title: Weekly and every 2 weeks cetuximab maintenance therapy after platinum-based chemotherapy plus cetuximab as first-line treatment for non-small cell lung cancer: randomized non-comparative phase IIIb NEXT trial.
abstract: The First-Line Erbitux in Lung Cancer (FLEX) trial showed that the addition of cetuximab to chemotherapy followed by weekly cetuximab maintenance significantly improved survival in the first-line treatment of advanced non-small cell lung cancer (NSCLC). The phase IIIb NSCLC Erbitux Trial (NEXT) trial (NCT00820755) investigated the efficacy and safety of weekly and every 2 weeks cetuximab maintenance therapy in this setting. Patients were treated with platinum-based chemotherapy plus cetuximab, and those progression-free after four to six cycles were randomized to every 2 weeks (500 mg/m(2)) or weekly (250 mg/m(2)) cetuximab maintenance. Randomization was stratified for tumor histology and response status. The primary endpoint for a regimen would be reached if the lower boundary of the 95 % confidence interval (CI) for the 1-year survival rate exceeded 55 %. A planned 480 patients were to be randomized. However, enrollment was curtailed following a negative opinion from the European Medicines Agency with regard to the use of cetuximab in this setting. After combination therapy, 311/583 (53.3 %) patients without progression were randomized to maintenance therapy: 157 to every 2 weeks cetuximab and 154 to weekly cetuximab. Baseline characteristics were balanced between these groups and exposure to cetuximab was similar. The 1-year survival rate was 62.8 % (95 % CI, 54.7-70.0) for every 2 weeks cetuximab and 64.4 % (95 % CI, 56.2-71.4) for weekly cetuximab. Safety profiles were similar, manageable, and in line with expectations. Therefore, in patients with advanced NSCLC who were progression-free after four to six cycles of first-line chemotherapy plus cetuximab, weekly and every 2 weeks cetuximab maintenance therapy were associated with similar survival outcomes.
authors.affiliation: LungenClinic Grosshansdorf, Woehrendamm 80, 22927, Grosshansdorf, Germany, d.heigener@lungenclinic.de.
authors.forename: David F
authors.initials: DF
authors.lastname: Heigener
authors.forename: José Rodrigues
authors.initials: JR
authors.lastname: Pereira
authors.forename: Enriqueta
authors.initials: E
authors.lastname: Felip
authors.forename: Juraj
authors.initials: J
authors.lastname: Mazal
authors.forename: Lyudmila
authors.initials: L
authors.lastname: Manzyuk
authors.forename: Eng Huat
authors.initials: EH
authors.lastname: Tan
authors.forename: Ofer
authors.initials: O
authors.lastname: Merimsky
authors.forename: Barbara
authors.initials: B
authors.lastname: Sarholz
authors.forename: Regina
authors.initials: R
authors.lastname: Esser
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gatzemeier
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001938:Brazil; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000068818:Cetuximab / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006801:Humans; D007557:Israel; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D012846:Singapore; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000068818:Cetuximab