Postoperative Chemoradiotherapy and Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck: Radiation Therapy Oncology Group RTOG-0234
Postoperative Chemoradiotherapy and Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck: Radiation Therapy Oncology Group RTOG-0234
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DOI：
10.1200/jco.2013.53.9163
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发表时间：
2014-08-10
影响因子：
45.3
通讯作者：
Ang, Kian
中科院分区：
文献类型：
--
作者：
Harari, Paul M.;Harris, Jonathan;Ang, Kian
目的报道一项随机II期试验(放射治疗肿瘤组RTOG-0234)研究同期放化疗和西妥昔单抗在具有高危病理特征的头颈部鳞状细胞癌(SCCHN)患者术后治疗的结果。患者和方法符合病理要求的III至IV期SCCHN大体切除阳性边缘和/或包膜外淋巴结和/或两个或两个以上淋巴结转移。西妥昔单抗加顺铂30 mg/m(2例)或多西紫杉醇15 mg/m(2例)每周1次60Gy射线照射。中位随访期为4.4年，顺铂组和多西他赛组的2年总生存率分别为69%和79%，2年无瘤生存率分别为57%和66%。与p16阴性的口咽部肿瘤患者相比，p16阳性的口咽部肿瘤患者的生存结果明显改善。顺铂组和多西他赛组3~4级骨髓抑制发生率分别为28%和14%；黏膜炎发生率分别为56%和54%。本研究中的DFS与RTOG-9501试验(可切除的高危头颈部鳞状细胞癌手术后放疗与放化疗的第三阶段组间试验)的DFS进行了比较，顺铂组与对照组的风险比为0.76(P=0.05)，多西他赛组与对照组的风险比为0.69(P=0.01)，反映了2年DFS的绝对改善，分别为2.5%和11.1%。结论SCCHN患者术后放化疗和西妥昔单抗的应用是可行的，且毒性可预测。与历史对照相比，多西紫杉醇方案显示了良好的结果，改善了DFS和OS，并已开始在II/III期试验中进行正式测试。(C)美国临床肿瘤学会2014年
PurposeTo report results of a randomized phase II trial (Radiation Therapy Oncology Group RTOG-0234) examining concurrent chemoradiotherapy and cetuximab in the postoperative treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) with high-risk pathologic features.Patients and MethodsEligibility required pathologic stage III to IV SCCHN with gross total resection showing positive margins and/or extracapsular nodal extension and/or two or more nodal metastases. Patients were randomly assigned to 60 Gy radiation with cetuximab once per week plus either cisplatin 30 mg/m(2) or docetaxel 15 mg/m(2) once per week.ResultsBetween April 2004 and December 2006, 238 patients were enrolled. With a median follow-up of 4.4 years, 2-year overall survival (OS) was 69% for the cisplatin arm and 79% for the docetaxel arm; 2-year disease-free survival (DFS) was 57% and 66%, respectively. Patients with p16-positive oropharynx tumors showed markedly improved survival outcome relative to patients with p16-negative oropharynx tumors. Grade 3 to 4 myelosuppression was observed in 28% of patients in the cisplatin arm and 14% in the docetaxel arm; mucositis was observed in 56% and 54%, respectively. DFS in this study was compared with that in the chemoradiotherapy arm of the RTOG-9501 trial (Phase III Intergroup Trial of Surgery Followed by Radiotherapy Versus Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck), which had a hazard ratio of 0.76 for the cisplatin arm versus control (P = .05) and 0.69 for the docetaxel arm versus control (P = .01), reflecting absolute improvement in 2-year DFS of 2.5% and 11.1%, respectively.ConclusionThe delivery of postoperative chemoradiotherapy and cetuximab to patients with SCCHN is feasible and tolerated with predictable toxicity. The docetaxel regimen shows favorable outcome with improved DFS and OS relative to historical controls and has commenced formal testing in a phase II/III trial. (C) 2014 by American Society of Clinical Oncology