Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer
Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer
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DOI：
10.1016/j.radonc.2013.08.012
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发表时间：
2013-11-01
影响因子：
5.7
通讯作者：
Kramar, Andrew
中科院分区：
文献类型：
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作者：
Lartigau, Eric F.;Tresch, Emmanuelle;Kramar, Andrew
目的：头颈部癌复发与预后不良有关。当手术和/或放疗和/或化疗联合使用时，显示出高毒性率。此外，治疗的持续时间往往与预期的生存期（中位生存期< 1年）在伦理上不相容。正常组织的耐受性限制了再照射的使用，立体定向体部放射治疗（SBRT）可以提供精确的照射，同时保留健康组织。在完成可行性研究后，报告了使用西妥昔单抗进行SBRT的多中心研究（里尔，Nancy Sx Nice）的结果。本研究的目的是提供无毒的短期SBRT（2周），以获得与较长protocols.Methods和材料所证明的相同的局部控制：患者不可手术的复发，或新的原发性肿瘤在以前的照射区域，包括（WHO < 3）。再照射（RT）剂量为36戈伊，分6次6戈伊，至85%等剂量线，覆盖95%的PTV，同时注射5次西妥昔单抗（CT）。结果：2007年11月至2010年8月，共纳入60例患者（男46例，女14例），其中56例接受了CT + RT，3例未接受治疗，1例仅接受了CT。中位年龄为60（42-87）），所有56例患者均患有鳞状细胞癌，并接受了西妥昔单抗合并治疗。既往放疗与SBRT开始之间的平均时间为38个月。41例患者观察到皮肤毒性。有1例因出血和营养不良而中毒死亡。中位随访时间为11.4个月。3个月时，缓解率为58.4%（95% CI：43.2-72.4%），疾病控制率为91.7%（95% CI：80.0-97.7%）。1年OS率为47.5%（95%CI：30.8-62.4）。结论：西妥昔单抗短SBRT是一种有效的挽救治疗，对既往接受过放疗的HNC预后不良的患者有良好的缓解率。治疗是可行的，适当注意限制关键结构，急性毒性是可以接受的。该组合可能是该人群的参考治疗。(C)2013爱思唯尔爱尔兰有限公司版权所有。
Purpose: Recurrent head and neck cancer is associated to a poor survival prognosis. A high toxicity rate is demonstrated when surgery and/or radiotherapy and/or chemotherapy are combined. Furthermore, the duration of treatment is often not ethically compatible with the expected survival (median survival < 1 year). Normal tissues tolerance limits the use of reirradiation and stereotactic body radiotherapy (SBRT) could offer precise irradiation while sparing healthy tissues. After completion of a feasibility study, results of a multicentric study (Lille, Nancy Sx Nice) using SBRT with cetuximab are reported. The aim of the study was to deliver non toxic short course SBRT (2 weeks) in order to get the same local control as the one demonstrated with longer protocols.Methods and materials: Patients with inoperable recurrent, or new primary tumor in a previously irradiated area, were included (WHO < 3). Reirradiation (RT) dose was 36 Gy in six fractions of 6 Gy to the 85% isodose line covering 95% of the PTV with 5 injections of concomitant cetuximab (CT). All patients had previous radiotherapy, 85% had previous surgery and 48% previous chemotherapy.Results: Between 11/2007 and 08/2010, 60 were included (46 men and 14 women), 56 received CT + RT, 3 were not treated and 1 received only CT. Median age was 60 (42-87)) and all 56 patients had squamous carcinoma and received concomitant cetuximab. Mean time between previous radiotherapy and the start of SBRT was 38 months. Cutaneous toxicity was observed for 41 patients. There was one toxic death from hemorrhage and denutrition. Median follow-up was 11.4 months. At 3 months, response rate was 58.4% (95% CI: 43.2-72.4%) and disease control rate was 91.7% (95% CI: 80.0-97.7%). The one-year OS rate was 47.5% (95% CI: 30.8-62.4).Conclusion: These results suggest that short SBRT with cetuximab is an effective salvage treatment with good response rate in this poor prognosis population with previously irradiated HNC. Treatment is feasible and, with appropriate care to limiting critical structure, acute toxicities are acceptable. This combination may be the reference treatment is this population. (C) 2013 Elsevier Ireland Ltd. All rights reserved.