scholarly journals A tertiary care audit of using abiraterone acetate in patients of metastatic castrate-resistant prostate cancer

2020 ◽  
Vol 09 (01) ◽  
pp. 23-26
Author(s):  
Amit Joshi ◽  
Sameer Shrirangwar ◽  
Vanita Noronha ◽  
Nilesh Sable ◽  
Archi Agarwal ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Tertiary Care ◽  
Abiraterone Acetate ◽  
Clinical Trial Setting ◽  
Care Institute ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
Clinical Records ◽  
Trial Setting

Abstract Introduction: This is a retrospective analysis to assess the safety and efficacy of abiraterone acetate (AA) in metastatic castrate-resistant prostate cancer (mCRPC) patients treated at tertiary care institute. Materials and Methods: The clinical records of mCRPC patients treated with AA at our tertiary care institute between July 2013 and December 2015 were reviewed. The treatment efficacy, toxicities, and its determinants were analyzed. Results: A total of 59 mCRPC patients treated with AA were reviewed, of whom 37 were chemo-naive and 22 had received prior chemotherapy (postchemo). The median follow-up duration was 10.0/15.0 months for chemo-naïve/postchemotherapy patients. 43.2%/36.36% of chemo-naive/postchemo patients had visceral metastases. The median overall survival (OS) and progression-free survival (PFS) were 15/7.8 months and 10/5.3 months for chemo-naive/postchemo patients, respectively. Median time to best prostate-specific antigen response was 3.4 months. Abiraterone was relatively well tolerated with no grade 4 toxicity or treatment-related death. We found the presence of previous taxene use and baseline symptoms to be significantly determinant of OS with abiraterone. Conclusion: The present study reported the efficacy of abiraterone in both chemo-naïve and postchemo patients of mCRPC outside clinical trial setting. We found lower OS and PFS with abiraterone as compared to that reported in the clinical trial setting in both chemo-naïve and postchemo patients, and particularly in those patients with the visceral disease, and further clinical trial for abiraterone in this subgroup of patients is warranted.

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.

Overall survival after 177Lu-PSMA-617 molecular radiotherapy in patients with metastatic castrate-resistant prostate cancer: Post-hoc analysis of a prospective phase II trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5549-5549 ◽  
Author(s):  
Jeremie Calais ◽  
Jeannine Gartmann ◽  
Wesley R Armstrong ◽  
Pan Thin ◽  
Kathleen Nguyen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Post Hoc Analysis ◽  
Molecular Radiotherapy ◽  
Prospective Phase ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
Post Hoc

5549 Background: This was an open-label randomized prospective bi-centric single-arm phase II clinical trial of 177Lu-PSMA-617 molecular radiotherapy in patients with progressive metastatic castrate-resistant prostate cancer (mCRPC) conducted at University of California Los Angeles (USA) and Excel Diagnostics & Nuclear Oncology Center (Houston, TX, USA) (NCT03042312). The study was investigator-initiated under an investigational new drug approval protocol (IND#133661) with authorization of charging for investigational drug (cost-recovery, Title 21 CFR 312.8). We report here the post-hoc analysis of overall survival (OS) in a single-study site cohort (UCLA). Methods: Patients with progressive mCRPC (biochemical, radiographic, or clinical) after ≥1 novel androgen axis drug (NAAD), either chemotherapy (CTX) naïve or post-CTX, with sufficient bone marrow reserve, normal kidney function, and sufficient PSMA-target expression by PET were eligible. Patients received up to 4 cycles of 177Lu-PSMA-617 every 8±1 weeks and were randomized into 2 treatment activities groups (6.0 or 7.4 GBq). Efficacy was defined as serum PSA decline of ≥50% from baseline and served as primary endpoint (hypothesis: ≥40% of responders after 2 cycles). Results: 43 patients were randomized to the 6.0 GBq (n= 14) and 7.4 GBq (n=29) treatment arms. 11/43 (26%) were CTX naïve while 10/43 (23%), 12/43 (28%), 5/43 (12%) and 5/43 (12%) had received 1, 2, 3 or 4 CTX regimens. Median baseline PSA was 29.2 ng/ml (mean 228.8, range 0.5-2082.6). 21/43 (49%) completed 4 cycles of 177Lu-PSMA-617 whereas 4/43 (9%), 13/43 (30%) and 5/43 (12%) underwent 1, 2 and 3 cycles. PSA decline of ≥50% was observed in 11/43 of patients (26%) after 2 cycles and in 16/43 (37%) at any time (best PSA response). 9/43 (21%) had a PSA decline of ≥90% and 23/43 (53%) had any PSA decline (>0%). After a median follow-up of 19.5 months the median OS was 14.8, 15.7 and 13.5 months in the whole cohort, the 6.0 GBq and 7.4 GBq treatment arms, respectively (p=0.68). Patients showing a PSA decline of ≥50% after 2 cycles and at any time had a longer OS: median 20.1 months vs. 13.6 (p=0.091) and 20.1 vs. 11.6 (p=0.002), respectively. Conclusions: In this post-hoc analysis of a single-site cohort of 43 patients included in a prospective phase II trial the median OS after 177Lu-PSMA-617 molecular radiotherapy in patients with progressive mCRPC was 14.8 months. There was no difference of efficacy between the 6.0 GBq and 7.4 GBq treatment arms. Clinical trial information: NCT03042312 .

scholarly journals New Therapeutics to Treat Castrate-Resistant Prostate Cancer

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Ömer Acar ◽  
Tarık Esen ◽  
Nathan A. Lack
Keyword(s):  
Prostate Cancer ◽  
Late Stage ◽  
Endocrine Disruptor ◽  
Patient Survival ◽  
Abiraterone Acetate ◽  
Phase Iii ◽  
Bone Targeting ◽  
Phase Iii Trials ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant

The effective treatment of castrate-resistant prostate cancer (CRPC) has proven to be very challenging. Until recently, docetaxel was the only therapeutic demonstrated to extend overall patient survival. Yet recently, a considerable number of new therapeutics have been approved to treat CRPC patients. These remarkable advances now give new tools for the therapeutic management of late-stage prostate cancer. In this review, we will examine mechanistic and clinical data of several newly approved therapeutics including the chemotherapeutic cabazitaxel, antiandrogen enzalutamide, endocrine disruptor abiraterone acetate, immunotherapy sipuleucel-T, and bone-targeting radiopharmaceutical alpharadin. In addition, we will examine other promising therapeutics that are currently in Phase III trials.

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