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David S. Ettinger, MD, FACP, FCCP


IMPACT Trial of Adjuvant Gefitinib in EGFR-Mutated NSCLC

By: Joseph Fanelli
Posted: Tuesday, January 25, 2022

For patients with EGFR-mutated non–small cell lung cancer (NSCLC), adjuvant therapy with gefitinib may prevent early relapse of the disease, but the combination did not prolong disease-free or overall survival, according to phase III IMPACT trial findings published in the Journal of Clinical Oncology. However, Kazuhiko Nakagawa, MD, PhD, of Kindai University, Osaka-Sayama, Japan, and colleagues noted that the similar survival results when compared with cisplatin may justify the use of gefitinib is select patients, “especially those deemed ineligible for platinum-doublet adjuvant therapy.”

In this open-label study, the authors enrolled 232 patients with completely resected pathologic stage II and III NSCLC harboring EGFR mutations. Half of the patients were given 250 mg once daily of gefitinib for 24 months, whereas the other half received 80 mg/m2 of cisplatin plus 25 mg/m2 of vinorelbine once every 3 weeks for four cycles.

The median disease-free survival for the patients treated with gefitinib was 35.9 months and 25.1 months for those treated with cisplatin plus vinorelbine. However, the authors noted, the Kaplan-Meier curves crossed about 4 years after surgery, with no statistically significant difference between the two groups.

Overall survival also did not appear to vary significantly, as the 5-year overall survival rate was 78.0% for those treated with gefitinib and 74.6% for those treated with cisplatin plus vinorelbine. No patients in the gefitinib group died as a result of treatment, whereas three patients in the cisplatin-plus-vinorelbine cohort died.

Disclosure: For full disclosures of the study authors, visit

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