Adjuvant treatment with the targeted therapy gefitinib (Iressa, AstraZeneca) significantly improved disease-free survival (DFS) over standard of care after surgery for patients with non–small cell lung cancer (NSCLC), according to research that will be presented at the 2017 ASCO Annual Meeting (June 2-6, 2017; Chicago, IL).
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Patients with stage II-IIIA NSCLC are considered at high risk for recurrence, with a 5-year survival estimate of approximately 40%. Thirty percent of this patient population harbor epidermal growth factor receptor (EGFR) mutations that may respond to targeted therapies in the adjuvant setting.
However, two previous trials—BR19 and RADIANT—showed no benefit when adding targeted therapies to adjuvant care protocols.
“The earlier trials only looked to see if patients showed overexpression, or overactivity, of EGFR, but not mutations in EGFR,” said Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute (Guangzhou, China). “Our trial recruited patients who had been confirmed to have activating EGFR mutations, so we believe these reasons account for why other trials showed no benefit of a targeted therapy while ours did.”
Dr Wu and colleagues conducted a randomized phase 3 trial to determine whether the EGFR-targeted gefitinib improves outcomes over cisplatin-based chemotherapy in this patient population. The study included data from 222 patients randomly assigned to daily gefitinib (250 mg) or four 3-week cycles of vinorelbine (25 mg/m2 on days 1 and 8) plus cisplatin (75 mg/m2 on day 1). DFS served as the study’s primary outcome measure.
After a median follow-up of 36.5 months (range, 0.1-68.2), the researchers observed a significant increase in DFS among patients assigned to gefinitinb (median, 28.7 months vs 18 months; P < .005), as well as a significant increase in 3-year DFS (34% vs 27%; P = .013).
A total of 76 patient deaths occurred on study (gefitinib, n = 41; chemotherapy, n = 35). Patients assigned gefitinib further experienced fewer grade 3 or higher adverse events (12.3% vs 48.3%; P < .001). The researchers observed no instances of interstitial lung disease among patients assigned gefinitib.
A subgroup analysis showed a significant correlation between lymph node status (pN1/N2) and DFS in the gefitinib arm (P < .05).
The researchers plan to use tissue samples collected during the course of the trial to further study potential biomarkers for gefitinib response and resistance.
“We intend to follow these patients until we can fully measure overall survival as opposed to DFS, which just measures disease recurrence,” Dr Wu said.—Cameron Kelsall
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