Helbekkmo N, Sundstrøm S H, Aasebø U, Brunsvig P Fr, von Plessen C, Hjelde H H, Garpestad O K, Bailey A, Bremnes R M
Institute of Clinical Medicine, University of Tromsø and Department of Oncology, University Hospital of Northern Norway, 9038 Tromsø, Norway.
Br J Cancer. 2007 Aug 6;97(3):283-9. doi: 10.1038/sj.bjc.6603869. Epub 2007 Jun 26.
This randomised phase III study in advanced non-small cell lung cancer (NSCLC) patients was conducted to compare vinorelbine/carboplatin (VC) and gemcitabine/carboplatin (GC) regarding efficacy, health-related quality of life (HRQOL) and toxicity. Chemonaive patients with NSCLC stage IIIB/IV and WHO performance status 0-2 were eligible. No upper age limit was defined. Patients received vinorelbine 25 mg m(-2) or gemcitabine 1000 mg m(-2) on days 1 and 8 and carboplatin AUC4 on day 1 and three courses with 3-week cycles. HRQOL questionnaires were completed at baseline, before chemotherapy and every 8 weeks until 49 weeks. During 14 months, 432 patients were included (VC, n=218; GC, n=214). Median survival was 7.3 vs 6.4 months, 1-year survival 28 vs 30% and 2-year survival 7 vs 7% in the VC and GC arm, respectively (P=0.89). HRQOL, represented by global QOL, nausea/vomiting, dyspnoea and pain, showed no significant differences. More grade 3-4 anaemia (P<0.01), thrombocytopenia (P<0.01) and transfusions of blood (P<0.01) or platelets (P<0.01) were observed in the GC arm. There was more grade 3-4 leucopoenia (P<0.01) in the VC arm, but the rate of neutropenic infections was the same (P=0.87). In conclusion, overall survival and HRQOL are similar, while grade 3-4 toxicity requiring interventions are less frequent when VC is compared to GC in advanced NSCLC.
这项针对晚期非小细胞肺癌（NSCLC）患者的随机III期研究旨在比较长春瑞滨/卡铂（VC）和吉西他滨/卡铂（GC）在疗效、健康相关生活质量（HRQOL）及毒性方面的差异。符合条件的为未经化疗的IIIB/IV期NSCLC患者，且世界卫生组织体能状态为0 - 2级，未设定年龄上限。患者在第1天和第8天接受长春瑞滨25 mg m(-2)或吉西他滨1000 mg m(-2)，并在第1天接受卡铂AUC4，每3周为一个疗程，共三个疗程。HRQOL问卷在基线、化疗前以及化疗后每8周直至49周时完成。在14个月期间，共纳入432例患者（VC组，n = 218；GC组，n = 214）。VC组和GC组的中位生存期分别为7.3个月和6.4个月，1年生存率分别为28%和30%，2年生存率分别为7%和7%（P = 0.89）。以总体生活质量、恶心/呕吐、呼吸困难和疼痛所代表的HRQOL无显著差异。GC组观察到更多的3 - 4级贫血（P < 0.01）、血小板减少症（P < 0.01）以及输血（P < 0.01）或输血小板（P < 0.01）情况。VC组有更多的3 - 4级白细胞减少症（P < 0.01），但中性粒细胞感染率相同（P = 0.87）。总之，在晚期NSCLC中，与GC相比，VC的总生存期和HRQOL相似，但需要干预的3 - 4级毒性反应发生率更低。
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