Makoto Maemondo, M.D., Ph.D., Akira Inoue, M.D., Ph.D., Kunihiko Kobayashi, M.D., Ph.D., Shunichi Sugawara, M.D., Ph.D., Satoshi Oizumi, M.D., Ph.D., Hiroshi Isobe, M.D., Ph.D., Akihiko Gemma, M.D., Ph.D., Masao Harada, M.D., Ph.D., Hirohisa Yoshizawa, M.D., Ph.D., Ichiro Kinoshita, M.D., Ph.D., Yuka Fujita, M.D., Ph.D., Shoji Okinaga, M.D., Ph.D., Haruto Hirano, M.D., Ph.D., Kozo Yoshimori, M.D., Ph.D., Toshiyuki Harada, M.D., Ph.D., Takashi Ogura, M.D., Masahiro Ando, M.D., Ph.D., Hitoshi Miyazawa, M.S., Tomoaki Tanaka, Ph.D., Yasuo Saijo, M.D., Ph.D., Koichi Hagiwara, M.D., Ph.D., Satoshi Morita, Ph.D., Toshihiro Nukiwa, M.D., Ph.D., for the North-East Japan Study Group. NEJM Volume 362:2380-2388 June 24, 2010 Number 25
Background Non–small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor (EGFR) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib, but little is known about how its efficacy and safety profile compares with that of standard chemotherapy.
Results In the planned interim analysis of data for the first 200 patients, progression-free survival was significantly longer in the gefitinib group than in the standard-chemotherapy group (hazard ratio for death or disease progression with gefitinib, 0.36; P<0.001), resulting in early termination of the study. The gefitinib group had a significantly longer median progression-free survival (10.8 months, vs. 5.4 months in the chemotherapy group; hazard ratio, 0.30; 95% confidence interval, 0.22 to 0.41; P<0.001), as well as a higher response rate (73.7% vs. 30.7%, P<0.001). The median overall survival was 30.5 months in the gefitinib group and 23.6 months in the chemotherapy group (P=0.31). The most common adverse events in the gefitinib group were rash (71.1%) and elevated aminotransferase levels (55.3%), and in the chemotherapy group, neutropenia (77.0%), anemia (64.6%), appetite loss (56.6%), and sensory neuropathy (54.9%). One patient receiving gefitinib died from interstitial lung disease.
Weblink here
