1. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer.
- Author
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Eastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, and Morris MJ
- Subjects
- Adenocarcinoma mortality, Adenocarcinoma secondary, Adult, Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Chemotherapy, Adjuvant, Disease Progression, Docetaxel adverse effects, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Progression-Free Survival, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Risk Assessment, Risk Factors, Time Factors, United States, Adenocarcinoma therapy, Androgen Antagonists therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Docetaxel therapeutic use, Neoadjuvant Therapy adverse effects, Neoadjuvant Therapy mortality, Prostatectomy adverse effects, Prostatectomy mortality, Prostatic Neoplasms therapy
- Abstract
Purpose: Radical prostatectomy (RP) alone is often inadequate in curing men with clinically localized, high-risk prostate cancer (PC). We hypothesized that chemohormonal therapy (CHT) with androgen-deprivation therapy plus docetaxel before RP would improve biochemical progression-free survival (BPFS) over RP alone., Patients and Methods: Men with clinically localized, high-risk PC were assigned to RP alone or neoadjuvant CHT with androgen deprivation plus docetaxel (75 mg/m
2 body surface area every 3 weeks for 6 cycles) and RP. The primary end point was 3-year BPFS. Biochemical failure was defined as a serum prostate-specific antigen level > 0.2 ng/mL that increased on 2 consecutive occasions that were at least 3 months apart. Secondary end points included 5-year BPFS, overall BPFS, local recurrence, metastasis-free survival (MFS), PC-specific mortality, and overall survival (OS)., Results: In total, 788 men were randomly assigned. Median follow-up time was 6.1 years. The overall rates of grade 3 and 4 adverse events during chemotherapy were 26% and 19%, respectively. No difference was seen in 3-year BPFS between neoadjuvant CHT plus RP and RP alone (0.89 v 0.84, respectively; 95% CI for the difference, -0.01 to 0.11; P = .11). Neoadjuvant CHT was associated with improved overall BPFS (hazard ratio [HR], 0.69; 95% CI, 0.48 to 0.99), improved MFS (HR, 0.70; 95% CI, 0.51 to 0.95), and improved OS (HR, 0.61; 95% CI, 0.40 to 0.94) compared with RP alone., Conclusion: The primary study end point, 3-year BPFS, was not met. Although some improvement was seen in secondary end points, any potential benefit must be weighed against toxicity. Our data do not support the routine use of neoadjuvant CHT and RP in patients with clinically localized, high-risk PC at this time., Competing Interests: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.- Published
- 2020
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