Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer

H. Yoshioka, M. Shimokawa, T. Seto, S. Morita, Y. Yatabe, I. Okamoto, J. Tsurutani, M. Satouchi, T. Hirashima, S. Atagi, K. Shibata, H. Saito, S. Toyooka, N. Yamamoto, K. Nakagawa, T. Mitsudomi

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Abstract

Background: Primary analysis of the phase III study WJTOG 3405 demonstrated superiority of progression-free survival (PFS) for gefitinib (G) in patients treated with the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) gefitinib compared with cisplatin plus docetaxel (CD) as the first-line treatment of stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. This report presents final overall survival (OS) data. Patients and methods: Patients were randomized between G (250 mg/day orally) and cisplatin (80 mg/m2 intravenously) plus docetaxel (60 mg/m2 i.v.), administered every 21 days for three to six cycles. After the exclusion of 5 patients, 172 patients (86 in each group, modified intention-to-treat population) were included in the survival analysis. OS was re-evaluated using updated data (data cutoff, 30 September 2013; median follow-up time 59.1 months). The Kaplan-Meier method and the log-rank test were used for analysis, and hazard ratios (HRs) for death were calculated using the Cox proportional hazards model. Results: OS events in the G group and CD group were 68 (79.1%) out of 86 and 59 (68.6%) out of 86, respectively. Median survival time for G and CD were 34.9 and 37.3 months, respectively, with an HR of 1.252 [95% confidence interval (CI): 0.883-1.775, P = 0.2070]. Multivariate analysis identified postoperative recurrence and stage IIIB/IV disease as independent prognostic factors, with an HR of 0.459 (95% CI: 0.312-0.673, P < 0.001). Median survival time (postoperative recurrence versus stage IIIB/IV disease) were 44.5 and 27.5 months in the G group and 45.5 and 32.8 months in the CD group, respectively. Conclusion: G did not show OS benefits over CD as the first-line treatment. OS of patients with postoperative recurrence was better than that of stage IIIB/IV disease, even though both groups had metastatic disease. This study was registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539.

Original languageEnglish
Pages (from-to)1978-1984
Number of pages7
JournalAnnals of Oncology
Volume30
Issue number12
DOIs
Publication statusPublished - Dec 1 2019

Keywords

  • EGFR mutation
  • gefitinib
  • non-small-cell lung cancer
  • overall survival
  • platinum doublet chemotherapy

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Yoshioka, H., Shimokawa, M., Seto, T., Morita, S., Yatabe, Y., Okamoto, I., Tsurutani, J., Satouchi, M., Hirashima, T., Atagi, S., Shibata, K., Saito, H., Toyooka, S., Yamamoto, N., Nakagawa, K., & Mitsudomi, T. (2019). Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. Annals of Oncology, 30(12), 1978-1984. https://doi.org/10.1093/annonc/mdz399