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Gefitinib
Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 15, 2025 · Captured 2026-09-09.
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Evidence (gefitinib):
A randomized phase III trial evaluated gefitinib versus placebo in 1,692 patients with previously treated NSCLC and showed the following:
A randomized phase III trial evaluated gefitinib versus placebo in 1,692 patients with previously treated NSCLC and showed the following:
Gefitinib did not improve OS.
A randomized phase III trial evaluated gefitinib versus placebo in 1,692 patients with previously treated NSCLC and showed the following:
Median survival did not differ significantly between the groups in the overall population (5.6 months for gefitinib and 5.1 months for placebo; HR, 0.89; 95% CI, 0.77–1.02; P = .087) or among the 812 patients with adenocarcinoma (6.3 months vs. 5.4 months; HR, 0.84; CI, 0.68–1.03; P = .089).
A randomized phase III trial evaluated gefitinib versus placebo in 1,692 patients with previously treated NSCLC and showed the following:
Preplanned subgroup analyses showed significantly longer survival in the gefitinib group than in the placebo group for never-smokers (n = 375; 95% CI, 0.67 [0.49–0.92]; P = .012; median survival, 8.9 months vs. 6.1 months) and for patients of Asian origin (n = 342; 95% CI, 0.66 [0.48–0.91]; P = .01; median survival, 9.5 months vs. 5.5 months).[17][Level of evidence A1]
Source links and citations
In a large randomized trial, gefitinib was compared with docetaxel in patients with locally advanced or metastatic NSCLC who had been pretreated with platinum-based chemotherapy.[18] The primary objective was to compare OS between the groups with coprimary analyses to assess noninferiority in the overall population and superiority in patients with high EGFR gene copy number in the intention-to-treat population. The 1,466 patients were randomly assigned to receive gefitinib (250 mg per day by mouth; n = 733) or docetaxel (75 mg/m2 intravenously [IV] every 3 weeks; n = 733).
Source links and citations
In a large randomized trial, gefitinib was compared with docetaxel in patients with locally advanced or metastatic NSCLC who had been pretreated with platinum-based chemotherapy.[18] The primary objective was to compare OS between the groups with coprimary analyses to assess noninferiority in the overall population and superiority in patients with high EGFR gene copy number in the intention-to-treat population. The 1,466 patients were randomly assigned to receive gefitinib (250 mg per day by mouth; n = 733) or docetaxel (75 mg/m2 intravenously [IV] every 3 weeks; n = 733).
Noninferiority of gefitinib compared with docetaxel was confirmed for OS (HR, 1.020; 95% CI, 0.905–1.150). However, superiority of gefitinib in patients with high EGFR gene copy number (85 patients vs. 89 patients) was not proven (HR, 1.09; 95% CI, 0.78–1.51; P = .62).
In a large randomized trial, gefitinib was compared with docetaxel in patients with locally advanced or metastatic NSCLC who had been pretreated with platinum-based chemotherapy.[18] The primary objective was to compare OS between the groups with coprimary analyses to assess noninferiority in the overall population and superiority in patients with high EGFR gene copy number in the intention-to-treat population. The 1,466 patients were randomly assigned to receive gefitinib (250 mg per day by mouth; n = 733) or docetaxel (75 mg/m2 intravenously [IV] every 3 weeks; n = 733).
In the gefitinib group, the most common adverse events were rash or acne (49% vs. 10%) and diarrhea (35% vs. 25%). In the docetaxel group, neutropenia (5% vs. 74%), asthenia (25% vs. 47%), and alopecia (3% vs. 36%) were most common.
In a large randomized trial, gefitinib was compared with docetaxel in patients with locally advanced or metastatic NSCLC who had been pretreated with platinum-based chemotherapy.[18] The primary objective was to compare OS between the groups with coprimary analyses to assess noninferiority in the overall population and superiority in patients with high EGFR gene copy number in the intention-to-treat population. The 1,466 patients were randomly assigned to receive gefitinib (250 mg per day by mouth; n = 733) or docetaxel (75 mg/m2 intravenously [IV] every 3 weeks; n = 733).
This trial established noninferior survival of patients treated with gefitinib compared with docetaxel, suggesting that gefitinib is a valid treatment for pretreated patients with advanced NSCLC.
Objective response to erlotinib and gefitinib is more likely in patients who have never smoked, are female, are of East Asian race, or have adenocarcinoma or bronchioloalveolar carcinoma.[19-25] Responses may be associated with the presence of sensitizing variants in the tyrosine kinase domain of EGFR [20-22,24,25] and with the absence of KRAS variants.[23-25][Level of evidence C2] Survival benefit may be greater in patients with EGFR protein expression by immunohistochemistry or increased EGFR gene copy number by fluorescence in situ hybridization studies (FISH),[24,25] but the clinical utility of EGFR testing by immunohistochemistry has been questioned.[26]
Publication references
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Preserved source evidence · Not medical advice