TY - JOUR
T1 - Evaluating the value of number of cycles of docetaxel and prednisone in men with metastatic castration-resistant prostate cancer
AU - Pond, Gregory R.
AU - Armstrong, Andrew J.
AU - Wood, Brian A.
AU - Brookes, Melissa
AU - Leopold, Lance
AU - Berry, William R.
AU - De Wit, Ronald
AU - Eisenberger, Mario A.
AU - Tannock, Ian F.
AU - Sonpavde, Guru
PY - 2012/2
Y1 - 2012/2
N2 - 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.
AB - 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.
KW - Docetaxel
KW - Metastatic castration-resistant prostate cancer
KW - Prednisone
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UR - http://www.scopus.com/inward/citedby.url?scp=83955161760&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2011.06.034
DO - 10.1016/j.eururo.2011.06.034
M3 - Article
C2 - 21715086
AN - SCOPUS:83955161760
SN - 0302-2838
VL - 61
SP - 363
EP - 369
JO - European Urology
JF - European Urology
IS - 2
ER -