Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 2, Issue 4, Pages 299-305Publisher
ELSEVIER SCIENCE INC
DOI: 10.1097/01.JTO.0000263712.61697.69
Keywords
epidermal growth factor receptor; cyclooxygenase-2; gefitinib; celecoxib; non-small cell lung cancer
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Funding
- NATIONAL CANCER INSTITUTE [P30CA022453] Funding Source: NIH RePORTER
- NCI NIH HHS [CA-22453] Funding Source: Medline
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Background: Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has demonstrated a response rate of 9%-18% in relapsed non-small cell lung cancer (NSCLC) patients. The probability of response to gefitinib was not influenced by response to previous chemotherapy. Preclinical studies have suggested that celecoxib, a cyclooxygenase-2 inhibitor, has antitumor activity in NSCLC and can enhance the activity of EGFR inhibitors. We conducted a phase II study evaluating the combination of gefitinib and celecoxib in platinum-refractory NSCLC patients, defined as patients whose disease had progressed on platinum-based chemotherapy or within 3 months of completing such therapy. Methods: Platinum-refractory NSCLC patients with performance status of 0-2 and adequate organ function were included. Patients should not have been on a NSAID for 30 continuous days before study enrollment. Patients were treated with gefitinib 250 mg daily and celecoxib 400 mg twice daily. Disease assessment was performed every 8 weeks. Results: Twenty-seven patients were enrolled. The response rate was 7% (2/27). The median time to progression was 2.2 months, and the median survival was 4.6 months. One female, nonsmoking patient is progression free more than 3 years after study enrollment. The drug combination was well tolerated, with the most common adverse effects being skin rash and diarrhea. Conclusion: In unselected platinum-refractory NSCLC patients, the response rate to the combination of celecoxib and gefitinib was similar to that observed with gefitinib alone.
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