scholarly journals COSMiC details

2015 ◽  
Vol 9 (1-2) ◽  
Author(s):  
CUAJ Editorial
Keyword(s):  
Prostate Cancer ◽  
Observational Study ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Additional Information ◽  
Patient Reported ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
Cancer Of The Prostate ◽  
The Impact

A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting. The COSMiC Prospective Prostate Cancer Registry.The purpose of this non-interventional, prospective, observational study is to temporally evaluate the impact of abiraterone acetate (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population.Study participants must have a confirmed diagnosis of mCRPC according to medical history and have rising PSA levels or radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI) despite ongoing conventional ADT.Study participants will complete Quality of Life and Patient Satisfaction questionnaires longitudinally at defined time points. Safety and efficacy data, as well as levels of health care resource utilization associated with ZYTIGA therapy, will also be prospectively collected and analyzed.Once enrolled, study participants will be followed for a maximum of 72 weeks from the time of initiation of ZYTIGA treatment, or up to the time of early study withdrawal/termination.For additional information please contact Richard K. Plante at [email protected]

scholarly journals Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: Final results of COSMiC

2020 ◽  
Vol 14 (12) ◽  
Author(s):  
Geoffrey Gotto ◽  
Darrel E. Drachenberg ◽  
Joseph Chin ◽  
Richard Casey ◽  
Vincent Fradet ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Cognitive Status ◽  
Patient Reported ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant

Introduction: Abiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castrate-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Here, we report their patient-reported outcomes (PROs). Methods: After a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]). Results: At a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients’ PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P. Conclusions: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.

Assessment of urologists experience with abiraterone acetate and with a real-world trial: Results obtained from a Canadian Observational Study in Metastatic Cancer of the Prostate (COSMiC).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 238-238
Author(s):  
Andrew Feifer ◽  
Vincent Fradet ◽  
Darrel Drachenberg ◽  
Geoffrey Gotto ◽  
Ricardo A. Rendon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Observational Study ◽  
Real World ◽  
Active Sites ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Ease Of Use ◽  
Therapeutic Area ◽  
Patient Reported ◽  
Cancer Of The Prostate

238 Background: Abiraterone Acetate (AA) is a selective inhibitor of the androgen biosynthesis and has significantly improved OS for mCRPC patients. Canadian Observational Study in Metastatic Cancer of the Prostate (COSMiC) is a Non-Interventional Observational Study pPhase IV clinical trial; NCT02364531) specifically designed to (1) collect real-world drug-specific outcomes (clinical and patient reported outcomes) and (2) assess urologists experience with incorporation of AA in their practice. Here we report data collected from COSMiC trial on the success of AA integration into the urology practice and physicians experience in participating in the trial. Methods: (1) A comprehensive questionnaire was developed to assess urologists experience with (a) integration and usage of AA in their practice and (b) COSMiC trial. (2) Questionnaire was sent to the active trial sites (47 sites) and collected data from 30 sites is summarized here. Results: 93.3% of participants in COSMiC trial were urologists (63.3% community vs. 30% academic). The ease of use and success in integration of AA in urology practice was rated easy by 50% of the participants, easy once they overcame few barriers by 46.7% and challenging by 3.3%. Drug-related barriers identified included time involvement (50%), resource issues such as nursing support (23.3%), and lack of appropriate infrastructure (33.3%). 90% of the active sites indicated that treating mCRPC patients with AA will be part of their practice post-trial. As part of this report we also assessed and identified physicians barriers in participating in COSMiC trial. 86.7% of the sites reported that trials such as COSMiC will add value to the therapeutic area and 93.3% of the sites reported interest in participating in trials of this nature in future. Conclusions: This report indicates that integration of AA in urology practices is considered easy and manageable for most urologists, in some cases after overcoming few initial barriers. There is high interest in participating in future real-world trials of this nature among urologists and such studies add value to the therapeutic area. Clinical trial information: NCT02364531.

Patient-reported outcomes with metastatic castrate-resistant prostate cancer.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 207-207
Author(s):  
Jimmy Mullally ◽  
Christopher Davella ◽  
Rahul Atul Parikh ◽  
G J. Van Londen ◽  
Leonard Joseph Appleman
Keyword(s):  
Prostate Cancer ◽  
Cognitive Impairment ◽  
Disease Progression ◽  
Well Being ◽  
Open Label ◽  
Hormonal Function ◽  
Patient Reported ◽  
Data Points ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant

207 Background: Prostate cancer accounts for approximately 10% of cancer deaths in men worldwide. Clinical trials for metastatic castrate resistant prostate cancer (mCRPC) have established survival benefit with use of abiraterone (ABI) with prednisone or enzalutamide (ENZ). Despite their wide utilization, little is known about patient quality-of-life (QOL) outcomes for these agents. Our study evaluates patient reported QOL while taking ENZ or ABI/prednisone. Methods: 22 mCRPC patients were enrolled in an open label, nonrandomized manner to receive oral ENZ (n=12) or ABI/prednisone (n=6) per oncologist’s discretion. Patients completed multiple QOL validated questionnaires, including EPIC-26, FACT-P, and FACT-COG at baseline, 1,2,3,6,9 and 12 months or until progression/change of therapy. Surveys were scored by treatment group using mean, median, range, and standard deviations. QOL parameters were compared between the two groups with two-sided, two-sample T test and linear mixed models. Results: Surveys discontinued prior to 1 year secondary to disease progression/change of therapy were 58% and 33% for ENZ and ABI, respectively. By month 3, 50% of surveys were returned for ENZ and 33% for ABI. Month-to-month comparisons of QOL parameters including urinary irritation, incontinence, bowel, sexual, hormonal function, and overall well-being showed no significant differences between treatment groups or different rates of change. Perceived Cognitive Impairment was significantly lower for patients on ABI in month 3, yet Perceived Cognitive Ability favored ENZ in months 2 and 3. All other data points for cognition showed no significant differences. Conclusions: Data from FACT-COG shows discordance in perceived Cognitive Impairment and Abilities between ENZ and ABI in months 2-3. Other QOL domains indicated no difference between the two groups. The study was limited by a significant portion of patients with disease progression/change of therapy. For those on therapy, survey compliance remained high. Thus, the use of questionnaires is a feasible means of assessing patient outcomes and can be adapted to larger studies.

Contemporary trends in abiraterone and enzalutamide prescription by provider specialty.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 366-366
Author(s):  
Daniel Pucheril ◽  
Ye Wang ◽  
Dimitar V. Zlatev ◽  
Paul L. Nguyen ◽  
Adam S. Kibel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Abiraterone Acetate ◽  
Optimal Timing ◽  
Part D ◽  
Southern States ◽  
Radiation Oncologists ◽  
Medical Oncologists ◽  
Specific Outcome ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant

366 Background: Androgen deprivation therapy (ADT) with LHRH-agonists and anti-androgens, is established in the management of prostate cancer and is administered by urologists, medical oncologists, and radiation oncologists. Newer agents for ADT, abiraterone acetate (ABI) and enzalutamide (ENZA) were approved by the FDA in 2011 and 2012, respectively, for the management of metastatic castrate resistant prostate cancer (mCRPC) after failing chemotherapy. We evaluated the contemporary economic burden of ABI and ENZA and their adoption by specialty. Methods: Because a majority of men with mCRPC are > 65 years of age, we utilized Medicare Part D data from 2013-15. The specific outcome variables of interest included the aggregate reimbursement and total number of prescriptions for ABI and ENZA, by specialty. Descriptive statistics and trend analysis were performed. Results: From 2013-15, the total number of prescription rose from 52457 to 81058 for ABI and from 17141 to 69181 for ENZA. Though medical oncologists prescribed more than 75% of ABI/ENZA prescriptions each year, the proportion of prescriptions written by urologists increased annually. The greatest increase in the percentage of prescriptions originating from urology occurred from 2013-2014 for ABI (3.96% to 8.62%) and from 2014-15 for ENZA (5.42% to 15.64%); meanwhile, prescriptions by radiation oncology were negligible throughout the study. Southern states accounted for greater than one third of ABI and ENZA prescriptions. By 2015, the aggregate reimbursement of Part D claims for ENZA and ABI was $790 million each. Among all medication claims, ENZA and ABI represent the 29th and 30th most expensive by aggregate cost. Conclusions: While medical oncologists account for the vast majority of ENZA and ABI prescriptions, the prescriptions by urologists is increasing while prescriptions by radiation oncologists remain negligible. Though approved for mCRPC patients, ENZA and ABI are already among the costliest medications covered by Medicare. As Level 1 indications for the use of these medications increase and now include castrate-sensitive patients, further study should be directed at determining optimal timing and indication for prescription.

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