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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
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
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
Click on the PDF icon at the top of this introduction to read the full article.
Re-personalizing precision medicine: is there a role for patient-reported outcomes?
In the opinion of most, precision medicine is the future of cancer therapeutics. By producing response rates well into double digits, and substantially extending progression-free and overall survival, the molecular testing of tumors to select optimal treatment may be a way to justify the high cost of new and emerging therapeutics. The road to this future will likely be long and winding, however, with a string of incremental successes amid inevitable disappointments. Our patients will walk this road with us, agreeing to testing and treatment when those tests come back positive for an eligible mutation.
Click on the PDF icon at the top of this introduction to read the full article.
In the opinion of most, precision medicine is the future of cancer therapeutics. By producing response rates well into double digits, and substantially extending progression-free and overall survival, the molecular testing of tumors to select optimal treatment may be a way to justify the high cost of new and emerging therapeutics. The road to this future will likely be long and winding, however, with a string of incremental successes amid inevitable disappointments. Our patients will walk this road with us, agreeing to testing and treatment when those tests come back positive for an eligible mutation.
Click on the PDF icon at the top of this introduction to read the full article.
In the opinion of most, precision medicine is the future of cancer therapeutics. By producing response rates well into double digits, and substantially extending progression-free and overall survival, the molecular testing of tumors to select optimal treatment may be a way to justify the high cost of new and emerging therapeutics. The road to this future will likely be long and winding, however, with a string of incremental successes amid inevitable disappointments. Our patients will walk this road with us, agreeing to testing and treatment when those tests come back positive for an eligible mutation.
Click on the PDF icon at the top of this introduction to read the full article.