Cancer Chemotherapy and Pharmacology

, Volume 62, Issue 2, pp 253–261

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)

  • Fernando Rivera
  • M. Eugenia Vega-Villegas
  • Marta López-Brea
  • Dolores Isla
  • Marta Mayorga
  • Piedad Galdós
  • Antonio Rubio
  • Adolfo Del Valle
  • Fe García-Reija
  • Belen García-Montesinos
  • Julio Rodríguez-Iglesias
  • Jose Mayordomo
  • Julio Rama
  • Ramón Saiz-Bustillo
  • Jaime Sanz-Ortiz
Original Article

DOI: 10.1007/s00280-007-0599-0

Cite this article as:
Rivera, F., Vega-Villegas, M.E., López-Brea, M. et al. Cancer Chemother Pharmacol (2008) 62: 253. doi:10.1007/s00280-007-0599-0

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.

Copyright information

© Springer-Verlag 2007

Authors and Affiliations

  • Fernando Rivera
    • 1
  • M. Eugenia Vega-Villegas
    • 1
  • Marta López-Brea
    • 1
  • Dolores Isla
    • 2
  • Marta Mayorga
    • 3
  • Piedad Galdós
    • 4
  • Antonio Rubio
    • 5
  • Adolfo Del Valle
    • 5
  • Fe García-Reija
    • 6
  • Belen García-Montesinos
    • 6
  • Julio Rodríguez-Iglesias
    • 5
  • Jose Mayordomo
    • 2
  • Julio Rama
    • 5
  • Ramón Saiz-Bustillo
    • 6
  • Jaime Sanz-Ortiz
    • 1
  1. 1.Department of Medical OncologyHospital Universitario Marqués de ValdecillaSantanderSpain
  2. 2.Department of Medical OncologyHospital Universitario Lozana BlesaZaragozaSpain
  3. 3.Department of PathologyHospital Universitario Marqués de ValdecillaSantanderSpain
  4. 4.Department of RadiotherapyHospital Universitario Marqués de ValdecillaSantanderSpain
  5. 5.Department of OtorrhinolaringologyHospital Universitario Marqués de ValdecillaSantanderSpain
  6. 6.Department of Maxilofacial SurgeryHospital Universitario Marqués de ValdecillaSantanderSpain

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