Subramanian Sundaram, Sridharan Nithya, Balasundaram V, Chaudhari Sameer
V. S Hospital and Cancer Center, Chennai, Tamil Nadu, India.
Medical advisor, Biocon Ltd, Bengaluru, Karnataka, India.
South Asian J Cancer. 2019 Apr-Jun;8(2):112-115. doi: 10.4103/sajc.sajc_89_18.
Epidermal growth factor receptor (EGFR) is overly expressed in esophageal squamous cell carcinoma (ESCC) and is important prognostic and predictive biomarker. Nimotuzumab is a humanized anti-EGFR monoclonal antibody and has documented promising clinical outcomes and survival rates in various solid tumors with high EGFR expression.
Attempt to fill gap on paucity of data in India on the efficacy of Nimotuzumab in the treatment of locally advanced/metastatic ESCC.
Hospital records of 15 patients with unresectable, locally advanced/metastatic esophageal cancers, histologically confirmed squamous cell carcinoma being treated with Nimotuzumab along with standard treatments from October 2006 to November 2016 were retrospectively analyzed.
The tumor response rate and overall survival (OS) were analyzed. All patients were assessed for toxicity and adverse events (AEs) as per Common Terminology Criteria for Adverse Events (CTCAE) v4.
Majority had lower thoracic esophageal cancer. Tumor response rate observed was as follows 33% had a complete response, 67% had a partial response, and objective response rate was 100%. Survival rate at 1-, 3-, and 5-year was 58.33%, 29.17%, and 29.17%, respectively. Median OS was 26.8 months (95% confidence interval, 2.63-not reached). No Grade III or Grade IV AEs were observed. No added toxicity was observed due to nimotuzumab.
Nimotuzumab combined with standard treatment in locally advanced/metastatic ESCC improved the survival rate and achieved a better tumor response rate without accumulation of toxicity and was well tolerated.
表皮生长因子受体（EGFR）在食管鳞状细胞癌（ESCC）中过度表达，是重要的预后和预测生物标志物。尼妥珠单抗是一种人源化抗EGFR单克隆抗体，在多种EGFR高表达的实体瘤中已证明具有良好的临床疗效和生存率。
试图填补印度关于尼妥珠单抗治疗局部晚期/转移性ESCC疗效数据匮乏的空白。
回顾性分析了2006年10月至2016年11月期间15例经组织学确诊为鳞状细胞癌、无法切除的局部晚期/转移性食管癌患者的医院记录，这些患者接受了尼妥珠单抗联合标准治疗。
分析肿瘤缓解率和总生存期（OS）。所有患者均按照不良事件通用术语标准（CTCAE）v4评估毒性和不良事件（AE）。
大多数患者为食管下段癌。观察到的肿瘤缓解率如下：33%完全缓解，67%部分缓解，客观缓解率为100%。1年、3年和5年生存率分别为58.33%、29.17%和29.17%。中位OS为26.8个月（95%置信区间，2.63 - 未达到）。未观察到III级或IV级AE。未观察到因尼妥珠单抗导致的额外毒性。
尼妥珠单抗联合标准治疗局部晚期/转移性ESCC可提高生存率，实现更好的肿瘤缓解率，且无毒性累积，耐受性良好。
