东亚非小细胞肺癌临床试验取得成功

Author: Tony S. Mok, M.D., Yi-Long Wu, M.D., F.A.C.S., Sumitra Thongprasert, M.D., Chih-Hsin Yang, M.D., Ph.D., Da-Tong Chu, M.D., Nagahiro Saijo, M.D., Ph.D., Patrapim Sunpaweravong, M.D., Baohui Han, M.D., Benjamin Margono, M.D., Ph.D., F.C.C.P., Yukito Ichinose, M.D., Yutaka Nishiwaki, M.D., Ph.D., Yuichiro Ohe, M.D., Ph.D., Jin-Ji Yang, M.D., Busyamas Chewaskulyong, M.D., Haiyi Jiang, M.D., Emma L. Duffield, M.Sc., Claire L. Watkins, M.Sc., Alison A. Armour, F.R.C.R., and Masahiro Fukuoka, M.D., Ph.D.

The New England Journal of Medicine, September 3 2009

Summary: The study compared the efficacy of gefitinib and carboplatin–paclitaxel as first-line treatments for patients with advanced pulmonary adenocarcinoma in East Asia who were nonsmokers or former light smokers. The primary endpoint was progression-free survival, and the study showed that gefitinib was both noninferior and superior to carboplatin–paclitaxel in this population. Patients on gefitinib had higher 12-month rates of progression-free survival compared to those on carboplatin–paclitaxel. The presence of the EGFR mutation was found to be a strong predictor of a better response to gefitinib.

The results indicated that gefitinib led to a significantly longer progression-free survival in patients with EGFR mutations compared to carboplatin–paclitaxel. However, in patients without the mutation, carboplatin–paclitaxel was more effective. Gefitinib also showed a higher objective response rate and better quality of life outcomes. Adverse events like rash or acne and diarrhea were more common with gefitinib, while neurotoxic effects and myelosuppression were higher with carboplatin–paclitaxel.

The study highlights the importance of determining EGFR mutation status before initiating treatment for pulmonary adenocarcinoma, as it significantly impacts the efficacy of gefitinib. Overall, gefitinib proved to be a superior first-line treatment option for nonsmokers or former light smokers with pulmonary adenocarcinoma in East Asia, particularly in patients with EGFR mutations, offering better progression-free survival, objective response rates, and quality of life with fewer adverse events compared to carboplatin–paclitaxel.

Read the full article in The New England Journal of Medicine.