Borrega Pablo, Velasco Amalia, Bolaños Matilde, del Mar Perez María, Mel José Ramón, Reina Juan José, Rodríguez-Jaraiz María Angeles, Chaves Manuel, González-Barón Manuel
Hospital San Pedro de Alcáantara, Cáaceres, Spain.
Urol Oncol. 2004 Jan-Feb;22(1):32-5. doi: 10.1016/S1078-1439(03)00102-9.
The purpose of this study was to investigate the efficacy and safety of combination chemotherapy using estramustine and vinorelbine in chemotherapy-naïve patients with hormone-resistant prostate cancer (HRPC). The patients (n = 54) received oral estramustine 840 mg/day on Days 1 to 14 and IV vinorelbine 25 mg/m(2) on Days 1 and 8 of every 3 wk cycle. The median number of cycles per patient was 9 (range, 1 to 27). Fifty-three patients were evaluable for toxicity and survival and 52 for prostate specific antigen (PSA) response. Median age was 68 (range, 46-80). PSA sustained decrease >50% was seen in 52% of patients (95% CI: 38-66%). A complete response was seen in 3 and a partial response in 12 of 25 patients with measurable disease, for an overall objective response of 60% (95% CI: 41-79%). Improvement in performance status was observed in 30 out of 43 evaluable for clinical benefit response. The median duration of response was 7 mo and median time to progression was 6 mo. The median survival time was 15 mo. The most common adverse event was mild gastrointestinal toxicity. In general, toxicity G3-4 was low: granulocytopenia Grade 3-4 (8%), thrombocytopenia Grade 3 (6%), and anemia Grade 3 (13%). Other Grade 3 toxicities included deep vein thrombosis (4%), hepatic (2%), cardiac ischemia (2%), fatigue (6%), and sensory neuropathy (2%). There were 2 treatment-related deaths (4%). We conclude that vinorelbine and estramustine as used in this trial is an efficacious and well-tolerated therapeutic regimen in the management of HRPC.
本研究旨在调查雌莫司汀和长春瑞滨联合化疗在未经化疗的激素抵抗性前列腺癌（HRPC）患者中的疗效和安全性。54例患者在每3周周期的第1至14天接受口服雌莫司汀840mg/天，在第1天和第8天接受静脉注射长春瑞滨25mg/m²。每位患者的中位周期数为9个（范围1至27个）。53例患者可评估毒性和生存情况，52例可评估前列腺特异性抗原（PSA）反应。中位年龄为68岁（范围46 - 80岁）。52%的患者（95%CI：38 - 66%）出现PSA持续下降>50%。25例可测量疾病患者中，3例完全缓解，12例部分缓解，总体客观缓解率为60%（95%CI：41 - 79%）。43例可评估临床获益反应的患者中，30例观察到体能状态改善。中位缓解持续时间为7个月，中位疾病进展时间为6个月。中位生存时间为15个月。最常见的不良事件是轻度胃肠道毒性。总体而言，3 - 4级毒性较低：3 - 4级粒细胞减少（8%）、3级血小板减少（6%）、3级贫血（13%）。其他3级毒性包括深静脉血栓形成（4%）、肝脏毒性（2%）、心脏缺血（2%）、疲劳（6%）和感觉神经病变（2%）。有2例治疗相关死亡（4%）。我们得出结论，本试验中使用的长春瑞滨和雌莫司汀是治疗HRPC的一种有效且耐受性良好的治疗方案。
