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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)

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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/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.

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: 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).

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.

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Authors and Affiliations

  1. Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, 39008, Santander, Spain

    Fernando Rivera, M. Eugenia Vega-Villegas, Marta López-Brea & Jaime Sanz-Ortiz

  2. Department of Medical Oncology, Hospital Universitario Lozana Blesa, Zaragoza, Spain

    Dolores Isla & Jose Mayordomo

  3. Department of Pathology, Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Marta Mayorga

  4. Department of Radiotherapy, Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Piedad Galdós

  5. Department of Otorrhinolaringology, Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Antonio Rubio, Adolfo Del Valle, Julio Rodríguez-Iglesias & Julio Rama

  6. Department of Maxilofacial Surgery, Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Fe García-Reija, Belen García-Montesinos & Ramón Saiz-Bustillo

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  1. Fernando Rivera
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Correspondence to Fernando Rivera.

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Rivera, F., Vega-Villegas, M.E., López-Brea, M. et al. 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). Cancer Chemother Pharmacol 62, 253–261 (2008). https://doi.org/10.1007/s00280-007-0599-0

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