Crawford J, O'Rourke M, Schiller J H, Spiridonidis C H, Yanovich S, Ozer H, Langleben A, Hutchins L, Koletsky A, Clamon G, Burman S, White R, Hohneker J
Duke University Medical Center, Durham, NC 27710, USA.
J Clin Oncol. 1996 Oct;14(10):2774-84. doi: 10.1200/JCO.1996.14.10.2774.
This prospective randomized trial was performed to compare the effectiveness of intravenous vinorelbine tartrate with intravenous fluorouracil and leucovorin (5-FU/LV) on the primary end points of survival, quality of life (QOL), and relief of cancer-related symptoms in patients with advanced non-small-cell lung cancer (NSCLC). Secondary end points included tumor response rates and time to treatment failure. In addition, the safety of both treatment regimens was evaluated in this multicenter study.
Two hundred sixteen patients with stage IV NSCLC were enrolled onto this study from 18 centers. Vinorelbine was administered at a dose of 30 mg/m2/wk. 5-FU/LV was administered at a dose of 425 mg/m2 and 20 mg/m2, respectively, for 5 consecutive days every 4 weeks. Patients with progressive disease or toxicity were removed from study while responding and stable patients were continued on therapy.
The median survival time of patients who received vinorelbine was 30 weeks, with 25% of patients alive at 1 year, compared with a median survival time of 22 weeks and 16% of patients alive at 1 year for those treated with 5-FU/LV (P = .03, log-rank test). This improvement in survival was associated with a higher objective response rate (12% v 3%) and time to treatment failure (10 weeks v 8 weeks) for vinorelbine versus 5-FU/LV. The dose-limiting toxicity of vinorelbine was granulocytopenia, with 54% of patients experiencing grade 3/4 granulocytopenia. Nonhematologic toxicity of vinorelbine was generally grade 1 or 2. The most common grade 3 toxicities were related to injection-site reactions.
This trial confirms the efficacy of vinorelbine in patients with advanced NSCLC. The clinical activity and relatively favorable toxicity profile of this agent make it a reasonable and useful treatment option in the management of patients with this disease.
本前瞻性随机试验旨在比较静脉注射酒石酸长春瑞滨与静脉注射氟尿嘧啶和亚叶酸钙（5-FU/LV）在晚期非小细胞肺癌（NSCLC）患者生存、生活质量（QOL）及癌症相关症状缓解等主要终点方面的有效性。次要终点包括肿瘤反应率和治疗失败时间。此外，在这项多中心研究中评估了两种治疗方案的安全性。
来自18个中心的216例IV期NSCLC患者纳入本研究。长春瑞滨以30mg/m²/周的剂量给药。5-FU/LV分别以425mg/m²和20mg/m²的剂量，每4周连续给药5天。疾病进展或出现毒性反应的患者退出研究，有反应和病情稳定的患者继续接受治疗。
接受长春瑞滨治疗的患者中位生存时间为30周，1年时25%的患者存活；相比之下，接受5-FU/LV治疗的患者中位生存时间为22周，1年时16%的患者存活（P = 0.03，对数秩检验）。长春瑞滨组生存的改善与更高的客观反应率（12%对3%）和治疗失败时间（10周对8周）相关，与5-FU/LV组相比。长春瑞滨的剂量限制性毒性为粒细胞减少，54%的患者出现3/4级粒细胞减少。长春瑞滨的非血液学毒性一般为1或2级。最常见的3级毒性反应与注射部位反应有关。
本试验证实了长春瑞滨在晚期NSCLC患者中的疗效。该药物的临床活性和相对良好的毒性特征使其成为治疗该疾病患者的合理且有用的治疗选择。
