Abstract | BACKGROUND: METHODS: Our single-center, prospective landmark analysis included 183 patients with advanced NSCLC who received 250 mg of gefitinib orally once daily in an expanded-use program at our institution. Thirty-three of the 183 patients were previously untreated. The patients included in this analysis had all received at least 12 weeks of gefitinib. RESULTS: The objective tumor response rate was 3.8%, but an additional 53.5% of patients experienced clinically meaningful disease stabilization. Median progression-free survival time was 3.6 months, and median overall survival time was 8.8 months. The 1-year survival rate for the entire cohort was 35%. Predictors of longer survival included female gender, adenocarcinoma or bronchoalveolar carcinoma histology, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Adverse events were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. CONCLUSIONS: In this single-center experience, gefitinib demonstrated clinically significant antitumor activity and provided good palliation in a predominantly pretreated group of patients. Our results, which are likely to be reproducible in a community setting, demonstrated a 1-year survival rate of 35% in a cohort of patients who were able to take the drug for at least 12 weeks.
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Authors | George R Simon, John C Ruckdeschel, Charles Williams, Alan Cantor, Alberto Chiappori, Caio M Rocha Lima, Scott Antonia, Eric Haura, Henry Wagner, Lary Robinson, Eric Sommers, Michael Alberts, Gerold Bepler |
Journal | Cancer control : journal of the Moffitt Cancer Center
(Cancer Control)
2003 Sep-Oct
Vol. 10
Issue 5
Pg. 388-95
ISSN: 1073-2748 [Print] United States |
PMID | 14581894
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)
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Chemical References |
- Antineoplastic Agents
- Quinazolines
- Epidermal Growth Factor
- Gefitinib
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality, pathology)
- Epidermal Growth Factor
(antagonists & inhibitors)
- Female
- Gefitinib
- Humans
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Middle Aged
- Quinazolines
(therapeutic use)
- Survival Rate
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