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首页> 外文期刊>Lung cancer: Journal of the International Association for the Study of Lung Cancer >Randomized multicentric phase II study of carboplatin/gemcitabine and cisplatin/vinorelbine in advanced non-small cell lung cancer GFPC 99-01 study (Groupe francais de pneumo-cancerologie).
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Randomized multicentric phase II study of carboplatin/gemcitabine and cisplatin/vinorelbine in advanced non-small cell lung cancer GFPC 99-01 study (Groupe francais de pneumo-cancerologie).

机译：随机多中心II期研究卡铂/吉西他滨和顺铂/ vinorelbine在先进的非小细胞肺癌GFPC 99 - 01研究(Groupe法国pneumo-cancerologie)。

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摘要

PURPOSE: To evaluate the efficacy and safety of gemcitabine and carboplatin in the treatment of previously untreated patients with advanced non-small cell lung cancer (NSCLC). METHODS: A randomized phase II study was conducted by the Groupe Francais de Pneumo-Cancerologie (GFPC) in 15 centers. The patients were randomized in either arm A (GC): gemcitabine 1250 mg/m2 on days 1 and 8+carboplatin AUC 6 mg/(mLmin) on day 1; or in arm B (VP): vinorelbine 30 mg/m2 weekly+cisplatin 80 mg/m2 on day 1. Treatment cycles were repeated every 3 weeks. RESULTS: A total of 100 patients were randomized with stage IV or stage III NSCLC with malignant pleural effusion: 51 patients in arm A and 49 patients in arm B. A total of 190 cycles were administered in the GC arm and 172 cycles in the VP arm, with a median of four cycles per patient in each arm. The dose intensity was 84.9% for gemcitabine, 99.8% for carboplatin, 97.7% for cisplatin and 67.7% for vinorelbine. The objective response rates were 19.6% (95% CI, 9.8-33.1) for GC and 29.2% (95% CI, 17.0-44.1) for VP in an ITT analysis. The response duration was 169 days in arm A and 226 days in arm B. The TTP was similar with 140 days (GC) and 148 days (VP), respectively. Overall survival rates were 334 days in the GC combination and 304 days in the VP combination. Overall, the treatment was safe and toxicities observed were different in each arm: neutropenia was the most common toxicity in the VP treatment, whereas thrombocytopenia was more frequent in the GC combination. Anemia was similar in both arms. Non-haematologic toxicity was mild. One toxic death in arm A and three toxic deaths in arm B were observed. CONCLUSION: In terms of response rate, the gemcitabine-carboplatin combination was not efficient enough to allow further phase III study. Survival data are in the same range as the standard arm. This chemotherapy is feasible and may represent an alternative to a standard cisplatin-based regimen, allowing treatment in an outpatient setting.
机译：目的:评估的有效性和安全性吉西他滨和卡铂治疗以前未经治疗的患者非小细胞肺癌(NSCLC)。随机二期进行的研究法国Pneumo-Cancerologie GFPC) in group的15个中心。要么手臂(GC):吉西他滨1250 mg / m2在天1和8 +卡铂AUC 6毫克/天(mLmin) 1;在臂B(副总裁):vinorelbine 30毫克/平方米每周1天+顺铂80 mg / m2。重复周期是每3周。共有100名患者被随机分配阶段IV或III期非小细胞肺癌和恶性胸膜积液:51例在手臂和49个病人臂b .总共有190个周期管理GC的胳膊,172次的副总裁的手臂,用中间的四个周期每个病人每个手臂。吉西他滨的剂量强度为84.9%,为顺铂和卡铂为99.8%,97.7%vinorelbine为67.7%。利率分别为19.6% (95% CI, 9.8 - -33.1) GC和29.2% (95% CI, 17.0 - -44.1)在ITT公司副总裁分析。胳膊手臂和226天b TTP是相似的148天140天(GC)和(副总裁)分别。天在GC组合和304天的副总裁组合。毒性观察每个手臂是不同的:嗜中性白血球减少症是最常见的毒性副总裁治疗,而血小板减少症是更多频繁的GC的组合。类似的武器。是温和的。有毒的手臂B观察死亡人数。在响应速度方面,gemcitabine-carboplatin组合并不高效足以允许进一步的第三阶段研究。标准的手臂。可能代表另一个标准吗cisplatin-based方案,允许在一个治疗门诊。

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