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Gefitinib monotherapy in chemotherapy-naive patients with inoperable stage III/IV non-small-cell lung cancer.
- Source :
-
Clinical lung cancer [Clin Lung Cancer] 2006 May; Vol. 7 (6), pp. 406-11. - Publication Year :
- 2006
-
Abstract
- Background: Gefitinib is an orally active epidermal growth factor receptor tyrosine kinase inhibitor with activity in previously treated patients with advanced-stage non-small-cell lung cancer (NSCLC). However, little is known of its activity as monotherapy in chemotherapy-naive patients. This phase II study (1839IL/0456) evaluated first-line gefitinib in patients with advanced-stage NSCLC.<br />Patients and Methods: Eligible patients with proven inoperable stage III/IV NSCLC, no previous chemotherapy, and a performance status of 0-2 received gefitinib 250 mg per day until disease progression. Patient reevaluation was performed by radiography and computed tomography at regular intervals.<br />Results: Fifty-eight of 59 patients were available for analysis. Response rate (complete plus partial responses) was 5% (3 of 58 patients); 40% (23 of 58 patients) exhibited stable disease (overall disease control rate, 45% [26 of 58 patients]). Median progression-free survival was 7 weeks, and median overall survival was 29 weeks. All responders were women and/or nonsmokers with adenocarcinoma or bronchoalveolar carcinoma. Gefitinib treatment was well tolerated; skin toxicities occurred in 71% of patients, including severe skin toxicities in 2 patients, and mild to moderate diarrhea occurred in 50% of patients.<br />Conclusion: Gefitinib monotherapy has some efficacy in chemotherapy-naive patients with advanced-stage or metastatic NSCLC. However, activity seems to be limited to particular patient groups.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents administration & dosage
Antineoplastic Agents adverse effects
Carcinoma, Non-Small-Cell Lung mortality
Carcinoma, Non-Small-Cell Lung pathology
ErbB Receptors antagonists & inhibitors
Female
Gefitinib
Germany
Humans
Lung Neoplasms mortality
Lung Neoplasms pathology
Male
Middle Aged
Neoplasm Staging
Protein Kinase Inhibitors administration & dosage
Protein Kinase Inhibitors adverse effects
Protein Kinase Inhibitors therapeutic use
Quinazolines administration & dosage
Quinazolines adverse effects
Survival Analysis
Treatment Outcome
Antineoplastic Agents therapeutic use
Carcinoma, Non-Small-Cell Lung drug therapy
Lung Neoplasms drug therapy
Quinazolines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1525-7304
- Volume :
- 7
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Clinical lung cancer
- Publication Type :
- Academic Journal
- Accession number :
- 16800967
- Full Text :
- https://doi.org/10.3816/clc.2006.n.025