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Wong YN , Manola J , Hudes GR , Roth BJ , Moul JW , Barsevick AM , Scher RM , Volk MJ , Vaughn DJ , Williams SD , Fisch MJ , Cella D , Carducci MA , Wilding G
Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial
Clin Genitourin Cancer. 2018 Apr;16(2) :e315-e322
PMID: 29173976    PMCID: PMC5975965    URL: https://www.ncbi.nlm.nih.gov/pubmed/29173976
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INTRODUCTION: This multicenter phase 2 study assessed the combination of estramustine and weekly paclitaxel with metastatic castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: We enrolled 77 patients who had received no prior chemotherapy for CRPC between 1998 and 2000; a total of 74 subjects were eligible for the study. Each 8-week cycle included paclitaxel 90 mg/m(2) provided intravenously weekly for 6 weeks, followed by 2 weeks off therapy and oral estramustine 280 mg twice daily for 3 days beginning 24 hours before the first dose of paclitaxel. The primary end point was rate of objective or prostate-specific antigen (PSA) response at 16 weeks. A 50% response rate was considered of further interest. RESULTS: Eligible patients received a median of 3 cycles (range, 1-10 cycles). The response rate among patients with measurable disease was 34% (95% confidence interval [CI], 19-52). The PSA response rate was 58% (95% CI, 47-70). Clinical benefit rate was 45% (95% CI, 33-57). The median progression-free survival was 5.9 months (95% CI, 4.4-6.7). The median overall survival was 17.6 months (95% CI, 14.6-20.8). The most common clinical grade 3/4 toxicities were fatigue (14%) and sensory neuropathy (7%). Grade 3/4 hematologic toxicities included lymphopenia (21%) and anemia (9%). There was one toxicity-related death. Quality-of-life scores improved by week 8, but the change was not statistically significant. CONCLUSION: The combination has activity defined by PSA declines in CRPC but did not meet the protocol-specified end point for efficacy as defined by objective response rate. Since this study was conducted, more effective, better-tolerated regimens have been developed.
Wong, Yu-Ning Manola, Judith Hudes, Gary R Roth, Bruce J Moul, Judd W Barsevick, Andrea M Scher, Richard M Volk, Michael J Vaughn, David J Williams, Stephen D Fisch, Michael J Cella, David Carducci, Michael A Wilding, George eng Clin Genitourin Cancer. 2018 Apr;16(2):e315-e322. doi: 10.1016/j.clgc.2017.10.001. Epub 2017 Oct 16.