Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: Results of the Japan Clinical Oncology Group Study 9104
Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: Results of the Japan Clinical Oncology Group Study 9104
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DOI：
10.1200/jco.2002.12.071
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发表时间：
2002-07-15
影响因子：
45.3
通讯作者：
Saijo, N
中科院分区：
文献类型：
--
作者：
Takada, M;Fukuoka, M;Saijo, N
目的：为了评估有限期小细胞肺癌（LS-SCLC）胸部放疗（TRT）的最佳时机，日本临床肿瘤学组肺癌研究小组进行了一项III期研究，其中患者被随机分配接受序贯TRT或同时TRT。患者和方法：我们治疗了231例LS-SCLC患者。TRT包括45戈伊，持续3周（1.5戈伊，每日2次），患者被随机分配接受序贯或同步TRT。所有患者均接受顺铂+依托泊苷治疗，每3周（序贯组）或4周（并行组），共4个周期。TRT开始在第2天的第一个周期的化疗在并发臂和第四个周期后，在序贯arm.Results：并发放疗比序贯放疗产生更好的生存（P = 0.097的对数秩检验）。序贯组的中位生存时间为19.7个月，同期组为27.2个月，序贯组的2年、3年和5年生存率分别为35.1%、20.2%和18.3%，同期组分别为54.4%、29.8%和23.7%。同时接受放疗的患者。血液学毒性更严重的同时armb. However，严重的食管炎是罕见的，在两个武器，发生在9%的患者在同时armb.Conclusion和4%的序贯armb. This研究强烈表明，顺铂+足叶乙甙和同步放疗是更有效的治疗LS-小细胞肺癌比顺铂+足叶乙甙和序贯放疗。(C)2002年，美国临床肿瘤学会。
Purpose: To evaluate the optimal timing for thoracic radiotherapy (TRT) in limited-stage small-cell lung cancer (LS-SCLC), the Lung Cancer Study Group of the Japan Clinical Oncology Group conducted a phase III study in which patients were randomized to sequential TRT or concurrent TRT.Patients and Methods: We treated 231 patients with LS-SCLC. TRT consisted of 45 Gy over 3 weeks (1.5 Gy twice daily), and the patients were randomly assigned to receive either sequential or concurrent TRT. All patients received four cycles of cisplatin plus etoposide every 3 weeks (sequential arm) or 4 weeks (concurrent arm). TRT was begun on day 2 of the first cycle of chemotherapy in the concurrent arm and after the fourth cycle in the sequential arm.Results: Concurrent radiotherapy yielded better survival than sequential radiotherapy (P = .097 by log-rank test). The median survival time was 19.7 months in the sequential arm versus 27.2 months in the concurrent arm. The 2-, 3-, and 5-year survival rates for patients who received sequential radiotherapy were 35.1%, 20.2%, and 18.3%, respectively, as opposed to 54.4%, 29.8% and 23.7%, respectively, for the patients who received concurrent radiotherapy. Hematologic toxicity was more severe in the concurrent arm. However, severe esophagitis was infrequent in both arms, occurring in 9% of the patients in the concurrent arm and 4% in the sequential arm.Conclusion: This study strongly suggests that cisplatin plus etoposide and concurrent radiotherapy is more effective for the treatment of LS-SCLC than cisplatin plus etoposide and sequential radiotherapy. (C) 2002 by American Society of Clinical Oncology.