Kim, Seung Tae; Uhm, Ji Eun; Lee, Jeeyun; Sun, Jong-mu; Sohn, Insuk; Kim, Seon Woo; Jung, Sin-Ho; Park, Yeon Hee; Ahn, Jin Seok; Park, Keunchil; Ahn, Myung-Ju
Lung cancer (Amsterdam, Netherlands)
2012Jan ; 75 ( 1 ) :82-8.
PMID : 21684626
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Kim, Seung Tae -
Uhm, Ji Eun -
Lee, Jeeyun -
Sun, Jong-mu -
Sohn, Insuk -
Kim, Seon Woo -
Jung, Sin-Ho -
Park, Yeon Hee -
Ahn, Jin Seok -
Park, Keunchil -
Ahn, Myung-Ju -
ABSTRACT
PURPOSE: Gefitinib and erlotinib are potent EGFR TKIs, with antitumor activity. In this randomized, single-center, non-comparative phase II trial, the efficacy and safety of gefitinib and erlotinib was evaluated as the second-line therapy for advanced non-small cell lung cancer (NSCLC). PATIENTS AND
METHODS: Patients with locally advanced, metastatic stage IIIB/IV NSCLC who failed first-line chemotherapy and had either EGFR mutation or at least two out of three clinical factors associated with higher incidence of EGFR mutations (female, adenocarcinoma histology, and never-smoker) were eligible.
RESULTS: A total of 96 (48 per arm) patients were randomly assigned to gefitinib- or erlotinib-arm, respectively. Baseline characteristics were well-balanced between the two arms. The response rates (RR) were 47.9% in the gefitinib arm and 39.6% in the erlotinib arm. Median PFS was 4.9 months (95% CI, 1.3-8.5) in the gefitinib arm and 3.1 months (95% CI, 0.0-6.4) in the erlotinib arm. The most common grade 3/4 toxicity was skin rash. Exploratory analyses showed that there was no significant difference in RR and PFS in the gefitinib arm compared to the erlotinib arm (RR (%) 47.9 vs. 39.6, p=0.269; median survival (months) 4.9 vs. 3.1, p=0.336). There was no significant difference in QOL between the two arms. CONCLUSION: Both gefitinib and erlotinib showed effective activity and tolerable toxicity profiles as second-line treatment for the selected population of NSCLC. We may consider conducting a phase III trial to directly compare the efficacy and toxicity between gefitinib and erlotinib in an enriched patient population. CI - Copyright ??2011 Elsevier Ireland Ltd. All rights reserved.
Gefitinib; Erlotinib; Non-small cell lung cancer
MESH
Adult, Aged, Aged, 80 and over, Antineoplastic Agents/adverse effects/*therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy/enzymology/genetics/pathology, Drug Resistance, Neoplasm, Erlotinib Hydrochloride, Female, Humans, Lung Neoplasms/*drug therapy/enzymology/genetics/pathology, Male, Middle Aged, Mutation, Neoplasm Staging/methods, Protein Kinase Inhibitors/*therapeutic use, Quality of Life, Quinazolines/adverse effects/*therapeutic use, Receptor, Epidermal Growth Factor/antagonists & inhibitors/genetics
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