A Randomized Phase III Trial of Combined Paclitaxel, Carboplatin, and Radiation Therapy Followed by Weekly Paclitaxel or Observation for Patients With Locally Advanced Inoperable Non-Small-Cell Lung Cancer
A Randomized Phase III Trial of Combined Paclitaxel, Carboplatin, and Radiation Therapy Followed by Weekly Paclitaxel or Observation for Patients With Locally Advanced Inoperable Non-Small-Cell Lung Cancer
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DOI：
10.1016/j.cllc.2011.10.005
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发表时间：
2012-05-01
影响因子：
3.6
通讯作者：
Reynolds, Craig
中科院分区：
文献类型：
--
作者：
Carter, Dennis L.;Garfield, David;Reynolds, Craig
这项研究探讨了在标准诱导化疗和放疗后对IIIA或IIIB期NSCLC和PS为0-1的患者进行额外维持化疗和观察的效果。虽然两组的中位生存期都超过了预期，但观察组的OS和PFS更高；在没有额外化疗的情况下，PFS明显更好(P=.04)。背景：这项研究旨在确定标准诱导化疗/放射治疗(XRT)后额外维持化疗对III期非小细胞肺癌(NSCLC)的疗效和安全性。主要目标是增加一年的存活率。患者和方法：符合条件的患者(N=220)已确认为IIIA或IIIB期非小细胞肺癌，并且东部合作肿瘤学小组(ECOG)的表现状态为0-1。诱导化疗(紫杉醇200 mg/m(2)+卡铂AUC=6/3周)2周期后，紫杉醇45 mg/m(2)+卡铂AUC×每周x7，同时每日XRT(累积剂量=66.6Gy37次)，观察或维持。在随机分组前，101名患者(46%)因进展性疾病(n=34)、毒性(n=33)、患者要求(n=13)、死亡(n=7)或其他(n=14)原因而停止治疗。其余119名患者被随机分配到“观察组”或“维持组”(6个周期的紫杉醇70 mg/m(2)/wk[3周开始/1周结束])；计划的6个周期中的中位数5个在维持组实施。结果：观察组与维持组的1、4年生存率分别为77%、66%、38%、17%(中位数分别为26.9个月、16.1个月，P=0.07)，1、4年无功能生存期(PFS)分别为46%、24%、25%、13%(中位数10.2个月、8.2个月，P=0.04)。常见的毒性是中性粒细胞减少、血小板减少和疲劳。结论：两组患者的中位生存期均超过标准，观察组最显著的是26.9个月的生存期。维持化疗，当加入诱导和同步放化疗方案时，并没有改善临床结果，终点倾向于标准的手臂。
This study explored the effects of additional maintenance chemotherapy vs. observation after standard induction chemotherapy and radiation in patients with stage IIIA or IIIB NSCLC and PS 0-1. Although median survival in both groups surpassed expectations, OS and PFS were greater in the observation group; PFS was significantly better (P = .04) without the additional chemotherapy.Background: This study was designed to determine the efficacy and safety of additional maintenance chemotherapy after standard induction chemotherapy/radiation therapy (XRT) in stage III non-small-cell lung cancer (NSCLC). The primary objective was to increase 1-year survival. Patients and Methods: Eligible patients (N = 220) had confirmed stage IIIA or IIIB NSCLC, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients received induction chemotherapy (paclitaxel 200 mg/m(2) + carboplatin AUC = 6/3 weeks) for 2 cycles, followed by paclitaxel 45 mg/m(2) + carboplatin AUC x 2 weekly x7 and concurrent daily XRT (cumulative dose = 66.6 Gy in 37 fractions) and then observation or maintenance. Before randomization, 101 patients (46%) discontinued treatment due to progressive disease (n = 34), toxicity (n = 33), patient request (n = 13), death (n = 7), or other (n = 14). The remaining 119 patients were randomly assigned to either "observation" or "maintenance" (6 cycles of paclitaxel 70 mg/m(2)/wk [3 weeks on/1 week off]); a median of 5 of 6 planned cycles was delivered in the maintenance arm. Results: For the observation group vs. the maintenance group, the estimated 1- and 4-year survival rates were 77% vs. 66% and 38% vs. 17% (median, 26.9 months vs. 16.1 months, respectively [P = .07]); the estimated 1- and 4-year performance-free survival (PFS) were 46% vs. 24% and 25% vs. 13% (median, 10.2 months vs. 8.2 months, respectively [P = .04]). Common toxicities were neutropenia, thrombocytopenia, and fatigue. Conclusion: Median survival in both groups surpassed the standard, most notably the 26.9-month survival in the observation group. Maintenance chemotherapy, when added to a regimen of both induction and concurrent chemoradiotherapy, did not improve clinical outcomes, with endpoints favoring the standard arm.