title: Induction chemotherapy with cisplatin/docetaxel versus cisplatin/5-fluorouracil for locally advanced squamous cell carcinoma of the head and neck: a randomised phase II study.
abstract: A combination of cisplatin and 5-fluorouracil (PF) is considered the standard induction chemotherapy regimen for squamous cell carcinoma of the head and neck (SCCHN). The present study compares the efficacy and safety of a new combination of cisplatin/docetaxel versus the PF regimen. A total of 83 chemotherapy-naive patients with locally advanced SCCHN were randomised to receive every 21 d (i) docetaxel 85 mg/m2 i.v. on day 1 and cisplatin 40 mg/m2 i.v. on days 1 and 2 (arm A) or (ii) cisplatin 100 mg/m2 i.v. on day 1 followed by 5-fluorouracil 1000 mg/m2 in 24 h continuous infusion for 5 d (arm B). A total of 287 cycles (range 1-3 per patient) were administered. Among 76 patients evaluable for response, the overall response rate in arm A was 70% (complete response (CR) 26%, partial response (PR) 44%) and in arm B 69% (CR 16%, PR 54%), respectively. Median survival in arm A was 7.6 months (95% CI: 5.8-11.1) and 9.9 months (95% CI: 7.4-14.6) for arm B. The most frequent grade 3/4 toxicity in arm A was neutropaenia (34.1%) and diarrhoea (9.8%) versus mucositis (29.3%) and neutropaenia (19.5%) in arm B. Both schedules present a similar efficacy, with different but acceptable toxicity patterns.
authors.affiliation: Servicio de Oncología Médica, Hospital Clínico Universitario, Paseo de San Vicente, 182, 37007-Salamanca, Spain.
authors.forename: Emilio
authors.initials: E
authors.lastname: Fonseca
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Grau
authors.forename: Javier
authors.initials: J
authors.lastname: Sastre
authors.forename: Jesús María
authors.initials: JM
authors.lastname: García-Gómez
authors.forename: Antonio
authors.initials: A
authors.lastname: Rueda
authors.forename: Miguel
authors.initials: M
authors.lastname: Pastor
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Lara
authors.forename: Marta
authors.initials: M
authors.lastname: Navalón
authors.forename: Alfonso
authors.initials: A
authors.lastname: Berrocal
authors.forename: José Luis
authors.initials: JL
authors.lastname: Tisaire
authors.forename: Juan Jesús
authors.initials: JJ
authors.lastname: Cruz
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil