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Pilot trial of adjuvant paclitaxel (T) and estramustine phosphate (EMP) for high-risk prostate cancer patients after radical prostatectomy (RP)



Pilot trial of adjuvant paclitaxel (T) and estramustine phosphate (EMP) for high-risk prostate cancer patients after radical prostatectomy (RP)



Journal of Clinical Oncology 23(16_suppl): 4775-4775



NlmCategory="UNASSIGNED">4775 Background: A previous study from our center demonstrated that preoperative prostate specific antigen (PSA) and prostatectomy pathology can identify patients with a high risk of 2-year PSA failure (D'Amico, et al., J. Urology, 1998). We hypothesize that chemotherapy active in hormone-refractory prostate cancer could decrease this risk. We are performing a pilot trial of adjuvant T plus EMP in patients with a 2-year PSA failure risk of ≥50%. Men within 12 weeks of RP with a ≥50% predicted risk of 2-year PSA failure, as predicted by the above study, received T 90mg/m2 days 2, 9, and 16 every 28 days, and EMP 420mg orally days 1-3, 8-10, and 15-17 every 28 days. Four cycles were given. Men were followed with serial PSA examinations every three months after completing therapy. As of December 2004, 15 patients have been accrued. Median age: 60 (51-69). Median predicted 2-year PSA failure risk: 70 (52-99). 13 patients have completed therapy with a median follow-up of 12 (1.5-31) months. Prolonged neutrophil recovery required a dose reduction of therapy in 1 patient. There were no grade 4 adverse events. Grade 3 toxicities included a deep venous thrombosis (1 patient). 3 patients have had PSA failure (pretreatment risks: 70%, 80%, 99%) at 17, 17, and 11 months, respectively. They have been treated with salvage radiation therapy to the prostatic bed (3 patients) and salvage hormonal therapy (2 patients). It is feasible and safe to administer adjuvant weekly paclitaxel and estramustine phosphate to men after RP. Further patient enrollment and follow-up are required for assessment of risk reduction (Supported by Bristol-Myers Squibb). [Table: see text].

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Accession: 058558082

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PMID: 27944003



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