DELTA study
Data presented during the same session from the phase III DELTA (Docetaxel and Erlotinib Lung Cancer Trial) reinforced the role of chemotherapy over erlotinib in the second- and third-line setting of advanced NSCLC patients with EGFR wild-type status.
Among all 301 EGFR-unselected Japanese patients, docetaxel chemotherapy and erlotinib resulted in similar median progression-free (3.2 months vs. 2.0 months; HR 1.22; P = .092) and overall survival (12.2 months vs. 14.8 months; HR 0.90; P = .527).
Among the subset of 199 patients found to be EGFR wild-type, however, median progression-free survival was significantly longer at 2.9 months with chemotherapy vs. 1.3 months with erlotinib (HR 1.45; P = .01). A Cox regression analysis that adjusted for gender, performance status, and histology confirmed this benefit of chemotherapy on progression (HR 1.57; no P value given), said Dr. Yoshio Okana of Kochi (Japan) National Hospital.
Further, EGFR wild-type patients given chemotherapy had significantly better response rates (20% vs. 5.6%; P = .003) and disease control (70.6% vs. 53%; P = .017), although overall survival was similar (10.1 months vs. 9.0 months; HR 0.97; P .907), he said.
PROSE was funded by the Italian Ministry of Health, Italian Association for Cancer Research, and a grant from Biodesix. Dr. Gregorc reported no financial conflicts; several coauthors reported ties with Biodesix. DELTA was funded by the Japanese National Health Organization. Dr. Okano reported no conflicts; several coauthors reported ties with Chugai Pharma and Sanofi.