Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer
Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer
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DOI：
10.1093/jnci/92.13.1074
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发表时间：
2000-07-05
影响因子：
10.3
通讯作者：
Thatcher, N
中科院分区：
文献类型：
--
作者：
Ranson, M;Davidson, N;Thatcher, N
背景资料：在II期临床试验中，紫杉醇已被证明在晚期非小细胞肺癌（NSCLC）患者中具有抗肿瘤活性，然而，紫杉醇作为单药与单独支持治疗相比的生存和生活质量（QOL）益处尚未在随机临床试验中进行评估。研究方法：共有157例既往未接受过化疗的IIIB或IV期NSCLC患者被随机分配接受最佳支持治疗（78例患者）或紫杉醇加支持治疗（79例患者）。紫杉醇每3周静脉输注3小时，支持治疗包括姑息性放疗和皮质类固醇、抗生素、镇痛剂、止吐剂、输血和其他对症治疗。研究的主要终点是生存率，疾病进展时间、缓解率、不良事件和生活质量是次要终点。结果：治疗前特征在两组之间均匀分布。紫杉醇加支持治疗组的生存率在统计学上显著优于单纯支持治疗组（双侧P = 0.037）（中位生存期= 6.8个月vs 4.8个月）。Cos多变量分析显示紫杉醇加支持治疗与生存率改善有统计学意义（双侧P = 0.048）。两个治疗组的QOL相似，除了鹿特丹症状自评量表的功能活动评分，其中QOL数据在统计学上显著支持紫杉醇加支持治疗组（双侧P = .043），结论：与最佳支持治疗相比，在最佳支持治疗中添加紫杉醇可显著改善晚期NSCLC患者的生存率和疾病进展时间，QOL方面。
Background: In phase II trials, paclitaxel has been shown to have antitumor activity in patients,vith advanced non-small-cell lung cancer (NSCLC), However, the survival and quality-of-life (QOL) benefits of paclitaxel used as a single agent compared with supportive care alone have not been assessed in a randomized clinical trial. Methods: A total of 157 patients with stage IIIB or IV NSCLC who had received no prior chemotherapy were randomly assigned to receive either best supportive care alone (78 patients) or paclitaxel plus supportive care (79 patients). Paclitaxel was administered as a 3-hour intravenous infusion every 3 weeks, Supportive care included palliative radiotherapy and supportive therapy with corticosteroids, antibiotics, analgesics, antiemetics, transfusions, and other symptomatic therapy as required, The primary end point of the study was survival, Time to disease progression, response rate, adverse events, and QOL were secondary end points. Results: Pretreatment characteristics were evenly distributed between the two arms. Survival was statistically significantly better in the paclitaxel plus supportive care arm than in the supportive care alone arm (two-sided P = .037) (median survival = 6.8 months versus 4.8 months). Cos multivariate analysis showed paclitaxel plus supportive care to be statistically significantly associated with improved survival (two-sided P = .048). QOL was similar for both treatment arms, except for the functional activity score of the Rotterdam Symptom Checklist, where QOL data statistically significantly favored the paclitaxel plus supportive care arm (two-sided P = .043), Conclusion: The addition of paclitaxel to best supportive care significantly improved survival and time to disease progression compared with best supportive care in patients with advanced NSCLC and may improve some aspects of QOL.