Abstract
Background: The prognosis of patients with Epidermal Growth Factor Receptor (EGFR) overexpression in inoperable Locally Advanced Squamous Cell Carcinoma of Head and Neck (LASCCHN) remains poor. Nimotuzumab is an Anti EGFR humanized monoclonal antibody approved for treatment of LASCCHN, with concurrent chemoradiation. Objective: To assess the efficacy and safety of nimotuzumab with concurrent chemoradiation in inoperable LASCCHN patients. Methodology: This is a single-centre, single arm, retrospective study evaluating 35 patients with histologically confirmed inoperable LASCCHN (stages III-IV). The patients were administered IV cisplatin 50 mg/m2 and IV nimotuzumab 200 mg for 6 - 7 weeks, along with radiotherapy of 6600 - 7000 cGy over 35 fractions. Patients were evaluated over response evaluation criteria in solid tumors (RECIST) criteria 12 weeks after the last cycle of chemotherapy. They were also followed up for overall survival and relapse free survival. Results: The median duration of follow-up was 20 months. The most common site of cancer was oropharynx (68.6%). One patient was lost to follow up. Objective Response Rate (ORR) was observed in 97% of the patients with 17 patients (48.6%) achieving complete response (CR) and 17 patients (48.6%) achieving partial response (PR). The median overall survival was 22.7 months (95% CI: 21.30, 34.27). The median relapse free survival was 16.7 months (95% CI: 9.80, 24.50). Nimotuzumab was safe and well tolerated with few mild, self-limiting adverse events. Conclusion: Nimotuzumab with chemoradiation is a safe and efficacious option in patients with LASCCHN. Larger studies are needed to verify the same.
Highlights
Head and neck cancers (HNC) account for about 5% of all cancers [1]
Nimotuzumab is an Anti Epidermal Growth Factor Receptor (EGFR) humanized monoclonal antibody approved for treatment of LASCCHN, with concurrent chemoradiation
Surgery and radiotherapy (RT) remains the mainstay in the management of initial stages of head and neck cancers (HNC), chemotherapy involving the use of drugs such as cisplatin, is recommended along with radiotherapy, in non-resectable and locally advanced cases of squamous cell carcinoma of the head and neck (LASCCHN)
Summary
Head and neck cancers (HNC) account for about 5% of all cancers [1]. In India, approximately 0.7 million new cases of HNCs are being diagnosed annually; while about 33% of the 0.3 million cancer related deaths are attributed to tobacco related cancers [2]. Surgery and radiotherapy (RT) remains the mainstay in the management of initial stages of HNCs, chemotherapy involving the use of drugs such as cisplatin, is recommended along with radiotherapy, in non-resectable and locally advanced cases of squamous cell carcinoma of the head and neck (LASCCHN). Such an approach may not be beneficial in advanced cases, where the prognosis with such therapies remains dismal [3]. Patients were evaluated over response evaluation criteria in solid tumors (RECIST) criteria 12 weeks after the last cycle of chemotherapy They were followed up for overall survival and relapse free survival. Conclusion: Nimotuzumab with chemoradiation is a safe and efficacious option in patients
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