GU cancers
Affirm Trial | 2012 | Prostate - metastatic |
Prevail Trial | 2014 | Prostate - metastatic |
CHAARTED trial (docetaxel) | 2015 | Prostate - metastatic |
Latitude Trial | 2017 | Prostate - metastatic |
Titan Trial | 2019 | Prostate - metastatic |
Enzamet Trial | 2019 | Prostate - metastatic |
TheraP Trial | 2021 | Prostate - metastatic |
Vision Trial | 2021 | Prostate - metastatic |
ARASENS trial, Docetaxel+ADT +/- Darolutamide | 2022 | Prostate - metastatic |
Sunitinib versus INF-alfa | 2007 | RCC - advanced |
Temsirolimus vs INF-alfa trial | 2007 | RCC - advanced |
IMDC analysis | 2009 | RCC - advanced |
Affirm Trial
Scher HI et al, NEJM, 2012, PMID 22894553
Prostate - metastatic
Background: Phase III, Double blinded, RCT included 1,199 patients with metastatic, castration-resistant prostate cancer after one or two chemotherapy regimens.
Arm A: Enzalutamide 160 mg daily
Arm B: Placebo
Primary Endpoint: OS
mFollow up: 14.4 mo
OS: 18.4 mo vs 13.6 mo, arm A vs B; HR 0.63, 95% CI 0.53-0.75; P<.001
Secondary endpoints: PSA-level response rate (54% vs 2%, P<0.001), soft-tissue response rate (29% vs 4%, P<0.001), quality-of-life response (43% vs 18%, P<0.001), the time to PSA progression (8.3mo vs 3.0mo; P<0.001), radiographic PFS (8.3mo vs. 2.9mo; P<0.001)
Main Adverse events: Grade 3-4 events (45.3% vs 53.1% arm A vs B). Most common: Fatigue (34% vs 29%), Diarrhea (21% vs 18%), Hot flash (20% vs 10%), musculoskeletal pain (14% vs 10%), seizure (0.6% vs 0%)
Conclusions: Enzalutamide improved OS, PSA response rate, quality of life response, time to PSA progression, soft tissue response rate, radiographic PFS, time to first skeletal related event when compared to placebo in men with metastatic, castration resistant prostate cancer.
Summarized by Pragnan Kancharla, MD