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- Title
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).
- Authors
Rivera, Fernando; Vega-Villegas, M. Eugenia; López-Brea, Marta; Isla, Dolores; Mayorga, Marta; Galdós, Piedad; Rubio, Antonio; Valle, Adolfo; Garc&a#x00ED;a-Reija, Fe; García-Montesinos, Belen; Rodríguez-Iglesias, Julio; Mayordomo, Jose; Rama, Julio; Saiz-Bustillo, Ramón; Sanz-Ortiz, Jaime
- Abstract
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. PF: cisplatin 100 mg/m2 i.v. Day 1 (D1) and 5-FU 1,000 mg/m2 per day i.v. continous infusion D1–D5, every 21 days. UFTVP: cisplatin 100 mg/m2 i.v. D1; UFT 200 mg/m2 per day p.o. D1–D21 and vinorelbine 25 mg/m2 i.v. D1 and D8, every 21 days. Four IC courses were planned in both arms. 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: PF:36%/UFTVP:31% ( P: no significative (NS)). G 3–4 toxicity (PF/UFTVP): neutropenia: 52%/72%; febrile neutropenia: 3%/20% ( P < 0.001); anaemia:1%/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). 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.
- Subjects
RANDOMIZED controlled trials; CISPLATIN; VINORELBINE; DRUG efficacy; DRUG therapy; CANCER treatment; SQUAMOUS cell carcinoma; HEAD &; neck cancer
- Publication
Cancer Chemotherapy & Pharmacology, 2008, Vol 62, Issue 2, p253
- ISSN
0344-5704
- Publication type
Article
- DOI
10.1007/s00280-007-0599-0