(CHICAGO, IL) – First-line gefitinib for advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation offers a distinct survival benefit, according to the updated results of a Phase 3 trial comparing gefitinib with cisplatin plus docetaxel presented at the 2012 American Society of Clinical Oncology Annual Meeting.
Previously published data showed that randomized, Phase 3 WJTOG3405 trial met its primary endpoint of progression free survival (PFS); however, the short follow-up period made the impact on overall survival (OS) difficult to determine, noted lead author Tetsuya Mitsudomi, MD, PhD, vice director and chief of the department of thoracic surgery at Aichi Cancer Center Hospital in Nagoya, Japan. The current study presents updated OS data.
Median survival time (MST) for the gefitinib arm was 36 months (95% CI: 26.3 — not reported), which was not significantly different from 39 months (95% CI: 31.2 — not reported) for the cisplatin plus docetaxel (CD) arm (HR=1.185, 95% CI 0.767–1.829). In the gefitinib arm, the MST of 36 months for patients with exon 19 deletion was comparable to that of patients with L858R (35 months). In the CD arm, 78 patients (91%) received EGFR-tyrosine kinase inhibitor (TKI) as second-line or later treatment, whereas in the gefitinib arm, 52 patients (61%) received a platinum doublet. Accordingly, 130 patients received both a platinum doublet and an EGFR- TKI and 34 patients received EGFR-TKI without platinum doublet during their whole course of therapy. MST for the former and the latter groups was 36 months (95% CI: 31.2–45.7) and 45 months (95% CI: 25.6 — not reported), without any significant difference.
Dr. Mitsudomi and colleagues concluded that the updated OS analysis revealed that gefitinib for advanced NSCLC with EGFR mutation offers a distinct survival benefit of 3 years and there was no difference in OS whether the first-line treatment was gefitinib or cisplatin plus docetaxel.