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Long-term community-based results of breast-conserving therapy in early-stage breast cancer
Background Multicenter clinical trials conducted primarily at academic centers have shown that breast-conserving therapy (BCT) and mastectomy lead to equivalent overall survival (OS) for women with early-stage breast cancer.
Objective To determine rates of BCT and OS after conservation therapy in a large urban community practice, compare them with national rates, and identify risk factors for survival.
Methods We identified 1,172 T1-2, N0 breast cancer patients diagnosed during 1997-2007 in our hospital tumor registry and compared the rates of BCT and adjuvant radiotherapy with a similar population in the SEER [Surveillance, Epidemiology, and End Results] database (N = 232,898) for the same treatment period. Cox proportional hazards models were used to assess the influence of age at diagnosis, tumor grade, biomarker status, margin status, and receipt of hormones, radiation, or chemotherapy on OS after BCT.
Results The rate of breast-conserving surgery (BCS) was higher in our practice compared with the national average (90.9% and 66.4%, respectively). The rate of adjuvant radiation after BCS in our practice was 93.7%; survival estimates were higher for patients treated with adjuvant radiation across all age groups, compared with the national estimates (92.5% and 72.9%). Younger age and receipt of radiation were associated with improved survival.
Limitations Retrospective study design; confounding factors such as comorbidities were not considered.
Conclusions We had high rates of BCT and adjuvant radiation in early-stage breast cancer patients in our community practice, which resulted in excellent survival rates that compared favorably with those in large academic centers and emphasizes the role of appropriate use of adjuvant radiation.
Funding Vantage Oncology
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Background Multicenter clinical trials conducted primarily at academic centers have shown that breast-conserving therapy (BCT) and mastectomy lead to equivalent overall survival (OS) for women with early-stage breast cancer.
Objective To determine rates of BCT and OS after conservation therapy in a large urban community practice, compare them with national rates, and identify risk factors for survival.
Methods We identified 1,172 T1-2, N0 breast cancer patients diagnosed during 1997-2007 in our hospital tumor registry and compared the rates of BCT and adjuvant radiotherapy with a similar population in the SEER [Surveillance, Epidemiology, and End Results] database (N = 232,898) for the same treatment period. Cox proportional hazards models were used to assess the influence of age at diagnosis, tumor grade, biomarker status, margin status, and receipt of hormones, radiation, or chemotherapy on OS after BCT.
Results The rate of breast-conserving surgery (BCS) was higher in our practice compared with the national average (90.9% and 66.4%, respectively). The rate of adjuvant radiation after BCS in our practice was 93.7%; survival estimates were higher for patients treated with adjuvant radiation across all age groups, compared with the national estimates (92.5% and 72.9%). Younger age and receipt of radiation were associated with improved survival.
Limitations Retrospective study design; confounding factors such as comorbidities were not considered.
Conclusions We had high rates of BCT and adjuvant radiation in early-stage breast cancer patients in our community practice, which resulted in excellent survival rates that compared favorably with those in large academic centers and emphasizes the role of appropriate use of adjuvant radiation.
Funding Vantage Oncology
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Background Multicenter clinical trials conducted primarily at academic centers have shown that breast-conserving therapy (BCT) and mastectomy lead to equivalent overall survival (OS) for women with early-stage breast cancer.
Objective To determine rates of BCT and OS after conservation therapy in a large urban community practice, compare them with national rates, and identify risk factors for survival.
Methods We identified 1,172 T1-2, N0 breast cancer patients diagnosed during 1997-2007 in our hospital tumor registry and compared the rates of BCT and adjuvant radiotherapy with a similar population in the SEER [Surveillance, Epidemiology, and End Results] database (N = 232,898) for the same treatment period. Cox proportional hazards models were used to assess the influence of age at diagnosis, tumor grade, biomarker status, margin status, and receipt of hormones, radiation, or chemotherapy on OS after BCT.
Results The rate of breast-conserving surgery (BCS) was higher in our practice compared with the national average (90.9% and 66.4%, respectively). The rate of adjuvant radiation after BCS in our practice was 93.7%; survival estimates were higher for patients treated with adjuvant radiation across all age groups, compared with the national estimates (92.5% and 72.9%). Younger age and receipt of radiation were associated with improved survival.
Limitations Retrospective study design; confounding factors such as comorbidities were not considered.
Conclusions We had high rates of BCT and adjuvant radiation in early-stage breast cancer patients in our community practice, which resulted in excellent survival rates that compared favorably with those in large academic centers and emphasizes the role of appropriate use of adjuvant radiation.
Funding Vantage Oncology
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Culture-broker and medical decoder: contributions of caregivers in American Indian cancer trajectories
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Prognostic significance of HPV status in postoperative squamous-cell carcinoma of the head and neck
Background There are limited data on the prognostic significance of human papillomavirus (HPV) status in relation to traditional risk factors for head and neck squamous-cell carcinoma (HNSCC) in the postoperative setting.
Objective To clarify the impact of HPV status on the risk for HNSCC in the postoperative setting.
Methods We retrospectively evaluated an institutional cohort of 128 patients with HNSCC patients who had been treated with definitive surgery with or without adjuvant radiotherapy or chemoradiotherapy. Patient, disease, and treatment factors were analyzed as potential prognostic indicators.
Results Lymph node extracapsular extension (ECE), perineural invasion (PNI), and lymphovascular space invasion (LVSI) positivity predicted poorer locoregional control (LRC), disease-free survival (DFS), and overall survival (OS). Positive margins related to poorer DFS and OS. HPV status alone did not predict LRC, DFS, or OS. Compared with patients who were HPV-positive and ECE-negative, both HPV-positive and HPV-negative patients with ECE experienced significantly poorer OS (78.6%, 60%, and 43.7%, respectively; P = .010 and P = .018, respectively).
Limitations Retrospective, single-institution study; small patient cohort; short follow-up time
Conclusion The influence of HPV in postoperative HNSCC seems limited compared with traditional risk factors such as ECE, LVSI, and PNI. De-escalation of postoperative treatment based on HPV status alone should be approached with caution.
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Background There are limited data on the prognostic significance of human papillomavirus (HPV) status in relation to traditional risk factors for head and neck squamous-cell carcinoma (HNSCC) in the postoperative setting.
Objective To clarify the impact of HPV status on the risk for HNSCC in the postoperative setting.
Methods We retrospectively evaluated an institutional cohort of 128 patients with HNSCC patients who had been treated with definitive surgery with or without adjuvant radiotherapy or chemoradiotherapy. Patient, disease, and treatment factors were analyzed as potential prognostic indicators.
Results Lymph node extracapsular extension (ECE), perineural invasion (PNI), and lymphovascular space invasion (LVSI) positivity predicted poorer locoregional control (LRC), disease-free survival (DFS), and overall survival (OS). Positive margins related to poorer DFS and OS. HPV status alone did not predict LRC, DFS, or OS. Compared with patients who were HPV-positive and ECE-negative, both HPV-positive and HPV-negative patients with ECE experienced significantly poorer OS (78.6%, 60%, and 43.7%, respectively; P = .010 and P = .018, respectively).
Limitations Retrospective, single-institution study; small patient cohort; short follow-up time
Conclusion The influence of HPV in postoperative HNSCC seems limited compared with traditional risk factors such as ECE, LVSI, and PNI. De-escalation of postoperative treatment based on HPV status alone should be approached with caution.
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Background There are limited data on the prognostic significance of human papillomavirus (HPV) status in relation to traditional risk factors for head and neck squamous-cell carcinoma (HNSCC) in the postoperative setting.
Objective To clarify the impact of HPV status on the risk for HNSCC in the postoperative setting.
Methods We retrospectively evaluated an institutional cohort of 128 patients with HNSCC patients who had been treated with definitive surgery with or without adjuvant radiotherapy or chemoradiotherapy. Patient, disease, and treatment factors were analyzed as potential prognostic indicators.
Results Lymph node extracapsular extension (ECE), perineural invasion (PNI), and lymphovascular space invasion (LVSI) positivity predicted poorer locoregional control (LRC), disease-free survival (DFS), and overall survival (OS). Positive margins related to poorer DFS and OS. HPV status alone did not predict LRC, DFS, or OS. Compared with patients who were HPV-positive and ECE-negative, both HPV-positive and HPV-negative patients with ECE experienced significantly poorer OS (78.6%, 60%, and 43.7%, respectively; P = .010 and P = .018, respectively).
Limitations Retrospective, single-institution study; small patient cohort; short follow-up time
Conclusion The influence of HPV in postoperative HNSCC seems limited compared with traditional risk factors such as ECE, LVSI, and PNI. De-escalation of postoperative treatment based on HPV status alone should be approached with caution.
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Omission of dexamethasone from antiemetic treatment for highly emetogenic chemotherapy in breast cancer patients with hepatitis B infection or diabetes mellitus
Patients and methods During August 2009 and September 2007, we reviewed the medical records of patients with breast cancer who were HBV carriers or had been diagnosed with DM. 97 patients were treated with anthracycline- and cyclophosphamide- containing regimens with omission of dexamethasone in antiemetic treatment because of their HBV or DM status.
Results The number of patients treated with Gra only, Apr and Gra, Apr and Pal, were 29, 29, and 39, respectively. Complete response (CR) in the acute phase (0-<24 hours after chemotherapy) or delayed phase (24-120 hours after chemotherapy) for Gra only, Apr-Gra, and Apr-Pal was 44.8% and 44.8%, 72.4% and 72.4%, and 76.9% and 74.4%, respectively. Complete control (CC) in the acute or delayed phase in each regimen for Gra only, Apr-Gra, and Apr-Pal was 31.0% and 27.6%, 48.2% and 51.7%, and 46.2% and 46.2%, respectively. Apr-Gra or Apr-Pal tended to be superior to Gra only in CR and CC in both the acute and delayed phases. HBV reactivation or aggravation of DM control was not observed in any of the 3 therapy options. CR and CC were about 20% higher for the dexamethasone-containing regimen than for the non-dexamethasone regimen in both the acute and delayed phases.
Conclusion Omission of dexamethasone in antiemetic treatment is tolerable when anthracycline- and cyclophosphamide-containing chemotherapy is administered to patients with breast cancer who have comorbidities of being HBV carriers or of DM.
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Patients and methods During August 2009 and September 2007, we reviewed the medical records of patients with breast cancer who were HBV carriers or had been diagnosed with DM. 97 patients were treated with anthracycline- and cyclophosphamide- containing regimens with omission of dexamethasone in antiemetic treatment because of their HBV or DM status.
Results The number of patients treated with Gra only, Apr and Gra, Apr and Pal, were 29, 29, and 39, respectively. Complete response (CR) in the acute phase (0-<24 hours after chemotherapy) or delayed phase (24-120 hours after chemotherapy) for Gra only, Apr-Gra, and Apr-Pal was 44.8% and 44.8%, 72.4% and 72.4%, and 76.9% and 74.4%, respectively. Complete control (CC) in the acute or delayed phase in each regimen for Gra only, Apr-Gra, and Apr-Pal was 31.0% and 27.6%, 48.2% and 51.7%, and 46.2% and 46.2%, respectively. Apr-Gra or Apr-Pal tended to be superior to Gra only in CR and CC in both the acute and delayed phases. HBV reactivation or aggravation of DM control was not observed in any of the 3 therapy options. CR and CC were about 20% higher for the dexamethasone-containing regimen than for the non-dexamethasone regimen in both the acute and delayed phases.
Conclusion Omission of dexamethasone in antiemetic treatment is tolerable when anthracycline- and cyclophosphamide-containing chemotherapy is administered to patients with breast cancer who have comorbidities of being HBV carriers or of DM.
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Patients and methods During August 2009 and September 2007, we reviewed the medical records of patients with breast cancer who were HBV carriers or had been diagnosed with DM. 97 patients were treated with anthracycline- and cyclophosphamide- containing regimens with omission of dexamethasone in antiemetic treatment because of their HBV or DM status.
Results The number of patients treated with Gra only, Apr and Gra, Apr and Pal, were 29, 29, and 39, respectively. Complete response (CR) in the acute phase (0-<24 hours after chemotherapy) or delayed phase (24-120 hours after chemotherapy) for Gra only, Apr-Gra, and Apr-Pal was 44.8% and 44.8%, 72.4% and 72.4%, and 76.9% and 74.4%, respectively. Complete control (CC) in the acute or delayed phase in each regimen for Gra only, Apr-Gra, and Apr-Pal was 31.0% and 27.6%, 48.2% and 51.7%, and 46.2% and 46.2%, respectively. Apr-Gra or Apr-Pal tended to be superior to Gra only in CR and CC in both the acute and delayed phases. HBV reactivation or aggravation of DM control was not observed in any of the 3 therapy options. CR and CC were about 20% higher for the dexamethasone-containing regimen than for the non-dexamethasone regimen in both the acute and delayed phases.
Conclusion Omission of dexamethasone in antiemetic treatment is tolerable when anthracycline- and cyclophosphamide-containing chemotherapy is administered to patients with breast cancer who have comorbidities of being HBV carriers or of DM.
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Reaching high-risk underserved individuals for cancer genetic counseling by video-teleconferencing
Background Breast and colorectal cancers are common cancers for which genetic risk assessment and counseling are available. However, these services are often limited to metropolitan areas and are not readily accessible to underserved populations. Moreover, ethnic and racial disparities present additional obstacles to identifying and screening high-risk individuals and have a bearing on treatment outcomes.
Objective To provide cancer genetic risk assessment and counseling through telemedicine to the remote, underserved primarily Hispanic population of the Texas-Mexico border region.
Methods Program participants were mailed a questionnaire to assess their satisfaction with the program so that we could determine the acceptability of video-teleconferencing for cancer risk assessment.
Results The overall level of satisfaction with the program was very high, demonstrating the acceptability of a cancer genetic risk assessment program that relied on telemedicine to reach and underserved minority community.
Limitations Delivery model requires the availability of and access to communication technologies; trained staff are needed at remote sites for sample collection and patient handling.
Conclusion Video-teleconferencing is an acceptable method of providing cancer risk assessment in a remote, underserved population.
Funding Supported primarily by a grant from the Cancer Prevention and Research Institute of Texas (PP120089 [GT]), NIH-NCI P30 CA54174 (CTRC at UTHSCSA); and a grant from the Valley Baptist Legacy Foundation.
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Background Breast and colorectal cancers are common cancers for which genetic risk assessment and counseling are available. However, these services are often limited to metropolitan areas and are not readily accessible to underserved populations. Moreover, ethnic and racial disparities present additional obstacles to identifying and screening high-risk individuals and have a bearing on treatment outcomes.
Objective To provide cancer genetic risk assessment and counseling through telemedicine to the remote, underserved primarily Hispanic population of the Texas-Mexico border region.
Methods Program participants were mailed a questionnaire to assess their satisfaction with the program so that we could determine the acceptability of video-teleconferencing for cancer risk assessment.
Results The overall level of satisfaction with the program was very high, demonstrating the acceptability of a cancer genetic risk assessment program that relied on telemedicine to reach and underserved minority community.
Limitations Delivery model requires the availability of and access to communication technologies; trained staff are needed at remote sites for sample collection and patient handling.
Conclusion Video-teleconferencing is an acceptable method of providing cancer risk assessment in a remote, underserved population.
Funding Supported primarily by a grant from the Cancer Prevention and Research Institute of Texas (PP120089 [GT]), NIH-NCI P30 CA54174 (CTRC at UTHSCSA); and a grant from the Valley Baptist Legacy Foundation.
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Background Breast and colorectal cancers are common cancers for which genetic risk assessment and counseling are available. However, these services are often limited to metropolitan areas and are not readily accessible to underserved populations. Moreover, ethnic and racial disparities present additional obstacles to identifying and screening high-risk individuals and have a bearing on treatment outcomes.
Objective To provide cancer genetic risk assessment and counseling through telemedicine to the remote, underserved primarily Hispanic population of the Texas-Mexico border region.
Methods Program participants were mailed a questionnaire to assess their satisfaction with the program so that we could determine the acceptability of video-teleconferencing for cancer risk assessment.
Results The overall level of satisfaction with the program was very high, demonstrating the acceptability of a cancer genetic risk assessment program that relied on telemedicine to reach and underserved minority community.
Limitations Delivery model requires the availability of and access to communication technologies; trained staff are needed at remote sites for sample collection and patient handling.
Conclusion Video-teleconferencing is an acceptable method of providing cancer risk assessment in a remote, underserved population.
Funding Supported primarily by a grant from the Cancer Prevention and Research Institute of Texas (PP120089 [GT]), NIH-NCI P30 CA54174 (CTRC at UTHSCSA); and a grant from the Valley Baptist Legacy Foundation.
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Diagnostic work-up for the detection of malnutrition in hospitalized cancer patients
Objective To evaluate and compare the use of various diagnostic tests for the detection of malnutrition in patients hospitalized for cancer treatment.
Methods In this single-center, non-interventional reliability study, the nutritional status of 50 patients with cancer was assessed using the Nutritional Risk Screening (NRS-2002), a bioimpedance analysis (BIA), and the measurement of laboratory parameters that reflect the serum visceral protein level. For statistical analysis, the comparison of means and the agreement of the methods were calculated.
Results NRS-2002, BIA, and lab parameters differed widely among patients classified as well-nourished or malnourished (10%- 80%, depending on the method). Significant results in the comparison of means were observed for body mass index, serum protein, and some BIA parameters. The analysis of agreement identified a compelling agreement for pre-albumin and retinol-binding protein (RBP) (kappa = 0.81).
Limitations Small sample size, heterogeneous group of patients, non-interventional reliability study.
Conclusion The tested diagnostic methods for detecting malnutrition did not have an evident agreement among each other with a limited exchangeability. In routine hospital practice several methods should be applied in order to identify cancer patients at risk of malnutrition.
Funding/sponsorship Fresenius Kabi provided the BIA-unit and software.
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Objective To evaluate and compare the use of various diagnostic tests for the detection of malnutrition in patients hospitalized for cancer treatment.
Methods In this single-center, non-interventional reliability study, the nutritional status of 50 patients with cancer was assessed using the Nutritional Risk Screening (NRS-2002), a bioimpedance analysis (BIA), and the measurement of laboratory parameters that reflect the serum visceral protein level. For statistical analysis, the comparison of means and the agreement of the methods were calculated.
Results NRS-2002, BIA, and lab parameters differed widely among patients classified as well-nourished or malnourished (10%- 80%, depending on the method). Significant results in the comparison of means were observed for body mass index, serum protein, and some BIA parameters. The analysis of agreement identified a compelling agreement for pre-albumin and retinol-binding protein (RBP) (kappa = 0.81).
Limitations Small sample size, heterogeneous group of patients, non-interventional reliability study.
Conclusion The tested diagnostic methods for detecting malnutrition did not have an evident agreement among each other with a limited exchangeability. In routine hospital practice several methods should be applied in order to identify cancer patients at risk of malnutrition.
Funding/sponsorship Fresenius Kabi provided the BIA-unit and software.
Click on the PDF icon at the top of this introduction to read the full article.
Objective To evaluate and compare the use of various diagnostic tests for the detection of malnutrition in patients hospitalized for cancer treatment.
Methods In this single-center, non-interventional reliability study, the nutritional status of 50 patients with cancer was assessed using the Nutritional Risk Screening (NRS-2002), a bioimpedance analysis (BIA), and the measurement of laboratory parameters that reflect the serum visceral protein level. For statistical analysis, the comparison of means and the agreement of the methods were calculated.
Results NRS-2002, BIA, and lab parameters differed widely among patients classified as well-nourished or malnourished (10%- 80%, depending on the method). Significant results in the comparison of means were observed for body mass index, serum protein, and some BIA parameters. The analysis of agreement identified a compelling agreement for pre-albumin and retinol-binding protein (RBP) (kappa = 0.81).
Limitations Small sample size, heterogeneous group of patients, non-interventional reliability study.
Conclusion The tested diagnostic methods for detecting malnutrition did not have an evident agreement among each other with a limited exchangeability. In routine hospital practice several methods should be applied in order to identify cancer patients at risk of malnutrition.
Funding/sponsorship Fresenius Kabi provided the BIA-unit and software.
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Repeated measures analysis of patient-reported outcomes in prostate cancer after abiraterone acetate
Background Metastatic castration-resistant prostate cancer (mCRPC) is typically associated with declining health-related quality of life (HR-QoL).
Objective To assess patient experience with abiraterone acetate (hereafter abiraterone) plus prednisone longitudinally.
Methods COU-AA-302 was a phase 3, multinational, randomized, double-blind study that enrolled asymptomatic or mildly symptomatic, chemotherapy-naïve patients with mCRPC. Patients were randomized to 1 g abiraterone daily plus 5 mg prednisone BID (n = 546) or placebo plus prednisone (n = 542) in continuous 28-day cycles. Patient-reported outcomes (PROs) were collected using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, consisting of 4 well-being subscales (physical, social/family, emotional, functional) and a prostate cancer-specific subscale (PCS). The trial outcome index (TOI) is a composite of the physical well-being, functional well-being, and PCS scores. Least squares mean change from baseline at each cycle up to 1 year (cycle13) was compared between treatment arms using a mixed-effects model for repeated measures, which assumed that data were “missing at random.” A pattern-mixture model (PMM) with multiple imputation was performed to address the assumption that data were “missing not at random.”
Results Significant differences favoring abiraterone-prednisone were observed for FACT-P total, TOI, and PCS scores, and for all well-being subscales except social/family well-being over the first year of treatment. These results were supported by the PMM with multiple imputation.
Limitations Attrition after 1 year limited our ability to analyze the PRO data beyond that time point.
Conclusions Abiraterone-prednisone confers sustained HR-QoL benefits over the course of treatment.
Funding Janssen Research & Development
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Background Metastatic castration-resistant prostate cancer (mCRPC) is typically associated with declining health-related quality of life (HR-QoL).
Objective To assess patient experience with abiraterone acetate (hereafter abiraterone) plus prednisone longitudinally.
Methods COU-AA-302 was a phase 3, multinational, randomized, double-blind study that enrolled asymptomatic or mildly symptomatic, chemotherapy-naïve patients with mCRPC. Patients were randomized to 1 g abiraterone daily plus 5 mg prednisone BID (n = 546) or placebo plus prednisone (n = 542) in continuous 28-day cycles. Patient-reported outcomes (PROs) were collected using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, consisting of 4 well-being subscales (physical, social/family, emotional, functional) and a prostate cancer-specific subscale (PCS). The trial outcome index (TOI) is a composite of the physical well-being, functional well-being, and PCS scores. Least squares mean change from baseline at each cycle up to 1 year (cycle13) was compared between treatment arms using a mixed-effects model for repeated measures, which assumed that data were “missing at random.” A pattern-mixture model (PMM) with multiple imputation was performed to address the assumption that data were “missing not at random.”
Results Significant differences favoring abiraterone-prednisone were observed for FACT-P total, TOI, and PCS scores, and for all well-being subscales except social/family well-being over the first year of treatment. These results were supported by the PMM with multiple imputation.
Limitations Attrition after 1 year limited our ability to analyze the PRO data beyond that time point.
Conclusions Abiraterone-prednisone confers sustained HR-QoL benefits over the course of treatment.
Funding Janssen Research & Development
Click on the PDF icon at the top of this introduction to read the full article.
Background Metastatic castration-resistant prostate cancer (mCRPC) is typically associated with declining health-related quality of life (HR-QoL).
Objective To assess patient experience with abiraterone acetate (hereafter abiraterone) plus prednisone longitudinally.
Methods COU-AA-302 was a phase 3, multinational, randomized, double-blind study that enrolled asymptomatic or mildly symptomatic, chemotherapy-naïve patients with mCRPC. Patients were randomized to 1 g abiraterone daily plus 5 mg prednisone BID (n = 546) or placebo plus prednisone (n = 542) in continuous 28-day cycles. Patient-reported outcomes (PROs) were collected using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, consisting of 4 well-being subscales (physical, social/family, emotional, functional) and a prostate cancer-specific subscale (PCS). The trial outcome index (TOI) is a composite of the physical well-being, functional well-being, and PCS scores. Least squares mean change from baseline at each cycle up to 1 year (cycle13) was compared between treatment arms using a mixed-effects model for repeated measures, which assumed that data were “missing at random.” A pattern-mixture model (PMM) with multiple imputation was performed to address the assumption that data were “missing not at random.”
Results Significant differences favoring abiraterone-prednisone were observed for FACT-P total, TOI, and PCS scores, and for all well-being subscales except social/family well-being over the first year of treatment. These results were supported by the PMM with multiple imputation.
Limitations Attrition after 1 year limited our ability to analyze the PRO data beyond that time point.
Conclusions Abiraterone-prednisone confers sustained HR-QoL benefits over the course of treatment.
Funding Janssen Research & Development
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Olanzapine versus fosaprepitant for the prevention of concurrent chemotherapy radiotherapy-induced nausea and vomiting
Background Concurrent chemotherapy radiation therapy may result in significant nausea and vomiting. There have been few studies reporting effective interventions for preventing treatment-related nausea and vomiting.
Objective To compare olanzapine with fosaprepitant for the prevention of nausea and vomiting in patients receiving concurrent highly emetogenic chemotherapy (HEC) and radiotherapy for locally advanced head and neck or esophageal cancer.
Methods 120 chemotherapy and radiotherapy naïve patients with head and neck cancer who were receiving concurrent local radiation and cisplatin were randomized to receive either olanzapine or fosaprepitant in combination with palonosetron and dexamethasone for the prevention of chemotherapy- and radiation-induced nausea and vomiting. The olanzapine, palonosetron, dexamethasone (OPD) regimen was 10 mg oral olanzapine , 0.25 mg IV palonosetron, and 20 mg IV dexamethasone before chemotherapy on day 1, and 10 mg/day of oral olanzapine before chemotherapy on days 2-4. The fosaprepitant, palonosetron, dexamethasone (FPD) regimen was 150 mg IV fosaprepitant, 0.25 mg IV palonosetron, and 12 mg IV dexamethasone before chemotherapy on day 1, and 4 mg dexamethasone PO BID, before chemotherapy days 2 and 3.
Results 101 of the 120 patients were evaluable. In 51 patients who received the OPD regimen, the complete response (CR; no emesis, no rescue medication) rate was 88% for the acute period (24 h after chemotherapy), 76% for the delayed period (days 2-5), and 76% for the overall period (0-120 h). In 50 patients who received the FPD regimen, the CR was 84% acute, 74% delayed, and 74% overall (P > .01 for all periods). Patients with no nausea (0, on a scale 0-10, visual analogue scale) were: OPD: 86% acute, 71% delayed, 71% overall; FPD: 78% acute, 40% delayed, 40% overall (P > .01 for acute; P < .01 for delayed and overall) There were no grade 3 or 4 toxicities.
Conclusions CR was similar for OPD and FPD; nausea in the delayed and overall periods was signifcantly improved with OPD compared with FPD (P < .01).
Funding Reich Endowment for the Care of the Whole Patient
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Background Concurrent chemotherapy radiation therapy may result in significant nausea and vomiting. There have been few studies reporting effective interventions for preventing treatment-related nausea and vomiting.
Objective To compare olanzapine with fosaprepitant for the prevention of nausea and vomiting in patients receiving concurrent highly emetogenic chemotherapy (HEC) and radiotherapy for locally advanced head and neck or esophageal cancer.
Methods 120 chemotherapy and radiotherapy naïve patients with head and neck cancer who were receiving concurrent local radiation and cisplatin were randomized to receive either olanzapine or fosaprepitant in combination with palonosetron and dexamethasone for the prevention of chemotherapy- and radiation-induced nausea and vomiting. The olanzapine, palonosetron, dexamethasone (OPD) regimen was 10 mg oral olanzapine , 0.25 mg IV palonosetron, and 20 mg IV dexamethasone before chemotherapy on day 1, and 10 mg/day of oral olanzapine before chemotherapy on days 2-4. The fosaprepitant, palonosetron, dexamethasone (FPD) regimen was 150 mg IV fosaprepitant, 0.25 mg IV palonosetron, and 12 mg IV dexamethasone before chemotherapy on day 1, and 4 mg dexamethasone PO BID, before chemotherapy days 2 and 3.
Results 101 of the 120 patients were evaluable. In 51 patients who received the OPD regimen, the complete response (CR; no emesis, no rescue medication) rate was 88% for the acute period (24 h after chemotherapy), 76% for the delayed period (days 2-5), and 76% for the overall period (0-120 h). In 50 patients who received the FPD regimen, the CR was 84% acute, 74% delayed, and 74% overall (P > .01 for all periods). Patients with no nausea (0, on a scale 0-10, visual analogue scale) were: OPD: 86% acute, 71% delayed, 71% overall; FPD: 78% acute, 40% delayed, 40% overall (P > .01 for acute; P < .01 for delayed and overall) There were no grade 3 or 4 toxicities.
Conclusions CR was similar for OPD and FPD; nausea in the delayed and overall periods was signifcantly improved with OPD compared with FPD (P < .01).
Funding Reich Endowment for the Care of the Whole Patient
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Background Concurrent chemotherapy radiation therapy may result in significant nausea and vomiting. There have been few studies reporting effective interventions for preventing treatment-related nausea and vomiting.
Objective To compare olanzapine with fosaprepitant for the prevention of nausea and vomiting in patients receiving concurrent highly emetogenic chemotherapy (HEC) and radiotherapy for locally advanced head and neck or esophageal cancer.
Methods 120 chemotherapy and radiotherapy naïve patients with head and neck cancer who were receiving concurrent local radiation and cisplatin were randomized to receive either olanzapine or fosaprepitant in combination with palonosetron and dexamethasone for the prevention of chemotherapy- and radiation-induced nausea and vomiting. The olanzapine, palonosetron, dexamethasone (OPD) regimen was 10 mg oral olanzapine , 0.25 mg IV palonosetron, and 20 mg IV dexamethasone before chemotherapy on day 1, and 10 mg/day of oral olanzapine before chemotherapy on days 2-4. The fosaprepitant, palonosetron, dexamethasone (FPD) regimen was 150 mg IV fosaprepitant, 0.25 mg IV palonosetron, and 12 mg IV dexamethasone before chemotherapy on day 1, and 4 mg dexamethasone PO BID, before chemotherapy days 2 and 3.
Results 101 of the 120 patients were evaluable. In 51 patients who received the OPD regimen, the complete response (CR; no emesis, no rescue medication) rate was 88% for the acute period (24 h after chemotherapy), 76% for the delayed period (days 2-5), and 76% for the overall period (0-120 h). In 50 patients who received the FPD regimen, the CR was 84% acute, 74% delayed, and 74% overall (P > .01 for all periods). Patients with no nausea (0, on a scale 0-10, visual analogue scale) were: OPD: 86% acute, 71% delayed, 71% overall; FPD: 78% acute, 40% delayed, 40% overall (P > .01 for acute; P < .01 for delayed and overall) There were no grade 3 or 4 toxicities.
Conclusions CR was similar for OPD and FPD; nausea in the delayed and overall periods was signifcantly improved with OPD compared with FPD (P < .01).
Funding Reich Endowment for the Care of the Whole Patient
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Voluntary reporting to assess symptom burden among Yemeni cancer patients: common symptoms are frequently missed
Objective To assess the symptom burden experienced by Yemeni cancer patients by using VR and systematic assessment (SA).
Methods 50 cancer patients were asked an open question to voluntarily report their symptoms. This was followed by an SA of a list of 20 common physical symptoms that was drawn up based on the literature.
Results From 375 symptom entries related to the 20 symptoms, VR accounted for 66 entries (18%) and SA for 309 (82%). The mean number of VR symptoms/patient was 1.3, and the mean number of VR plus SA symptoms was 7.5 (P < .001). In all, 74% of VR symptoms and 57% of SA symptoms were moderate or severe. For each symptom, the percentage of patients who experienced it and did not report it voluntarily (missed) was 100% for bleeding, constipation, early satiety, hoarseness, taste changes, and weight loss. These were followed by anorexia (97%), skin symptoms (92%), dry mouth (91%), edema (89%), dyspnea (88%), sore mouth (88%), fatigue/weakness (85%), diarrhea (80%), dysphagia (80%), nausea (76%), cough (75%), urinary symptoms (75%), vomiting (62%), and pain (18%). Pain was the most common voluntarily reported symptom (56% of patients), the most commonly distressing (42%), and the least under-reported (18%).
Limitations Relatively small sample size; the SA included only 20 symptoms.
Conclusions SA of symptoms yields a more accurate estimation of symptom burden than does VR. As with many developing countries where the majority of cancer patients present at an incurable disease stage, Yemeni cancer patients suffer a high symptom burden, especially pain.
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Objective To assess the symptom burden experienced by Yemeni cancer patients by using VR and systematic assessment (SA).
Methods 50 cancer patients were asked an open question to voluntarily report their symptoms. This was followed by an SA of a list of 20 common physical symptoms that was drawn up based on the literature.
Results From 375 symptom entries related to the 20 symptoms, VR accounted for 66 entries (18%) and SA for 309 (82%). The mean number of VR symptoms/patient was 1.3, and the mean number of VR plus SA symptoms was 7.5 (P < .001). In all, 74% of VR symptoms and 57% of SA symptoms were moderate or severe. For each symptom, the percentage of patients who experienced it and did not report it voluntarily (missed) was 100% for bleeding, constipation, early satiety, hoarseness, taste changes, and weight loss. These were followed by anorexia (97%), skin symptoms (92%), dry mouth (91%), edema (89%), dyspnea (88%), sore mouth (88%), fatigue/weakness (85%), diarrhea (80%), dysphagia (80%), nausea (76%), cough (75%), urinary symptoms (75%), vomiting (62%), and pain (18%). Pain was the most common voluntarily reported symptom (56% of patients), the most commonly distressing (42%), and the least under-reported (18%).
Limitations Relatively small sample size; the SA included only 20 symptoms.
Conclusions SA of symptoms yields a more accurate estimation of symptom burden than does VR. As with many developing countries where the majority of cancer patients present at an incurable disease stage, Yemeni cancer patients suffer a high symptom burden, especially pain.
Click on the PDF icon at the top of this introduction to read the full article.
Objective To assess the symptom burden experienced by Yemeni cancer patients by using VR and systematic assessment (SA).
Methods 50 cancer patients were asked an open question to voluntarily report their symptoms. This was followed by an SA of a list of 20 common physical symptoms that was drawn up based on the literature.
Results From 375 symptom entries related to the 20 symptoms, VR accounted for 66 entries (18%) and SA for 309 (82%). The mean number of VR symptoms/patient was 1.3, and the mean number of VR plus SA symptoms was 7.5 (P < .001). In all, 74% of VR symptoms and 57% of SA symptoms were moderate or severe. For each symptom, the percentage of patients who experienced it and did not report it voluntarily (missed) was 100% for bleeding, constipation, early satiety, hoarseness, taste changes, and weight loss. These were followed by anorexia (97%), skin symptoms (92%), dry mouth (91%), edema (89%), dyspnea (88%), sore mouth (88%), fatigue/weakness (85%), diarrhea (80%), dysphagia (80%), nausea (76%), cough (75%), urinary symptoms (75%), vomiting (62%), and pain (18%). Pain was the most common voluntarily reported symptom (56% of patients), the most commonly distressing (42%), and the least under-reported (18%).
Limitations Relatively small sample size; the SA included only 20 symptoms.
Conclusions SA of symptoms yields a more accurate estimation of symptom burden than does VR. As with many developing countries where the majority of cancer patients present at an incurable disease stage, Yemeni cancer patients suffer a high symptom burden, especially pain.
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Oral anticancer therapy: a comprehensive assessment of patient perceptions and challenges
Background Oral anticancer agents are more convenient to use and better tolerated than traditional intravenous therapy but come with significant concerns about patient noncompliance, adverse effects, and high cost. Identifying areas for improvement in the medication use process may help ensure optimal use of these agents.
Methods 30 patients who were receiving oral anticancer therapy were administered a brief survey during their visits to an ambulatory Department of Veterans’ Affairs oncology clinic where pharmacists are heavily involved in providing initial and follow-up medication use education. Veterans aged 18 years or older were considered for inclusion into the study if they were currently being treated with an oral anticancer medication from a specified list for at least 1 month. Topics addressed included drug information sources, regimen compliance, management of side effects, and cost. The results were results were analyzed using univariate descriptive statistics.
Results Most of the patients were satisfied with their oral treatment, reporting ease of use with minimal side effect occurrence. Oncologists and pharmacists were equally named as sources of drug information.
Limitations Sample size was small and patients were overwhelmingly male. Response bias may be partially responsible for the observed results for regimen management, side effect occurrence, missed doses, and overall treatment satisfaction.
Conclusion Oral anticancer therapy represents a significant therapeutic advance for many types of cancer. Pharmacists can serve as vital informational resources to these patients. Further studies examining the role of pharmacist-led educational programs in terms of overall patient outcomes are warranted.
Background Oral anticancer agents are more convenient to use and better tolerated than traditional intravenous therapy but come with significant concerns about patient noncompliance, adverse effects, and high cost. Identifying areas for improvement in the medication use process may help ensure optimal use of these agents.
Methods 30 patients who were receiving oral anticancer therapy were administered a brief survey during their visits to an ambulatory Department of Veterans’ Affairs oncology clinic where pharmacists are heavily involved in providing initial and follow-up medication use education. Veterans aged 18 years or older were considered for inclusion into the study if they were currently being treated with an oral anticancer medication from a specified list for at least 1 month. Topics addressed included drug information sources, regimen compliance, management of side effects, and cost. The results were results were analyzed using univariate descriptive statistics.
Results Most of the patients were satisfied with their oral treatment, reporting ease of use with minimal side effect occurrence. Oncologists and pharmacists were equally named as sources of drug information.
Limitations Sample size was small and patients were overwhelmingly male. Response bias may be partially responsible for the observed results for regimen management, side effect occurrence, missed doses, and overall treatment satisfaction.
Conclusion Oral anticancer therapy represents a significant therapeutic advance for many types of cancer. Pharmacists can serve as vital informational resources to these patients. Further studies examining the role of pharmacist-led educational programs in terms of overall patient outcomes are warranted.
Background Oral anticancer agents are more convenient to use and better tolerated than traditional intravenous therapy but come with significant concerns about patient noncompliance, adverse effects, and high cost. Identifying areas for improvement in the medication use process may help ensure optimal use of these agents.
Methods 30 patients who were receiving oral anticancer therapy were administered a brief survey during their visits to an ambulatory Department of Veterans’ Affairs oncology clinic where pharmacists are heavily involved in providing initial and follow-up medication use education. Veterans aged 18 years or older were considered for inclusion into the study if they were currently being treated with an oral anticancer medication from a specified list for at least 1 month. Topics addressed included drug information sources, regimen compliance, management of side effects, and cost. The results were results were analyzed using univariate descriptive statistics.
Results Most of the patients were satisfied with their oral treatment, reporting ease of use with minimal side effect occurrence. Oncologists and pharmacists were equally named as sources of drug information.
Limitations Sample size was small and patients were overwhelmingly male. Response bias may be partially responsible for the observed results for regimen management, side effect occurrence, missed doses, and overall treatment satisfaction.
Conclusion Oral anticancer therapy represents a significant therapeutic advance for many types of cancer. Pharmacists can serve as vital informational resources to these patients. Further studies examining the role of pharmacist-led educational programs in terms of overall patient outcomes are warranted.