Socinski Mark A, Schell Michael J, Peterman Amy, Bakri Kamal, Yates Steven, Gitten Robert, Unger Paul, Lee Joanna, Lee Ji-Hyun, Tynan Maureen, Moore Martha, Kies Merrill S
Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC 27599, USA.
J Clin Oncol. 2002 Mar 1;20(5):1335-43. doi: 10.1200/JCO.2002.20.5.1335.
To compare four cycles of therapy versus continuous therapy to determine the optimal duration of chemotherapy in advanced non-small-cell lung cancer (NSCLC).
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).
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 nonhematologic 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).
This study shows no overall benefit in survival, response rates, or QOL to continuing treatment with carboplatin/paclitaxel beyond four cycles in advanced NSCLC.
比较四个周期的治疗与持续治疗，以确定晚期非小细胞肺癌（NSCLC）化疗的最佳疗程。
ⅢB/Ⅳ期NSCLC患者被随机分为A组（每21天接受4个周期的卡铂，曲线下面积为6，以及紫杉醇200mg/m²）或B组（持续接受卡铂/紫杉醇治疗直至病情进展）。病情进展时，两组所有患者均接受二线每周一次的紫杉醇治疗，剂量为80mg/m²/周。主要终点为生存率和生活质量（QOL）。
230例患者被随机分组。A组57%的患者完成了4个疗程的治疗。在116例B组患者中，接受化疗的中位周期数为4个（范围为0至19个周期）。42%的患者接受了5个或更多周期的治疗；18%的患者接受了8个或更多周期的治疗。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组分别为8.5个月和34%（对数秩检验P = 0.63）。除神经病变外，两组血液学和非血液学毒性发生率相似。2至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%至26.2%）增加到第8周期的43%（95%CI，28.6%至57.4%）。生活质量方面无差异。仅45%的患者接受了二线治疗（A组为42%，B组为47%，P = 0.42）。
本研究表明，晚期NSCLC患者在接受卡铂/紫杉醇治疗超过4个周期后，在生存率、缓解率或生活质量方面并无总体获益。
