Fumoleau P, Delozier T, Extra J M, Canobbio L, Delgado F M, Hurteloup P
Centre René Gauducheau-I.C.E.R.C., CRLCC Nantes-Atlantique, St Herblain, France.
Semin Oncol. 1995 Apr;22(2 Suppl 5):22-8; discussion 28-9.
Phase II studies of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) have been conducted mainly at a dose of 30 mg/m2/wk, and this schedule has been used extensively in the treatment of advanced breast cancer. Vinorelbine used in a first-line setting as a single agent in 25 patients with previously untreated advanced metastatic breast cancer produced objective responses in 15 patients (60%) and complete responses (CR) in five (20%). A large multicenter study to assess the response rate by the main site of disease involvement included 145 assessable patients. The overall response rate was 41% (10 CRs and 50 partial responses: skin, 70%; lymph nodes, 67%; primary tumor, 56%; lungs, 33%; measurable bone, 27%; and liver, 23%). The median time to disease progression was 25 weeks and the median overall survival duration was 18 months. Neutropenia was the principal toxicity with grade 3/4 suppression noted; however, this was not accompanied by serious infection (incidence of grade 3/4 infection < 1%). Other grade 3/4 toxicity also was uncommon. Another phase II study included 50 patients assessable for toxicity and response. The overall response rate was 50% (2% CRs). In a salvage setting (second- and third-line treatment), 33 patients were treated with an overall response rate of 30% (two CRs). Rates of toxicity were no greater than in first-line patients. The most notable results for combination vinorelbine therapy were with a schedule of vinorelbine 25 mg/m2 on days 1 and 8 and doxorubicin 50 mg/m2 on day 1, with cycles repeated every 21 days. The overall response rate for the 89 evaluable patients was 74% (19 [21%] CRs; 47 [53%] partial responses). These data indicate that vinorelbine is a highly active agent with a favorable toxicity profile in the treatment of breast cancer.
长春瑞滨（商品名：诺维本；由位于北卡罗来纳州三角研究园的百时美施贵宝公司生产；法国巴黎的皮尔法伯制药公司生产）的Ⅱ期研究主要采用30mg/m²/周的剂量进行，该给药方案已广泛用于晚期乳腺癌的治疗。在25例先前未经治疗的晚期转移性乳腺癌患者中，将长春瑞滨作为一线单药治疗，15例患者（60%）出现客观缓解，5例（20%）完全缓解。一项评估按疾病主要受累部位划分的缓解率的大型多中心研究纳入了145例可评估患者。总体缓解率为41%（10例完全缓解和50例部分缓解：皮肤，70%；淋巴结，67%；原发肿瘤，56%；肺，33%；可测量的骨，27%；肝脏，23%）。疾病进展的中位时间为25周，中位总生存期为18个月。中性粒细胞减少是主要毒性，出现3/4级抑制；然而，并未伴随严重感染（3/4级感染发生率<1%）。其他3/4级毒性也不常见。另一项Ⅱ期研究纳入了50例可评估毒性和缓解情况的患者。总体缓解率为50%（2%完全缓解）。在挽救治疗（二线和三线治疗）中，33例患者接受治疗，总体缓解率为30%（2例完全缓解）。毒性发生率不高于一线治疗患者。长春瑞滨联合治疗最显著的结果是采用长春瑞滨25mg/m²于第1天和第8天给药，多柔比星50mg/m²于第1天给药的方案，每21天重复一个周期。89例可评估患者的总体缓解率为74%（19例[21%]完全缓解；47例[53%]部分缓解）。这些数据表明，长春瑞滨在乳腺癌治疗中是一种活性很高且毒性特征良好的药物。
