Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: Results of an eastern cooperative oncology group trial
Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: Results of an eastern cooperative oncology group trial
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DOI：
10.1200/jco.2000.18.3.623
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发表时间：
2000-02-01
影响因子：
45.3
通讯作者：
Johnson, D
中科院分区：
文献类型：
--
作者：
Bonomi, P;Kim, KM;Johnson, D
目的：在晚期非小细胞肺癌(NSCLC)中，以顺铂为基础的化疗比单纯的支持性治疗提供了适度的生存优势。为了确定新的药物紫杉醇是否会进一步提高非小细胞肺癌患者的生存率，东方合作肿瘤学小组进行了一项随机试验，比较了紫杉醇+顺铂和标准化疗方案(顺铂和依托泊苷)。患者和方法：该研究由一个多机构合作小组在化疗初期的IIIB至IV期非小细胞肺癌患者中进行，随机接受紫杉醇+顺铂或依托泊苷+顺铂。紫杉醇分两个剂量水平(135 mg/m(2)和250 mg/m(2))，依托泊苷100 mg/m(2)，每日1次，第1~3天。每个方案每21天重复一次，每个方案包括顺铂(75 mg/m(2))。紫杉醇联合方案的生存率(中位生存期9.9个月，1年生存率38.9%)明显优于依托泊苷加顺铂(中位生存期7.6个月，1年生存率31.8%；P=0.048)。比较两个剂量水平的紫杉醇的存活率显示没有显著差异。IIIB期患者中位生存期：依托泊苷加顺铂患者为7.9个月，而所有紫杉醇患者为13.1个月(P=.152)。在N期亚组中，依托泊苷联合顺铂的中位生存期为7.6个月，而紫杉醇为8.9个月(P=.246)。除了小剂量紫杉醇方案中粒细胞减少增加和肌痛增加、神经毒性增加，以及可能增加与治疗相关的心脏事件外，所有三组患者的毒性都是相似的。生活质量(QOL)在这6个月中显著下降。结论：由于这些观察的结果，紫杉醇(135 mg/m(2))联合顺铂已取代依托泊苷和顺铂作为我们最近完成的III期试验的参考方案。J Clin Oncol18：623-631.(C)2000年，由美国临床肿瘤学会提供。
purpose: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non-small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide.Patients and Methods: The study was carried out by a multi-institutional cooperative group in chemotherapy-naive stage IIIB to IV NSCLC patients randomized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Paclitaxel was administered at two different dose levels (135 mg/m(2) and 250 mg/m(2)), and etoposide was given at a dose of 100 mg/m(2) daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin (75 mg/m(2)).Results: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combined paclitaxel regimens (median survival time, 9.9 months; 1-year survival rate, 38.9%) compared with etoposide plus cisplatin (median survival time, 7.6 months; 1-year survival rate, 31.8%; P = .048). Comparing survival for the two dose levels of paclitaxel revealed no significant difference. The median survival duration for the stage IIIB subgroup was 7.9 months for etoposide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P = .152). For the stage N subgroup, the median survival time for etoposide plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P = .246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, increased treatment-related cardiac events with high-dose paclitaxel, toxicity was similar across all three arms. Quality of life (QOL) declined significantly over the 6 months. However, QOL scores were not significantly different among the regimens.Conclusion: As a result of these observations, paclitaxel (135 mg/m(2)) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial. J Clin Oncol 18:623-631. (C) 2000 by American Society of Clinical Oncology.