Palliative chemotherapy beyond three courses conveys no survival or consistent quality-of-life benefits in advanced non-small-cell lung cancer.
Palliative chemotherapy beyond three courses conveys no survival or consistent quality-of-life benefits in advanced non-small-cell lung cancer.
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DOI：
10.1038/sj.bjc.6603383
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发表时间：
2006-10-23
影响因子：
8.8
通讯作者：
Sorenson, S
中科院分区：
文献类型：
--
作者：
von Plessen, C;Bergman, B;Andresen, O;Bremnes, R M;Sundstrom, S;Gilleryd, M;Stephens, R;Vilsvik, J;Aasebo, U;Sorenson, S
这项随机多中心试验旨在确定晚期非小细胞肺癌(NSCLC)姑息化疗的最佳持续时间。我们比较了三个疗程和六个疗程的新一代铂为主的联合化疗对生活质量和生存的影响。IIIB或IV期非小细胞肺癌患者被随机分为3个(C3)或6个(C6)疗程，分别在第1天接受卡铂(曲线下面积4，查特鲁特公式，相当于卡尔弗氏AUC5)治疗，在第3周周期的第1天和第8天接受长春瑞滨25 mg m−2治疗。用EORTC生活质量问卷(QLQ)-C30和QLQ-LC13测量18周时的生活质量和总体生存情况。次要终点是无进展生存和需要姑息性放射治疗。297例患者被随机分组(C3150例，C6147例)。他们的中位年龄为65岁，30%患有PS 2，76%患有IV期疾病。78分别有54%的C3和C6患者完成了所有预定的化疗疗程。生活质量调查问卷的遵从率为88%。在全球生活质量、疼痛或疲劳方面，在长达26周的时间里，两组之间没有显著差异。18周和26周时，C3臂的呼吸困难缓解率较低(P<；0.05)，但这一发现在不同的分析方法中是不一致的。中位生存期C3组为28周，C6组为32周(P=0.75，HR 1.04，95%CI 0.82~1.31)。C3和C6组的1年和2年生存率分别为25%和9%，而C3组和C6组分别为25%和5%。C3组和C6组的中位无进展生存期分别为16周和21周(P=0.21，HR 0.86，95%CI为0.68~1.08)。总之，超过三个疗程的卡铂和长春瑞滨姑息化疗对晚期非小细胞肺癌患者的生存期或生活质量没有影响。
This randomised multicentre trial was conducted to establish the optimal duration of palliative chemotherapy in advanced non-small-cell lung cancer (NSCLC). We compared a policy of three vs six courses of new-generation platinum-based combination chemotherapy with regard to effects on quality of life (QoL) and survival. Patients with stage IIIB or IV NSCLC and WHO performance status (PS) 0–2 were randomised to receive three (C3) or six (C6) courses of carboplatin (area under the curve (AUC) 4, Chatelut's formula, equivalent to Calvert's AUC 5) on day 1 and vinorelbine 25 mg m−2 on days 1 and 8 of a 3-week cycle. Key end points were QoL at 18 weeks, measured with EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-LC13, and overall survival. Secondary end points were progression-free survival and need of palliative radiotherapy. Two hundred and ninety-seven patients were randomised (C3 150, C6 147). Their median age was 65 years, 30% had PS 2 and 76% stage IV disease. Seventy-eight and 54% of C3 and C6 patients, respectively, completed all scheduled chemotherapy courses. Compliance with QoL questionnaires was 88%. There were no significant group differences in global QoL, pain or fatigue up to 26 weeks. The dyspnoea palliation rate was lower in the C3 arm at 18 and 26 weeks (P<0.05), but this finding was inconsistent across different methods of analysis. Median survival in the C3 group was 28 vs 32 weeks in the C6 group (P=0.75, HR 1.04, 95% CI 0.82–1.31). One- and 2-year survival rates were 25 and 9% vs 25 and 5% in the C3 and C6 arm, respectively. Median progression-free survival was 16 and 21 weeks in the C3 and C6 groups, respectively (P=0.21, HR 0.86, 95% CI 0.68–1.08). In conclusion, palliative chemotherapy with carboplatin and vinorelbine beyond three courses conveys no survival or consistent QoL benefits in advanced NSCLC.