Comparison of Abiraterone Acetate and Docetaxel with Androgen Deprivation Therapy in High-risk and Metastatic Hormone-naïve Prostate Cancer: A Systematic Review and Network Meta-analysis

Wallis, Christopher J.D.; Klaassen, Zachary; Bhindi, Bimal; Goldberg, Hanan; Chandrasekar, Thenappan; Farrell, Ann; Boorjian, Stephen A.; Kulkarni, Girish S.; Karnes, R. Jeffrey; Satkunasivam, Raj

doi:10.1016/j.eururo.2017.10.002

Cited by 95 publications

(92 citation statements)

References 91 publications

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“…More recently, the use of abiraterone acetate and prednisone with ADT in the early castration‐sensitive setting was also shown to improve overall survival in the LATITUDE and STAMPEDE (Arm G) phase III clinical trials. There have been no prospective clinical trials comparing docetaxel and abiraterone in this setting, although some analyses show similar efficacy . However, this does not take into account challenges encountered when delivering chemotherapy in a real‐world setting.…”

Section: Introductionmentioning

confidence: 99%

Clinical effectiveness of docetaxel for castration‐sensitive prostate cancer in a real‐world population‐based analysis

et al. 2018

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Background: Adding docetaxel to androgen deprivation therapy (ADT) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) has known efficacy, with an overall survival benefit in Phase III clinical trials. The effectiveness of docetaxel with ADT in the general patient population remains undefined. Patients and Methods:We conducted a population-based retrospective review using the British Columbia Provincial Pharmacy Database. To be included, patients had to have castration-sensitive prostate cancer not previously treated (except in the adjuvant setting) and have received at least one cycle of docetaxel, with complete records available for review. Safety and clinical effectiveness were evaluated.Results: From April 2015 to February 2017, we identified 183 cases; 156 met inclusion criteria. Most patients had high-volume disease (80%). All 6 planned docetaxel cycles were delivered in 126 cases (81%). Dose reductions and delays were required in 39% and 16% of cases. Grade 3-4 adverse events were noted in 40%, with no treatmentrelated deaths. The rate of febrile neutropenia was 18% and was significantly associated with the presence of high-volume disease (P = 0.038). PSA ≤ 0.2 ng/L was achieved in 27% of patients after 6 months of ADT and maintained in 16% after 12 months. Patients with over 20 bone metastases had worse time to castration resistant prostate cancer (CRPC) and time to treatment for CRPC, and a trend toward worse overall survival. CRPC developed in 41% within 1 year, with a median time to CRPC of 14.4 months. Treatment for CRPC was given in 84 cases, with 90% receiving either abiraterone or enzalutamide in the first-line, with a PSA decline ≥50% occurring in 47%. Conclusions:The effectiveness of docetaxel with ADT in a general population of patients with mCSPC was associated with poorer outcomes and high rates of toxicity compared to the published studies. Response rates to first-line treatment for mCRPC with abiraterone or enzalutamide appear similar to reported outcomes. K E Y W O R D S clinical effectiveness, docetaxel, prostate cancer The Prostate. 2019;79:281-287.wileyonlinelibrary.com/journal/pros

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Section: Introductionmentioning

confidence: 99%

Clinical effectiveness of docetaxel for castration‐sensitive prostate cancer in a real‐world population‐based analysis

et al. 2018

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“…Compared with best supportive care, enzalutamide had an ICER of $154,300 per QALY . The cost‐effectiveness findings regarding abiraterone are notable; as mentioned above, a meta‐analysis revealed no improvement in OS when abiraterone plus ADT was compared with docetaxel plus ADT …”

Section: Prostate Cancermentioning

confidence: 99%

“…Most recently, data from the STAMPEDE trial and the LATITUDE trial indicated that the addition of abiraterone to ADT was associated with a significantly higher rate of OS and lower treatment failure rate compared with ADT alone. Despite such findings, a recent systematic review and meta‐analysis was performed comparing abiraterone and ADT versus docetaxel and ADT in men with metastatic, hormone‐naive prostate cancer and demonstrated no difference in OS . Trials examining the role of enzalutamide for men with castration‐naive prostate cancer are ongoing (ie, the ARCHES trial) …”

Section: Prostate Cancermentioning

confidence: 99%

“…Despite such findings, a recent systematic review and metaanalysis was performed comparing abiraterone and ADT versus docetaxel and ADT in men with metastatic, hormone-naive prostate cancer and demonstrated no difference in OS. 40 Trials examining the role of enzalutamide for men with castration-naive prostate cancer are ongoing (ie, the ARCHES trial). 41…”

Section: Costs Of Abiraterone and Enzalutamide For Crpcmentioning

confidence: 99%

“…29 The cost-effectiveness findings regarding abiraterone are notable; as mentioned above, a meta-analysis revealed no improvement in OS when abiraterone plus ADT was compared with docetaxel plus ADT. 40 Immunotherapy for Prostate Cancer: Sipuleucel-T Sipuleucel-T is the sole immunotherapeutic agent available for men with CRPC. It is an option for asymptomatic or minimally symptomatic men with good performance status and no prior docetaxel chemotherapy.…”

Section: Cost Effectiveness Of Abiraterone and Enzalutamidementioning

confidence: 99%

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Cost considerations for systemic therapy for patients with advanced genitourinary malignancies

Henry

Leung

Filson

2018

Cancer

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The rising cost of health care in the United States has been the focus of intense debate within the medical, legal, and legislative arenas, with the cost of cancer care representing an important component. Cost effectiveness is not always easy to define, and there is no standard metric in assessing this measure related to cancer therapies. Significant controversy surrounds exactly what is the appropriate cost per added year of life. This review examines cost, effectiveness, and comparative cost effectiveness of novel systemic therapies for patients with urologic malignancies. Cancer 2018;124:2897-905. © 2018 American Cancer Society.

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Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment

Wallach¹,

Deng

McCoy

et al. 2021

JAMA Netw Open

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IMPORTANCE With a growing interest in the use of real-world evidence for regulatory decisionmaking, it is important to understand whether real-world data can be used to emulate the results of randomized clinical trials. OBJECTIVETo use electronic health record and administrative claims data to emulate the ongoing PRONOUNCE trial (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease). DESIGN, SETTING, AND PARTICIPANTS This retrospective, propensity-matched cohort study included adult men with a diagnosis of prostate cancer and cardiovascular disease who initiated either degarelix or leuprolide between December 24, 2008, and June 30, 2019. Participants were commercially insured individuals and Medicare Advantage beneficiaries included in a large US administrative claims database. EXPOSURES Degarelix or leuprolide. MAIN OUTCOMES AND MEASURESThe primary end point was time to first occurrence of a major adverse cardiovascular event (MACE), defined as death due to any cause, myocardial infarction, or stroke, analogous to the PRONOUNCE trial. Secondary end points were time to death due to any cause, myocardial infarction, stroke, and angina. Cox proportional hazards regression was used to evaluate primary and secondary end points. RESULTSA total of 32 172 men initiated degarelix or leuprolide for prostate cancer; of them, 9490 (29.5%) had cardiovascular disease, and 7800 (24.2%) met the PRONOUNCE trial eligibility criteria and were included in this study. Overall, 165 participants (2.1%) were Asian, 1390 (17.8%) were Black, 663 (8.5%) were Hispanic, and 5258 (67.4%) were White. The mean (SD) age was 74.4 (7.4) years.Among 2226 propensity score-matched patients, no significant difference was observed in the risk of MACE for patients taking degarelix vs those taking leuprolide (10.18 vs 8.60 events per 100 person-years; hazard ratio [

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Comparison of Abiraterone Acetate and Docetaxel with Androgen Deprivation Therapy in High-risk and Metastatic Hormone-naïve Prostate Cancer: A Systematic Review and Network Meta-analysis

Cited by 95 publications

References 91 publications

Clinical effectiveness of docetaxel for castration‐sensitive prostate cancer in a real‐world population‐based analysis

Clinical effectiveness of docetaxel for castration‐sensitive prostate cancer in a real‐world population‐based analysis

Cost considerations for systemic therapy for patients with advanced genitourinary malignancies

Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment

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