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Previous Volume 357:1695-1704 October 25, 2007 Number 17 Next

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ABSTRACT

Background Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease.

Methods We randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival.

Results A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P=0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P=0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group.

Conclusions As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00003888 [ClinicalTrials.gov] .)

Source Information

From Universitair Ziekenhuis Antwerpen, Edegem, Belgium (J.B.V.); the National Institute of Oncology, Budapest, Hungary (E.R.); Universitair Medisch Centrum Nijmegen, Nijmegen, the Netherlands (C.H.); EORTC Data Center, Brussels (T.G., I.D.); Institut Catala d'Oncologia, Barcelona (R.M.); Centre Oscar Lambret, Lille, France (M.D., J.-L.L.); Charing Cross Hospital, London (J.S.S.); the Institute of Oncology and Radiology, Belgrade, Serbia (S.J.); University Hospital Motol, Prague, Czech Republic (J. Betka); Caritasklinik St. Theresia, Saarbrucken, Germany (J.H.P.); Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp, Belgium (D.W.); Institut Jules Bordet, Brussels (A.A.); Centre Régional de Lutte contre le Cancer Val d'Aurelle, Montpellier, France (D.C.); Kaiser Franz Josef Spital, Vienna (H.R.K.); Sanofi-Aventis Global Oncology, Paris (A.R.); and Clinique de Genolier, Genolier, Switzerland (J. Bernier).

Address reprint requests to Dr. Vermorken at the Department of Medical Oncology, Universitair Ziekenhuis Antwerpen, Wilrijkstraat 10, 2650 Edegem, Belgium, or at jan.b.vermorken{at}uza.be.

Full Text of this Article

Related Letters:

Chemotherapy in Unresectable Head and Neck Cancer
Bölke E., Peiper M., Gripp S., Vermorken J. B.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:1075, Mar 6, 2008. Correspondence

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