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Background A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy.
Methods We randomly assigned 501 patients (all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were candidates for organ preservation) to receive either TPF or PF induction chemotherapy, followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week. The primary end point was overall survival.
Results With a minimum of 2 years of follow-up (
Conclusions Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy. (ClinicalTrials.gov number, NCT00273546
[ClinicalTrials.gov]
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3 years for 69% of patients), significantly more patients survived in the TPF group than in the PF group (hazard ratio for death, 0.70; P=0.006). Estimates of overall survival at 3 years were 62% in the TPF group and 48% in the PF group; the median overall survival was 71 months and 30 months, respectively (P=0.006). There was better locoregional control in the TPF group than in the PF group (P=0.04), but the incidence of distant metastases in the two groups did not differ significantly (P=0.14). Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group.
Source Information
From the Dana–Farber Cancer Institute, Boston (M.R.P., R.B.T., A.D.C., C.M.N., R.I.H.); Sanofi-Aventis, Malvern, PA (D.M.H.); Hospital Iturraspe, Santa Fe (C.R.B., R.C.V.), and Instituto Angel H. Roffo, Buenos Aires (E.M., B.R.) — both in Argentina; London Regional Cancer Centre, London, ON, Canada (E.W., V.V.); Cancer Research Center, Moscow (V.G., S.T., I.R.); Emory Winship Cancer Institute, Atlanta (D.M.S.); University of Maryland Greenebaum Cancer Center, Baltimore (K.C.); Maine Center for Cancer Medicine and Blood Disorders, Scarborough, ME (T.J.E., M.D.); Vanderbilt University (B.A.M.) and Metro Nashville General Hospital (A.C.) — both in Nashville; Sylvester Cancer Center, University of Miami, Miami (L.E.R., A.M.M.); University of Virginia, Charlottesville (R.B.C., P.W.R.); Veterans Affairs Western New York Healthcare System, Buffalo (M.S., L.S.); University of Pittsburgh, Pittsburgh (S.A.); and Vincent Lombardi Cancer Center, Washington, DC (K.W.H.).
Address reprint requests to Dr. Posner at the Dana–Farber Cancer Institute, 44 Binney St., SW 430, Boston, MA 02115, or at marshall_posner{at}dfci.harvard.edu.
Related Letters:
Treatment of Head and Neck Cancer
Forastiere A., Weber R., Ang K., Trotti A. III, Pajak T. F., Ridge J. A., Saghir F., Feldman L. E., Nutting C. M., Bhide S. A., Harrington K. J., Posner M. R., Haddad R. I., Tishler R. B.
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N Engl J Med 2008;
358:1076-1078, Mar 6, 2008.
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