Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor (EGFR).

Lung Cancer - Non-Small Cell Metastatic
Session Type and Session Title: 
Poster Discussion Session, Lung Cancer - Non-small Cell Metastatic
Abstract Number: 


J Clin Oncol 30, 2012 (suppl; abstr 7521)
Tetsuya Mitsudomi, Satoshi Morita, Yasushi Yatabe, Shunichi Negoro, Isamu Okamoto, Takashi Seto, Miyako Satouchi, Hirohito Tada, Tomonori Hirashima, Kazuhiro Asami, Nobuyuki Katakami, Minoru Takada, Hiroshige Yoshioka, Kazuhiko Shibata, Shinzoh Kudoh, Eiji Shimizu, Hiroshi Saito, Shinichi Toyooka, Kazuhiko Nakagawa, Masahiro Fukuoka, West Japan Oncology Group; Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan; Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan; Department of Pathology and Molecular Diagnostics, Aichi Cancer Center Hospital, Nagoya, Japan; Medical Oncology Division, Hyogo Cancer Center, Akashi, Japan; Department of Medical Oncology, Kinki University School of Medicine, Osaka, Japan; Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan; Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Hyogo, Japan; Department of General Thoracic Surgery, Osaka City General Hospital, Osaka, Japan; Department of Thoracic Oncology, Osaka Prefectual Medical Center for Respiratory and Allergic Diseases, Osaka, Japan; Department of Respiratory Medicine, Kinki-Chuo Chest Medical Center, Sakai, Japan; Clinical Research Center, Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Kobe, Japan; Department of Medical Oncology, Sakai Hospital Kinki University School of Medicine, Osaka, Japan; Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan; Department of Medical Oncology, Koseiren Takaoka Hospital, Takaoka, Japan; Department of Respiratory Medicine, Osaka City University Medical School, Osaka, Japan; Division of Medical Oncology and Molecular Respirology, Tottori University, Tottori, Japan; Department of Respiratory Medicine, Aichi Cancer Center, Aichi Hospital, Okazaki, Japan; Department of Cancer and Thoracic Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan; Cancer Center, Izumi Municipal Hospital, Osaka, Japan

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Background: WJTOG3405 met its primary endpoint of progression free survival (PFS) (9.2 months (mo.) for G vs. 6.3 mo. for CD, hazard ratio (HR) 0.489, 95% confidence interval (CI): 0.336-0.710). (Mitsudomi et al., Lancet Oncol., 2010). However, the impact on overall survival (OS) was not clear then because of relatively short follow-up period. Methods: Overall survival (OS) was re-evaluated using updated data (data cutoff, 31 July, 2011, median follow-up, 34 months) for 172 patients. Results: Eighty-two events had occurred (48%). Median survival time (MST) for G arm was 36 mo. (95% CI: 26.3 -) which was not significantly different from 39 mo. (95% CI: 31.2 -) for CD arm (HR 1.185, 95% CI 0.767-1.829). Multivariate analysis using Cox proportional hazards model revealed that none of covariates (treatment arm, smoking status, sex, age, postoperative recurrence or IIIB/IV, and mutation type) significantly affected OS. In the G arm, MST of patients with exon 19 deletion (36 mo.) was comparable to that of patients with L858R (35 mo.). In the CD arm, 78 patients (91%) received EGFR-TKI as the 2nd or later line treatment, whereas in the G arm, 52 patients (61%) received platinum doublet. Accordingly, 130 patients received both platinum doublet and EGFR-tyrosine kinase inhibitor (TKI) and 34 patients received EGFR-TKI without platinum doublet in their whole courses of therapy. MST for the former and the latter group were 36 months (95% CI: 31.2-45.7) and 45 months (95% CI: 25.6-), without significant difference. Conclusions: This update OS analysis revealed that G for advanced NSCLC with EGFR mutation offers distinct survival benefit of 3 years. There was no difference in OS whether the first-line treatment was G or CD, in accordance with the precedent studies. The reason why PFS difference was not translated into OS difference is probably due to high cross over rate to EGFR-TKI. However, it was noteworthy that 40% of patients in the G arm could be managed without platinum doublet and yet had similar outcome.