Platinum-based chemotherapy plus cetuximab in head and neck cancer.
Standard
Platinum-based chemotherapy plus cetuximab in head and neck cancer. / Vermorken, Jan B; Mesia, Ricard; Rivera, Fernando; Remenar, Eva; Kawecki, Andrzej; Rottey, Sylvie; Erfan, Jozsef; Zabolotnyy, Dmytro; Kienzer, Heinz-Roland; Cupissol, Didier; Frederic, Peyrade; Benasso, Marco; Vynnychenko, Ihor; Dominique, De Raucourt; Bokemeyer, Carsten; Schueler, Armin; Amellal, Nadia; Hitt, Ricardo.
In: NEW ENGL J MED, Vol. 359, No. 11, 11, 2008, p. 1116-1127.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Platinum-based chemotherapy plus cetuximab in head and neck cancer.
AU - Vermorken, Jan B
AU - Mesia, Ricard
AU - Rivera, Fernando
AU - Remenar, Eva
AU - Kawecki, Andrzej
AU - Rottey, Sylvie
AU - Erfan, Jozsef
AU - Zabolotnyy, Dmytro
AU - Kienzer, Heinz-Roland
AU - Cupissol, Didier
AU - Frederic, Peyrade
AU - Benasso, Marco
AU - Vynnychenko, Ihor
AU - Dominique, De Raucourt
AU - Bokemeyer, Carsten
AU - Schueler, Armin
AU - Amellal, Nadia
AU - Hitt, Ricardo
PY - 2008
Y1 - 2008
N2 - 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
AB - 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
M3 - SCORING: Zeitschriftenaufsatz
VL - 359
SP - 1116
EP - 1127
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 11
M1 - 11
ER -
