Yadav Abhishek, Goyal Pankaj, Agrawal Chaturbhuj R, Bothra Sneha J, Jain Parveen, Choudhury Kumardeep Dutta, Gupta Sunil Kumar, Sharma Manish, Bajaj Rajat, Upadhyay Amitabh, Dash Prashanta, Doval Dinesh C
Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.
Indian J Cancer. 2020 Jan-Mar;57(1):76-83. doi: 10.4103/ijc.IJC_469_18.
Squamous cell carcinoma of head and neck (SCCHN) account for approximately 30-33% of all cancer and the median survival for recurrent and metastatic(R/M) SCCHN remains less than 1 year despite modern advances in therapy. Chemotherapy, usually single agent remains the backbone of therapy in these patients. EGFR antibodies are being used in (R/M) SCCHN. Nimotuzumab is one such agent that has anti-EGFR action similar to other agents without similar skin toxicity.
Prospective, interventional, non-randomized study done at Rajiv Gandhi Cancer Institute and Research Centre. A total 124 patients were enrolled and divided into Arm A (Chemotherapy + Nimotuzumab) and Arm B (Chemotherapy) in a ratio of 1:1 i.e., 62 in each arm. They were evaluated and treated as per protocol after a written informed consent. Statistical analysis was done using the SPSS software. Quantitative variables were compared using Unpaired t-test/Mann-Whitney Test. Qualitative variables were compared using Chi-Square test /Fisher's exact test. Kaplan-Meier analysis was used to assess the PFS, with log rank test for comparison between the groups. A p value of < 0.05 was considered statistically significant.
The most frequent primary location of tumor was oral cavity (n=38, 69%) and (n=33, 56.9%) in both arms. The overall response rate in Arm A was 38.2% and 19% in Arm B (p= 0.023). The disease control rate in Arm A was 74.5% and 43.1% Arm B (p= 0.0007). The median PFS in Arm A was 5.2 months whereas it was 3.2 months in Arm B (p= 0.009).
In this study, the combination of Nimotuzumab plus platinum/taxane based chemotherapy was active and well tolerated in Indian patients in R/M SCCHN. Addition of Nimotuzumab to chemotherapy had a response rate of 38.2% and median PFS of 5.2 months are strong arguments for clinically testing this combination.
头颈部鳞状细胞癌（SCCHN）约占所有癌症的30%-33%，尽管现代治疗取得了进展，但复发和转移性（R/M）SCCHN的中位生存期仍不足1年。化疗通常采用单药治疗，仍是这些患者治疗的主要手段。表皮生长因子受体（EGFR）抗体正用于（R/M）SCCHN的治疗。尼妥珠单抗就是这样一种药物，它具有与其他药物相似的抗EGFR作用，但没有类似的皮肤毒性。
在拉吉夫·甘地癌症研究所和研究中心进行的前瞻性、干预性、非随机研究。共纳入124例患者，按1:1的比例分为A组（化疗+尼妥珠单抗）和B组（化疗），每组62例。在获得书面知情同意后，根据方案对患者进行评估和治疗。使用SPSS软件进行统计分析。定量变量采用非配对t检验/曼-惠特尼检验进行比较。定性变量采用卡方检验/费舍尔精确检验进行比较。采用Kaplan-Meier分析评估无进展生存期（PFS），并使用对数秩检验比较组间差异。p值<0.05被认为具有统计学意义。
两组中最常见的肿瘤原发部位均为口腔（A组n=38，69%；B组n=33，56.9%）。A组的总缓解率为38.2%，B组为19%（p=0.023）。A组的疾病控制率为74.5%，B组为43.1%（p=0.0007）。A组的中位PFS为5.2个月，而B组为3.2个月（p=0.009）。
在本研究中，尼妥珠单抗联合铂类/紫杉类化疗在印度R/M SCCHN患者中具有活性且耐受性良好。化疗加用尼妥珠单抗的缓解率为38.2%，中位PFS为5.2个月，这些有力证据支持对该联合方案进行临床测试。
