Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer
Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer
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DOI：
10.1200/jco.20.5.1335
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发表时间：
2002-03-01
影响因子：
45.3
通讯作者：
Kies, MS
中科院分区：
文献类型：
--
作者：
Socinski, MA;Schell, MJ;Kies, MS
目的：比较四个周期的治疗与连续治疗，以确定晚期非小细胞肺癌（NSCLC）化疗的最佳持续时间。患者和方法：IIIB/IV期NSCLC患者被随机分配到A组（四个周期的卡铂曲线下面积为6和紫杉醇200 mg/m2，每21天）或B组（卡铂/紫杉醇连续治疗，直至进展）。在进展时，两组的所有患者均接受紫杉醇80 mg/m2/wk二线治疗。主要终点为生存率和生活质量（QOL）。57%的A组患者完成了四个疗程。在116例B组患者中，输送的中位周期数为4个（范围：0 - 19个周期）。42%的人接受了五个或更多的周期; 18%的人接受了八个或更多的周期。A组和B组的总体缓解率分别为22%和24%（P = 0.80）。A组的中位生存时间和1年生存率分别为6.6个月和28%，B组为8.5个月和34%（对数秩P = 0.63）。两组之间的血液学和非血液学毒性发生率相似，但神经病变除外。2 - 4级神经病变的发生率从第4周期的19.9%（95%置信区间[CI]，13.6%-26.2%）增加至第8周期的43%（95% CI，28.6%-57.4%）。QOL无差异。只有45%的患者接受了二线治疗（A组42%，B组47%，P = 0.42）。结论：本研究显示，在晚期NSCLC中，卡铂/紫杉醇持续治疗超过4个周期后，在生存率、缓解率或QOL方面没有总体获益。(C)2002年，美国临床肿瘤学会。
Purpose : To compare four cycles of therapy versus continuous therapy to determine the optimal duration of chemotherapy in advanced non-small-cell lung cancer (NSCLC).Patients and Methods: Stage IIIB/IV NSCLC patients were randomized to arm A (four cycles of carboplatin at an area under the curve of 6 and paclitaxel 200 mg/m(2) every 21 days) or arm B (continuous treatment with carboplatin/paclitaxel until progression). At progression, all patients on both arms were to receive second-line weekly paclitaxel at 80 mg/m(2)/wk. The primary end points were survival and quality of life (QOL).Results: Two hundred thirty patients were randomized. Fifty-seven percent of arm A patients completed four courses of therapy. In the 116 arm B patients, the median number of cycles delivered was four (range, zero to 19 cycles). Forty-two percent received five or more cycles; 18% received eight or more cycles. Overall response rates were 22% and 24% for arms A and B, respectively (P = .80). Median survival time and 1-year survival rates were 6.6 months and 28% for arm A and 8.5 months and 34% for arm B, respectively (log-rank P = .63). Rates of hematologic and nonhemotologic toxicity were similar between the two arms, except for neuropathy. The rate of grade 2 to 4 neuropathy increased from 19.9% (95% confidence interval [CI], 13.6% to 26.2%) at cycle 4 to 43% (95% CI, 28.6% to 57.4%) at cycle 8. There were no differences in QOL. Only 45% of patients received second-line therapy (42% in arm A v 47% in arm B, P = .42).Conclusion: This study shows no overall benefit in survival, response rates, or QOL to continuing treatment with carboplatin/paclitaxel beyond four cycles in advanced NSCLC. (C) 2002 by American Society of Clinical Oncology.