Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy
Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy
复制标题
DOI：
10.1200/jco.2000.18.10.2095
复制
发表时间：
2000-05-01
影响因子：
45.3
通讯作者：
Berille, J
中科院分区：
文献类型：
--
作者：
Shepherd, FA;Dancey, J;Berille, J
目的：评估对于既往接受过铂类化疗的非小细胞肺癌患者，使用单药多西他赛治疗是否会比最佳支持治疗带来更长的生存期。次要终点包括疗效评估（仅多西他赛组）、毒性和生活质量。 患者和方法：体能状态为 0 至 2 且具有可测量或可评估病变的 IIIB/IV 期非小细胞肺癌患者，如果他们接受了一种或多种铂类化疗方案并且具有足够的血液学和生物化学，则有资格参加该研究 参数。如果他们有症状性脑转移或之前接受过紫杉醇加热，则被排除在外。根据体能状态和对顺铂化疗的最佳反应对患者进行分层，然后随机接受多西紫杉醇100 mg/m(2)（49名患者）或75 mg/m(2)（55名患者）治疗或最佳支持治疗。每 3 周对双臂患者进行一次评估。结果：104 名患者（其中 103 名符合进入研究的资格）的预后因素得到了很好的平衡，在 84 名具有可测量病变的患者中，6 名（7.1%）实现了部分缓解（每个剂量水平有 3 名患者）。多西紫杉醇患者的疾病进展时间比最佳支持治疗患者更长（分别为 10.6 周和 6.7 周；P
Purpose: To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with nonsmall-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life.Patients and Methods: Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters. They were excluded if they had symptomatic brain metastases or if they had previously been heated with paclitaxel. Patients were stratified by performance status and best response to cisplatin chemotherapy and were then randomized to treatment with docetaxel 100 mg/m(2) (49 patients) or 75 mg/m(2) (55 patients) or best supportive care. Patients in both arms were assessed every 3 weeks.Results: One hundred four patients (103 of whom were eligible for entry onto the study) were well balanced for prognostic factors, Of 84 patients with measurable lesions, six (7.1%) achieved partial responses (three patients at each dose level). Time to progression was longer for docetaxel patients than for best supportive care patients (10.6 v 6.7 weeks, respectively; P