• DOI:10.1056/NEJMOA050753
• Corpus ID: 2401958

Erlotinib in previously treated non-small-cell lung cancer.

@article{Shepherd2005ErlotinibIP,
  title={Erlotinib in previously treated non-small-cell lung cancer.},
  author={Frances A. Shepherd and J Rodrigues Pereira and Tudor Eliade Ciuleanu and Eng Huat Tan and Vera Hirsh and Sumitra Thongprasert and Daniel Campos and Savitree Maoleekoonpiroj and Michael Smylie and Renato G Martins and Maximiliano van Kooten and Mircea Dediu and Brian P. Findlay and Dongsheng Tu and Dianne B. Johnston and Andrea Bezjak and Gary M. Clark and P. Moreno Santabarbara and Lesley Seymour},
  journal={The New England journal of medicine},
  year={2005},
  volume={353 2},
  pages={
          123-32
        }
}

• F. Shepherd, J. Rodrigues Pereira, +16 authors L. Seymour
• Published 14 July 2005
• Medicine
• The New England journal of medicine

BACKGROUND
We conducted a randomized, placebo-controlled, double-blind trial to determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival in non-small-cell lung cancer after the failure of first-line or second-line chemotherapy.

METHODS
Patients with stage IIIB or IV non-small-cell lung cancer, with performance status from 0 to 3, were eligible if they had received one or two prior chemotherapy regimens. The patients were stratified according to center, performance status, response to prior chemotherapy, number of prior regimens, and prior platinum-based therapy and were randomly assigned in a 2:1 ratio to receive oral erlotinib, at a dose of 150 mg daily, or placebo.

RESULTS
The median age of the 731 patients who underwent randomization was 61.4 years; 49 percent had received two prior chemotherapy regimens, and 93 percent had received platinum-based chemotherapy. The response rate was 8.9 percent in the erlotinib group and less than 1 percent in the placebo group (P<0.001); the median duration of the response was 7.9 months and 3.7 months, respectively. Progression-free survival was 2.2 months and 1.8 months, respectively (hazard ratio, 0.61, adjusted for stratification categories; P<0.001). Overall survival was 6.7 months and 4.7 months, respectively (hazard ratio, 0.70; P<0.001), in favor of erlotinib. Five percent of patients discontinued erlotinib because of toxic effects.

CONCLUSIONS
Erlotinib can prolong survival in patients with non-small-cell lung cancer after first-line or second-line chemotherapy.