We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.
Gefitinib significantly prolonged DFS compared with standard-of-care chemotherapy in patients with EGFR–positive stage II or IIIa non–small cell lung cancer, according to a phase 3 clinical trial scheduled for presentation at the ASCO Annual Meeting.
“Lung resection and chemotherapy is standard of care for stage II or IIIa NSCLC,” Yi-Long Wu, MD, director of Guangdong Lung Cancer Institute at Guangdong General Hospital in Guangzhou, China, told HemOnc Today. “But the long-term survival (40%) is not satisfactory and most patients develop disease recurrence in 2 years. Adjuvant chemotherapy gives patients with lung cancer only 10% to 15% survival benefit and patients experience severe toxicity. We hoped this study could tell us how to get much longer remission time and lower toxicity for these patients.”
Approximately 25% of patients diagnosed with NSCLC are eligible for surgery, of whom about 30% harbor an EGFR mutation and may benefit from adjuvant treatment with EGFR–targeted therapy to reduce recurrence risk.
Two previous trials that assessed adjuvant targeted therapy did not show benefit for NSCLC, in part because they included participants with stages I, II and III disease, Wu said.
“The earlier trials only looked to see if patients showed overexpression or over-activity of EFGR, but not mutations in EGFR,” Wu said in a press release. “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.”
Gefitinib (Iressa, AstraZeneca) — initially approved by the FDA in 2003 as a third-line therapy for NSCLC — blocks EGFR signaling and is approved as a first-line therapy for advanced NSCLC with an EGFR mutation.
Researchers randomly assigned 222 patients with EGFR mutations to receive gefitinib daily for 24 months or vinorelbine plus cisplatin chemotherapy every 3 weeks for four cycles. Follow-up for disease recurrence occurred at 3 years.
DFS in the intent-to-treat population served as the primary endpoint.
Patients who received gefitinib demonstrated significantly longer median DFS than those who received chemotherapy (28.7 months vs. 18 months; HR = 0.6; 95% CI, 0.42-0.87), as well as significantly higher rates of 3-year DFS (34% vs. 27%; P = 0.013).
“The patients taking gefitinib lived about 10 months longer without recurrence than patients who received chemotherapy, and patients are able to take [gefitinib] for almost 2 years and tolerate it very well,” Wu told HemOnc Today.
PAGE BREAK
Seventy-six patients (34.2%) died during the trial period — 41 in the gefitinib group and 35 in the chemotherapy group.
Results of a subgroup analysis showed lymph node status (pN1/N2) significantly correlated with DFS in patients treated with gefitinib (P < .05).
Fewer gefitinib-treated patients experienced adverse events (12.3% vs. 48.3%; P < 0.001). The most common serious side effects of gefitinib included elevated liver enzymes. Patients who received chemotherapy experienced vomiting, nausea, low blood counts and anemia.
“Seventy-nine percent of patients took gefitinib for more than 1 year and 70% took it for more than 18 months,” Wu said. “No unexpected toxicities were found.”
Researchers retained a tissue repository from the surgically removed lung tumors and plan to perform a comprehensive biomarker analysis to find other potential biomarkers for gefitinib response or resistance, in addition to EGFR.
“Although there are no final OS data reported, we saw longer survival without disease, fewer toxicities and a higher quality of life using gefitinib instead of chemotherapy in a postsurgery setting,” Wu said. – byChuck Gormley
Reference:
Wu Y-L, et al. Abstract 8500. Scheduled for presentation at: ASCO Annual Meeting; June 2-6, 2017; Chicago.
Disclosure: The Chinese Thoracic Oncology Group and AstraZeneca China funded this study. Johnson reports stock and ownership interest with KEW Group; honoraria from Chugai Pharma and Merck; consultant or advisory roles with Amgen, AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Clovis Oncology, Genentech, GlaxoSmithKline, KEW Group, Eli Lilly, Merck, Novartis, and Transgene; research funding from Novartis; and expert testimony for Genentech. Wu reports consultant or advisory roles with AstraZeneca, Boehringer Ingelheim, Merck and Roche; honoraria from AstraZeneca, Eli Lilly, Pfizer, Pierre Fabre, Roche and Sanofi; and researching funding from Boehringer Ingelheim and Roche.
We’re sorry, but an unexpected error has occurred.
Please refresh your browser and try again. If this error persists, please contact ITSupport@wyanokegroup.com for assistance.
Would you like to receive email reminders to complete your saved activities from Healio CME?
Activity saved! You'll receive reminders to complete your saved activities from Healio CME.