A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902

作者：Rosenthal Seth A; Hunt Daniel; Sartor Oliver; Pienta Kenneth J; Gomella Leonard; Grignon David; Rajan Raghu; Kerlin Kevin J; Jones Christopher U; Dobelbower Michael; Shipley William U; Zeitzer Kenneth; Hamstra Daniel A; Donavanik Viroon; Rotman Marvin; Hartford Alan C; Michalski Jeffrey; Seider Michael; Kim Harold; Kuban Deborah A; Moughan Jennifer; Sandler Howard

来源：International Journal of Radiation Oncology, Biology, Physics, 2015, 93(2): 294-302.

DOI：10.1016/j.ijrobp.2015.05.024

Purpose: Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS).
Methods and Materials: Patients with high-risk PCa (prostate-specific antigen 20100 ng/mL and Gleason score [GS] >= 7 or clinical stage >= T2 and GS >= 8) were randomized to RT and AS (AS + RT) alone or with adjuvant CT (AS + RT + CT). CT was given as four 21-day cycles, delivered beginning 28 days after 70.2 Gy of RT. AS was given as luteinizing hormone-releasing hormone for 24 months, beginning 2 months before RT plus an oral antiandrogen for 4 months before and during RT. The study was designed based on a 6% improvement in OS from 79% to 85% at 5 years, with 90% power and a 2-sided alpha of 0.05.
Results: A total of 397 patients (380 eligible) were randomized. The patients had high-risk PCa, 68% with GS 8 to 10 and 34% T3 to T4 tumors, and median prostate-specific antigen of 22.6 ng/mL. The median follow-up period was 9.2 years. The trial closed early because of excess thromboembolic toxicity in the CT arm. The 10-year results for all randomized patients revealed no significant difference between the AS + RT and AS + RT + CT arms in OS (65% vs 63%; P = . 81), biochemical failure (58% vs 54%; P = . 82), local progression (11% vs 7%; P = . 09), distant metastases (16% vs 14%; P = . 42), or disease-free survival (22% vs 26%; P = . 61).
Conclusions: NRG Oncology RTOG 9902 showed no significant differences in OS, biochemical failure, local progression, distant metastases, or disease-free survival with the addition of adjuvant CT to LT AS + RT. The trial results provide valuable data regarding the natural history of high-risk PCa treated with LT AS + RT and have implications for the feasibility of clinical trial accrual and tolerability using CT for PCa.

• 出版日期2015-10-1
• 单位McGill