Randomized trial of chemotherapy and radiation therapy with or without warfarin for limited-stage small-cell lung cancer: A cancer and leukemia group B study
Randomized trial of chemotherapy and radiation therapy with or without warfarin for limited-stage small-cell lung cancer: A cancer and leukemia group B study
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DOI：
10.1200/jco.1997.15.11.3378
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发表时间：
1997-11-01
影响因子：
45.3
通讯作者：
Green, MR
中科院分区：
文献类型：
--
作者：
Maurer, LH;Herndon, JE;Green, MR
目的：退伍军人管理局合作研究项目和癌症和白血病B组（CALGB）的研究表明，在化疗中加入华法林可以提高小细胞肺癌（SCLC）的疗效和/或生存率。这项随机研究评估了华法林联合化疗和放疗在有限期SCLC中的效果。患者和方法：患者随机接受华法林治疗或不接受华法林治疗。所有患者均接受了3个周期的阿霉素、环磷酰胺和依托泊苷（ACE）治疗。第4和第5周期（顺铂、环磷酰胺和依托泊苷[PCE]）与放疗同时给予，放化疗后给予3个周期的ACE，但由于肺毒性发生率高而停用。结果：华法林治疗组和对照组在有效率、生存率、无失败生存期、无疾病生存期或复发模式方面没有显著差异，在按照初始设计治疗的患者中，华法林治疗后无失败生存期的增加接近显著性（P = .07），修正前的结果虽然不显著，但没有重叠的治疗生存曲线。8个月的里程碑分析显示，华法林治疗完全缓解者的中位生存时间为33个月，而未接受华法林治疗的完全或部分缓解者的中位生存时间小于或等于13.75个月（P = 0.05）。在修订前的人群中，完全缓解者之间的差异不显著（P = 0.103）。结论：华法林似乎并没有显著改善有限期SCLC的预后。然而，在方案修订之前，人群之间某些变量的差异与先前研究中观察到的抗凝剂的有利作用相对应。(C) 1997年由美国临床肿瘤学会。
Purpose: Studies by the Veterans Administration Cooperative Studies program and Cancer and Leukemia Group B (CALGB) suggested that the addition of warfarin to chemotherapy knight enhance response and/or survival in small-cell lung cancer (SCLC). This randomized study evaluated the effect of warfarin with chemotherapy and radiation therapy in limited-stage SCLC.Patients and Methods: patients were randomized to receive warfarin or no warfarin. All patients received three cycles of doxorubicin, cyclophosphamide, and etoposide (ACE). Cycles 4 and 5 (cisplatin, cyclophosphamide, and etoposide [PCE]) were given concurrently with radiation therapy, Three cycles of ACE were given after chemoradiation therapy, but were discontinued due to ct high rate of pulmonary toxicity.Results: There were no significant differences in response rates, survival, failure-free survival, disease-free survival, or patterns of relapse between the warfarin-treated ansi control groups, in patients treated according to the initial design, an increase in failure-free survival seen with warfarin treatment approached significance (P = .07), Preamendment results, while not significant, did not have superimposable treatment survival curves. a landmark analysis at 8 months showed a median survival time after the landmark for complete responders of 33 months with warfarin treatment compared with less than or equal to 13.75 months for complete or partial responders not treated with warfarin (P = .05). Differences between the complete responders in this preamendment population were not significant (P = .103),Conclusion: Warfarin does not appear to improve outcome significantly-in limited-stage SCLC. However, the differences in some variables between populations before the protocol amendment correspond to the favorable effects of anticoagulants observed in previous studies. (C) 1997 by American Society of Clinical Oncology.