Le Chevalier T, Pujol J L, Douillard J Y, Alberola V, Monnier A, Riviere A, Lianes P, Chomy P, Cigolari S, Besson F
Institut Gustave Roussy, Villejuif, France.
Semin Oncol. 1994 Oct;21(5 Suppl 10):28-33; discussion 33-4.
Phase II studies have demonstrated that vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) alone or in combination with cisplatin has promising activity against non-small cell lung cancer (NSCLC). On the basis of these preliminary trials, a phase III study was designed to compare intravenous vinorelbine (30 mg/m2 weekly) plus cisplatin (120 mg/m2 on day 1 and day 29 and then every 6 weeks) with vindesine (3 mg/m2 weekly for 6 weeks and then every 2 weeks) plus cisplatin, and to evaluate whether the best of these regimens afforded a survival benefit compared with intravenous vinorelbine alone, an outpatient regimen. This report presents an expanded analysis of data from this previously published study. Six hundred twelve patients were enrolled in this trial: 206 in the vinorelbine plus cisplatin arm, 200 in the vindesine plus cisplatin group, and 206 in the single-agent vinorelbine arm. The vinorelbine plus cisplatin regimen was superior to the other two arms of the study in objective response rate (30% v 19% for vindesine plus cisplatin [P = .02] and 14% for vinorelbine alone [P = .001]), median survival duration (40 weeks v 32 weeks for vindesine plus cisplatin and 31 weeks for vinorelbine alone), and 1-year survival rate (35% v 27% for vindesine plus cisplatin and 30% for vinorelbine alone). An adjusted log-rank test provided a significant advantage for vinorelbine plus cisplatin when compared with vindesine plus cisplatin (P = .04) and with vinorelbine alone (P = .02). The major difference in survival between the two cisplatin-containing regimens occurred in patients with metastatic (stage IV) NSCLC. The incidence of granulocytopenia was significantly higher in the vinorelbine plus cisplatin arm compared with the other two treatment groups, but neurotoxicity was significantly more frequent in the vindesine plus cisplatin group. The results of this study indicate that the combination of vinorelbine plus cisplatin is a viable treatment option for patients with NSCLC and may provide advantages compared with other commonly used regimens.
II期研究表明，长春瑞滨（诺维本；百时美施贵宝公司，北卡罗来纳州三角研究园；法国巴黎皮尔法伯制药公司）单独使用或与顺铂联合使用，对非小细胞肺癌（NSCLC）具有可观的活性。基于这些初步试验，设计了一项III期研究，以比较静脉注射长春瑞滨（30 mg/m²，每周一次）加顺铂（第1天和第29天各120 mg/m²，然后每6周一次）与长春地辛（3 mg/m²，每周一次，共6周，然后每2周一次）加顺铂，并评估这些方案中最佳方案与单独静脉注射长春瑞滨（一种门诊治疗方案）相比是否能带来生存获益。本报告对这项先前发表研究的数据进行了扩展分析。612例患者参加了该试验：长春瑞滨加顺铂组206例，长春地辛加顺铂组200例，长春瑞滨单药组206例。长春瑞滨加顺铂方案在客观缓解率（长春地辛加顺铂组为19%[P = 0.02]，长春瑞滨单药组为14%[P = 0.001]）、中位生存期（长春地辛加顺铂组为32周，长春瑞滨单药组为31周）和1年生存率（长春地辛加顺铂组为27%，长春瑞滨单药组为30%）方面均优于研究的其他两组。与长春地辛加顺铂组（P = 0.04）和长春瑞滨单药组（P = 0.02）相比，校正对数秩检验显示长春瑞滨加顺铂具有显著优势。两种含顺铂方案在生存方面的主要差异出现在转移性（IV期）NSCLC患者中。长春瑞滨加顺铂组的粒细胞减少发生率显著高于其他两个治疗组，但长春地辛加顺铂组的神经毒性更为常见。本研究结果表明，长春瑞滨加顺铂联合方案是NSCLC患者的一种可行治疗选择，与其他常用方案相比可能具有优势。
