2 blockade with pertuzumab* and trastuzumab (Herceptin) improved progression-free survival for women with HER2-positive disease who also received docetaxel (Taxotere) in CLEOPATRA. The pairing has also produced good results in the NeoSphere trial, and early reports from studies pairing lapatinib (Tykerb) with trastuzumab have been encouraging.

On Dec. 7, an early-morning press briefing has been scheduled for investigators to outline findings of four noteworthy studies.

– Swedish researchers will report that diabetes and obesity after age 60 are risk factors for breast cancer. Low lipids also increased risk, but high lipids did not in their study comparing medical records of more than 23,000 women. Similarly, risk went up with use of the diabetes drug glargine but down with metformin.

– Gene expression patterns at diagnosis of hormone receptor–positive breast cancer can predict which women will have recurrences late, early, or not at all, according to researchers from the United States.

– Women treated with brachytherapy were about twice as likely to undergo subsequent mastectomy when compared with those treated by whole breast irradiation in a study of more than 150,000 Medicare claims.

– A ductal carcinoma in situ (DCIS) risk score based on the multigene Oncotype DX assay has been validated for prediction of breast cancer recurrence in DCIS patients.

Other Dec. 7 highlights will include presentations from four studies of bisphosphonate use in breast cancer patients and an Institute of Medicine report on "Breast Cancer and the Environment."

For ongoing coverage of these and other presentations at the San Antonio Breast Cancer Symposium, visit http://www.oncologyreport.com.

*Correction, Dec. 8, 2011: An earlier version of this story referred to pertuzumab by the trade name Omnitarg. That trade name was discontinued by Genentech in 2007 and currently the drug goes by pertuzumab.

The 2011 San Antonio Breast Cancer Symposium that opened Dec. 6 features a hefty number of studies that could change clinical practice in the treatment of breast cancer.

Oncologists have been eagerly awaiting data from the phase III BOLERO-2 and CLEOPATRA trials, which are to be presented Dec. 8 and 9, respectively.

– BOLERO-2 investigators reported that pairing everolimus (Afinitor) with exemestane (Aromasin) increased median progression-free survival by 4.1 months in an interim analysis presented this fall at the European Multidisciplinary Cancer Congress in Stockholm. Women in this study had estrogen receptor-positive disease that was resistant to hormone therapy.

– Genentech announced last summer that dual HER2 blockade with pertuzumab* and trastuzumab (Herceptin) improved progression-free survival for women with HER2-positive disease who also received docetaxel (Taxotere) in CLEOPATRA. The pairing has also produced good results in the NeoSphere trial, and early reports from studies pairing lapatinib (Tykerb) with trastuzumab have been encouraging.

On Dec. 7, an early-morning press briefing has been scheduled for investigators to outline findings of four noteworthy studies.

– Swedish researchers will report that diabetes and obesity after age 60 are risk factors for breast cancer. Low lipids also increased risk, but high lipids did not in their study comparing medical records of more than 23,000 women. Similarly, risk went up with use of the diabetes drug glargine but down with metformin.

– Gene expression patterns at diagnosis of hormone receptor–positive breast cancer can predict which women will have recurrences late, early, or not at all, according to researchers from the United States.

– Women treated with brachytherapy were about twice as likely to undergo subsequent mastectomy when compared with those treated by whole breast irradiation in a study of more than 150,000 Medicare claims.

– A ductal carcinoma in situ (DCIS) risk score based on the multigene Oncotype DX assay has been validated for prediction of breast cancer recurrence in DCIS patients.

Other Dec. 7 highlights will include presentations from four studies of bisphosphonate use in breast cancer patients and an Institute of Medicine report on "Breast Cancer and the Environment."

For ongoing coverage of these and other presentations at the San Antonio Breast Cancer Symposium, visit http://www.oncologyreport.com.

*Correction, Dec. 8, 2011: An earlier version of this story referred to pertuzumab by the trade name Omnitarg. That trade name was discontinued by Genentech in 2007 and currently the drug goes by pertuzumab.

Scant research has focused on breast cancer in very young women. This retrospective case series by investigators at the Mayo Clinic assessed girls and women younger than 25 years who were given a diagnosis of primary breast cancer between 1935 and 2005 and who received care at that institution.

The investigators highlighted many of the challenges clinicians face when a young patient presents with a lump or other signs associated with breast cancer. For example, they note that, in its early stages, breast carcinoma in young women can be similar in appearance to fibroadenoma. When a patient postpones care or a clinician dismisses the lump because of a low index of suspicion, diagnosis can be delayed. That is problematic because invasive breast carcinoma in girls and young women is more aggressive and associated with a poorer prognosis overall.

Details of the trial

Eleven women 20 to 24 years old and one 18-year-old teen were found to have breast cancer. Of these, eight of the women detected the mass themselves, one observed bloody nipple discharge associated with constitutional symptoms, and another experienced severe constitutional symptoms associated with disseminated malignancy. In one case, the physician detected a breast mass in an asymptomatic woman. Details on the remaining woman were unavailable.

Palpable masses were noted in most of the women at the time of clinical evaluation, and the median greatest diameter was 4 cm. After the original history and exam, breast cancer was suspected in only 2 of the 11 women.

Among the 11 young women who had breast cancer, one had received mantle and abdominal radiotherapy for previously diagnosed Hodgkin’s disease. Two women had a family history suggesting hereditary breast cancer. None of the women were tested for a BRCA mutation. Regional or local recurrence was identified in three women, and contralateral breast cancer was found in two women (one of whom was subsequently also found to have ovarian cancer). At the time of the last follow-up (a median of 25.5 months), four women had died as a result of breast cancer, one had died from advanced ovarian cancer, two were alive with disease, and five were alive with no evidence of disease.

We want to hear from you! Tell us what you think.

Scant research has focused on breast cancer in very young women. This retrospective case series by investigators at the Mayo Clinic assessed girls and women younger than 25 years who were given a diagnosis of primary breast cancer between 1935 and 2005 and who received care at that institution.

The investigators highlighted many of the challenges clinicians face when a young patient presents with a lump or other signs associated with breast cancer. For example, they note that, in its early stages, breast carcinoma in young women can be similar in appearance to fibroadenoma. When a patient postpones care or a clinician dismisses the lump because of a low index of suspicion, diagnosis can be delayed. That is problematic because invasive breast carcinoma in girls and young women is more aggressive and associated with a poorer prognosis overall.

Details of the trial

Eleven women 20 to 24 years old and one 18-year-old teen were found to have breast cancer. Of these, eight of the women detected the mass themselves, one observed bloody nipple discharge associated with constitutional symptoms, and another experienced severe constitutional symptoms associated with disseminated malignancy. In one case, the physician detected a breast mass in an asymptomatic woman. Details on the remaining woman were unavailable.

Palpable masses were noted in most of the women at the time of clinical evaluation, and the median greatest diameter was 4 cm. After the original history and exam, breast cancer was suspected in only 2 of the 11 women.

Among the 11 young women who had breast cancer, one had received mantle and abdominal radiotherapy for previously diagnosed Hodgkin’s disease. Two women had a family history suggesting hereditary breast cancer. None of the women were tested for a BRCA mutation. Regional or local recurrence was identified in three women, and contralateral breast cancer was found in two women (one of whom was subsequently also found to have ovarian cancer). At the time of the last follow-up (a median of 25.5 months), four women had died as a result of breast cancer, one had died from advanced ovarian cancer, two were alive with disease, and five were alive with no evidence of disease.

We want to hear from you! Tell us what you think.

Scant research has focused on breast cancer in very young women. This retrospective case series by investigators at the Mayo Clinic assessed girls and women younger than 25 years who were given a diagnosis of primary breast cancer between 1935 and 2005 and who received care at that institution.

The investigators highlighted many of the challenges clinicians face when a young patient presents with a lump or other signs associated with breast cancer. For example, they note that, in its early stages, breast carcinoma in young women can be similar in appearance to fibroadenoma. When a patient postpones care or a clinician dismisses the lump because of a low index of suspicion, diagnosis can be delayed. That is problematic because invasive breast carcinoma in girls and young women is more aggressive and associated with a poorer prognosis overall.

Details of the trial

Eleven women 20 to 24 years old and one 18-year-old teen were found to have breast cancer. Of these, eight of the women detected the mass themselves, one observed bloody nipple discharge associated with constitutional symptoms, and another experienced severe constitutional symptoms associated with disseminated malignancy. In one case, the physician detected a breast mass in an asymptomatic woman. Details on the remaining woman were unavailable.

Palpable masses were noted in most of the women at the time of clinical evaluation, and the median greatest diameter was 4 cm. After the original history and exam, breast cancer was suspected in only 2 of the 11 women.

Among the 11 young women who had breast cancer, one had received mantle and abdominal radiotherapy for previously diagnosed Hodgkin’s disease. Two women had a family history suggesting hereditary breast cancer. None of the women were tested for a BRCA mutation. Regional or local recurrence was identified in three women, and contralateral breast cancer was found in two women (one of whom was subsequently also found to have ovarian cancer). At the time of the last follow-up (a median of 25.5 months), four women had died as a result of breast cancer, one had died from advanced ovarian cancer, two were alive with disease, and five were alive with no evidence of disease.

We want to hear from you! Tell us what you think.

Legislation introduced in the U.S. House of Representatives would require that women be informed of their breast density when they receive their mammogram results, and that those with denser breasts be advised that they could benefit from additional screening.

The Breast Density and Mammography Reporting Act of 2011 (H.R. 3102), introduced in October by Rep. Rosa DeLauro (D-Conn.) and Rep. Steve Israel (D-N.Y.), is modeled after laws enacted in Connecticut in 2009 and in Texas earlier this year. Similar legislation was recently passed by the California legislature, but was vetoed by the governor.

Bills on breast density are also slated to be introduced in at least six other states next year, according to the consumer advocacy group Are You Dense.

The movement to pass these bills has grown largely from the outrage of women who have received years of normal mammogram results only to find out that they have an advanced-stage breast cancer that went undetected because of their dense breast tissue.

That was the experience of Are You Dense founder Nancy M. Cappello, Ph.D., who successfully lobbied lawmakers to enact the Connecticut legislation.

Although information on breast density is available on the mammography report sent to referring physicians, it's not mentioned in the “lay letter” received by women, Dr. Cappello said. That leaves most women in the dark about the fact that dense breasts can make mammograms more difficult to read, and that women with extremely dense breasts are at a higher risk for breast cancer, she said.

“It's a hoax in some respects, a cruel hoax,” she said.

Are You Dense and its supporters around the country have been working state by state to enact laws that require that women be notified of their breast density and their options for additional screening. They are also working at the federal level to change either the law or the regulations surrounding mammography.

Dr. Cappello said that trying to legislate the change wasn't her first choice, but without a national cancer organization or physician group stepping up to educate women, she doesn't have a better option for standardizing the communication on breast density.

In November, Dr. Cappello took her case to the Food and Drug Administration's National Mammography Quality Assurance Advisory Committee. The asked the committee, which provides nonbinding advice to the FDA, to recommend changing the federally mandated lay letter to include information on breast density. While the advisory committee members reached a consensus that breast tissue density should be reported in the mammography lay letter, several of the members said they were unsure what recommendation could be made to physicians and patients about what to do with the information. The committee also did not come to an agreement on the best say to further evaluate patients with dense breasts through other imaging modalities.

But given the uncertain timeframe for any action by the FDA, Are You Dense plans to continue its efforts to enact breast density legislation in the states and at the federal level.

So far, Dr. Cappello's legislative efforts have failed to gain support from major physician groups and patient advocacy organizations. Susan G. Komen for the Cure and the American Cancer Society both stayed on the sidelines during the recent legislative debate in California. The California chapter of the American College of Obstetricians and Gynecologists and the California Medical Association opposed the bill.

“It was a very difficult bill for us to oppose,” said Dr. Philip Diamond, a San Diego ob.gyn. and chair of ACOG District IX in California.

The problem was that the bill went beyond notifying women about their density and on to suggest that they speak with their physician about supplemental screening. The bill's language on supplemental screening goes beyond the existing evidence, Dr. Diamond said, and raised a host of concerns about what the cost of screening would mean for state-funded health programs.

“In the absence of a guideline nationally by either the cancer society or the radiology society or anyone, it's impossible to be able to figure out who needs supplement screening and who doesn't,” he said.

A big concern in California, Dr. Diamond said, is that such legislation would lead to the automatic ordering of supplemental ultrasounds and MRIs, regardless of the individual risk factors of the women involved.

That's exactly what has happened after the Connecticut law was enacted, according to New Haven ob.gyn. Howard Shaw, vice chair for the Connecticut section of ACOG.

Although the law has probably raised some awareness of the breast density issues for women, it has also sparked a reflexive ordering of supplemental testing for any women with dense breasts, he said, adding that the ordering is largely driven by liability concerns.

“There is a feeling by many that we're just going to order it because, if we don't order it and something happens, we're going to have a problem,” said Dr. Steven Fleischman, associate chief of ob.gyn. at Yale–New Haven Hospital and the legislative chair of ACOG District I.

Another problem with the Connecticut law is that there's a lack of data on how it's working, he said. Because there was no tracking component built into the law, there are many lingering questions about the number of supplemental tests, the additional costs, and whether more cancers are being detected earlier, he said.

“It's not just about cost; it's about 'Are we getting more cases, and are we getting them earlier,'” Dr. Fleischman said.

The digital mammogram (left) was negative, while the molecular breast imaging scan detected a ductal carcinoma in situ in this dense breast.

Source Courtesy Mayo Clinic

Legislation introduced in the U.S. House of Representatives would require that women be informed of their breast density when they receive their mammogram results, and that those with denser breasts be advised that they could benefit from additional screening.

The Breast Density and Mammography Reporting Act of 2011 (H.R. 3102), introduced in October by Rep. Rosa DeLauro (D-Conn.) and Rep. Steve Israel (D-N.Y.), is modeled after laws enacted in Connecticut in 2009 and in Texas earlier this year. Similar legislation was recently passed by the California legislature, but was vetoed by the governor.

Bills on breast density are also slated to be introduced in at least six other states next year, according to the consumer advocacy group Are You Dense.

The movement to pass these bills has grown largely from the outrage of women who have received years of normal mammogram results only to find out that they have an advanced-stage breast cancer that went undetected because of their dense breast tissue.

That was the experience of Are You Dense founder Nancy M. Cappello, Ph.D., who successfully lobbied lawmakers to enact the Connecticut legislation.

Although information on breast density is available on the mammography report sent to referring physicians, it's not mentioned in the “lay letter” received by women, Dr. Cappello said. That leaves most women in the dark about the fact that dense breasts can make mammograms more difficult to read, and that women with extremely dense breasts are at a higher risk for breast cancer, she said.

“It's a hoax in some respects, a cruel hoax,” she said.

Are You Dense and its supporters around the country have been working state by state to enact laws that require that women be notified of their breast density and their options for additional screening. They are also working at the federal level to change either the law or the regulations surrounding mammography.

Dr. Cappello said that trying to legislate the change wasn't her first choice, but without a national cancer organization or physician group stepping up to educate women, she doesn't have a better option for standardizing the communication on breast density.

In November, Dr. Cappello took her case to the Food and Drug Administration's National Mammography Quality Assurance Advisory Committee. The asked the committee, which provides nonbinding advice to the FDA, to recommend changing the federally mandated lay letter to include information on breast density. While the advisory committee members reached a consensus that breast tissue density should be reported in the mammography lay letter, several of the members said they were unsure what recommendation could be made to physicians and patients about what to do with the information. The committee also did not come to an agreement on the best say to further evaluate patients with dense breasts through other imaging modalities.

But given the uncertain timeframe for any action by the FDA, Are You Dense plans to continue its efforts to enact breast density legislation in the states and at the federal level.

So far, Dr. Cappello's legislative efforts have failed to gain support from major physician groups and patient advocacy organizations. Susan G. Komen for the Cure and the American Cancer Society both stayed on the sidelines during the recent legislative debate in California. The California chapter of the American College of Obstetricians and Gynecologists and the California Medical Association opposed the bill.

“It was a very difficult bill for us to oppose,” said Dr. Philip Diamond, a San Diego ob.gyn. and chair of ACOG District IX in California.

The problem was that the bill went beyond notifying women about their density and on to suggest that they speak with their physician about supplemental screening. The bill's language on supplemental screening goes beyond the existing evidence, Dr. Diamond said, and raised a host of concerns about what the cost of screening would mean for state-funded health programs.

“In the absence of a guideline nationally by either the cancer society or the radiology society or anyone, it's impossible to be able to figure out who needs supplement screening and who doesn't,” he said.

A big concern in California, Dr. Diamond said, is that such legislation would lead to the automatic ordering of supplemental ultrasounds and MRIs, regardless of the individual risk factors of the women involved.

That's exactly what has happened after the Connecticut law was enacted, according to New Haven ob.gyn. Howard Shaw, vice chair for the Connecticut section of ACOG.

Although the law has probably raised some awareness of the breast density issues for women, it has also sparked a reflexive ordering of supplemental testing for any women with dense breasts, he said, adding that the ordering is largely driven by liability concerns.

“There is a feeling by many that we're just going to order it because, if we don't order it and something happens, we're going to have a problem,” said Dr. Steven Fleischman, associate chief of ob.gyn. at Yale–New Haven Hospital and the legislative chair of ACOG District I.

Another problem with the Connecticut law is that there's a lack of data on how it's working, he said. Because there was no tracking component built into the law, there are many lingering questions about the number of supplemental tests, the additional costs, and whether more cancers are being detected earlier, he said.

“It's not just about cost; it's about 'Are we getting more cases, and are we getting them earlier,'” Dr. Fleischman said.

The digital mammogram (left) was negative, while the molecular breast imaging scan detected a ductal carcinoma in situ in this dense breast.

Source Courtesy Mayo Clinic

Legislation introduced in the U.S. House of Representatives would require that women be informed of their breast density when they receive their mammogram results, and that those with denser breasts be advised that they could benefit from additional screening.

The Breast Density and Mammography Reporting Act of 2011 (H.R. 3102), introduced in October by Rep. Rosa DeLauro (D-Conn.) and Rep. Steve Israel (D-N.Y.), is modeled after laws enacted in Connecticut in 2009 and in Texas earlier this year. Similar legislation was recently passed by the California legislature, but was vetoed by the governor.

Bills on breast density are also slated to be introduced in at least six other states next year, according to the consumer advocacy group Are You Dense.

The movement to pass these bills has grown largely from the outrage of women who have received years of normal mammogram results only to find out that they have an advanced-stage breast cancer that went undetected because of their dense breast tissue.

That was the experience of Are You Dense founder Nancy M. Cappello, Ph.D., who successfully lobbied lawmakers to enact the Connecticut legislation.

Although information on breast density is available on the mammography report sent to referring physicians, it's not mentioned in the “lay letter” received by women, Dr. Cappello said. That leaves most women in the dark about the fact that dense breasts can make mammograms more difficult to read, and that women with extremely dense breasts are at a higher risk for breast cancer, she said.

“It's a hoax in some respects, a cruel hoax,” she said.

Are You Dense and its supporters around the country have been working state by state to enact laws that require that women be notified of their breast density and their options for additional screening. They are also working at the federal level to change either the law or the regulations surrounding mammography.

Dr. Cappello said that trying to legislate the change wasn't her first choice, but without a national cancer organization or physician group stepping up to educate women, she doesn't have a better option for standardizing the communication on breast density.

In November, Dr. Cappello took her case to the Food and Drug Administration's National Mammography Quality Assurance Advisory Committee. The asked the committee, which provides nonbinding advice to the FDA, to recommend changing the federally mandated lay letter to include information on breast density. While the advisory committee members reached a consensus that breast tissue density should be reported in the mammography lay letter, several of the members said they were unsure what recommendation could be made to physicians and patients about what to do with the information. The committee also did not come to an agreement on the best say to further evaluate patients with dense breasts through other imaging modalities.

But given the uncertain timeframe for any action by the FDA, Are You Dense plans to continue its efforts to enact breast density legislation in the states and at the federal level.

So far, Dr. Cappello's legislative efforts have failed to gain support from major physician groups and patient advocacy organizations. Susan G. Komen for the Cure and the American Cancer Society both stayed on the sidelines during the recent legislative debate in California. The California chapter of the American College of Obstetricians and Gynecologists and the California Medical Association opposed the bill.

“It was a very difficult bill for us to oppose,” said Dr. Philip Diamond, a San Diego ob.gyn. and chair of ACOG District IX in California.

The problem was that the bill went beyond notifying women about their density and on to suggest that they speak with their physician about supplemental screening. The bill's language on supplemental screening goes beyond the existing evidence, Dr. Diamond said, and raised a host of concerns about what the cost of screening would mean for state-funded health programs.

“In the absence of a guideline nationally by either the cancer society or the radiology society or anyone, it's impossible to be able to figure out who needs supplement screening and who doesn't,” he said.

A big concern in California, Dr. Diamond said, is that such legislation would lead to the automatic ordering of supplemental ultrasounds and MRIs, regardless of the individual risk factors of the women involved.

That's exactly what has happened after the Connecticut law was enacted, according to New Haven ob.gyn. Howard Shaw, vice chair for the Connecticut section of ACOG.

Although the law has probably raised some awareness of the breast density issues for women, it has also sparked a reflexive ordering of supplemental testing for any women with dense breasts, he said, adding that the ordering is largely driven by liability concerns.

“There is a feeling by many that we're just going to order it because, if we don't order it and something happens, we're going to have a problem,” said Dr. Steven Fleischman, associate chief of ob.gyn. at Yale–New Haven Hospital and the legislative chair of ACOG District I.

Another problem with the Connecticut law is that there's a lack of data on how it's working, he said. Because there was no tracking component built into the law, there are many lingering questions about the number of supplemental tests, the additional costs, and whether more cancers are being detected earlier, he said.

“It's not just about cost; it's about 'Are we getting more cases, and are we getting them earlier,'” Dr. Fleischman said.

The digital mammogram (left) was negative, while the molecular breast imaging scan detected a ductal carcinoma in situ in this dense breast.

Source Courtesy Mayo Clinic

Family history data support annual mammograms in 40s

Women aged 40–49 years with and without a family history of breast cancer had almost the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.

The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, NY. Dr. Destounis presented the results of her study in a press briefing.

A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.

Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the US Preventive Services Task Force. ...

* For a PDF of the full article, click in the link to the left of this introduction.

Family history data support annual mammograms in 40s

Women aged 40–49 years with and without a family history of breast cancer had almost the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.

The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, NY. Dr. Destounis presented the results of her study in a press briefing.

A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.

Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the US Preventive Services Task Force. ...

* For a PDF of the full article, click in the link to the left of this introduction.

Family history data support annual mammograms in 40s

Women aged 40–49 years with and without a family history of breast cancer had almost the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.

The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, NY. Dr. Destounis presented the results of her study in a press briefing.

A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.

Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the US Preventive Services Task Force. ...

* For a PDF of the full article, click in the link to the left of this introduction.

Bevacizumab improves survival in HER2-positive metastatic disease

Bevacizumab (Avastin) improved progression-free survival (PFS) when added to standard treatment in a study of more than 400 women with human epidermal growth factor receptor 2 (HER2)–positive locally recurrent or metastatic breast cancer.

That finding, which emerged from the AVEREL trial, adds another wrinkle in the ongoing controversy regarding use of bevacizumab in breast cancer treatment.

For the primary endpoint of investigator- assessed PFS, conducted at a median follow-up of 26 months, the addition of bevacizumab resulted in a hazard ratio (HR) of 0.82 (P = 0.0775), compared with treatment with trastuzumab (Herceptin) and docetaxel alone. This difference was not statistically significant. Median investigator-assessed PFS was 16.5 months with bevacizumab versus 13.7 months without it.

In an assessment by an independent review committee (IRC), however, a significant improvement in PFS was seen with the addition of bevacizumab (hazard ratio, 0.72; P = 0.0162). Median IRC-assessed PFS was 16.8 months with bevacizumab, compared with 13.9 months without the drug.

* For a PDF of the full article, click in the link to the left of this introduction.

Bevacizumab improves survival in HER2-positive metastatic disease

Bevacizumab (Avastin) improved progression-free survival (PFS) when added to standard treatment in a study of more than 400 women with human epidermal growth factor receptor 2 (HER2)–positive locally recurrent or metastatic breast cancer.

That finding, which emerged from the AVEREL trial, adds another wrinkle in the ongoing controversy regarding use of bevacizumab in breast cancer treatment.

For the primary endpoint of investigator- assessed PFS, conducted at a median follow-up of 26 months, the addition of bevacizumab resulted in a hazard ratio (HR) of 0.82 (P = 0.0775), compared with treatment with trastuzumab (Herceptin) and docetaxel alone. This difference was not statistically significant. Median investigator-assessed PFS was 16.5 months with bevacizumab versus 13.7 months without it.

In an assessment by an independent review committee (IRC), however, a significant improvement in PFS was seen with the addition of bevacizumab (hazard ratio, 0.72; P = 0.0162). Median IRC-assessed PFS was 16.8 months with bevacizumab, compared with 13.9 months without the drug.

* For a PDF of the full article, click in the link to the left of this introduction.

Bevacizumab improves survival in HER2-positive metastatic disease

Bevacizumab (Avastin) improved progression-free survival (PFS) when added to standard treatment in a study of more than 400 women with human epidermal growth factor receptor 2 (HER2)–positive locally recurrent or metastatic breast cancer.

That finding, which emerged from the AVEREL trial, adds another wrinkle in the ongoing controversy regarding use of bevacizumab in breast cancer treatment.

For the primary endpoint of investigator- assessed PFS, conducted at a median follow-up of 26 months, the addition of bevacizumab resulted in a hazard ratio (HR) of 0.82 (P = 0.0775), compared with treatment with trastuzumab (Herceptin) and docetaxel alone. This difference was not statistically significant. Median investigator-assessed PFS was 16.5 months with bevacizumab versus 13.7 months without it.

In an assessment by an independent review committee (IRC), however, a significant improvement in PFS was seen with the addition of bevacizumab (hazard ratio, 0.72; P = 0.0162). Median IRC-assessed PFS was 16.8 months with bevacizumab, compared with 13.9 months without the drug.

* For a PDF of the full article, click in the link to the left of this introduction.

Whole-breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly improved disease-free survival, but not overall survival, in a randomized, multicenter phase III trial of women with node-positive or high-risk node-negative disease who were treated with breast-conserving surgery and adjuvant therapy. An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months (between March 2000 and March 2007), WBI plus RNI significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (hazard ratio [HR], 0.58; P = 0.02) and distant recurrence from 13.0% to 7.6% (HR, 0.64; P = 0.002), according to the lead investigator, Dr. Timothy Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ontario, Canada.

As a result, disease-free survival rate improved from 84.0% for WBI to 89.7% for WBI plus RNI (HR, 0.67; P = 0.003). Overall survival in the intergroup trial was 90.7% with WBI, compared with 92.3% with the combined radiation regimen, but the difference did not reach statistical significance (HR, 0.76; P = 0.07). In view of the positive findings from the National Cancer Institute of Canada Clinical Trials Group MA.20 study, the data safety monitoring committee recommended that the results be released. The data were presented by Dr. Whelan at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO).¹

Report prepared by Matt Stenger, MS

* For a PDF of the complete article, click on the link to the left of this introduction.

Whole-breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly improved disease-free survival, but not overall survival, in a randomized, multicenter phase III trial of women with node-positive or high-risk node-negative disease who were treated with breast-conserving surgery and adjuvant therapy. An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months (between March 2000 and March 2007), WBI plus RNI significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (hazard ratio [HR], 0.58; P = 0.02) and distant recurrence from 13.0% to 7.6% (HR, 0.64; P = 0.002), according to the lead investigator, Dr. Timothy Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ontario, Canada.

As a result, disease-free survival rate improved from 84.0% for WBI to 89.7% for WBI plus RNI (HR, 0.67; P = 0.003). Overall survival in the intergroup trial was 90.7% with WBI, compared with 92.3% with the combined radiation regimen, but the difference did not reach statistical significance (HR, 0.76; P = 0.07). In view of the positive findings from the National Cancer Institute of Canada Clinical Trials Group MA.20 study, the data safety monitoring committee recommended that the results be released. The data were presented by Dr. Whelan at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO).¹

Report prepared by Matt Stenger, MS

* For a PDF of the complete article, click on the link to the left of this introduction.

Whole-breast irradiation (WBI) plus regional nodal irradiation (RNI) significantly improved disease-free survival, but not overall survival, in a randomized, multicenter phase III trial of women with node-positive or high-risk node-negative disease who were treated with breast-conserving surgery and adjuvant therapy. An interim analysis of 1,832 women with breast cancer found that after a median follow-up of 62 months (between March 2000 and March 2007), WBI plus RNI significantly reduced the risk of locoregional recurrence from 5.5% to 3.2% (hazard ratio [HR], 0.58; P = 0.02) and distant recurrence from 13.0% to 7.6% (HR, 0.64; P = 0.002), according to the lead investigator, Dr. Timothy Whelan, head of radiation oncology at McMaster University and the Juravinski Cancer Centre, Hamilton, Ontario, Canada.

As a result, disease-free survival rate improved from 84.0% for WBI to 89.7% for WBI plus RNI (HR, 0.67; P = 0.003). Overall survival in the intergroup trial was 90.7% with WBI, compared with 92.3% with the combined radiation regimen, but the difference did not reach statistical significance (HR, 0.76; P = 0.07). In view of the positive findings from the National Cancer Institute of Canada Clinical Trials Group MA.20 study, the data safety monitoring committee recommended that the results be released. The data were presented by Dr. Whelan at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO).¹

Report prepared by Matt Stenger, MS

* For a PDF of the complete article, click on the link to the left of this introduction.

Dr. David Henry is your audio tour guide to the November 2011 issue of Community Oncology. Issue highlights include Community Translations, which addresses the role of everolimus in treating hormone-resistant ER-positive breast cancer; a review of guidelines for screening cancer patients for distress by Amy E. Lowery and Jimmie C. Holland; and original research on the impact of bone metastases and skeletal-related events on healthcare costs in prostate cancer patients on hormonal therapy by May Hagiwara, et.al. Also, reports from recent oncology meetings and regulatory news from Congress and the FDA.

Dr. David Henry is your audio tour guide to the November 2011 issue of Community Oncology. Issue highlights include Community Translations, which addresses the role of everolimus in treating hormone-resistant ER-positive breast cancer; a review of guidelines for screening cancer patients for distress by Amy E. Lowery and Jimmie C. Holland; and original research on the impact of bone metastases and skeletal-related events on healthcare costs in prostate cancer patients on hormonal therapy by May Hagiwara, et.al. Also, reports from recent oncology meetings and regulatory news from Congress and the FDA.

Dr. David Henry is your audio tour guide to the November 2011 issue of Community Oncology. Issue highlights include Community Translations, which addresses the role of everolimus in treating hormone-resistant ER-positive breast cancer; a review of guidelines for screening cancer patients for distress by Amy E. Lowery and Jimmie C. Holland; and original research on the impact of bone metastases and skeletal-related events on healthcare costs in prostate cancer patients on hormonal therapy by May Hagiwara, et.al. Also, reports from recent oncology meetings and regulatory news from Congress and the FDA.

CHICAGO – Women aged 40-49 years with and without a family history of breast cancer had virtually the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.

The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, N.Y. Dr. Destounis presented the results of her study in a press briefing at the annual meeting of the Radiological Society of North America.

A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.

Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the United States Preventive Services Task Force.

"These conflicting recommendations have led to confusion among patients and physicians," Dr. Destounis said.

In the present study, Dr. Destounis and her colleagues analyzed data on women between the ages of 40 and 49 years who underwent screening mammography at the center between 2000 and 2010.

In all, 1,116 cancers were found in 1,071 patients aged 40-49 years. Of these patients, 373 were diagnosed by screening mammography. Of these 373 women, 144 (39%) had a family history of breast cancer, 228 (61%) did not, and 1 patient did not know her family history. (A total of 7 patients with and 16 patients without a family history of breast cancer also had a personal history of breast cancer.)

Among women with a family history, 32% (46) had a first-degree relative with a premenopausal history, 38% (54) had a first-degree relative with a postmenopausal history, and 31% (44) had a second- or third-degree relative with a pre- or postmenopausal history of the disease.

The incidence of invasive breast cancer was virtually the same – 63% (91) and 64% (146), respectively – in women with and without a family history. The incidence of noninvasive disease in the two groups was also similar, at 37% and 36%, respectively. Those with and without a family history shared similar rates of lymph node metastatic disease (31% and 29%) as well.

"Family history does not seem to [affect] the rate of invasive disease in our patient cohort," Dr. Destounis said.

The following types of lesions were found in women with and without a family history, respectively: mass (42, 86), microcalcification (69, 97), mass with calcification (21, 18), architectural distortion (11, 18), and asymmetry (1, 9).

All 144 patients with a family history and 227 of 228 patients in the no family history group proceeded to surgery. One patient had metastatic disease and opted for no surgery or treatment.

Among women with and without a family history, 63% and 68%, respectively, underwent a lumpectomy. Some of these patients did not have clear margins after surgery and went on to mastectomy. In all, 38% (54) of women with a family history and 31% (71) women without a family history went on to mastectomy.

Since no difference in the rate of invasive breast cancer between women with and without a family history was found in this population, "the recommendation should be that women in their 40s have a screening mammogram yearly," she said.

Dr. Destounis and her colleagues are currently collecting additional data on breast density, demographics, and survival rates for this patient group.

Dr. Destounis disclosed that she has been an investigator for Siemens AG, Fujifilm Holdings, Hologic Inc., and Koning Corp. She has also served as an advisory board member for Philips Electronics and Matakina International Ltd.

CHICAGO – Women aged 40-49 years with and without a family history of breast cancer had virtually the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.

The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, N.Y. Dr. Destounis presented the results of her study in a press briefing at the annual meeting of the Radiological Society of North America.

A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.

Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the United States Preventive Services Task Force.

"These conflicting recommendations have led to confusion among patients and physicians," Dr. Destounis said.

In the present study, Dr. Destounis and her colleagues analyzed data on women between the ages of 40 and 49 years who underwent screening mammography at the center between 2000 and 2010.

In all, 1,116 cancers were found in 1,071 patients aged 40-49 years. Of these patients, 373 were diagnosed by screening mammography. Of these 373 women, 144 (39%) had a family history of breast cancer, 228 (61%) did not, and 1 patient did not know her family history. (A total of 7 patients with and 16 patients without a family history of breast cancer also had a personal history of breast cancer.)

Among women with a family history, 32% (46) had a first-degree relative with a premenopausal history, 38% (54) had a first-degree relative with a postmenopausal history, and 31% (44) had a second- or third-degree relative with a pre- or postmenopausal history of the disease.

The incidence of invasive breast cancer was virtually the same – 63% (91) and 64% (146), respectively – in women with and without a family history. The incidence of noninvasive disease in the two groups was also similar, at 37% and 36%, respectively. Those with and without a family history shared similar rates of lymph node metastatic disease (31% and 29%) as well.

"Family history does not seem to [affect] the rate of invasive disease in our patient cohort," Dr. Destounis said.

The following types of lesions were found in women with and without a family history, respectively: mass (42, 86), microcalcification (69, 97), mass with calcification (21, 18), architectural distortion (11, 18), and asymmetry (1, 9).

All 144 patients with a family history and 227 of 228 patients in the no family history group proceeded to surgery. One patient had metastatic disease and opted for no surgery or treatment.

Among women with and without a family history, 63% and 68%, respectively, underwent a lumpectomy. Some of these patients did not have clear margins after surgery and went on to mastectomy. In all, 38% (54) of women with a family history and 31% (71) women without a family history went on to mastectomy.

Since no difference in the rate of invasive breast cancer between women with and without a family history was found in this population, "the recommendation should be that women in their 40s have a screening mammogram yearly," she said.

Dr. Destounis and her colleagues are currently collecting additional data on breast density, demographics, and survival rates for this patient group.

Dr. Destounis disclosed that she has been an investigator for Siemens AG, Fujifilm Holdings, Hologic Inc., and Koning Corp. She has also served as an advisory board member for Philips Electronics and Matakina International Ltd.

CHICAGO – Women aged 40-49 years with and without a family history of breast cancer had virtually the same rates of invasive disease in a retrospective analysis of data on more than 1,000 patients diagnosed over a 10-year period at a single site.

The finding adds weight to the American Cancer Society’s recommendation in favor of annual screening mammograms for women beginning at age 40, said principal author Dr. Stamatia V. Destounis of Elizabeth Wende Breast Care LLC in Rochester, N.Y. Dr. Destounis presented the results of her study in a press briefing at the annual meeting of the Radiological Society of North America.

A study presented at last year’s meeting by researchers at the London Breast Institute of the Princess Grace Hospital indicated that annual mammograms could reduce by half the risk of mastectomy in women who were diagnosed with breast cancer between the ages of 40 and 50 years.

Both studies challenge the recommendation against routine annual mammography for women under the age of 50 made in 2009 by the United States Preventive Services Task Force.

"These conflicting recommendations have led to confusion among patients and physicians," Dr. Destounis said.

In the present study, Dr. Destounis and her colleagues analyzed data on women between the ages of 40 and 49 years who underwent screening mammography at the center between 2000 and 2010.

In all, 1,116 cancers were found in 1,071 patients aged 40-49 years. Of these patients, 373 were diagnosed by screening mammography. Of these 373 women, 144 (39%) had a family history of breast cancer, 228 (61%) did not, and 1 patient did not know her family history. (A total of 7 patients with and 16 patients without a family history of breast cancer also had a personal history of breast cancer.)

Among women with a family history, 32% (46) had a first-degree relative with a premenopausal history, 38% (54) had a first-degree relative with a postmenopausal history, and 31% (44) had a second- or third-degree relative with a pre- or postmenopausal history of the disease.

The incidence of invasive breast cancer was virtually the same – 63% (91) and 64% (146), respectively – in women with and without a family history. The incidence of noninvasive disease in the two groups was also similar, at 37% and 36%, respectively. Those with and without a family history shared similar rates of lymph node metastatic disease (31% and 29%) as well.

"Family history does not seem to [affect] the rate of invasive disease in our patient cohort," Dr. Destounis said.

The following types of lesions were found in women with and without a family history, respectively: mass (42, 86), microcalcification (69, 97), mass with calcification (21, 18), architectural distortion (11, 18), and asymmetry (1, 9).

All 144 patients with a family history and 227 of 228 patients in the no family history group proceeded to surgery. One patient had metastatic disease and opted for no surgery or treatment.

Among women with and without a family history, 63% and 68%, respectively, underwent a lumpectomy. Some of these patients did not have clear margins after surgery and went on to mastectomy. In all, 38% (54) of women with a family history and 31% (71) women without a family history went on to mastectomy.

Since no difference in the rate of invasive breast cancer between women with and without a family history was found in this population, "the recommendation should be that women in their 40s have a screening mammogram yearly," she said.

Dr. Destounis and her colleagues are currently collecting additional data on breast density, demographics, and survival rates for this patient group.

Dr. Destounis disclosed that she has been an investigator for Siemens AG, Fujifilm Holdings, Hologic Inc., and Koning Corp. She has also served as an advisory board member for Philips Electronics and Matakina International Ltd.