PROSPECTIVE STUDY COMPARING CONCURRENT CHEMORADIATION WITH OR WITHOUT GEFITINIB IN TREATMENT OF LOCALLY ADVANCED HEAD AND NECK CARCINOMA

Abstract

ABSTRACT BACKGROUND-Concurrent chemoradiotherapy (CTRT) is now an acceptable definitive therapy for locally advanced head and neck carcinomas. But, multiple studies revealed that addition of anti-EGFR agent with CTRT  improves the loco-regional response at a cost of higher but acceptable toxicity. Our study aimed at assessing CTRT with or without Gefitinib in terms of treatment response and acute toxicity profile. MATERIALS AND METHODS- Patients with Locally advanced, non-metastatic, squamous cell carcinoma of Head-neck were  randomised in two groups-the control group  received  external beam radiotherapy  66Gy/33 fractions/6.5 weeks along with concurrent  injection Cisplatin at the dose of 100mg/m2 on day 1, 22, and 43 during radiation and the study group received concurrent chemoradiotherapy  along with  Tab Gefitinib-250 mg during the  duration of radiotherapy. Response assessment was done  after completion of treatment and all patients were followed up for treatment related acute toxicity during the course of treatment and then at every month for at least 6 months.  RESULTS- 46.66% of study arm (CTRT+Gefitinib) patients showed complete response and  Overall response was 79%. In control arm (CTRT alone), there was 51.6% complete response  and Overall response was 77%, though difference was statistically not significant (p value 0.84). Although statistically not significant, Gefitinib containing arm had numerically higher hematological, gastro-intestinal toxicity and weight loss. CONCLUSION- Gefitinib along with chemoradiation showed numerically higher overall response (complete response + partial response) and comparable acute toxicity profile in comparison to chemoradiation alone.