Long term survival of gemcitabine and cisplatin followed by radiation in advance head and neck cancer.

Abstract

e17083 Background: In this retrospective study we evaluated the response, efficacy, toxicity and long term follow-up of patients treated with gemcitabine and cisplatin followed by radiation or chemo-radiation (RT/CRT) in non metastatic advance head and neck cancer. Methods: A total of 446 patients were included in this study treated from 2005 – 2009 in our institution. Pretreatment AJCC stage; T1-3 N0/N+ 139 (31%), T4 N0/N+ 307 (69%). All patients received gemcitabine 1 gm /m2 (day 1, 8) and cisplatin 75 mg/m2 (day1 only). This cycle was repeated every 3 weeks followed by radiation from 55 – 70 Gy in 20 – 35 fractions respectively. 383 (86%) patients received 2 cycles of induction chemotherapy (IC). A total of 299 (67%) patients received concurrent 3 weekly cisplatin (75 mg/m2). Patient characteristics included; Male: female 2:1, Median age 50 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%). Histological diversity; squamous cell carcinoma 373 (84%), undifferentiated carcinoma 53 (12%), others 20 (4%). Results: Response to IC: 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 treatment in 153 (34%) patients. G3/G4 toxicity for induction chemotherapy 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 and 10 year OS, DFS and RFS were 56%, 53%, 45%, 41%, 30% and 27% respectively. 149 (33%) patients are alive, disease free and maintaining routine follow up. Conclusions: The long term follow up of our study with comparable survival outcomes and acceptable toxicity merits further evaluation in randomized trials.