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Previous Volume 359:1116-1127 September 11, 2008 Number 11 Next

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ABSTRACT

Background Cetuximab is effective in platinum-resistant recurrent or metastatic squamous-cell carcinoma of the head and neck. We investigated the efficacy of cetuximab plus platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck.

Methods We randomly assigned 220 of 442 eligible patients with untreated recurrent or metastatic squamous-cell carcinoma of the head and neck to receive cisplatin (at a dose of 100 mg per square meter of body-surface area on day 1) or carboplatin (at an area under the curve of 5 mg per milliliter per minute, as a 1-hour intravenous infusion on day 1) plus fluorouracil (at a dose of 1000 mg per square meter per day for 4 days) every 3 weeks for a maximum of 6 cycles and 222 patients to receive the same chemotherapy plus cetuximab (at a dose of 400 mg per square meter initially, as a 2-hour intravenous infusion, then 250 mg per square meter, as a 1-hour intravenous infusion per week) for a maximum of 6 cycles. Patients with stable disease who received chemotherapy plus cetuximab continued to receive cetuximab until disease progression or unacceptable toxic effects, whichever occurred first.

Results Adding cetuximab to platinum-based chemotherapy with fluorouracil (platinum–fluorouracil) significantly prolonged the median overall survival from 7.4 months in the chemotherapy-alone group to 10.1 months in the group that received chemotherapy plus cetuximab (hazard ratio for death, 0.80; 95% confidence interval, 0.64 to 0.99; P=0.04). The addition of cetuximab prolonged the median progression-free survival time from 3.3 to 5.6 months (hazard ratio for progression, 0.54; P<0.001) and increased the response rate from 20% to 36% (P<0.001). The most common grade 3 or 4 adverse events in the chemotherapy-alone and cetuximab groups were anemia (19% and 13%, respectively), neutropenia (23% and 22%), and thrombocytopenia (11% in both groups). Sepsis occurred in 9 patients in the cetuximab group and in 1 patient in the chemotherapy-alone group (P=0.02). Of 219 patients receiving cetuximab, 9% had grade 3 skin reactions and 3% had grade 3 or 4 infusion-related reactions. There were no cetuximab-related deaths.

Conclusions As compared with platinum-based chemotherapy plus fluorouracil alone, cetuximab plus platinum–fluorouracil chemotherapy improved overall survival when given as first-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00122460 [ClinicalTrials.gov] .)

Source Information

From Antwerp University Hospital, Edegem (J.B.V.); and Ghent University Hospital, Ghent (S.R.) — both in Belgium; Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona (R.M.); Hospital Universitario Marqués de Valdecilla, Santander (F.R.); and Hospital 12 de Octubre, Madrid (R.H.) — all in Spain; Orszagos Onkologiai Intezet, Budapest (E.R.), and Szabolcs-Szatmar Bereg Megyei Josa Andras Korh, Nyiregyhaza (J.E.) — both in Hungary; Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland (A.K.); Institute of Otolaryngology, Academy of Medical Sciences of Ukraine, Kiev (D.Z.); and Sumy Regional Oncology Center, Sumy (I.V.) — both in Ukraine; Ludwig Boltzmann Institute for Applied Cancer Research, Kaiser Franz Josef Spital, Vienna (H.-R.K.); Centre Val d'Aurelle Paul Lamarque Service d'Oncologie, Montpellier (D.C.); Centre Antoine Lacassagne, Nice (F.P.); and Centre François Baclesse, Caen (D.D.R.) — all in France; Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (M.B.); and Universitaetskrankenhaus Hamburg-Eppendorf, Hamburg (C.B.); and Merck, Darmstadt (A.S., N.A.) — both in Germany.

Address reprint requests to Dr. Vermorken at Antwerp University Hospital, Department of Medical Oncology, Wilrijkstraat 10, 2650 Edegem, Belgium, or at jan.b.vermorken{at}uza.be.

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This article has been cited by other articles:

• (2008). Cetuximab for Head and Neck Cancer. JWatch Oncology and Hematology 2008: 1-1 [Full Text]