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Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin–paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002)

2012; Elsevier BV; Volume: 24; Issue: 1 Linguagem: Inglês

10.1093/annonc/mds214

1569-8041

Akira Inoue, Kunihiko Kobayashi, Makoto Maemondo, Shunichi Sugawara, Satoshi Oizumi, Hiroshi Isobe, Akihiko Gemma, M. Harada, Hirohisa Yoshizawa, Ichiro Kinoshita, Yasuko Fujita, Shoji Okinaga, Haruto Hirano, Kozo Yoshimori, Toshiyuki Harada, Yasuo Saijo, Koichi Hagiwara, Satoshi Morita, T. Nukiwa,

Lung Cancer Research Studies

ABSTRACT Background NEJ002 study, comparing gefitinib with carboplatin (CBDCA) and paclitaxel (PTX; Taxol) as the first-line treatment for advanced non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation, previously reported superiority of gefitinib over CBDCA/PTX on progression-free survival (PFS). Subsequent analysis was carried out mainly regarding overall survival (OS). Materials and methods For all 228 patients in NEJ002, survival data were updated in December, 2010. Detailed information regarding subsequent chemotherapy after the protocol treatment was also assessed retrospectively and the impact of some key drugs on OS was evaluated. Results The median survival time (MST) was 27.7 months for the gefitinib group, and was 26.6 months for the CBDCA/PTX group (HR, 0.887; P =0.483). The OS of patients who received platinum throughout their treatment ( n =186) was not statistically different from that of patients who never received platinum ( n =40). The MST of patients treated with gefitinib, platinum, and pemetrexed (PEM) or docetaxel (DOC, Taxotere; n =76) was around 3 years. Conclusions No significant difference in OS was observed between gefitinib and CBDCA/PTX in the NEJ002 study, probably due to a high crossover use of gefitinib in the CBDCA/PTX group. Considering the many benefits and the risk of missing an opportunity to use the most effective agent for EGFR-mutated NSCLC, the first-line gefitinib is strongly recommended.