Smith M R, Kaufman D, Oh W, Guerin K, Seiden M, Makatsoris T, Manola J, Kantoff P W
Massachusetts General Hospital, Boston, Massachusetts, USA.
Cancer. 2000 Oct 15;89(8):1824-8. doi: 10.1002/1097-0142(20001015)89:8<1824::aid-cncr24>3.0.co;2-r.
The aim of this study was to determine the safety and activity of vinorelbine in combination with estramustine in men with androgen-independent metastatic prostate cancer.
Twenty-five men with androgen-independent metastatic prostate cancer were treated with the combination of vinorelbine and estramustine. Vinorelbine 25 mg/m(2) was administered by intravenous bolus on Days 1 and 8. Estramustine 140 mg was administered three times a day by mouth on Days 1 through 14. Treatment was repeated every 21 days.
A total of 132 cycles of treatment were administered. The median number of cycles per patient was 5 (range: 1-16). Mild Grade 1 or 2 gastrointestinal toxicity and fatigue were the most common adverse effects. Hematologic toxicity was minimal. Treatment resulted in a sustained > 50% decrease in serum prostate-specific antigen (PSA) in 6 of 25 patients (24% of patients; 95% confidence interval (CI) 9-45%). The median duration of PSA response was 10 weeks (range: 3-39 weeks). Of the five men with bidimensionally measurable disease, none achieved a complete or partial response. There were no documented improvements in post-treatment bone scans. Median overall survival time was 14.1 months.
The combination of vinorelbine and estramustine is a well-tolerated and modestly active regimen in men with androgen-independent metastatic prostate cancer.
本研究的目的是确定长春瑞滨联合雌莫司汀治疗雄激素非依赖性转移性前列腺癌男性患者的安全性和活性。
25例雄激素非依赖性转移性前列腺癌男性患者接受长春瑞滨和雌莫司汀联合治疗。长春瑞滨25mg/m²于第1天和第8天静脉推注给药。雌莫司汀140mg于第1天至第14天每天口服3次。每21天重复治疗。
共进行了132个周期的治疗。每位患者的中位周期数为5个（范围：1 - 16个）。轻度1级或2级胃肠道毒性和疲劳是最常见的不良反应。血液学毒性极小。治疗使25例患者中的6例（24%的患者；95%置信区间9 - 45%）血清前列腺特异性抗原（PSA）持续下降>50%。PSA反应的中位持续时间为10周（范围：3 - 39周）。在5例具有二维可测量疾病的男性患者中，无一例达到完全或部分缓解。治疗后骨扫描未见记录在案的改善。中位总生存时间为14.1个月。
长春瑞滨和雌莫司汀联合方案在雄激素非依赖性转移性前列腺癌男性患者中耐受性良好且有一定活性。
