Randomized phase II study of cisplatin and 5-FU continuous infusion (PF) versus cisplatin, UFT and vinorelbine (UFTVP) as induction chemotherapy in locally advanced squamous cell head and neck cancer (LA-SCHNC).

ABSTRACT

OBJECTIVES: We conducted a multicentric randomized phase II trial comparing 5-FU continuous infusion (PF) and cisplatin, UFT and vinorelbine (UFTVP) as induction chemotherapy (IC) in locally advanced squamous cell head and neck cancer (LA-SCHNC). Primary objective was complete response (CR) to IC and overall survival (OS) was a secondary objective. MATERIALS AND METHODS: PF cisplatin 100 mg/m(2) i.v. Day 1 (D1) and 5-FU 1,000 mg/m(2) per day i.v. continous infusion D1-D5, every 21 days. UFTVP cisplatin 100 mg/m(2) i.v. D1; UFT 200 mg/m(2) per day p.o. D1-D21 and vinorelbine 25 mg/m(2) i.v. D1 and D8, every 21 days. Four IC courses were planned in both arms. RESULTS: A total of 206 patients (pts) were included (PF/UFTVP 99/107) oral cavity 8%/10%, oropharynx 20%/25%, hypopharynx 17%/14%, larynx 54%/50%. Stage (TNM, 2002) III 41%/35%, IVA 23%/27%, IVB 35%/38%. Complete response to IC PF36%/UFTVP31% (P no significative (NS)). G 3-4 toxicity (PF/UFTVP) neutropenia 52%/72%; febrile neutropenia 3%/20% (P < 0.001); anaemia1%/14% (P < 0.001); trombocytopenia 5%/0% (P = 0.02); mucositis 15%/7% (P < 0.001). Deaths during IC 2(2%)/3(3%). IC with UFTVP was associated with a favourable OS in the Cox analysis (actuarial 5 year OS 49% vs. 34%; HR 0.67, 95% CI 0.47-0.95, P 0.03). CONCLUSIONS: Although clinical response is equal in both arms, overall survival (Cox) is better in the UFTVP arm. Febrile neutropenia and anaemia were more frequent with UFTVP while mucositis and trombocytopenia were more severe with PF.