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Effectiveness and safety of ipilimumab therapy in advanced melanoma: evidence from clinical practice sites in the US

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Effectiveness and safety of ipilimumab therapy in advanced melanoma: evidence from clinical practice sites in the US
Background Ipilimumab was approved in 2011 by the US Food and Drug Administration in 2011 for the treatment of unresectable or metastatic (advanced) melanoma, although pivotal data using the approved 3 mg/kg monotherapy q3w × 4 were available only for patients with previously treated disease.

 

Objective To investigate patient and disease characteristics, survival outcomes, and safety in treatment-naïve patients receiving ipilimumab therapy.

 

Methods Adult patients with treatment-naïve advanced melanoma who received ≥1 dose of ipilimumab 3 mg/kg during April 2011-Sept 2012, with ≥12 months having elapsed since the start of treatment, were identified from 34 US sites. Personnel from each study site retrospectively abstracted existing data from individual patient medical records, which were collected and validated by an independent research organization.

 

Results In all, 273 patients were included in the study. The median age of the total study population was 64 years (range, 26-91), and 64.8% were men. At diagnosis, 56.0% were stage IV M1c, and 12.1% had brain metastases. 50 patients had a BRAF mutation, 181 were BRAF wild-type, and BRAF status was not known for 42. 78% of patients received all 4 planned doses of ipilimumab. Median survival from initiation of ipilimumab treatment was 14.5 months (95% confidence index [CI], 12.9-18.7). The overall one-year survival rate was 59.2% (95% CI, 53.0-64.8); and 71.0% and 54.9% for patients with BRAF-mutated and wild-type tumors, respectively. Adverse events of any grade, grade 3, and grade 4 occurred in 164 patients (60.1%), 45 (16.5%), and 8 (2.9%), respectively. The most common grade 3 or 4 adverse events were colitis (4.0%), fatigue (2.9%), and diarrhea (1.5%). Drug-related adverse events were primarily immune-related and occurred in 147 patients (53.8%), including grade 3/4 in 15.7% of patients (13.9% and 1.8%, respectively). No deaths were attributed to ipilimumab.

 

Conclusions This observational study provides real-world, clinical practice evidence supporting improved survival with the approved ipilimumab 3 mg/kg monotherapy in patients with treatment-naïve advanced melanoma, including prolonged survival in some patients. The safety profile was consistent with that reported in clinical trials.

 

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Issue
The Journal of Community and Supportive Oncology - 13(4)
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Page Number
131-138
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ipilimumab, melanoma, BRAF mutation, BRAF wild-type
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Background Ipilimumab was approved in 2011 by the US Food and Drug Administration in 2011 for the treatment of unresectable or metastatic (advanced) melanoma, although pivotal data using the approved 3 mg/kg monotherapy q3w × 4 were available only for patients with previously treated disease.

 

Objective To investigate patient and disease characteristics, survival outcomes, and safety in treatment-naïve patients receiving ipilimumab therapy.

 

Methods Adult patients with treatment-naïve advanced melanoma who received ≥1 dose of ipilimumab 3 mg/kg during April 2011-Sept 2012, with ≥12 months having elapsed since the start of treatment, were identified from 34 US sites. Personnel from each study site retrospectively abstracted existing data from individual patient medical records, which were collected and validated by an independent research organization.

 

Results In all, 273 patients were included in the study. The median age of the total study population was 64 years (range, 26-91), and 64.8% were men. At diagnosis, 56.0% were stage IV M1c, and 12.1% had brain metastases. 50 patients had a BRAF mutation, 181 were BRAF wild-type, and BRAF status was not known for 42. 78% of patients received all 4 planned doses of ipilimumab. Median survival from initiation of ipilimumab treatment was 14.5 months (95% confidence index [CI], 12.9-18.7). The overall one-year survival rate was 59.2% (95% CI, 53.0-64.8); and 71.0% and 54.9% for patients with BRAF-mutated and wild-type tumors, respectively. Adverse events of any grade, grade 3, and grade 4 occurred in 164 patients (60.1%), 45 (16.5%), and 8 (2.9%), respectively. The most common grade 3 or 4 adverse events were colitis (4.0%), fatigue (2.9%), and diarrhea (1.5%). Drug-related adverse events were primarily immune-related and occurred in 147 patients (53.8%), including grade 3/4 in 15.7% of patients (13.9% and 1.8%, respectively). No deaths were attributed to ipilimumab.

 

Conclusions This observational study provides real-world, clinical practice evidence supporting improved survival with the approved ipilimumab 3 mg/kg monotherapy in patients with treatment-naïve advanced melanoma, including prolonged survival in some patients. The safety profile was consistent with that reported in clinical trials.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background Ipilimumab was approved in 2011 by the US Food and Drug Administration in 2011 for the treatment of unresectable or metastatic (advanced) melanoma, although pivotal data using the approved 3 mg/kg monotherapy q3w × 4 were available only for patients with previously treated disease.

 

Objective To investigate patient and disease characteristics, survival outcomes, and safety in treatment-naïve patients receiving ipilimumab therapy.

 

Methods Adult patients with treatment-naïve advanced melanoma who received ≥1 dose of ipilimumab 3 mg/kg during April 2011-Sept 2012, with ≥12 months having elapsed since the start of treatment, were identified from 34 US sites. Personnel from each study site retrospectively abstracted existing data from individual patient medical records, which were collected and validated by an independent research organization.

 

Results In all, 273 patients were included in the study. The median age of the total study population was 64 years (range, 26-91), and 64.8% were men. At diagnosis, 56.0% were stage IV M1c, and 12.1% had brain metastases. 50 patients had a BRAF mutation, 181 were BRAF wild-type, and BRAF status was not known for 42. 78% of patients received all 4 planned doses of ipilimumab. Median survival from initiation of ipilimumab treatment was 14.5 months (95% confidence index [CI], 12.9-18.7). The overall one-year survival rate was 59.2% (95% CI, 53.0-64.8); and 71.0% and 54.9% for patients with BRAF-mutated and wild-type tumors, respectively. Adverse events of any grade, grade 3, and grade 4 occurred in 164 patients (60.1%), 45 (16.5%), and 8 (2.9%), respectively. The most common grade 3 or 4 adverse events were colitis (4.0%), fatigue (2.9%), and diarrhea (1.5%). Drug-related adverse events were primarily immune-related and occurred in 147 patients (53.8%), including grade 3/4 in 15.7% of patients (13.9% and 1.8%, respectively). No deaths were attributed to ipilimumab.

 

Conclusions This observational study provides real-world, clinical practice evidence supporting improved survival with the approved ipilimumab 3 mg/kg monotherapy in patients with treatment-naïve advanced melanoma, including prolonged survival in some patients. The safety profile was consistent with that reported in clinical trials.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 13(4)
Issue
The Journal of Community and Supportive Oncology - 13(4)
Page Number
131-138
Page Number
131-138
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Effectiveness and safety of ipilimumab therapy in advanced melanoma: evidence from clinical practice sites in the US
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Effectiveness and safety of ipilimumab therapy in advanced melanoma: evidence from clinical practice sites in the US
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ipilimumab, melanoma, BRAF mutation, BRAF wild-type
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ipilimumab, melanoma, BRAF mutation, BRAF wild-type
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The need for decision and communication aids: a survey of breast cancer survivors

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The need for decision and communication aids: a survey of breast cancer survivors
Background Qualitative studies have identified barriers to communication and informed decision making among breast cancer survivors making treatment decisions. The prevalence of these barriers is unknown.

 

Objective To quantify the need for decision support among breast cancer survivors.

 

Methods We surveyed 2,521 breast cancer survivors participating in an online registry hosted by the Cancer Support Community to find out what proportion of breast cancer patients: made decisions during their first visit with a specialist; received satisfactory information before that visit; asked questions and received responses; and endorsed expanded use of decision support.

 

Results We received 1,017 (41%) responses and analyzed 917 surveys from women who lived in the United States. Most of the respondents recalled making treatment decisions during their first visit (52%). A minority (14%) received information before the first specialist visit. At least 25% of respondents rated their satisfaction below 7 on a scale of 10 for decision-making, information, and questions asked and answered. Respondents endorsed the need for assistance with obtaining information, listing questions, taking notes, and making audio-recordings of visits.

 

Limitations The respondent sample skewed younger and had higher-stage cancer compared with all breast cancer survivors. Responses were subject to recall bias.

 

Conclusions Cancer survivors expressed gaps in their care with respect to reviewing information, asking questions, obtaining answers, and making decisions. Implementing decision and communication aids immediately upon diagnosis, when treatment decisions are being made, would address these gaps. 

 

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The Journal of Community and Supportive Oncology - 13(3)
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Page Number
104-112
Legacy Keywords
breast cancer, communication aid, decision aid,

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Background Qualitative studies have identified barriers to communication and informed decision making among breast cancer survivors making treatment decisions. The prevalence of these barriers is unknown.

 

Objective To quantify the need for decision support among breast cancer survivors.

 

Methods We surveyed 2,521 breast cancer survivors participating in an online registry hosted by the Cancer Support Community to find out what proportion of breast cancer patients: made decisions during their first visit with a specialist; received satisfactory information before that visit; asked questions and received responses; and endorsed expanded use of decision support.

 

Results We received 1,017 (41%) responses and analyzed 917 surveys from women who lived in the United States. Most of the respondents recalled making treatment decisions during their first visit (52%). A minority (14%) received information before the first specialist visit. At least 25% of respondents rated their satisfaction below 7 on a scale of 10 for decision-making, information, and questions asked and answered. Respondents endorsed the need for assistance with obtaining information, listing questions, taking notes, and making audio-recordings of visits.

 

Limitations The respondent sample skewed younger and had higher-stage cancer compared with all breast cancer survivors. Responses were subject to recall bias.

 

Conclusions Cancer survivors expressed gaps in their care with respect to reviewing information, asking questions, obtaining answers, and making decisions. Implementing decision and communication aids immediately upon diagnosis, when treatment decisions are being made, would address these gaps. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background Qualitative studies have identified barriers to communication and informed decision making among breast cancer survivors making treatment decisions. The prevalence of these barriers is unknown.

 

Objective To quantify the need for decision support among breast cancer survivors.

 

Methods We surveyed 2,521 breast cancer survivors participating in an online registry hosted by the Cancer Support Community to find out what proportion of breast cancer patients: made decisions during their first visit with a specialist; received satisfactory information before that visit; asked questions and received responses; and endorsed expanded use of decision support.

 

Results We received 1,017 (41%) responses and analyzed 917 surveys from women who lived in the United States. Most of the respondents recalled making treatment decisions during their first visit (52%). A minority (14%) received information before the first specialist visit. At least 25% of respondents rated their satisfaction below 7 on a scale of 10 for decision-making, information, and questions asked and answered. Respondents endorsed the need for assistance with obtaining information, listing questions, taking notes, and making audio-recordings of visits.

 

Limitations The respondent sample skewed younger and had higher-stage cancer compared with all breast cancer survivors. Responses were subject to recall bias.

 

Conclusions Cancer survivors expressed gaps in their care with respect to reviewing information, asking questions, obtaining answers, and making decisions. Implementing decision and communication aids immediately upon diagnosis, when treatment decisions are being made, would address these gaps. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 13(3)
Issue
The Journal of Community and Supportive Oncology - 13(3)
Page Number
104-112
Page Number
104-112
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Publications
Topics
Article Type
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The need for decision and communication aids: a survey of breast cancer survivors
Display Headline
The need for decision and communication aids: a survey of breast cancer survivors
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breast cancer, communication aid, decision aid,

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breast cancer, communication aid, decision aid,

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Cost of palliative external beam radiotherapy (EBRT) use for bone metastases secondary to prostate cancer

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Cost of palliative external beam radiotherapy (EBRT) use for bone metastases secondary to prostate cancer

Background Evaluations of the costs of palliative external beam radiation therapy (EBRT) for treatment of bone metastases are limited.

Objective To summarize EBRT lifetime care patterns in deceased men with metastatic prostate cancer treated in a cancer hospital in the United States.

Methods A retrospective review of electronic health records identified deceased adult prostate cancer (ICD-9 185.xx) patients with bone metastases (ICD-9 198.5) and who were treated for bone pain and metastasis management with EBRT between January 1, 1995 and December 17, 2012. Common Procedural Terminology codes were used to identify all EBRT episodes (total billed EBRT services; initial and final evaluation) to calculate length of EBRT treatments and per episode costs (2011 US$). Bootstrapping approximated the 95% confidence interval for final cost estimates.

Results 176 men were identified; 19 (10.8%) had bone metastases in >1 site. Eighty-nine men (50.6%) received >1 EBRT episode (range, 1-6; median, 2), with first episode length ranging from 1-44 calendar days (mean, 13.4; SD, 8.4) at a mean cost of $7,084 (SD, $4,028). About 70% of costs were attributable to hospital charges and 30% to physician charges.

Limitations Small sample size limits broad applicability to large populations of men with prostate cancer.

Conclusion Care costs for EBRT constitute one of many costs that should be taken into account when planning for palliative care of prostate cancer and bone metastasis.

Funding Grant from Amgen and support was provided by the Huntsman Cancer Institute for all datasets within the Utah Population Database.

 

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The Journal of Community and Supportive Oncology - 13(3)
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Page Number
95-103
Legacy Keywords
palliative external beam radiotherapy, EBRT, bone metastases, prostate cancer
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Background Evaluations of the costs of palliative external beam radiation therapy (EBRT) for treatment of bone metastases are limited.

Objective To summarize EBRT lifetime care patterns in deceased men with metastatic prostate cancer treated in a cancer hospital in the United States.

Methods A retrospective review of electronic health records identified deceased adult prostate cancer (ICD-9 185.xx) patients with bone metastases (ICD-9 198.5) and who were treated for bone pain and metastasis management with EBRT between January 1, 1995 and December 17, 2012. Common Procedural Terminology codes were used to identify all EBRT episodes (total billed EBRT services; initial and final evaluation) to calculate length of EBRT treatments and per episode costs (2011 US$). Bootstrapping approximated the 95% confidence interval for final cost estimates.

Results 176 men were identified; 19 (10.8%) had bone metastases in >1 site. Eighty-nine men (50.6%) received >1 EBRT episode (range, 1-6; median, 2), with first episode length ranging from 1-44 calendar days (mean, 13.4; SD, 8.4) at a mean cost of $7,084 (SD, $4,028). About 70% of costs were attributable to hospital charges and 30% to physician charges.

Limitations Small sample size limits broad applicability to large populations of men with prostate cancer.

Conclusion Care costs for EBRT constitute one of many costs that should be taken into account when planning for palliative care of prostate cancer and bone metastasis.

Funding Grant from Amgen and support was provided by the Huntsman Cancer Institute for all datasets within the Utah Population Database.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background Evaluations of the costs of palliative external beam radiation therapy (EBRT) for treatment of bone metastases are limited.

Objective To summarize EBRT lifetime care patterns in deceased men with metastatic prostate cancer treated in a cancer hospital in the United States.

Methods A retrospective review of electronic health records identified deceased adult prostate cancer (ICD-9 185.xx) patients with bone metastases (ICD-9 198.5) and who were treated for bone pain and metastasis management with EBRT between January 1, 1995 and December 17, 2012. Common Procedural Terminology codes were used to identify all EBRT episodes (total billed EBRT services; initial and final evaluation) to calculate length of EBRT treatments and per episode costs (2011 US$). Bootstrapping approximated the 95% confidence interval for final cost estimates.

Results 176 men were identified; 19 (10.8%) had bone metastases in >1 site. Eighty-nine men (50.6%) received >1 EBRT episode (range, 1-6; median, 2), with first episode length ranging from 1-44 calendar days (mean, 13.4; SD, 8.4) at a mean cost of $7,084 (SD, $4,028). About 70% of costs were attributable to hospital charges and 30% to physician charges.

Limitations Small sample size limits broad applicability to large populations of men with prostate cancer.

Conclusion Care costs for EBRT constitute one of many costs that should be taken into account when planning for palliative care of prostate cancer and bone metastasis.

Funding Grant from Amgen and support was provided by the Huntsman Cancer Institute for all datasets within the Utah Population Database.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 13(3)
Issue
The Journal of Community and Supportive Oncology - 13(3)
Page Number
95-103
Page Number
95-103
Publications
Publications
Topics
Article Type
Display Headline
Cost of palliative external beam radiotherapy (EBRT) use for bone metastases secondary to prostate cancer
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Cost of palliative external beam radiotherapy (EBRT) use for bone metastases secondary to prostate cancer
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palliative external beam radiotherapy, EBRT, bone metastases, prostate cancer
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palliative external beam radiotherapy, EBRT, bone metastases, prostate cancer
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Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106

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Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106

Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.


Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.


Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.


Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.


Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.


Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.


Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company

 

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Issue
The Journal of Community and Supportive Oncology - 13(3)
Publications
Topics
Page Number
87-94
Legacy Keywords
ArginMax, sexual functioning, quality of life, cancer survivors, breast cancer, gynecologic cancer, Female Sexual Function Inventory, FSFI, Functional Assessment of Cancer Therapy - General, FACT-G
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Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.


Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.


Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.


Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.


Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.


Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.


Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company

 

Click on the PDF icon at the top of this introduction to read the full article.​

 

Background Problems with sexual functioning are common following therapy for breast and gynecologic cancers, although there are few effective treatments.


Objective To assess the impact of ArginMax, a nutritional supplement comprised of extracts of L-arginine, ginseng, gingko, and damiana, as well as multivitamins and minerals, on sexual functioning and quality of life in female cancer survivors.


Methods This was a 12-week, randomized, placebo-controlled trial of eligible patients who were 6 months or more from active treatment and reporting problems with sexual interest, satisfaction, and functioning after therapy. The participants took 3 capsules of ArginMax or placebo twice daily. Outcome measures were the Female Sexual Function Inventory (FSFI) and the Functional Assessment of Cancer Therapy - General (FACT-G). Assessments were done at baseline, 4, 8, and 12 weeks.


Results 186 patients with a median age of 50 years were accrued between May 10, 2007 and March 24, 2010. 76% of the patients were non-Hispanic white. Most had breast or a gynecologic cancer (78% and 12%, respectively). At 12 weeks, there were no differences between the ArginMax group (n = 96) and placebo (n = 92) group in sexual desire, arousal, lubrication, orgasm, satisfaction or pain. However, FACT-G total scores were significantly better for participants who took ArginMax compared with those who took placebo (least squares [LS] means, 87.5 vs 82.9, respectively; P = .009). The Fact-G subscales that were most affected were Physical (25.37 vs. 23.51, P = .001) and Functional Well-Being (22.46 vs. 20.72, P = .007). Toxicities were similar for both groups.


Limitations Study results are limited by a lack of data on the participants’ psychological and physical symptoms and sexual partner variables.


Conclusions ArginMax had no significant impact on sexual functioning, but patient quality of life was significantly better at 12 weeks in participants who received ArginMax.


Funding Sponsored by NCI 3 U10 CA081851-12 and The Daily Wellness Company

 

Click on the PDF icon at the top of this introduction to read the full article.​

 

Issue
The Journal of Community and Supportive Oncology - 13(3)
Issue
The Journal of Community and Supportive Oncology - 13(3)
Page Number
87-94
Page Number
87-94
Publications
Publications
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Article Type
Display Headline
Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106
Display Headline
Effect of ArginMax on sexual functioning and quality of life among female cancer survivors: results of the WFU CCOP Research Base Protocol 97106
Legacy Keywords
ArginMax, sexual functioning, quality of life, cancer survivors, breast cancer, gynecologic cancer, Female Sexual Function Inventory, FSFI, Functional Assessment of Cancer Therapy - General, FACT-G
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ArginMax, sexual functioning, quality of life, cancer survivors, breast cancer, gynecologic cancer, Female Sexual Function Inventory, FSFI, Functional Assessment of Cancer Therapy - General, FACT-G
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Assessing the impact of a targeted electronic medical record intervention on the use of growth factor in cancer patients

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Assessing the impact of a targeted electronic medical record intervention on the use of growth factor in cancer patients

Background Patients receiving chemotherapy are at risk for febrile neutropenia following treatment. The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) recommend screening patients for risk of febrile neutropenia and risk stratification based on likelihood of febrile neutropenia events. The impact of the implementation of an electronic medical record (EMR) system on physician compliance with growth factor support guidelines has not been studied.

Objective To investigate whether implementation of automated orders in EMRs can improve adherence to national guidelines in prophylactic G-CSF use in chemotherapy patients.

Methods A retrospective chart review of cancer patients receiving chemotherapy from January 1, 2007 to August 1, 2008 (pre-EMR) and January 1, 2011 to December 31, 2011 (post-EMR) was conducted. Institutional adherence to ASCO and NCCN guidelines for G-CSF after the implementation of automatic electronic orders for pegfilgrastim in patients who received a high-risk chemotherapy regimen were examined. The results were compared with a similar study that had been conducted before the implementation of the EMR system.

Results The number of regimens that included guideline-driven growth factor usage and nonusage was 75.6% in the post-intervention arm, compared with 67.5% in the pre-intervention arm. This is a statistically significant difference between the pre-EMR and post-EMR compliance with national guidelines on growth factor usage (P = .041, based on chi-square test). The post-EMR implementation data of 1,042 individual new chemotherapy regimens showed correct use of G-CSF in 89.13% high-risk chemotherapy regimens and 58.74% intermediate-risk regimens, with risk factors and incorrect usage in 26.23% of intermediate-risk regimens without risk factors and 19.34% of low-risk regimens. The appropriateness of use in high- and low-risk regimens was the most compliant, because growth factor was built into chemotherapy plans of high-risk regimens and omitted from low-risk regimens.

Limitations This project was limited by a change in EMR systems at West Virginia University hospitals on January 1, 2009. All pre-EMR data was collected before 2009 and could not be further collected once the project began in 2013.

Conclusions Appropriateness of growth factor usage can be improved when integrated into an EMR. This can improve compliance and adherence to national recommendations. Further development and understanding of EMR is needed to improve usage to meet national guidelines, with particular attention paid to integration of risk factors into EMR to improve growth factor usage compliance.

Funding NIH Research Funding Development Grant, WVU office of research and graduate education

 

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The Journal of Community and Supportive Oncology - 13(3)
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Page Number
113-116
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febrile neutropenia, FN, granulocyte colony-stimulating factors, G-CSF, electronic medical record, EMR, growth factor
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Background Patients receiving chemotherapy are at risk for febrile neutropenia following treatment. The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) recommend screening patients for risk of febrile neutropenia and risk stratification based on likelihood of febrile neutropenia events. The impact of the implementation of an electronic medical record (EMR) system on physician compliance with growth factor support guidelines has not been studied.

Objective To investigate whether implementation of automated orders in EMRs can improve adherence to national guidelines in prophylactic G-CSF use in chemotherapy patients.

Methods A retrospective chart review of cancer patients receiving chemotherapy from January 1, 2007 to August 1, 2008 (pre-EMR) and January 1, 2011 to December 31, 2011 (post-EMR) was conducted. Institutional adherence to ASCO and NCCN guidelines for G-CSF after the implementation of automatic electronic orders for pegfilgrastim in patients who received a high-risk chemotherapy regimen were examined. The results were compared with a similar study that had been conducted before the implementation of the EMR system.

Results The number of regimens that included guideline-driven growth factor usage and nonusage was 75.6% in the post-intervention arm, compared with 67.5% in the pre-intervention arm. This is a statistically significant difference between the pre-EMR and post-EMR compliance with national guidelines on growth factor usage (P = .041, based on chi-square test). The post-EMR implementation data of 1,042 individual new chemotherapy regimens showed correct use of G-CSF in 89.13% high-risk chemotherapy regimens and 58.74% intermediate-risk regimens, with risk factors and incorrect usage in 26.23% of intermediate-risk regimens without risk factors and 19.34% of low-risk regimens. The appropriateness of use in high- and low-risk regimens was the most compliant, because growth factor was built into chemotherapy plans of high-risk regimens and omitted from low-risk regimens.

Limitations This project was limited by a change in EMR systems at West Virginia University hospitals on January 1, 2009. All pre-EMR data was collected before 2009 and could not be further collected once the project began in 2013.

Conclusions Appropriateness of growth factor usage can be improved when integrated into an EMR. This can improve compliance and adherence to national recommendations. Further development and understanding of EMR is needed to improve usage to meet national guidelines, with particular attention paid to integration of risk factors into EMR to improve growth factor usage compliance.

Funding NIH Research Funding Development Grant, WVU office of research and graduate education

 

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Background Patients receiving chemotherapy are at risk for febrile neutropenia following treatment. The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) recommend screening patients for risk of febrile neutropenia and risk stratification based on likelihood of febrile neutropenia events. The impact of the implementation of an electronic medical record (EMR) system on physician compliance with growth factor support guidelines has not been studied.

Objective To investigate whether implementation of automated orders in EMRs can improve adherence to national guidelines in prophylactic G-CSF use in chemotherapy patients.

Methods A retrospective chart review of cancer patients receiving chemotherapy from January 1, 2007 to August 1, 2008 (pre-EMR) and January 1, 2011 to December 31, 2011 (post-EMR) was conducted. Institutional adherence to ASCO and NCCN guidelines for G-CSF after the implementation of automatic electronic orders for pegfilgrastim in patients who received a high-risk chemotherapy regimen were examined. The results were compared with a similar study that had been conducted before the implementation of the EMR system.

Results The number of regimens that included guideline-driven growth factor usage and nonusage was 75.6% in the post-intervention arm, compared with 67.5% in the pre-intervention arm. This is a statistically significant difference between the pre-EMR and post-EMR compliance with national guidelines on growth factor usage (P = .041, based on chi-square test). The post-EMR implementation data of 1,042 individual new chemotherapy regimens showed correct use of G-CSF in 89.13% high-risk chemotherapy regimens and 58.74% intermediate-risk regimens, with risk factors and incorrect usage in 26.23% of intermediate-risk regimens without risk factors and 19.34% of low-risk regimens. The appropriateness of use in high- and low-risk regimens was the most compliant, because growth factor was built into chemotherapy plans of high-risk regimens and omitted from low-risk regimens.

Limitations This project was limited by a change in EMR systems at West Virginia University hospitals on January 1, 2009. All pre-EMR data was collected before 2009 and could not be further collected once the project began in 2013.

Conclusions Appropriateness of growth factor usage can be improved when integrated into an EMR. This can improve compliance and adherence to national recommendations. Further development and understanding of EMR is needed to improve usage to meet national guidelines, with particular attention paid to integration of risk factors into EMR to improve growth factor usage compliance.

Funding NIH Research Funding Development Grant, WVU office of research and graduate education

 

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The Journal of Community and Supportive Oncology - 13(3)
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The Journal of Community and Supportive Oncology - 13(3)
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113-116
Page Number
113-116
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Assessing the impact of a targeted electronic medical record intervention on the use of growth factor in cancer patients
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Assessing the impact of a targeted electronic medical record intervention on the use of growth factor in cancer patients
Legacy Keywords
febrile neutropenia, FN, granulocyte colony-stimulating factors, G-CSF, electronic medical record, EMR, growth factor
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febrile neutropenia, FN, granulocyte colony-stimulating factors, G-CSF, electronic medical record, EMR, growth factor
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Perceptions about participation in cancer clinical trials in New York state

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Background Clinical trials are valuable in advancing cancer care through the investigation of ways in which to better prevent, detect and diagnose, and/or treat cancer. Recruitment of adults into clinical trials has historically been low.

Objective To survey adult cancer patients who reside in New York state to better understand their participation in and attitudes about clinical trials.

Methods From January 2012-April 2013, we conducted a one-time survey about clinical trials in 8 cancer-treatment or cancer-patient support organizations in the state. Surveys were offered in person and online to adults with a past or current cancer diagnosis. Analysis was limited to adults who resided in the state and provided a self-reported status of previous participation in clinical trials.

Results Of the 1,832 participants who completed the survey, 1,475 were included in the analysis. Our sample represented all regions of the state. Most of the respondents (68.1%) had never participated in a clinical trial. Almost 32% said they had never received information about research studies. Most (84%) felt that patients should be asked to participate in clinical trials, but fewer (70%) were willing to be approached about participation.

Limitations The sample is predominantly white and female and overrepresents breast and hematologic cancers.

Conclusions Increased outreach coupled with a team approach to educate and enroll patients in clinical trials may be the necessary first steps to increase participation in trials and ensure a diverse sample of participants.

 

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The Journal of Community and Supportive Oncology - 13(2)
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Page Number
62-72
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cancer clinical trials, participation in trials
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Background Clinical trials are valuable in advancing cancer care through the investigation of ways in which to better prevent, detect and diagnose, and/or treat cancer. Recruitment of adults into clinical trials has historically been low.

Objective To survey adult cancer patients who reside in New York state to better understand their participation in and attitudes about clinical trials.

Methods From January 2012-April 2013, we conducted a one-time survey about clinical trials in 8 cancer-treatment or cancer-patient support organizations in the state. Surveys were offered in person and online to adults with a past or current cancer diagnosis. Analysis was limited to adults who resided in the state and provided a self-reported status of previous participation in clinical trials.

Results Of the 1,832 participants who completed the survey, 1,475 were included in the analysis. Our sample represented all regions of the state. Most of the respondents (68.1%) had never participated in a clinical trial. Almost 32% said they had never received information about research studies. Most (84%) felt that patients should be asked to participate in clinical trials, but fewer (70%) were willing to be approached about participation.

Limitations The sample is predominantly white and female and overrepresents breast and hematologic cancers.

Conclusions Increased outreach coupled with a team approach to educate and enroll patients in clinical trials may be the necessary first steps to increase participation in trials and ensure a diverse sample of participants.

 

Click on the PDF icon at the top of this introduction to read the full article.

Background Clinical trials are valuable in advancing cancer care through the investigation of ways in which to better prevent, detect and diagnose, and/or treat cancer. Recruitment of adults into clinical trials has historically been low.

Objective To survey adult cancer patients who reside in New York state to better understand their participation in and attitudes about clinical trials.

Methods From January 2012-April 2013, we conducted a one-time survey about clinical trials in 8 cancer-treatment or cancer-patient support organizations in the state. Surveys were offered in person and online to adults with a past or current cancer diagnosis. Analysis was limited to adults who resided in the state and provided a self-reported status of previous participation in clinical trials.

Results Of the 1,832 participants who completed the survey, 1,475 were included in the analysis. Our sample represented all regions of the state. Most of the respondents (68.1%) had never participated in a clinical trial. Almost 32% said they had never received information about research studies. Most (84%) felt that patients should be asked to participate in clinical trials, but fewer (70%) were willing to be approached about participation.

Limitations The sample is predominantly white and female and overrepresents breast and hematologic cancers.

Conclusions Increased outreach coupled with a team approach to educate and enroll patients in clinical trials may be the necessary first steps to increase participation in trials and ensure a diverse sample of participants.

 

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Issue
The Journal of Community and Supportive Oncology - 13(2)
Issue
The Journal of Community and Supportive Oncology - 13(2)
Page Number
62-72
Page Number
62-72
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cancer clinical trials, participation in trials
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cancer clinical trials, participation in trials
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Women with self-reported lower-limb lymphedema after treatment for gynecological cancers: are they more likely to self-report psychosocial symptoms and less likely to use services?

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Women with self-reported lower-limb lymphedema after treatment for gynecological cancers: are they more likely to self-report psychosocial symptoms and less likely to use services?

Background Survivorship for gynecological cancers has increased because of improved screening and treatment. Use of supportive care services after treatment is important to improve patient quality of life.

Objective To assess self-reported lower-limb lymphedema (LLL), depression, anxiety, quality of life, unmet supportive care needs, and service use among gynecological cancer survivors.

Methods In 2010, a population-based, cross-sectional mail survey was conducted among 160 gynecological cancer survivors 5-30 months after their diagnoses (response rate, 53%).

Results Overall, 30% of women self-reported symptoms of LLL, 21% and 24% self-reported symptoms of depression or anxiety, respectively. Women with LLL were more likely to also report symptoms of depression or anxiety, and had higher unmet supportive care needs. Services needed but not used by 10%-15% of women with LLL, anxiety, or depression were those of a lymphedema specialist, pain specialist, and physiotherapist for LLL, and a psychiatrist, psychologist, and pain specialist for anxiety and depression.

Limitations Small sample size, self-reported data, limited generalization to other countries, underrepresentation of older women (age >70 years) and women from non-Caucasian backgrounds.

Conclusions Women with LLL or high distress were less likely to use services they needed.

Funding Cancer Australia

 

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The Journal of Community and Supportive Oncology - 13(2)
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55-61
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lower-limb lymphedema, gynecological cancers, psychosocial symptoms, self-report, supportive care, quality of life
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Background Survivorship for gynecological cancers has increased because of improved screening and treatment. Use of supportive care services after treatment is important to improve patient quality of life.

Objective To assess self-reported lower-limb lymphedema (LLL), depression, anxiety, quality of life, unmet supportive care needs, and service use among gynecological cancer survivors.

Methods In 2010, a population-based, cross-sectional mail survey was conducted among 160 gynecological cancer survivors 5-30 months after their diagnoses (response rate, 53%).

Results Overall, 30% of women self-reported symptoms of LLL, 21% and 24% self-reported symptoms of depression or anxiety, respectively. Women with LLL were more likely to also report symptoms of depression or anxiety, and had higher unmet supportive care needs. Services needed but not used by 10%-15% of women with LLL, anxiety, or depression were those of a lymphedema specialist, pain specialist, and physiotherapist for LLL, and a psychiatrist, psychologist, and pain specialist for anxiety and depression.

Limitations Small sample size, self-reported data, limited generalization to other countries, underrepresentation of older women (age >70 years) and women from non-Caucasian backgrounds.

Conclusions Women with LLL or high distress were less likely to use services they needed.

Funding Cancer Australia

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Background Survivorship for gynecological cancers has increased because of improved screening and treatment. Use of supportive care services after treatment is important to improve patient quality of life.

Objective To assess self-reported lower-limb lymphedema (LLL), depression, anxiety, quality of life, unmet supportive care needs, and service use among gynecological cancer survivors.

Methods In 2010, a population-based, cross-sectional mail survey was conducted among 160 gynecological cancer survivors 5-30 months after their diagnoses (response rate, 53%).

Results Overall, 30% of women self-reported symptoms of LLL, 21% and 24% self-reported symptoms of depression or anxiety, respectively. Women with LLL were more likely to also report symptoms of depression or anxiety, and had higher unmet supportive care needs. Services needed but not used by 10%-15% of women with LLL, anxiety, or depression were those of a lymphedema specialist, pain specialist, and physiotherapist for LLL, and a psychiatrist, psychologist, and pain specialist for anxiety and depression.

Limitations Small sample size, self-reported data, limited generalization to other countries, underrepresentation of older women (age >70 years) and women from non-Caucasian backgrounds.

Conclusions Women with LLL or high distress were less likely to use services they needed.

Funding Cancer Australia

 

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Issue
The Journal of Community and Supportive Oncology - 13(2)
Issue
The Journal of Community and Supportive Oncology - 13(2)
Page Number
55-61
Page Number
55-61
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Women with self-reported lower-limb lymphedema after treatment for gynecological cancers: are they more likely to self-report psychosocial symptoms and less likely to use services?
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Women with self-reported lower-limb lymphedema after treatment for gynecological cancers: are they more likely to self-report psychosocial symptoms and less likely to use services?
Legacy Keywords
lower-limb lymphedema, gynecological cancers, psychosocial symptoms, self-report, supportive care, quality of life
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Joint breast and colorectal cancer screenings in medically underserved women

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Background Breast and colon cancer screening in rural community clinics is underused.

Objective To evaluate the effectiveness and cost-effectiveness of alternative interventions designed to promote simultaneous screening for breast and colon cancer in community clinics.

Methods A 3-arm, quasi-experimental evaluation was conducted during May 2008-August 2011 in 8 federally qualified health clinics in predominately rural Louisiana. Baseline screening rates reported by the clinics was <10% for breast cancer (using mammography) and 1%- 2% for colon cancer (using the fecal occult blood test [FOBT]). 744 women aged 50 years or older who were eligible for routine mammography and an FOBT were recruited. The combined screening efforts included: enhanced care; health literacy-informed education (education alone), or health literacy-informed education with nurse support (nurse support).

Results Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with nurse support. After adjusting for age, race, and literacy, patients who received nurse support were 2.21 times more likely to complete both screenings than were those who received the education alone (95% confidence interval [CI], 1.12-4.38; P = .023). The incremental cost per additional woman completing both screenings was $3,987 for education with nurse support over education alone, and $5,987 over enhanced care.

Limitations There were differences between the 3 arms in sociodemographic characteristics, literacy, and previous screening history. Not all variables that were significantly different between arms were adjusted for, therefore adjustments for key variables (age, race, literacy) were made in statistical analyses. Other limitations related generalizability of results.

Conclusions Although joint breast and colon cancer screening rates were increased substantially over existing baseline rates in all 3 arms, the completion rate for both tests was modest. Nurse support and telephone follow-up were most effective. However, it is not likely to be cost effective or affordable in clinics with limited resources.

Funding National Cancer Institute (R01-CA115869-05), supported in part by 1 U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health. 

 

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The Journal of Community and Supportive Oncology - 13(2)
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47-54
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breast cancer screening, colorectal cancer screenings, medically underserved women, fecal occult blood test, FOBT, mammography, nurse support, telephone follow-up
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Background Breast and colon cancer screening in rural community clinics is underused.

Objective To evaluate the effectiveness and cost-effectiveness of alternative interventions designed to promote simultaneous screening for breast and colon cancer in community clinics.

Methods A 3-arm, quasi-experimental evaluation was conducted during May 2008-August 2011 in 8 federally qualified health clinics in predominately rural Louisiana. Baseline screening rates reported by the clinics was <10% for breast cancer (using mammography) and 1%- 2% for colon cancer (using the fecal occult blood test [FOBT]). 744 women aged 50 years or older who were eligible for routine mammography and an FOBT were recruited. The combined screening efforts included: enhanced care; health literacy-informed education (education alone), or health literacy-informed education with nurse support (nurse support).

Results Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with nurse support. After adjusting for age, race, and literacy, patients who received nurse support were 2.21 times more likely to complete both screenings than were those who received the education alone (95% confidence interval [CI], 1.12-4.38; P = .023). The incremental cost per additional woman completing both screenings was $3,987 for education with nurse support over education alone, and $5,987 over enhanced care.

Limitations There were differences between the 3 arms in sociodemographic characteristics, literacy, and previous screening history. Not all variables that were significantly different between arms were adjusted for, therefore adjustments for key variables (age, race, literacy) were made in statistical analyses. Other limitations related generalizability of results.

Conclusions Although joint breast and colon cancer screening rates were increased substantially over existing baseline rates in all 3 arms, the completion rate for both tests was modest. Nurse support and telephone follow-up were most effective. However, it is not likely to be cost effective or affordable in clinics with limited resources.

Funding National Cancer Institute (R01-CA115869-05), supported in part by 1 U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health. 

 

Click on the PDF icon at the top of this introduction to read the full article.

Background Breast and colon cancer screening in rural community clinics is underused.

Objective To evaluate the effectiveness and cost-effectiveness of alternative interventions designed to promote simultaneous screening for breast and colon cancer in community clinics.

Methods A 3-arm, quasi-experimental evaluation was conducted during May 2008-August 2011 in 8 federally qualified health clinics in predominately rural Louisiana. Baseline screening rates reported by the clinics was <10% for breast cancer (using mammography) and 1%- 2% for colon cancer (using the fecal occult blood test [FOBT]). 744 women aged 50 years or older who were eligible for routine mammography and an FOBT were recruited. The combined screening efforts included: enhanced care; health literacy-informed education (education alone), or health literacy-informed education with nurse support (nurse support).

Results Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with nurse support. After adjusting for age, race, and literacy, patients who received nurse support were 2.21 times more likely to complete both screenings than were those who received the education alone (95% confidence interval [CI], 1.12-4.38; P = .023). The incremental cost per additional woman completing both screenings was $3,987 for education with nurse support over education alone, and $5,987 over enhanced care.

Limitations There were differences between the 3 arms in sociodemographic characteristics, literacy, and previous screening history. Not all variables that were significantly different between arms were adjusted for, therefore adjustments for key variables (age, race, literacy) were made in statistical analyses. Other limitations related generalizability of results.

Conclusions Although joint breast and colon cancer screening rates were increased substantially over existing baseline rates in all 3 arms, the completion rate for both tests was modest. Nurse support and telephone follow-up were most effective. However, it is not likely to be cost effective or affordable in clinics with limited resources.

Funding National Cancer Institute (R01-CA115869-05), supported in part by 1 U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health. 

 

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The Journal of Community and Supportive Oncology - 13(2)
Issue
The Journal of Community and Supportive Oncology - 13(2)
Page Number
47-54
Page Number
47-54
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breast cancer screening, colorectal cancer screenings, medically underserved women, fecal occult blood test, FOBT, mammography, nurse support, telephone follow-up
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Sustained antiemetic responses with APF530 (sustained-release granisetron) during multiple cycles of emetogenic chemotherapy

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Sustained antiemetic responses with APF530 (sustained-release granisetron) during multiple cycles of emetogenic chemotherapy
Background A phase 3 trial in patients with cancer who received chemotherapy has shown that subcutaneous (SC) APF530, a sustained-delivery formulation of granisetron, is noninferior to palonosetron in preventing acute (0-24 hours) and delayed (>24-120 hours) chemotherapy-induced nausea and vomiting (CINV).
 
Objective To investigate the sustainability of APF530 antiemetic responses during multiple chemotherapy cycles.
 
Methods 1,395 patients receiving moderately or highly emetogenic chemotherapy (MEC and HEC, respectively) were randomized either to APF530 250 or 500 mg SC (containing granisetron 5 or 10 mg, respectively) or palonosetron 0.25 mg intravenously before cycle 1 of chemotherapy. Patients who received palonosetron in cycle 1 were rerandomized in cycles 2-4 to APF530 250 or 500 mg; those who received APF530 in cycle 1 continued their APF530 dose. Between-group response rates were compared using the Fisher exact test.
 
Results Complete response (CR; no emesis, no rescue medication) for APF530 500 mg with HEC increased from 81.3% to 87.8% over 4 cycles in the acute phase of CINV, and from 67.1% to 83.1% in the delayed phase. Rates were slightly lower with MEC. Within-cycle CR rates between APF530 doses showed no significant differences. With HEC, APF530 500 mg provided sustained CRs through 4 cycles of chemotherapy in 68.4% of patients in the acute phase and in 57.9% in the delayed phase; with MEC, corresponding CRs were 56.5% and 41.3%. Nausea prevention was nearly as effective as emesis prevention.
 
Limitations Chemotherapy emetogenicity was classified according to Hesketh criteria during the time of this study. However, subsequent post hoc analyses indicate that reclassification according to newer ASCO emetogenicity guidelines did not alter the original study noninferiority conclusions.
 
Conclusion CR rates with APF530 during the acute and delayed phases of CINV in MEC and HEC were maintained over multiple cycles.
 
Funding/sponsors Heron Therapeutics Inc

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The Journal of Community and Supportive Oncology - 13(2)
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38-46
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chemotherapy-induced nausea and vomiting, CINV, APF530, sustained-release granisetron, emetogenic chemotherapy, antiemetic responses
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Background A phase 3 trial in patients with cancer who received chemotherapy has shown that subcutaneous (SC) APF530, a sustained-delivery formulation of granisetron, is noninferior to palonosetron in preventing acute (0-24 hours) and delayed (>24-120 hours) chemotherapy-induced nausea and vomiting (CINV).
 
Objective To investigate the sustainability of APF530 antiemetic responses during multiple chemotherapy cycles.
 
Methods 1,395 patients receiving moderately or highly emetogenic chemotherapy (MEC and HEC, respectively) were randomized either to APF530 250 or 500 mg SC (containing granisetron 5 or 10 mg, respectively) or palonosetron 0.25 mg intravenously before cycle 1 of chemotherapy. Patients who received palonosetron in cycle 1 were rerandomized in cycles 2-4 to APF530 250 or 500 mg; those who received APF530 in cycle 1 continued their APF530 dose. Between-group response rates were compared using the Fisher exact test.
 
Results Complete response (CR; no emesis, no rescue medication) for APF530 500 mg with HEC increased from 81.3% to 87.8% over 4 cycles in the acute phase of CINV, and from 67.1% to 83.1% in the delayed phase. Rates were slightly lower with MEC. Within-cycle CR rates between APF530 doses showed no significant differences. With HEC, APF530 500 mg provided sustained CRs through 4 cycles of chemotherapy in 68.4% of patients in the acute phase and in 57.9% in the delayed phase; with MEC, corresponding CRs were 56.5% and 41.3%. Nausea prevention was nearly as effective as emesis prevention.
 
Limitations Chemotherapy emetogenicity was classified according to Hesketh criteria during the time of this study. However, subsequent post hoc analyses indicate that reclassification according to newer ASCO emetogenicity guidelines did not alter the original study noninferiority conclusions.
 
Conclusion CR rates with APF530 during the acute and delayed phases of CINV in MEC and HEC were maintained over multiple cycles.
 
Funding/sponsors Heron Therapeutics Inc

Click on the PDF icon at the top of this introduction to read the full article.
 

 

Background A phase 3 trial in patients with cancer who received chemotherapy has shown that subcutaneous (SC) APF530, a sustained-delivery formulation of granisetron, is noninferior to palonosetron in preventing acute (0-24 hours) and delayed (>24-120 hours) chemotherapy-induced nausea and vomiting (CINV).
 
Objective To investigate the sustainability of APF530 antiemetic responses during multiple chemotherapy cycles.
 
Methods 1,395 patients receiving moderately or highly emetogenic chemotherapy (MEC and HEC, respectively) were randomized either to APF530 250 or 500 mg SC (containing granisetron 5 or 10 mg, respectively) or palonosetron 0.25 mg intravenously before cycle 1 of chemotherapy. Patients who received palonosetron in cycle 1 were rerandomized in cycles 2-4 to APF530 250 or 500 mg; those who received APF530 in cycle 1 continued their APF530 dose. Between-group response rates were compared using the Fisher exact test.
 
Results Complete response (CR; no emesis, no rescue medication) for APF530 500 mg with HEC increased from 81.3% to 87.8% over 4 cycles in the acute phase of CINV, and from 67.1% to 83.1% in the delayed phase. Rates were slightly lower with MEC. Within-cycle CR rates between APF530 doses showed no significant differences. With HEC, APF530 500 mg provided sustained CRs through 4 cycles of chemotherapy in 68.4% of patients in the acute phase and in 57.9% in the delayed phase; with MEC, corresponding CRs were 56.5% and 41.3%. Nausea prevention was nearly as effective as emesis prevention.
 
Limitations Chemotherapy emetogenicity was classified according to Hesketh criteria during the time of this study. However, subsequent post hoc analyses indicate that reclassification according to newer ASCO emetogenicity guidelines did not alter the original study noninferiority conclusions.
 
Conclusion CR rates with APF530 during the acute and delayed phases of CINV in MEC and HEC were maintained over multiple cycles.
 
Funding/sponsors Heron Therapeutics Inc

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The Journal of Community and Supportive Oncology - 13(2)
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The Journal of Community and Supportive Oncology - 13(2)
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38-46
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Sustained antiemetic responses with APF530 (sustained-release granisetron) during multiple cycles of emetogenic chemotherapy
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Sustained antiemetic responses with APF530 (sustained-release granisetron) during multiple cycles of emetogenic chemotherapy
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chemotherapy-induced nausea and vomiting, CINV, APF530, sustained-release granisetron, emetogenic chemotherapy, antiemetic responses
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Radiation exposure from diagnostic procedures in patients with newly diagnosed breast cancer

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Radiation exposure from diagnostic procedures in patients with newly diagnosed breast cancer

Radiation exposure is associated with an increased risk of secondary cancers. Knowing the approximate radiation exposure from diagnostic procedures in the first year after a breast cancer diagnosis could help educate patients and allow physicians to monitor them more closely for potential risks.

 

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The Journal of Community and Supportive Oncology - 13(1)
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27-29
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breast cancer, radiation exposure, secondary cancer, diagnostic procedures
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Radiation exposure is associated with an increased risk of secondary cancers. Knowing the approximate radiation exposure from diagnostic procedures in the first year after a breast cancer diagnosis could help educate patients and allow physicians to monitor them more closely for potential risks.

 

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Radiation exposure is associated with an increased risk of secondary cancers. Knowing the approximate radiation exposure from diagnostic procedures in the first year after a breast cancer diagnosis could help educate patients and allow physicians to monitor them more closely for potential risks.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

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The Journal of Community and Supportive Oncology - 13(1)
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The Journal of Community and Supportive Oncology - 13(1)
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27-29
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27-29
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Radiation exposure from diagnostic procedures in patients with newly diagnosed breast cancer
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Radiation exposure from diagnostic procedures in patients with newly diagnosed breast cancer
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breast cancer, radiation exposure, secondary cancer, diagnostic procedures
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