Abstract
Background: Head and neck cancers (HNCs) constitute 5% of all cancers globally and are the most common cancers in India. Chemotherapy and radiotherapy have not been proved to be effective in advanced cases and the prognosis remains dismal. This underscores the need for newer treatment options in these cases. Nimotuzumab, an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, was safer when combined with chemo- or radio-therapy. Aim: To evaluate the safety and efficacy of concurrently administered nimotuzumab with chemo-radiotherapy in patients with advanced inoperable squamous cell carcinomas of head and neck (LASCCHN). Methods: This was an open-label, single arm study evaluating 57 patients with histologically confirmed inoperable LASCCHN (stages III and IV) and eastern co-operative oncology group (ECOG) performance status 2 and IV nimotuzumab 200 mg weekly for 6 weeks, along with radiotherapy of 6600 cGy over 33 fractions. Patients were evaluated over response evaluation criteria in solid tumors (RECIST) criteria 24 weeks after the last cycle of chemotherapy. Results: Mean age of patient was 50 years old (29 - 79 years old). The most common site of cancer was oral cavity (56.1%). Forty six patients (80.7%) completed 6 cycles of therapy. Objective response rate (ORR) was 80.7%, with 34 patients (59.6%) achieving complete response (CR), and 12 (21%) achieving partial response (PR). Stable disease (SD) was noted in 8 (14%) patients and progressive disease in 3 (5.2%) patients. Conclusion: Addition of nimotuzumab is a safe and efficacious option in patients with inoperable LASCCHN. Our observations confirm the available Phase II data. The long term survival benefits based on this encouraging response rate need to be further evaluated in this subset of cancer patients.
Highlights
Ranking 6th, head and neck cancers (HNCs) constitute approximately 5% of all cancers globally [1], and are the most common cancers in India, with an incidence of approximately 0.2 - 0.25 million cases annually [2]
Out of all head and neck cancers occurring globally, 57.5% occur in Asia especially in India
The main exclusion criteria were patients who received chemotherapy, radiotherapy and/or immunotherapy, patients with distant metastases and known or suspected hypersensitivity to drugs used in the study
Summary
Ranking 6th, head and neck cancers (HNCs) constitute approximately 5% of all cancers globally [1], and are the most common cancers in India, with an incidence of approximately 0.2 - 0.25 million cases annually [2]. In India, tobacco chewing accounts for nearly 50% of oral and oropharyngeal tumours in men and over 90% in women. It has been associated with ionizing radiation, diesel exhausts, sulphuric acid mists, and mustard gas [4]. Chemotherapy and radiotherapy have not been proved to be effective in advanced cases and the prognosis remains dismal. This underscores the need for newer treatment options in these cases. Aim: To evaluate the safety and efficacy of concurrently administered nimotuzumab with chemo-radiotherapy in patients with advanced inoperable squamous cell carcinomas of head and neck (LASCCHN). The long term survival benefits based on this encouraging response rate need to be further evaluated in this subset of cancer patients
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
