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Previous studies have demonstrated that patients who have recurrent or metastatic squamous-cell head and neck cancer (SCHNC) that is resistant to platinum-based chemotherapy can be treated effectively with cetuximab. Belgian researchers hoped to discover whether cetuximab plus platinum-based chemotherapy would be an effective first-line treatment in patients with SCHNC. They conducted a randomized double-blind study that enrolled 442 patients with untreated recurrent or metastatic SCHNC.
On day 1 of the trial, 220 patients received 100 mg/m2 cisplatin or a 1-hour intravenous (IV) infusion of carboplatin at an area under the timeplasma concentration curve of 5 mg/mL per minute plus 1000 mg/ m2 fluorouracil for 4 days every 3 weeks. Patients received a maximum of 6 cycles. The remaining 222 patients received the same chemotherapy regimen for 6 cycles, with the addition of cetuximab at an initial dose of 400 mg/ m2 as a 2-hour IV infusion, followed by a weekly 1-hour 250 mg/m2 IV infusion. Cetuximab therapy was continued until patients experienced either unacceptable toxic effects or disease progression.
Median overall survival for patients who received cetuximab plus platinum-based chemotherapy with fluorouracil was significantly longer, at 10.1 months compared with 7.4 months for patients in the chemotherapy- only arm (HR for death, 0.80; 95% CI, 0.64 to 0.99; P
= .04). Cetuximab also extended PFS from 3.3 months to 5.6 months (HR, 0.54; P
<.001). The cetuximab group also had an 80% better response rate than the group that received chemotherapy alone (36% vs 20% respectively, P
The most common serious adverse events included anemia, neutropenia, and thrombocytopenia; incidence rates did not differ significantly between the 2 regimens. However, more patients in the cetuximab group than the chemotherapy-only group developed sepsis (9 patients vs 1 patient; P
= .02). The researchers concluded that cetuximab plus platinum-based fluorouracil chemotherapy as a first-line treatment for recurrent or metastatic SCHNC improved overall survival and PFS compared with platinum-based fluorouracil chemotherapy alone.
Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer.
N Engl J Med. 2008;359(11):1116- 1127.