Cisplatin, gemcitabine, and vinorelbine combination therapy in advanced non-small-cell lung cancer: A phase II randomized study of the Southern Italy Cooperative Oncology Group
Cisplatin, gemcitabine, and vinorelbine combination therapy in advanced non-small-cell lung cancer: A phase II randomized study of the Southern Italy Cooperative Oncology Group
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DOI：
10.1200/jco.1999.17.5.1526
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发表时间：
1999-05-01
影响因子：
45.3
通讯作者：
Comella, G
中科院分区：
文献类型：
--
作者：
Comella, P;Frasci, G;Comella, G
目的：在之前的一项I期研究中，顺铂（CDDP）、吉西他滨（GEM）和长春瑞滨（VNR）联合治疗非小细胞肺癌（NSCLC）患者是安全且非常有效的。本研究旨在更好地确定该方案的活性和毒性。患者和方法：111例年龄小于或等于70岁，IIIB期或IV期NSCLC，表现状态为0或1（东部肿瘤合作组量表）的首次化疗患者随机分为两个治疗组。A组患者在每3周周期的第1天和第8天接受CDDP 50 mg/m(2), GEM 1000 mg/m(2)和VNR 25 mg/m(2)治疗（57例患者）。B组患者接受CDDP 80mg /m(2)，表柔比星80mg /m(2)，长春地辛3mg /m(2)，每4周第1天给药，加口服150mg，每日3次洛尼达明（54例）。1996年12月，早期停止了随机分配，另外30名患者接受了实验方案的治疗，以获得对其活性更准确的估计。结果：在87例接受CDDP-GEM-VNR联合治疗的患者中，观察到4例完全缓解（cr）和46例部分缓解（pr），总缓解率为57%（95%置信区间[CI]， 46%至68%）。在B组的54例患者中记录了2例cr和18例pr，活动率为37% （95% CI， 24%至51%）。中位随访时间为19个月后，a组的中位无进展生存期和总生存期分别为32周和50周，B组的中位生存期分别为18周和33周。世界卫生组织3 - 4级中性粒细胞减少症和血小板减少症在A组分别占46%和14%，在B组分别占22%和11%。严重的非血液学毒性在两组均不常见。结论：CDDP-GEM- vnr联合治疗晚期非小细胞肺癌是一种非常有效的治疗方法，并且具有可控的毒性。一项比较CDDP-VNR和CDDP-GEM联合治疗方案的III期临床试验正在进行中。(C) 1999年由美国临床肿瘤学会出版。
Purpose: In a previous phase I study cisplatin (CDDP), gemcitabine (GEM), and vinorelbine (VNR) combination therapy was safe and very active in patients with non-small-cell lung cancer (NSCLC). This study was aimed at better defining the activity and toxicity of this regimen.Patients and Methods: One hundred eleven chemotherapy-naive patients, age less than or equal to 70 years, with stage IIIB or IV NSCLC and a performance status of 0 or 1 (Eastern Cooperative Oncology Group scale) were randomized to two treatment arms. Patients on arm A received CDDP 50 mg/m(2), GEM 1,000 mg/m(2), and VNR 25 mg/m(2) on days 1 and 8 of an every-3-weeks cycle (57 patients). Patients on arm B received CDDP 80 mg/m(2), epirubicin 80 mg/m(2), and vindesine 3 mg/m(2), all delivered on day 1 every 4 weeks, plus lonidamine orally 150 mg three times daily (54 patients). In December 1996, randomization was stopped early, and an additional 30 patients were treated with the experimental regimen to obtain a more accurate estimation of its activity rare.Results: Among 87 patients who received the CDDP-GEM-VNR combination, four complete responses (CRs) and 46 partial responses (PRs) were observed, for an overall response rate of 57% (95% confidence interval [CI], 46% to 68%). Two CRs and 18 PRs were recorded among 54 patients on arm B, giving a 37% activity rate (95% CI, 24% to 51%). After a median follow-up duration of 19 months, the median progression-free and overall survival durations were 32 and 50 weeks in arm A, and 18 and 33 weeks in arm B, respectively. World Health Organization grade 3 to 4 neutropenia and thrombocytopenia occurred in 46% and 14% of patients in arm A and in 22% and 11% of those in arm B, respectively. Severe nonhematologic toxicity was uncommon in both arms.Conclusion: The CDDP-GEM-VNR combination is a highly effective treatment for patients with advanced NSCLC and has a manageable toxicity A phase III trial comparing this new combination with both CDDP-VNR and CDDP-GEM regimens is underway J Clin Oncol 17:1526-1534. (C) 1999 by American Society of Clinical Oncology.