Induction gemcitabine and cisplatin followed by radiation therapy in advanced loco-regional head and neck cancer.

Abstract

e16043 Background: This retrospective study was performed to evaluate the efficacy and toxicity of induction chemotherapy with gemcitabine and cisplatin (GC) followed by radiation / concomitant chemoradiation (RT/CRT) in advanced loco-regional head and neck cancer (LRHANC). Methods: Between 2005 - 2009, 446 newly diagnosed advanced LRHANC patients were treated with induction GC followed by RT/CRT in our institution. M 69%: F 31%. Median age 50 years (range 18 – 81 years). Site; oral cavity 232 (52%), hypopharynx 45 (10%), nasopharynx 63 (14%), larynx 46 (10%), oropharynx 14 (3%), paranasal sinuses 33 (8%) and others 13 (3%). Histology; squamous cell carcinoma 373 (84%), undifferentiated carcinoma 53 (12%), others 20 (4%). Pre treatment AJCC stage (6th edition); T1-3 N0/N+ 139 (31%), T4 N0/N+ 307 (69%). Induction chemotherapy consisted of cisplatin 75 mg / m2 day 1 and gemcitabine 1 gm / m2 day 1 and 8 every 3 weeks. 383 (86%) patients received 2 cycles of induction GC. CRT with 3 weekly cisplatin 75mg/ m2 was given in 299 (67%) and RT alone in 147 (33%) patients. Radiation doses ranged from 55Gy - 70 Gy in 20 - 35 fractions. Results: Minimum follow-up was 2 years. Response to induction chemotherapy; complete response (CR) 58 (13%), partial response (PR) 315 (71%), stable disease (SD) 55 (12%) and progressive disease (PD) 18 (4%). Response to RT/CRT; CR 293 (66%) and persistent disease at 3 months post radiation in 153 (34%) patients. G3/G4 toxicity on induction GC was anemia 2%/0%, neutropenia 17%/4%, thrombocytopenia 2%/1%, vomiting 5%/1% and diarrhea 5%/1%. G1 transient elevation of ALT/ AST was 17% /11%. G3/4 elevation of creatinine was 2 %/1%. Nine patients (2%) had toxicity related hospital admissions during RT/CRT. The 5-year actuarial overall survival and relapse free survival were 67% and 44% respectively. Local control, regional control and distant control rates were 62%, 50% and 49% respectively. Conclusions: Induction GC followed by RT/CRT is a safe and effective approach in untreated head and neck cancer and merits further evaluation in controlled clinical trials.