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Cetuximab plus chemotherapy improved survival, response rate in head and neck cancer
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Patients with squamous-cell carcinoma of the head and neck may experience improved OS from first-line cetuximab plus platinum-fluorouracil chemotherapy.
Researchers from Antwerp University Hospital in Belgium and other sites in Belgium, Spain and Europe, conducted a randomized trial to determine the efficacy of cetuximab (Erbitux, ImClone Systems Inc.) plus platinum-fluorouracil chemotherapy in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck.
Patients were randomly assigned to cisplatin or carboplatin plus fluorouracil every three weeks for a maximum of six cycles (n=220) or to the same therapy plus cetuximab for a maximum of six cycles (n=222). Patients who received chemotherapy plus cetuximab and who had stable disease received therapy until toxicity or disease progression.
Median OS was 7.4 months in the chemotherapy alone group and 10.1 months in the chemotherapy plus cetuximab group (HR for death=0.80; P=.04). Median PFS was 3.3 months for chemotherapy alone and 5.6 months for chemotherapy plus cetuximab (HR for progression=0.54; P<.001).
The addition of cetuximab to chemotherapy increased the overall response rate from 20% for chemotherapy alone to 36% for chemotherapy plus cetuximab (OR=2.33; P<.001).
The most common grade-3 and grade-4 events for both groups were anemia, neutropenia and thrombocytopenia. The researchers reported no cetuximab-related deaths.
N Engl J Med. 2008;359:1116-1127.