Randomized, noncomparative, phase II trial of early switch from docetaxel to cabazitaxel or vice versa, with integrated biomarker analysis, in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer
Randomized, noncomparative, phase II trial of early switch from docetaxel to cabazitaxel or vice versa, with integrated biomarker analysis, in men with chemotherapy-naive …
Emmanuel S Antonarakis, Scott T Tagawa, Giuseppe Galletti, Daniel Worroll, Karla Ballman, Marie Vanhuyse, Guru Sonpavde, Scott North, Costantine Albany, Che-Kai Tsao, John Stewart, Atef Zaher, Ted Szatrowski, Wei Zhou, Ada Gjyrezi, Shinsuke Tasaki, Luigi Portella, Yang Bai, Timothy B Lannin, Shalu Suri, Conor N Gruber, Erica D Pratt, Brian J Kirby, Mario A Eisenberger, David M Nanus, Fred Saad, Paraskevi Giannakakou, TAXYNERGY Investigators
Journal of Clinical Oncology
Vol 25, Issue 28, p.3181
Sixty-three patients were randomly assigned to docetaxel (n= 41) or cabazitaxel (n= 22); 44.4% received prior potent androgen receptor–targeted therapy. Overall, 35 patients (55.6%) had confirmed≥ 50% PSA responses, exceeding the historical control rate of 45.4%(TAX327). Of 61 treated patients, 33 (54.1%) had≥ 30% PSA declines by C4 and did not switch taxane, 15 patients (24.6%) who did not achieve≥ 30% PSA declines by C4 switched taxane, and 13 patients (21.3%) discontinued therapy before or at C4. Of patients switching taxane, 46.7% subsequently achieved≥ 50% PSA decrease. In 26 CTC-evaluable patients, taxane-induced decrease in% ARNL (cycle 1 day 1 v cycle 1 day 8) was associated with a higher rate of≥ 50% PSA decrease at C4 (P=. 009). Median composite progression-free survival was 9.1 months (95% CI, 4.9 to 11.7 months); median overall survival was not reached at 14 …