Abstract: Slide Presentations |

Compassionate-Use Gefitinib in Non–Small Cell Lung Cancer: Survival and Safety in 21,064 Patients in an Expanded Access Program FREE TO VIEW

Judith Ochs, MD*; John J. Grous, MD; Annetta Krebs, MS
Author and Funding Information

AstraZeneca, Wilmington, DE


Chest. 2004;126(4_MeetingAbstracts):731S. doi:10.1378/chest.126.4_MeetingAbstracts.731S
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PURPOSE:  In patients with advanced non–small cell lung cancer (NSCLC), first- or second-line chemotherapy results in 1-year survival rates of ∼30%–35% but also causes substantial toxicity in many patients. In patients who refuse or are intolerant to chemotherapy, the 1-year survival rate is only ∼5%–10%. We present final analysis from >21,000 patients in an Expanded Access Program (EAP) with gefitinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor.

METHODS:  Stage III/IV NSCLC patients who failed or could not tolerate chemotherapy received gefitinib (250 mg/d) for as long as treatment provided clinical benefit without significant toxicity. Therapy duration and survival were measured from therapy start to last resupply data (ongoing patients) or last dose (withdrawn patients). Periodic follow-up data were not collected for surviving patients who withdrew, and patients were censored for survival at withdrawal until death was reported.

RESULTS:  Of 23,383 patients enrolled, 21,064 received 1 or more doses of gefitinib (stage IV, 71.8%; men, 52.4%; white, 87.8%; median age, 67 years). One-year survival was 29.9% (95% confidence interval [CI], 28.8%-31.1%). In patients who received gefitinib with potential for 1-year follow-up (n=9501), 20.1% received the drug for at least 6 months. In the overall population, serious treatment-related adverse events (SAEs) were reported for 2.3% of patients: 1.1% discontinued therapy and 0.3% had an investigator-assessed drug-related death. The incidence of interstitial lung disease from all causes was 0.3%; one third of these cases were fatal.

CONCLUSION:  One-year survival for >21,000 patients treated with gefitinib was comparable to single-agent chemotherapy in first- and second-line settings. SAEs were infrequent and mild compared with chemotherapy.

CLINICAL IMPLICATIONS:  “Real-world” experience with gefitinib showed a 1-year survival comparable to single-agent chemotherapy with substantially less toxicity.

DISCLOSURE:  J. Ochs, AstraZeneca

Monday, October 25, 2004

2:30 PM- 4:00 PM




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