Colleoni M, Graiff C, Vicario G, Nelli P, Sgarbossa G, Pancheri F, Manente P
Division of Medical Oncology, City Hospital, Castelfranco Veneto, Italy.
Am J Clin Oncol. 1997 Aug;20(4):383-6. doi: 10.1097/00000421-199708000-00013.
Hormone-refractory prostate cancer is characterized by a low response rate following second-line therapy. Encouraging results have been reported in Phase II studies with estramustine associated with vinblastine or etoposide. Vinorelbine is a new semisynthetic vinca alkaloid that has demonstrated activity in prostate cancer. We therefore evaluated the activity of the following schedule: estramustine, 400 mg/m2 orally days 1-42; etoposide, 50 mg/m2 orally days 1-14; and 28-42; vinorelbine, 20 mg/m2 days 1, 8, 28, and 35; cycles being repeated every 8 weeks. Twenty-five patients have been included and are assessable for response and side effects. Patient characteristics were as follows: median age, 71 years (range 55-81); ECOG performance status 0-2; nonosseous disease, 3 cases; bone metastases, 23 cases. Sixty-two cycles have been delivered. Two patients with measurable disease and six patients with bone disease had a partial remission for an overall response rate of 32% (95% confidence interval 15-53%). Seven patients had stabilization of disease and 10 had progression of disease. Median duration of response was 3 months (range 2-5). Prostate-specific antigen in 14 patients (56%) decreased from baseline by at least 50%. Toxicity was manageable. Neutropenia was mild, with only three cases of grade III-IV toxicity. Two patients had severe anemia. The results of this study indicate that the schedule is active and well tolerated in hormone-refractory prostate cancer patients.
激素难治性前列腺癌的特点是二线治疗后的缓解率较低。在雌莫司汀联合长春碱或依托泊苷的II期研究中报告了令人鼓舞的结果。长春瑞滨是一种新的半合成长春花生物碱，已在前列腺癌中显示出活性。因此，我们评估了以下方案的活性：雌莫司汀，400mg/m²，口服，第1 - 42天；依托泊苷，50mg/m²，口服，第1 - 14天和第28 - 42天；长春瑞滨，20mg/m²，第1、8、28和35天；每8周重复一个周期。纳入了25例患者，可评估其缓解情况和副作用。患者特征如下：中位年龄71岁（范围55 - 81岁）；东部肿瘤协作组（ECOG）体能状态0 - 2；非骨转移疾病3例；骨转移23例。已进行了62个周期的治疗。2例可测量疾病患者和6例骨疾病患者部分缓解，总缓解率为32%（95%置信区间15 - 53%）。7例患者疾病稳定，10例患者疾病进展。中位缓解持续时间为3个月（范围2 - 5个月）。14例患者（56%）的前列腺特异性抗原从基线水平至少下降了50%。毒性可控。中性粒细胞减少症较轻，只有3例III - IV级毒性。2例患者有严重贫血。本研究结果表明，该方案在激素难治性前列腺癌患者中具有活性且耐受性良好。
