Background The optimal regimen of chemotherapy and reirradiation (re-XRT) for recurrent head and neck squamous cell carcinoma (HNSCC) is controversial. We report the final outcomes of a multicenter phase II trial evaluating cetuximab and cisplatin-based chemotherapy concurrent with re-XRT for patients with recurrent HNSCC. Materials and methods Patients with unresectable recurrent disease or positive margins after salvage surgery arising within a previously irradiated field with KPS ≥ 70 were eligible for this trial. Cetuximab 400 mg/m2 was delivered as a loading dose in week 1 followed by weekly cetuximab 250 mg/m2 and cisplatin 30 mg/m2 concurrent with 6 weeks of intensity-modulated radiotherapy to a dose of 60-66 Gy in 30 daily fractions. Patients who previously received both concurrent cetuximab and cisplatin with radiation or who received radiotherapy less than 6 months prior were ineligible. Results From 2009 to 2013, 48 patients enrolled on this trial, 2 did not receive any protocol treatment. Of the remaining 46 patients, 34 were male and 12 female, with a median age of 62 years (range 36-85). Treatment was feasible and only 1 patient did not complete the treatment course. Common grade 3 or higher acute toxicities were lymphopenia (46%), pain (22%), dysphagia (13%), radiation dermatitis (13%), mucositis (11%) and anorexia (11%). There were no grade 5 acute toxicities. Eight grade 3 late toxicities were observed, four of which were swallowing related. With a median follow-up of 1.38 years, the 1-year overall survival (OS) was 60.4% and 1-year recurrence-free survival was 34.1%. On univariate analysis, OS was significantly improved with young age (P = 0.01). OS was not associated with radiation dose, surgery before re-XRT or interval from prior XRT. Conclusions Concurrent cisplatin and cetuximab with re-XRT is feasible and offers good treatment outcomes for patients with high-risk features. Younger patients had significantly improved OS. ClinicalTrials.Gov Identifier NCT00833261.

中文翻译：

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一项多机构的II期再照射联合每周一次顺铂和西妥昔单抗治疗复发性或继发性头颈部鳞状细胞癌的最终结果。

背景技术复发性头颈部鳞状细胞癌（HNSCC）的最佳化学疗法和再放射疗法（re-XRT）是有争议的。我们报告了一项多中心的II期临床试验的最终结果，该试验评估了西妥昔单抗和基于顺铂的化疗与再次XRT合并治疗HNSCC复发的患者。材料和方法在先前接受过KPS≥70照射的区域内发生无法挽救的复发性疾病或抢救手术后切缘阳性的患者有资格参加本试验。西妥昔单抗400 mg / m2作为负荷剂量在第1周内递送，随后每周一次西妥昔单抗250 mg / m2和顺铂30 mg / m2，同时进行6周的强度调节放疗，分30天内每天60-66 Gy。既往同时接受西妥昔单抗和顺铂同时放疗或在放疗前不到6个月接受放疗的患者则不合格。结果2009年至2013年，共有48例患者参加了该试验，其中2例未接受任何方案治疗。其余46例患者中，男性34例，女性12例，中位年龄62岁（范围36-85）。治疗是可行的，只有1名患者未完成治疗过程。常见的3级或更高的急性毒性是淋巴细胞减少症（46％），疼痛（22％），吞咽困难（13％），放射性皮炎（13％），粘膜炎（11％）和厌食症（11％）。没有5级急性毒性。观察到8种3级晚期毒性，其中4种与吞咽有关。中位随访期为1.38年，其1年总生存率（OS）为60.4％，1年无复发生存率为34。1％。单因素分析显示，OS随年龄的增长而显着改善（P = 0.01）。OS与放射剂量，再次XRT之前的手术或距先前XRT的间隔无关。结论顺铂和西妥昔单抗同时使用re-XRT是可行的，并为具有高风险特征的患者提供良好的治疗效果。年轻患者的OS明显改善。Clinical Trials.Gov标识符NCT00833261。