Concurrent cisplatin, etoposide, and chest radiotherapy in Pathologic stage IIIB non-small-cell lung cancer: A Southwest Oncology Group Phase II Study, SWOG 9019
Concurrent cisplatin, etoposide, and chest radiotherapy in Pathologic stage IIIB non-small-cell lung cancer: A Southwest Oncology Group Phase II Study, SWOG 9019
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DOI：
10.1200/jco.2002.03.055
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发表时间：
2002-08-15
影响因子：
45.3
通讯作者：
Livingston, RB
中科院分区：
文献类型：
--
作者：
Albain, KS;Crowley, JJ;Livingston, RB
目的：尚无已发表的病理证实的IIIB期非小细胞肺癌放化疗（chemRT）后的生存数据。单纯放疗（RT）或化疗后RT的研究产生的5年生存率低于10%。西南肿瘤组（SWOG）采用了相同的同步化疗诱导方案，在其前身trimodality试验中使用，以确定疗效，安全性和长期的结果，取代postinduction手术与额外的chemoRT.Patients和方法：符合条件的患者SWOG-9019有病理记录的T4 N 0/1，T4 N2，或N3期IIIB非小细胞肺癌。他们的肺功能足以承受综合治疗，与先前的试验要求相同。诱导治疗为顺铂+依托泊苷（PE）两个周期，同时每日一次胸部RT（45戈伊）。在没有进行性疾病，RT完成到61戈伊，顺铂加依托泊苷两个额外的周期。结果：50名合格的患者与肿瘤节点（TN）的子阶段确认中央审查：18，T4 N 0/1; 12，T4 N2;和20，N3。4级中性粒细胞减少症是最常见的毒性（32%）。3/4级食管炎发生率分别为12%和8%。中位随访时间为52个月，总中位生存期为15个月（10 - 22，95%置信区间）。3年和5年生存率分别为17%和15%（5年T4 NO/1，17%，T4 N2，13%;和N3，15%）。结论：可行性和长期生存支持这些结果作为一个标准的应用，与新的化疗药物的化疗RT试验的成熟结果可以进行比较。这些结果也证明了在正在进行的III期试验中使用SWOG-9019方法作为对照组的合理性。(C)2002年，美国临床肿瘤学会。
Purpose: There are no published survival data after chemoradiotherapy (chemoRT) in pathologically documented stage IIIB non-small-cell lung cancer. Studies of radiotherapy (RT) alone or chemotherapy followed by RT yield 5-year survivals less than 10%. The Southwest Oncology Group (SWOG) employed the same concurrent chemoRT induction regimen used in its predecessor trimodality trial to determine the efficacy, safety, and long-term outcome of replacing postinduction surgery with additional chemoRT.Patients and Methods: Eligible patients for SWOG-9019 had pathologic documentation of T4N0/1, T4N2, or N3 stage IIIB non-small-cell lung cancer. They had pulmonary function adequate to withstand combined-modality therapy, identical to the requirements of the previous trial with postchemoRT surgery. Induction therapy was two cycles of cisplatin plus etoposide (PE) concurrent with once-daily thoracic RT (45 Gy). In the absence of progressive disease, RT was completed to 61 Gy, with two additional cycles of cisplatin plus etoposide.Results: Fifty eligible patients were accrued with tumor-node (TN) substage confirmed on central review: 18, T4N0/1; 12, T4N2; and 20, N3. Grade 4 neutropenia was the most common toxicity (32%). Grade 3/4 esophagitis occurred in 12% and 8%. Median follow-up was 52 months, and overall median survival was 15 months (10 to 22, 95% confidence interval). Three- and 5-year survivals were 17% and 15% (5-year T4NO/1, 17%, T4N2, 13%; and N3,15%).Conclusion: Feasibility and long-term survival support the application of these results as a standard against which mature outcomes of chemoRT trials with new chemotherapy agents can be compared. These results also justify use of the SWOG-9019 approach as a control arm in ongoing phase III trials. (C) 2002 by American Society of Clinical Oncology.