Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized intergroup study 0099
Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized intergroup study 0099
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DOI：
10.1200/jco.1998.16.4.1310
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发表时间：
1998-04-01
影响因子：
45.3
通讯作者：
Ensley, JF
中科院分区：
文献类型：
--
作者：
Al-Sarraf, M;LeBlanc, M;Ensley, JF
目的：西南肿瘤学组 (SWOG) 在放射治疗肿瘤学组 (RTOG) 和东部肿瘤合作组 (ECOG) 的参与下协调了一项组间研究。这项随机 III 期试验比较了鼻咽癌患者的放化疗与单纯放疗。材料和方法：双臂均进行放疗：周一至周五 1.8 至 2.0 Gy/d 分次，共 35 至 39 次，总剂量为 70 Gy。研究组在放疗期间的第 1、22 和 43 天接受顺铂 100 mg/m(2) 化疗；放疗后，化疗第1天使用顺铂80 mg/m(2)，第1至4天使用氟尿嘧啶1,000 mg/m(2)/d，每4周进行3个疗程。根据肿瘤分期、淋巴结分期、体能状态和组织学对患者进行分层。结果：在登记的 193 例患者中，147 例（69 例放疗和 78 例放化疗）符合生存和毒性初步分析的条件。放疗组符合条件的患者的中位无进展生存期 (PFS) 为 15 个月，而放化疗组未达到。 3 年 PFS 率分别为 24% 和 69% (P < .001)。放疗组的中位生存时间为 34 个月，而放化疗组未达到，3 年生存率分别为 47% 和 78% (P = .005)。 185 名患者被纳入生存的二次分析。随机接受放疗的患者的 3 年生存率为 46%，放化疗组的 3 年生存率为 76% (P < .001)。 结论：我们得出的结论是，对于晚期鼻咽癌患者，在 PFS 和总生存方面，放化疗优于单独放疗。 (C) 1998 年美国临床肿瘤学会。
Purpose: The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTOG), and Eastern Cooperative Oncology Group (ECOG). This randomised phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers.Materials and Methods: Radiotherapy was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investigational arm received chemotherapy with cisplatin 100 mg/m(2) on days 1, 22, and 43 during radiotherapy; postradiotherapy, chemotherapy with cisplatin 80 mg/m(2) on day 1 and fluorouracil 1,000 mg/m(2)/d on days 1 to 4 was administered every 4 weeks for three courses. Patients were stratified by tumor stage, nodal stage, performance status, and histology.Results: Of 193 patients registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible for primary analysis for survival and toxicity. The median progression-free survival (PFS) time was 15 months for eligible patients on the radiotherapy arm and was not reached for the chemo-radiotherapy group. The 3-year PFS rate was 24% versus 69%, respectively (P < .001). The median survival time was 34 months for the radiotherapy group and not reached for the chemo-radiotherapy group, and the 3-year survival rate was 47% versus 78%, respectively(P = .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomised to radiotherapy was 46%, and for the chemoradiotherapy group was 76% (P < .001).Conclusion: We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival. (C) 1998 by American Society of Clinical Oncology.