Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer - West Japan Thoracic Oncology Group (WJTOG) 0104
Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer - West Japan Thoracic Oncology Group (WJTOG) 0104
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DOI：
10.1002/cncr.22024
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发表时间：
2006-08-01
期刊：
影响因子：
6.2
通讯作者：
Fukuoka, Masahiro
中科院分区：
文献类型：
--
作者：
Yamamoto, Nobuyuki;Nakagawa, Kazuhiko;Fukuoka, Masahiro
背景。吉西他滨联合卡铂 (GC) 以及吉西他滨联合长春瑞滨 (GV) 是晚期非小细胞肺癌 (NSCLC) 患者的积极且耐受性良好的化疗方案。作者对 GC 与 GV 进行了一项随机 II 期研究，以比较它们的功效和毒性。 128 名 IIIB 或 IV 期 NSCLC 患者随机接受第一天曲线下面积 5 的卡铂联合第 1 天和第 8 天的吉西他滨 1000 mg/m(2)（n = 64 名患者）或第 1 天和第 8 天的长春瑞滨 25 mg/m(2) 联合吉西他滨 1000 mg/m(2)（n = 64 名患者）每 3 个 周.结果。 GC 患者的缓解率为 20.3%，GV 患者的缓解率为 21.0%。 GC组的中位生存期为432天，I年生存率为57.6%； GV 组的中位生存期为 385 天，1 年生存率为 53.3%。 GC 组的中位无进展生存期为 165 天，GV 组的中位无进展生存期为 137 天。 GC 组中严重血液毒性（4 级）的发生率明显更高（45.3% vs. GV 组中的 25.8%；P = .022）。最值得注意的是，GC 组中 3 级或 4 级血小板减少症的发生率显着较高（81.3% vs. GV 组中的 6.5%；P < .001）。相反，严重的非血液毒性（3 级或 4 级）在 GV 组中更为常见（7.8% vs. GC 组中的 19.4%；P = .057）。结论。尽管GV和GC方案具有不同的毒性特征，但在本研究中NSCLC患者的生存率没有显着差异。
BACKGROUND. Combined gemcitabine and carboplatin (GC) and combined gemcitabine and vinorelbine (GV) are active and well tolerated chemotherapeutic regimens for patients with advanced nonsmall cell lung cancer (NSCLC). The authors conducted a randomized Phase II study of GC versus GV to compare them in terms of efficacy and toxicity.METHODS. One hundred twenty-eight patients with Stage IIIB or IV NSCLC were randomized to receive either carboplatin at an area under the curve of 5 on Day I combined with gemcitabine 1000 mg/m(2) on Days 1 and 8 (n = 64 patients) or vinorelbine 25 mg/m(2) combined with gemcitabine 1000 mg/m(2) on Days 1 and 8 (n = 64 patients) every 3 weeks.RESULTS. Response rates were 20.3% for the GC patients and 21.0% for the GV patients. In the GC arm, the median survival was 432 days, and the a I-year survival rate was 57.6%; in the GV arm, the median survival was 385 days, and the 1-year survival rate was 53.3% in the GV arm. The median progression-free survival was 165 days in the GC arm and 137 days in the GV arm. Severe hematologic toxicity (Grade 4) was significantly more frequent in the GC arm (45.3% vs. 25.8% in the GV arm; P = .022). Most notably, the incidence of Grade 3 or 4 thrombocytopenia was significantly higher in the GC arm (81.3% vs. 6.5% in the GV arm; P < .001). Conversely, severe nonhematologic toxicity (Grade 3 or 4) was more common in the GV arm (7.8% vs. 19.4% in the GC arm; P = .057).CONCLUSIONS. Although the GV and GC regimens had different toxicity profiles, there was no significant difference in survival among patients with NSCLC in the current study.