Randomized, placebo-controlled, phase III trial of sunitinib in combination with prednisone (SU+P) versus prednisone (P) alone in men with progressive metastatic castration-resistant prostate cancer (mCRPC).

• DOI: 10.1200/jco.2011.29.15_suppl.4515
• Publication Date: 2017-02-23T13:58:03Z
• Authors: Y. Ou; M. D. Michaelson; L. Sengeløv; F. Saad; N. Houede; P. J. Ostler; A. Stenzl; G. Daugaard; R. J. Jones; F. Laestadius; A. Bahl; D. E. Castellano; J. Gschwend; T. Maurina; D. Ye; I. Chen; S. Wang; E. C. Maneval; S. Oudard
• Keywords: Clinical endpoint; Interim analysis; Discontinuation

4515 Background: Options for treatment of men with mCRPC after progression on docetaxel-based chemotherapy are limited. SU is a multitargeted inhibitor VEGFR and PDGFR that showed antitumor activity in phase II trials advanced (Sonpavde; Michaelson; Zurita, 2009). Here, we report results III trial SU+P progressive chemotherapy. Methods: In this multicenter, double-blind study, eligible were stratified by ECOG performance status type (PSA or radiographic) randomized (2:1) to receive P 5 mg BID either 37.5 placebo (Pbo) continuous once-daily dosing schedule. Overall survival (OS) was the primary endpoint. Secondary endpoints included radiographic progression-free (PFS) improvement pain. Two interim analyses planned. Results: Between Jul 2008 Aug 2010, 873 (median age 68 years; 49% Gleason score ≥8) (n=584) Pbo (n=289). The study stopped futility at second analysis (Sep 2010) data monitoring committee. At time analysis, median duration 2.8 (range 0−17.5) 0−19.4) months (mo) Pbo+P arms, respectively. Reasons discontinuation disease (28.1 vs. 47.3%), adverse events (AEs; 21.4 5.9%) consent withdrawal (5.8 6.2%). most common treatment-related Grades 3/4 AEs fatigue (18.8 7.3%) anemia (6.2 5.5%). Efficacy shown table. Conclusions: Despite an PFS, did not improve OS compared second-line therapy mCRPC. No new unexpected safety issues identified. Further evaluation will determine whether select subpopulations may benefit from treatment. Endpoint (95% CI) (n=289) HR value OS, mo 13.1 (11.7−15.5) 12.8 (11.3−15.8) 1.03 (0.80−1.32) 0.5813* 5.6 (4.5−5.7) 3.7 (3.6−5.6) 0.76 (0.61−0.95) 0.0077* ORR, % (n=310) 5.5 (3.2−8.6) (n=160) 1.9 (0.4−5.4) NA 0.0495** * Stratified log-rank. ** Fisher's exact.