What is the efficacy of gefitinib for the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Answer

The IFUM results were supported by the most recent analysis of the IPASS (IRESSA Pan-ASia Study) study which assessed gefitinib vs. carboplatin/paclitaxel as a first-line treatment in these patients. The subset population consisted of 186 of 1217 patients (15%) determined to be EGFR positive by the same clinical trial assay as used in IFUM and had radiographic scans available for a retrospective assessment. IPASS showed an ORR of 67% with a median duration of response of 9.6 months in gefitinib-treated patients vs. 41% ORR with a median duration of response of 5.5 months for the carboplatin/paclitaxel group. Mean Progression Free Survival (PFS) was 10.8 months in the gefitinib group vs. 5.4 for the carboplatin/paclitaxel patients. [153]

Two large phase II trials led to the expedited original approval of gefitinib in the United States as a third-line therapy.

However, the Iressa Survival Evaluation in Lung Cancer (ISEL) trial, a large phase III randomized trial that compared gefitinib with placebo in patients who had progressed following first-line chemotherapy, found no significant improvement in median survival (5.6 vs 5.1 mo) overall and also in the adenocarcinoma subset (6.3 vs 5.4 mo). Planned subset analyses in patients who had never been smokers and those of Asian ethnicity showed significantly longer survival (8.9 vs 6.1 mo and 9.5 vs 5.5 mo) than with placebo. [151]


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