Abstract | PURPOSE: METHODS: A total of 136 eligible and assessable patients (101 untreated, 35 previously treated) received gefitinib 500 mg daily until progression or prohibitive toxicity. RESULTS: The median age was 68.0 years (range, 34.3 to 88.6); 51% were female; 89% had a performance status (PS) of 0% or 1% and 11% had a PS of 2. The Response Evaluation Criteria in Solid Tumors response rate was 17%, with 6% complete responses (CRs) among 69 previously untreated patients with measurable disease, and 9% with no CRs among 22 pretreated patients. Median survival was 13 months for both chemo-naïve (95% CI, 8 to 18) and previously treated patients (95% CI, 6 to 17). Overall survival at 3 years was 23% (95% CI, 14% to 32%). Toxicity consisted mainly of rash and diarrhea, but 2% of patients died of presumed interstitial lung disease. Exploratory subset analyses revealed improved survival among women (P = .031), patients developing a rash (P = .003), never-smokers (P = .061), and patients with a PS of 0 or 1 (P = .015). CONCLUSION:
Gefitinib is an active agent in advanced stage BAC. Several subsets demonstrate significantly improved clinical outcomes.
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Authors | Howard L West, Wilbur A Franklin, Jason McCoy, Paul H Gumerlock, Ralph Vance, Derick H M Lau, Kari Chansky, John J Crowley, David R Gandara |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 24
Issue 12
Pg. 1807-13
(Apr 20 2006)
ISSN: 1527-7755 [Electronic] United States |
PMID | 16622257
(Publication Type: Clinical Trial, Journal Article, Research Support, N.I.H., Extramural)
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Chemical References |
- Antineoplastic Agents
- Quinazolines
- Gefitinib
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Topics |
- Adenocarcinoma, Bronchiolo-Alveolar
(drug therapy)
- Administration, Oral
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(administration & dosage, adverse effects, therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy)
- Female
- Gefitinib
- Humans
- Lung Neoplasms
(drug therapy)
- Male
- Middle Aged
- Prospective Studies
- Quinazolines
(administration & dosage, adverse effects, therapeutic use)
- Survival Analysis
- Treatment Outcome
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