Department of Radiation Oncology, Case Western Reserve University, Cleveland, USA; University Hospitals of Cleveland, Cleveland, USA.
Department of Radiation Oncology, University of Texas Southwestern, Dallas, USA.
Ann Oncol. 2018 Apr 1;29(4):998-1003. doi: 10.1093/annonc/mdy018.
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.
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.
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.
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.
复发性头颈部鳞状细胞癌（HNSCC）的化疗和再放疗（re-XRT）最佳方案仍存在争议。我们报告了一项多中心 II 期试验的最终结果，该试验评估了西妥昔单抗联合顺铂化疗联合 re-XRT 治疗复发性 HNSCC 患者。
符合入组条件的患者为：在先前放疗野内出现不可切除的复发性疾病或挽救性手术后切缘阳性，KPS≥70。在第 1 周给予西妥昔单抗 400mg/m2 负荷剂量，然后每周给予西妥昔单抗 250mg/m2 和顺铂 30mg/m2，同时进行 6 周强度调制放疗，总剂量为 60-66Gy，30 次分割。先前接受过同步放化疗和西妥昔单抗和顺铂或放疗时间不足 6 个月的患者不符合入组条件。
2009 年至 2013 年，共有 48 例患者入组该试验，2 例患者未接受任何方案治疗。在其余 46 例患者中，34 例为男性，12 例为女性，中位年龄为 62 岁（范围 36-85 岁）。治疗是可行的，只有 1 例患者未完成治疗过程。常见的 3 级或以上急性毒性包括淋巴细胞减少症（46%）、疼痛（22%）、吞咽困难（13%）、放射性皮炎（13%）、黏膜炎（11%）和厌食症（11%）。无 5 级急性毒性。观察到 8 例 3 级迟发性毒性，其中 4 例与吞咽有关。中位随访 1.38 年后，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，年轻患者的 OS 显著改善（P=0.01）。OS 与放疗剂量、re-XRT 前手术或先前放疗间隔无相关性。
复发性头颈部鳞状细胞癌的化疗和再放疗（re-XRT）是可行的，为具有高危特征的患者提供了良好的治疗效果。年轻患者的 OS 显著提高。
NCT00833261。
