Memorial Sloan Kettering Cancer Center, New York, NY
Michael J. Morris , Patrick Hilden , Martin Edwin Gleave , Andrew J. Armstrong , Michael Anthony Carducci , Fred Saad , Erica Simone Dayan , Julie Filipenko , Ilyse Acosta , Glenn Heller , Howard I. Scher
Background: The optimal treatment (tx) of men with castration sensitive prostate cancer (CSPC) who biochemically recur following a radical prostatectomy (RRP) is not known. Data from E3805 suggest that men with metastatic CSPC live longer if they receive D in addition to ADT relative to ADT alone. We tested this hypothesis in non-metastatic CSPC, via a phase III study (TAX3503). Methods: PC pts who underwent an RRP with BCR and a doubling time ≤ 9 months (mo) were eligible. PSA ≥ 1 ng/mL and testosterone ≥100 ng/dl were required. Randomization was 1:1 to receive leuprolide 22.5 mg q3 mo x 18 mo, bicalutamide 50 mg x 30 days, with D at 75 mg/m2 q3 weeks x 10 cycles (Arm A) or without D (Arm B). The primary endpoint was PFS defined as a detectable PSA or death. Pts with T recovery >50 ng/dl were evaluable. The intent to treat population (ITT) was also examined. A sample size of 412, to yield 370 evaluable pts, was calculated to detect a HR of 1.6 with 90% power. The trial was closed by the sponsor after the pts completed treatment; remaining pts were then followed to PFS via a registry for 18 mo’s. A test to detect a difference in the hazard rates between arms was generated by the log rank statistic. Results: 413 pts were randomized. Median f/u time in the ITT population was 31.5 mo’s (0.0-60.2). Data are summarized below in the Table. Conclusions: The clinical benefit of ADT + D relative to ADT alone in men with high-risk BCR after RRP appears to be marginal, although there is a statistical trend towards improved PFS. Data are limited by the biases intrinsic to post-protocol registries and by short duration of follow up, although tracking of pts continues. Clinical trial information: NCT01813370
Population | Arm | N | Events | Median PFS (95% CI) | 1yr PFS prob | 2yr PFS prob | 3yr PFS prob | HR (A vs. B) |
---|---|---|---|---|---|---|---|---|
All randomized | A | 207 | 138 | 25.6 (25.0,27.8) | 0.952 (0.910,0.975) | 0.593 (0.514,0.663) | 0.189 (0.130,0.257) | 1.270 (1.006,1.603) P=0.044 |
B | 206 | 148 | 23.1 (22.6,25.0) | 0.960 (0.921,0.980) | 0.472 (0.396,0.544) | 0.104 (0.059,0.165) | ||
T-recovered | A | 129 | 106 | 26.5 (25.3,28.1) | 0.961 (0.909,0.984) | 0.641 (0.552,0.718) | 0.202 (0.133,0.280) | 1.285 (0.980,1.683) P=0.070 |
B | 130 | 107 | 24.8 (22.9,25.3) | 0.992 (0.947,0.999) | 0.527 (0.437,0.609) | 0.115 (0.060,0.188) |
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