Original Report

Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.

Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.

Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.

Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.

Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.

Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.

*Click on the link to the left for a PDF of the full article.

Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.

Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.

Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.

Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.

Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.

Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.

*Click on the link to the left for a PDF of the full article.

Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.

Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.

Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.

Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.

Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.

Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.

*Click on the link to the left for a PDF of the full article.

Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al

Background Coenzyme Q₁₀ (CoQ₁₀) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ₁₀ in female breast cancer patients with the primary objective of determining CoQ₁₀ ’s effects on self-reported fatigue, depression, and quality of life (QOL).

Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ₁₀ or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ₁₀ and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ₁₀ levels in the CoQ₁₀ and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ₁₀ levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ₁₀ and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).

Conclusions Supplementation with conventional doses of CoQ₁₀ led to sustained increases in plasma CoQ₁₀ levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

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

Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al

Background Coenzyme Q₁₀ (CoQ₁₀) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ₁₀ in female breast cancer patients with the primary objective of determining CoQ₁₀ ’s effects on self-reported fatigue, depression, and quality of life (QOL).

Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ₁₀ or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ₁₀ and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ₁₀ levels in the CoQ₁₀ and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ₁₀ levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ₁₀ and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).

Conclusions Supplementation with conventional doses of CoQ₁₀ led to sustained increases in plasma CoQ₁₀ levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

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

Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al

Background Coenzyme Q₁₀ (CoQ₁₀) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ₁₀ in female breast cancer patients with the primary objective of determining CoQ₁₀ ’s effects on self-reported fatigue, depression, and quality of life (QOL).

Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ₁₀ or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ₁₀ and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ₁₀ levels in the CoQ₁₀ and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ₁₀ levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ₁₀ and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).

Conclusions Supplementation with conventional doses of CoQ₁₀ led to sustained increases in plasma CoQ₁₀ levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

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

Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioningand health-related quality of life (HRQoL) has not been well-studied.

Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper  extremity function, activities, and HRQoL.

Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparingsentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and armvolume were measured objectively.  PROs included symptoms; arm function; limitations in social, recreational, occupational,and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariablelinear regression models.

Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM.

Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months).

Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL.

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

Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioningand health-related quality of life (HRQoL) has not been well-studied.

Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper  extremity function, activities, and HRQoL.

Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparingsentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and armvolume were measured objectively.  PROs included symptoms; arm function; limitations in social, recreational, occupational,and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariablelinear regression models.

Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM.

Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months).

Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL.

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

Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioningand health-related quality of life (HRQoL) has not been well-studied.

Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper  extremity function, activities, and HRQoL.

Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparingsentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and armvolume were measured objectively.  PROs included symptoms; arm function; limitations in social, recreational, occupational,and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariablelinear regression models.

Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM.

Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months).

Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL.

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

George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD

Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.

Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.

Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.

Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.

Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.

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

George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD

Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.

Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.

Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.

Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.

Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.

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

George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD

Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.

Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.

Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.

Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.

Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.

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

Kevin P. High, MD, MS; Doug Case, PhD;  MD, David Hurd, MD; Bayard Powell, MD; Glenn Lesser, MD; Ann R. Falsey, MD; Robert Siegel, MD; Joanna Metzner-Sadurski, MD; John C. Krauss, MD; Bernard Chinnasami, MD, George Sanders, MD, Steven Rousey, MD, Edward G. Shaw, MD

*For a PDF of the full article and accompanying commentary by Paul Sloan, click on the links to the left of this introduction.

Kevin P. High, MD, MS; Doug Case, PhD;  MD, David Hurd, MD; Bayard Powell, MD; Glenn Lesser, MD; Ann R. Falsey, MD; Robert Siegel, MD; Joanna Metzner-Sadurski, MD; John C. Krauss, MD; Bernard Chinnasami, MD, George Sanders, MD, Steven Rousey, MD, Edward G. Shaw, MD

*For a PDF of the full article and accompanying commentary by Paul Sloan, click on the links to the left of this introduction.

Kevin P. High, MD, MS; Doug Case, PhD;  MD, David Hurd, MD; Bayard Powell, MD; Glenn Lesser, MD; Ann R. Falsey, MD; Robert Siegel, MD; Joanna Metzner-Sadurski, MD; John C. Krauss, MD; Bernard Chinnasami, MD, George Sanders, MD, Steven Rousey, MD, Edward G. Shaw, MD

*For a PDF of the full article and accompanying commentary by Paul Sloan, click on the links to the left of this introduction.

Background Hypersensitivity reactions to chemotherapy agents occur with relatively high frequency with some of the most widely used chemotherapeutic drug classes. Desensitization using a standard 12-step protocol has been successful, but takes about 6.5 hours. Limited studies have shown that a faster protocol may also be safe.

Objective To determine when desensitization could be safely speeded up.

Methods Patients with documented HSRs (24 patients) were desensitized initially with the standard 12-step protocol for 1 or 2 treatments, for a total of 180 desensitizations. Those patients who had negative skin testing and who tolerated the desensitizations were switched to the more rapid desensitization protocol (16 patients).

Results All 16 patients were successfully desensitized, having received the full dose of their chemotherapy. Eight patients were not advanced to the rapid protocol because they had reactions during initial desensitizations or they had a positive skin test; all of them were successfully desensitized using the 12-step protocol at the slower rate of infusion. These data present criteria for defining which patients may be safely transitioned to a rapid desensitization protocol.

Limitation Most of the patients in the study (21 of 24) were women.

Conclusions Patients with HSRs to chemotherapy agents, who tolerate an initial 12-step desensitization and have a negative skin test, can be advanced to a more rapid protocol. It is likely that patients with HSRs to the taxanes can be started on the more rapid protocol without starting on the 12-step protocol.

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

Background Hypersensitivity reactions to chemotherapy agents occur with relatively high frequency with some of the most widely used chemotherapeutic drug classes. Desensitization using a standard 12-step protocol has been successful, but takes about 6.5 hours. Limited studies have shown that a faster protocol may also be safe.

Objective To determine when desensitization could be safely speeded up.

Methods Patients with documented HSRs (24 patients) were desensitized initially with the standard 12-step protocol for 1 or 2 treatments, for a total of 180 desensitizations. Those patients who had negative skin testing and who tolerated the desensitizations were switched to the more rapid desensitization protocol (16 patients).

Results All 16 patients were successfully desensitized, having received the full dose of their chemotherapy. Eight patients were not advanced to the rapid protocol because they had reactions during initial desensitizations or they had a positive skin test; all of them were successfully desensitized using the 12-step protocol at the slower rate of infusion. These data present criteria for defining which patients may be safely transitioned to a rapid desensitization protocol.

Limitation Most of the patients in the study (21 of 24) were women.

Conclusions Patients with HSRs to chemotherapy agents, who tolerate an initial 12-step desensitization and have a negative skin test, can be advanced to a more rapid protocol. It is likely that patients with HSRs to the taxanes can be started on the more rapid protocol without starting on the 12-step protocol.

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

Background Hypersensitivity reactions to chemotherapy agents occur with relatively high frequency with some of the most widely used chemotherapeutic drug classes. Desensitization using a standard 12-step protocol has been successful, but takes about 6.5 hours. Limited studies have shown that a faster protocol may also be safe.

Objective To determine when desensitization could be safely speeded up.

Methods Patients with documented HSRs (24 patients) were desensitized initially with the standard 12-step protocol for 1 or 2 treatments, for a total of 180 desensitizations. Those patients who had negative skin testing and who tolerated the desensitizations were switched to the more rapid desensitization protocol (16 patients).

Results All 16 patients were successfully desensitized, having received the full dose of their chemotherapy. Eight patients were not advanced to the rapid protocol because they had reactions during initial desensitizations or they had a positive skin test; all of them were successfully desensitized using the 12-step protocol at the slower rate of infusion. These data present criteria for defining which patients may be safely transitioned to a rapid desensitization protocol.

Limitation Most of the patients in the study (21 of 24) were women.

Conclusions Patients with HSRs to chemotherapy agents, who tolerate an initial 12-step desensitization and have a negative skin test, can be advanced to a more rapid protocol. It is likely that patients with HSRs to the taxanes can be started on the more rapid protocol without starting on the 12-step protocol.

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

Background Decision support interventions help patients who are facing difficult treatment decisions and improve shared decision making. There is little evidence of the economic impact of these interventions.

Objective To determine the costs of providing a decision support intervention in the form of consultation planning (CP) and consultation planning with recording and summary (CPRS) to women with breast cancer and to compare the cost benefit of CP and CPRS by telephone versus in person.

Methods Sixty-eight women with breast cancer who were being treated at a rural cancer resource center were randomized to CP in person or by telephone. All participants were then provided with an audio-recording of the physician consultation along with a typed summary for the full intervention (CPRS). Surveys completed by the participants and center staff provided data for measuring costs and willingness-to-pay (WTP) benefits. Societal perspective costs and incremental net benefit (INB) across delivery methods was determined.

Results Total CP costs were $208.72 for telephone and $264.00 for in-person delivery. Significantly lower telephone-group costs (P ˂ .001) were a result of lower participant travel expenses. Participants were willing to pay $154.12 for telephone and $144.03 for in-person CP (P = .85). WTP did not exceed costs of either delivery method compared with no intervention. INB of providing CP for telephone versus in person was $65.37, favoring telephone delivery. Sensitivity analysis revealed that with more efficient CP training, WTP became greater than the costs of delivering CP by telephone versus no intervention.

Limitations There may be some income distribution effects in the measurement of WTP.

Conclusions Providing CP by telephone was significantly less costly with no significant difference in benefit. Participants’ WTP only exceeded the full cost of CP with more efficient training or higher participant volume. A positive INB showed telephone delivery is efficient and may increase accessibility to decision support services, particularly in rural communities.


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



 

Background Decision support interventions help patients who are facing difficult treatment decisions and improve shared decision making. There is little evidence of the economic impact of these interventions.

Objective To determine the costs of providing a decision support intervention in the form of consultation planning (CP) and consultation planning with recording and summary (CPRS) to women with breast cancer and to compare the cost benefit of CP and CPRS by telephone versus in person.

Methods Sixty-eight women with breast cancer who were being treated at a rural cancer resource center were randomized to CP in person or by telephone. All participants were then provided with an audio-recording of the physician consultation along with a typed summary for the full intervention (CPRS). Surveys completed by the participants and center staff provided data for measuring costs and willingness-to-pay (WTP) benefits. Societal perspective costs and incremental net benefit (INB) across delivery methods was determined.

Results Total CP costs were $208.72 for telephone and $264.00 for in-person delivery. Significantly lower telephone-group costs (P ˂ .001) were a result of lower participant travel expenses. Participants were willing to pay $154.12 for telephone and $144.03 for in-person CP (P = .85). WTP did not exceed costs of either delivery method compared with no intervention. INB of providing CP for telephone versus in person was $65.37, favoring telephone delivery. Sensitivity analysis revealed that with more efficient CP training, WTP became greater than the costs of delivering CP by telephone versus no intervention.

Limitations There may be some income distribution effects in the measurement of WTP.

Conclusions Providing CP by telephone was significantly less costly with no significant difference in benefit. Participants’ WTP only exceeded the full cost of CP with more efficient training or higher participant volume. A positive INB showed telephone delivery is efficient and may increase accessibility to decision support services, particularly in rural communities.


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



 

Background Decision support interventions help patients who are facing difficult treatment decisions and improve shared decision making. There is little evidence of the economic impact of these interventions.

Objective To determine the costs of providing a decision support intervention in the form of consultation planning (CP) and consultation planning with recording and summary (CPRS) to women with breast cancer and to compare the cost benefit of CP and CPRS by telephone versus in person.

Methods Sixty-eight women with breast cancer who were being treated at a rural cancer resource center were randomized to CP in person or by telephone. All participants were then provided with an audio-recording of the physician consultation along with a typed summary for the full intervention (CPRS). Surveys completed by the participants and center staff provided data for measuring costs and willingness-to-pay (WTP) benefits. Societal perspective costs and incremental net benefit (INB) across delivery methods was determined.

Results Total CP costs were $208.72 for telephone and $264.00 for in-person delivery. Significantly lower telephone-group costs (P ˂ .001) were a result of lower participant travel expenses. Participants were willing to pay $154.12 for telephone and $144.03 for in-person CP (P = .85). WTP did not exceed costs of either delivery method compared with no intervention. INB of providing CP for telephone versus in person was $65.37, favoring telephone delivery. Sensitivity analysis revealed that with more efficient CP training, WTP became greater than the costs of delivering CP by telephone versus no intervention.

Limitations There may be some income distribution effects in the measurement of WTP.

Conclusions Providing CP by telephone was significantly less costly with no significant difference in benefit. Participants’ WTP only exceeded the full cost of CP with more efficient training or higher participant volume. A positive INB showed telephone delivery is efficient and may increase accessibility to decision support services, particularly in rural communities.


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Background Age is among the most important risk factors for neutropenia-related hospitalization, but evidence is limited regarding the relative contributions of age and other risk factors.

Objective To explore the associations among patient age, other risk factors, and neutropenic complications in patients with cancer receiving myelosuppressive chemotherapy.

Methods This retrospective cohort study, which used a US commercial insurance claims database, included patients aged 40 years or older with non-Hodgkin lymphoma (NHL), breast cancer, or lung cancer who initiated chemotherapy between January 1, 2006 and March 31, 2010. The primary endpoint was the risk of neutropenia-related hospitalization during the first chemotherapy course. We used cubic spline modeling to estimate the association between neutropenia-related hospitalization and age, adjusting for patient and treatment characteristics. Logistic regression analyses examined the effects of other risk factors.

Results A total of 15,638 patients were included (NHL, n = 2,506; breast cancer, n = 9,110; lung cancer, n = 4,022), mean age 56-66 years. Neutropenia-related hospitalization occurred in 8.7% of NHL patients, 4.2% of breast cancer patients, and 3.9% of lung cancer patients. The association between age and the risk of neutropenia-related hospitalization was stronger in NHL than in lung or breast cancer. Patient comorbidities and chemotherapy characteristics had considerable effects on risk of neutropenia-related hospitalization.

Limitations Disease stage and other clinical factors could not be identified from the claims data.

Conclusion In addition to age, oncologists should evaluate individual patient risk factors including patient comorbidities and type of chemotherapy regimen.

*To read the full article, click on the PDF icon at the top of this introduction.

Background Age is among the most important risk factors for neutropenia-related hospitalization, but evidence is limited regarding the relative contributions of age and other risk factors.

Objective To explore the associations among patient age, other risk factors, and neutropenic complications in patients with cancer receiving myelosuppressive chemotherapy.

Methods This retrospective cohort study, which used a US commercial insurance claims database, included patients aged 40 years or older with non-Hodgkin lymphoma (NHL), breast cancer, or lung cancer who initiated chemotherapy between January 1, 2006 and March 31, 2010. The primary endpoint was the risk of neutropenia-related hospitalization during the first chemotherapy course. We used cubic spline modeling to estimate the association between neutropenia-related hospitalization and age, adjusting for patient and treatment characteristics. Logistic regression analyses examined the effects of other risk factors.

Results A total of 15,638 patients were included (NHL, n = 2,506; breast cancer, n = 9,110; lung cancer, n = 4,022), mean age 56-66 years. Neutropenia-related hospitalization occurred in 8.7% of NHL patients, 4.2% of breast cancer patients, and 3.9% of lung cancer patients. The association between age and the risk of neutropenia-related hospitalization was stronger in NHL than in lung or breast cancer. Patient comorbidities and chemotherapy characteristics had considerable effects on risk of neutropenia-related hospitalization.

Limitations Disease stage and other clinical factors could not be identified from the claims data.

Conclusion In addition to age, oncologists should evaluate individual patient risk factors including patient comorbidities and type of chemotherapy regimen.

*To read the full article, click on the PDF icon at the top of this introduction.

Background Age is among the most important risk factors for neutropenia-related hospitalization, but evidence is limited regarding the relative contributions of age and other risk factors.

Objective To explore the associations among patient age, other risk factors, and neutropenic complications in patients with cancer receiving myelosuppressive chemotherapy.

Methods This retrospective cohort study, which used a US commercial insurance claims database, included patients aged 40 years or older with non-Hodgkin lymphoma (NHL), breast cancer, or lung cancer who initiated chemotherapy between January 1, 2006 and March 31, 2010. The primary endpoint was the risk of neutropenia-related hospitalization during the first chemotherapy course. We used cubic spline modeling to estimate the association between neutropenia-related hospitalization and age, adjusting for patient and treatment characteristics. Logistic regression analyses examined the effects of other risk factors.

Results A total of 15,638 patients were included (NHL, n = 2,506; breast cancer, n = 9,110; lung cancer, n = 4,022), mean age 56-66 years. Neutropenia-related hospitalization occurred in 8.7% of NHL patients, 4.2% of breast cancer patients, and 3.9% of lung cancer patients. The association between age and the risk of neutropenia-related hospitalization was stronger in NHL than in lung or breast cancer. Patient comorbidities and chemotherapy characteristics had considerable effects on risk of neutropenia-related hospitalization.

Limitations Disease stage and other clinical factors could not be identified from the claims data.

Conclusion In addition to age, oncologists should evaluate individual patient risk factors including patient comorbidities and type of chemotherapy regimen.

*To read the full article, click on the PDF icon at the top of this introduction.

Background and objective Genetic test uptake and cancer risk management have been understudied in medically underserved populations. Study aims were to quantify rates of BRCA1/2 genetic testing and evidence-based cancer risk management (ie, prophylactic surgeries and surveillance practices) in women who were seen for breast and ovarian cancer genetic counseling in a public, safety net health system.

Methods We conducted a retrospective medical record abstraction of 195 women who presented for breast or ovarian genetic counseling within a 2-year period (2008-2009) at Parkland Health & Hospital System in Dallas, Texas.

Results The identified women represented a racially and ethnically diverse population: 48% Hispanic, 37% non-Hispanic black, 12% non-Hispanic white, and 3% Asian. Among the 158 women who were medically eligible for genetic testing, 134 (84.8%) received BRCA1/2 results, with most tests funded through a financial assistance program. In all, 29 women (22%) tested positive for BRCA1/2 mutations. Financial and funding barriers were identified for 20 of the untested women. Among the identified high-risk women (mutation carriers, selected variants, and noncarriers with pretest BRCAPRO scores 30 or more), 26% had prophylactic breast surgeries and 33% had prophylactic ovarian surgeries within the follow-up period averaging 35 months. Of those who opted for surveillance, 71% had at least 1 mammogram or MRI and 38% had CA-125 tests. Trends indicated lower rates of all risk management behaviors, except for mammogram or MRI, among non-Hispanic black women.

Conclusions Within this racially and ethnically diverse sample, BRCA1/2 test uptake was high, but financial barriers were identified for nontested women. The rates of breast cancer risk management were generally comparable with other studies, but risk management for ovarian cancer was limited, especially among non-Hispanic black women. The reasons for these apparen disparities should be further explored.

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

Background and objective Genetic test uptake and cancer risk management have been understudied in medically underserved populations. Study aims were to quantify rates of BRCA1/2 genetic testing and evidence-based cancer risk management (ie, prophylactic surgeries and surveillance practices) in women who were seen for breast and ovarian cancer genetic counseling in a public, safety net health system.

Methods We conducted a retrospective medical record abstraction of 195 women who presented for breast or ovarian genetic counseling within a 2-year period (2008-2009) at Parkland Health & Hospital System in Dallas, Texas.

Results The identified women represented a racially and ethnically diverse population: 48% Hispanic, 37% non-Hispanic black, 12% non-Hispanic white, and 3% Asian. Among the 158 women who were medically eligible for genetic testing, 134 (84.8%) received BRCA1/2 results, with most tests funded through a financial assistance program. In all, 29 women (22%) tested positive for BRCA1/2 mutations. Financial and funding barriers were identified for 20 of the untested women. Among the identified high-risk women (mutation carriers, selected variants, and noncarriers with pretest BRCAPRO scores 30 or more), 26% had prophylactic breast surgeries and 33% had prophylactic ovarian surgeries within the follow-up period averaging 35 months. Of those who opted for surveillance, 71% had at least 1 mammogram or MRI and 38% had CA-125 tests. Trends indicated lower rates of all risk management behaviors, except for mammogram or MRI, among non-Hispanic black women.

Conclusions Within this racially and ethnically diverse sample, BRCA1/2 test uptake was high, but financial barriers were identified for nontested women. The rates of breast cancer risk management were generally comparable with other studies, but risk management for ovarian cancer was limited, especially among non-Hispanic black women. The reasons for these apparen disparities should be further explored.

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

Background and objective Genetic test uptake and cancer risk management have been understudied in medically underserved populations. Study aims were to quantify rates of BRCA1/2 genetic testing and evidence-based cancer risk management (ie, prophylactic surgeries and surveillance practices) in women who were seen for breast and ovarian cancer genetic counseling in a public, safety net health system.

Methods We conducted a retrospective medical record abstraction of 195 women who presented for breast or ovarian genetic counseling within a 2-year period (2008-2009) at Parkland Health & Hospital System in Dallas, Texas.

Results The identified women represented a racially and ethnically diverse population: 48% Hispanic, 37% non-Hispanic black, 12% non-Hispanic white, and 3% Asian. Among the 158 women who were medically eligible for genetic testing, 134 (84.8%) received BRCA1/2 results, with most tests funded through a financial assistance program. In all, 29 women (22%) tested positive for BRCA1/2 mutations. Financial and funding barriers were identified for 20 of the untested women. Among the identified high-risk women (mutation carriers, selected variants, and noncarriers with pretest BRCAPRO scores 30 or more), 26% had prophylactic breast surgeries and 33% had prophylactic ovarian surgeries within the follow-up period averaging 35 months. Of those who opted for surveillance, 71% had at least 1 mammogram or MRI and 38% had CA-125 tests. Trends indicated lower rates of all risk management behaviors, except for mammogram or MRI, among non-Hispanic black women.

Conclusions Within this racially and ethnically diverse sample, BRCA1/2 test uptake was high, but financial barriers were identified for nontested women. The rates of breast cancer risk management were generally comparable with other studies, but risk management for ovarian cancer was limited, especially among non-Hispanic black women. The reasons for these apparen disparities should be further explored.

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

Highlights from the 2012 Annual Meeting of the American Society of Clinical Oncology 48th Annual Meeting

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

Highlights from the 2012 Annual Meeting of the American Society of Clinical Oncology 48th Annual Meeting

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

Highlights from the 2012 Annual Meeting of the American Society of Clinical Oncology 48th Annual Meeting

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