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
Mené sur 172 patients atteints d'un cancer du poumon non à petites cellules EGFR+, de stade IIIB/IV ou récidivant après un traitement chirurgical, cet essai de phase III compare l'efficacité, du point de vue de la survie globale, du géfitinib et d'un traitement de première ligne combinant cisplatine et docétaxel
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 first-line treatment of stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small cell lung cancer (NSCLC). This report presents final overall survival (OS) data. Patients and methods : Patients were randomized between G (250mg/day orally) and cisplatin (80mg/m2 intravenously) plus docetaxel (60mg/m2 intravenously), 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 Sep. 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 a 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 a 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 G group and 45.5 and 32.8 months in CD group, respectively. Conclusion : G did not show OS benefits over CD as 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.
Annals of Oncology 2019