BACKGROUND: The optimal number of 3-wk docetaxel plus prednisone (DP) cycles for metastatic castration-resistant prostate cancer (mCRPC) is unclear. OBJECTIVE: A retrospective analysis of two clinical trials was performed to evaluate the association of the number of cycles with overall survival (OS). DESIGN, SETTING, AND PARTICIPANTS: An exploratory analysis compared outcomes of 332 men who received DP in the TAX-327 trial, which stipulated up to 10 cycles, and 220 men who received DP in CS-205, a randomized phase 2 trial comparing DP plusAT-101 (bcl-2 inhibitor) versus DP plus placebo, which allowed up to 17 cycles. MEASUREMENTS: Patients who completed 10 cycles of DP without progression in both trials were included. Men in both arms of CS-205 were combined for analysis, as no significant differences in outcomes were observed. OS was estimated from the date of cycle 10 docetaxel infusion. RESULTS AND LIMITATIONS: The number of men receiving 10 cycles was similar (p=0.26) in the two trials (166 [50.0%] in TAX-327 vs 99 [45.0%] in CS-205; the latter group received a median of five additional cycles). Six- and 12-mo estimated survival after cycle 10 was 92.2% (95% confidence interval [CI], 86.9-95.4%) and 74.6% (CI, 67.2-80.5%) in TAX-327, compared with 92.8% (CI, 85.5-96.5) and 63.4% (CI, 51.8-72.9%) in CS-205. Subanalyses suggested that <10 cycles may have a negative impact and prostate-specific antigen (PSA) declines at cycle 10 may carry a favorable impact. The significance of continued PSA declines up to 17 cycles is unclear. Limitations of a retrospective analysis apply. CONCLUSIONS: A survival benefit was not detected with >10 cycles of DP in men with mCRPC in this retrospective hypothesis-generating analysis.
RCT Entities:
BACKGROUND: The optimal number of 3-wk docetaxel plus prednisone (DP) cycles for metastatic castration-resistant prostate cancer (mCRPC) is unclear. OBJECTIVE: A retrospective analysis of two clinical trials was performed to evaluate the association of the number of cycles with overall survival (OS). DESIGN, SETTING, AND PARTICIPANTS: An exploratory analysis compared outcomes of 332 men who received DP in the TAX-327 trial, which stipulated up to 10 cycles, and 220 men who received DP in CS-205, a randomized phase 2 trial comparing DP plus AT-101 (bcl-2 inhibitor) versus DP plus placebo, which allowed up to 17 cycles. MEASUREMENTS: Patients who completed 10 cycles of DP without progression in both trials were included. Men in both arms of CS-205 were combined for analysis, as no significant differences in outcomes were observed. OS was estimated from the date of cycle 10 docetaxel infusion. RESULTS AND LIMITATIONS: The number of men receiving 10 cycles was similar (p=0.26) in the two trials (166 [50.0%] in TAX-327 vs 99 [45.0%] in CS-205; the latter group received a median of five additional cycles). Six- and 12-mo estimated survival after cycle 10 was 92.2% (95% confidence interval [CI], 86.9-95.4%) and 74.6% (CI, 67.2-80.5%) in TAX-327, compared with 92.8% (CI, 85.5-96.5) and 63.4% (CI, 51.8-72.9%) in CS-205. Subanalyses suggested that <10 cycles may have a negative impact and prostate-specific antigen (PSA) declines at cycle 10 may carry a favorable impact. The significance of continued PSA declines up to 17 cycles is unclear. Limitations of a retrospective analysis apply. CONCLUSIONS: A survival benefit was not detected with >10 cycles of DP in men with mCRPC in this retrospective hypothesis-generating analysis.
Authors: Daniel P Petrylak; Donna Pauler Ankerst; Caroline S Jiang; Catherine M Tangen; Maha H A Hussain; Primo N Lara; Jeffrey A Jones; Mary Ellen Taplin; Patrick A Burch; Manish Kohli; Mitchell C Benson; Eric J Small; Derek Raghavan; E David Crawford Journal: J Natl Cancer Inst Date: 2006-04-19 Impact factor: 13.506
Authors: Johann S de Bono; Christopher J Logothetis; Arturo Molina; Karim Fizazi; Scott North; Luis Chu; Kim N Chi; Robert J Jones; Oscar B Goodman; Fred Saad; John N Staffurth; Paul Mainwaring; Stephen Harland; Thomas W Flaig; Thomas E Hutson; Tina Cheng; Helen Patterson; John D Hainsworth; Charles J Ryan; Cora N Sternberg; Susan L Ellard; Aude Fléchon; Mansoor Saleh; Mark Scholz; Eleni Efstathiou; Andrea Zivi; Diletta Bianchini; Yohann Loriot; Nicole Chieffo; Thian Kheoh; Christopher M Haqq; Howard I Scher Journal: N Engl J Med Date: 2011-05-26 Impact factor: 91.245
Authors: G Sonpavde; V Matveev; J M Burke; J R Caton; M T Fleming; T E Hutson; M D Galsky; W R Berry; P Karlov; J T Holmlund; B A Wood; M Brookes; L Leopold Journal: Ann Oncol Date: 2011-11-23 Impact factor: 32.976
Authors: William Kevin Kelly; Susan Halabi; Michael Carducci; Daniel George; John F Mahoney; Walter M Stadler; Michael Morris; Philip Kantoff; J Paul Monk; Ellen Kaplan; Nicholas J Vogelzang; Eric J Small Journal: J Clin Oncol Date: 2012-03-26 Impact factor: 44.544
Authors: Johann Sebastian de Bono; Stephane Oudard; Mustafa Ozguroglu; Steinbjørn Hansen; Jean-Pascal Machiels; Ivo Kocak; Gwenaëlle Gravis; Istvan Bodrogi; Mary J Mackenzie; Liji Shen; Martin Roessner; Sunil Gupta; A Oliver Sartor Journal: Lancet Date: 2010-10-02 Impact factor: 79.321
Authors: Tomasz M Beer; Christopher W Ryan; Peter M Venner; Daniel P Petrylak; Gurkamal S Chatta; J Dean Ruether; Charles H Redfern; Louis Fehrenbacher; Mansoor N Saleh; David M Waterhouse; Michael A Carducci; Daniel Vicario; Robert Dreicer; Celestia S Higano; Frederick R Ahmann; Kim N Chi; W David Henner; Alan Arroyo; Fong W Clow Journal: J Clin Oncol Date: 2007-02-20 Impact factor: 44.544
Authors: Andrew J Armstrong; Elizabeth Garrett-Mayer; Yi-Chun Ou Yang; Michael A Carducci; Ian Tannock; Ronald de Wit; Mario Eisenberger Journal: J Clin Oncol Date: 2007-09-01 Impact factor: 44.544
Authors: Ian F Tannock; Ronald de Wit; William R Berry; Jozsef Horti; Anna Pluzanska; Kim N Chi; Stephane Oudard; Christine Théodore; Nicholas D James; Ingela Turesson; Mark A Rosenthal; Mario A Eisenberger Journal: N Engl J Med Date: 2004-10-07 Impact factor: 91.245
Authors: Dominik R Berthold; Gregory R Pond; Freidele Soban; Ronald de Wit; Mario Eisenberger; Ian F Tannock Journal: J Clin Oncol Date: 2008-01-10 Impact factor: 44.544
Authors: Howard I Scher; David Lu; Nicole A Schreiber; Jessica Louw; Ryon P Graf; Hebert A Vargas; Ann Johnson; Adam Jendrisak; Richard Bambury; Daniel Danila; Brigit McLaughlin; Justin Wahl; Stephanie B Greene; Glenn Heller; Dena Marrinucci; Martin Fleisher; Ryan Dittamore Journal: JAMA Oncol Date: 2016-11-01 Impact factor: 31.777