Safety and efficacy of nimotuzumab with concurrent chemoradiotherapy in unresectable locally advanced squamous cell carcinoma of head and neck: An Indian rural hospital experience

Abstract

Context: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.Aims:We retrospectively investigated efficacy and safety of nimotuzumab when combined with chemoradiation for LA-SCCHN.Settings and Design: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.Subjects and Methods: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).Results: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%).Conclusions:Nimotuzumab is an efficacious and safe option when added to concurrent CRT in unresectable, LA-SCCHN.

Nimotuzumab combined with radiotherapy+/- chemotherapy for definitive treatment of locally advanced squamous cell carcinoma of head and neck: a metanalysis of randomized controlled trials

“…Median PFS increased by 2 months (p = 0.009) without any significant increase in toxicity ( 36 ). Other studies of nimotuzumab in SCCHN ( 37 , 38 ) also showed similar results. It can be seen that the treatment of nimotuzumab combined with chemotherapy or RT or CRT for SCCHN can improve the short-term and long-term efficacy without increasing the toxic reaction.…”

Efficacy and safety of nanosomal docetaxel lipid suspension‑based chemotherapy in squamous cell carcinoma of the head and neck: A multicenter retrospective study

“…Docetaxel is recommended as a first-line therapy for recurrent, unresectable or metastatic SCCHN as a single agent or in combination with cisplatin/carboplatin with/without 5-FU/cetuximab ( 6 ). In this setting, docetaxel-based chemotherapy has reported an ORR of 33–97% in the treatment of SCCHN ( 37 , 38 ). Patients receiving NDLS-based palliative chemotherapy demonstrated an ORR of 50% and a median OS of 4.6 months (follow-up duration, 1.8–14.3 months) in the present study.…”