Rawat Shyamji, Tandan Hemu, Patel Sanandan, Chaudhari Sameer
Department of Radiation Oncology, NSCB Medical College and Government Hospital, Jabalpur, Madhya Pradesh, India.
South Asian J Cancer. 2019 Jan-Mar;8(1):52-56. doi: 10.4103/sajc.sajc_76_18.
Nimotuzumab is the only anti-epidermal growth factor receptor monoclonal antibody which can be safely added to concurrent chemoradiotherapy (CRT) to improve efficacy in the management of unresectable, locally advanced squamous cell carcinoma of head and neck (LA-SCCHN). However, the evidence available on this is limited.
We retrospectively investigated efficacy and safety of nimotuzumab when combined with chemoradiation for LA-SCCHN.
Hospital records of 39 patients from January 2012 to December 2016 diagnosed with locally advanced (Stage III-IVb), unresectable SCCHN, and treated with concurrent CRT with weekly nimotuzumab were reviewed retrospectively after fulfilling the inclusion/exclusion criteria.
Tumor response was calculated as per response evaluation criteria in solid tumors criteria 1.1. Association of tumor response with independent variables was assessed. Overall survival (OS) and progression-free survival (PFS) were calculated. All patients were assessed for toxicity as per common terminology criteria for adverse events Common Terminology Criteria for Adverse Events v 4.0 (U.S. Department of health and human services, National Institutes of Health, National Cancer Institute).
At 6 months after completion of treatment, objective response rate was 97.44% with 26 (66.67%) patients attaining Complete response (CR), 12 (30.77%) patients with Partial response (PR), and one patient (2.56%) had stable disease. Subgroup analysis did not show a significant association of tumor response with independent factors. OS at 1 and 2-year was 100% and 72.9%, while PFS at 1 and 2-year was 87% and 54.40%. The incidence of Grade I, II, III, and IV toxicity was 30%, 18.18%, 41.82%, and 10%, respectively. No grade V toxicity was observed. Common adverse events observed were mucositis (33.64%), skin reaction (24.55%), neutropenia (20.91%), vomiting (18.18%), and diarrhea (2.73%).
Nimotuzumab is an efficacious and safe option when added to concurrent CRT in unresectable, LA-SCCHN.
尼妥珠单抗是唯一一种可安全添加到同步放化疗（CRT）中以提高不可切除的局部晚期头颈部鳞状细胞癌（LA-SCCHN）治疗效果的抗表皮生长因子受体单克隆抗体。然而，关于这方面的现有证据有限。
我们回顾性研究了尼妥珠单抗联合放化疗治疗LA-SCCHN的疗效和安全性。
回顾性分析了2012年1月至2016年12月期间39例诊断为局部晚期（III-IVb期）、不可切除的SCCHN并接受每周一次尼妥珠单抗同步CRT治疗的患者的医院记录，这些记录符合纳入/排除标准。
根据实体瘤疗效评价标准1.1计算肿瘤反应。评估肿瘤反应与独立变量的相关性。计算总生存期（OS）和无进展生存期（PFS）。根据不良事件通用术语标准4.0（美国卫生与公众服务部、国立卫生研究院、国家癌症研究所）对所有患者进行毒性评估。
治疗完成6个月时，客观缓解率为97.44%，其中26例（66.67%）患者达到完全缓解（CR），12例（30.77%）患者部分缓解（PR），1例患者（2.56%）疾病稳定。亚组分析未显示肿瘤反应与独立因素之间存在显著相关性。1年和2年的OS分别为100%和72.9%，1年和2年的PFS分别为87%和54.40%。I级、II级、III级和IV级毒性的发生率分别为30%、18.18%、41.82%和10%。未观察到V级毒性。观察到的常见不良事件有黏膜炎（33.64%）、皮肤反应（24.55%）、中性粒细胞减少（20.91%）、呕吐（18.18%）和腹泻（2.73%）。
在不可切除的LA-SCCHN患者中，尼妥珠单抗添加到同步CRT中是一种有效且安全的选择。
