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Journal Article
A Phase II Study of Single-Agent Gemcitabine as a Second-Line Treatment in Advanced Non-Small Cell Lung Cancer
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- Authors
- Seong M. Cho, Young Jun Kim, Gwi Suk Heo, Sang Man Shin
- Issue Date
- 2006-09
- Citation
- Sensors and Actuators B : Chemical, v.117, no.1, pp.50-57
- ISSN
- 0925-4005
- Publisher
- Elsevier
- Language
- English
- Type
- Journal Article
- Abstract
- Objective: To evaluate the efficacy and safety of the single-agent gemcitabine in advanced non-small cell lung cancer (NSCLC) as second-line chemotherapy. Methods: Between February 2002 and November 2 004, a total of 27 patients, who had previously been treated with paclitaxel and platinum as first line chemotherapy, were enrolled in the study. Patients were treated with gemcitabine (1000 mg/m2) on days 1, 8 and 15 in a 28 day cycle. The response was assessed every two cycles. Toxicities were evaluated according to common toxicity criteria (CTC). Results: The median age was 62 (range, 46-79) years old. Among the 27 patients, 26 were male. Twenty-three patients had an ECOG performance status of 0 or 1 and four patients had a status of 2. Pathologically, 24 patients had squamous cell carcinoma and 3 had adenocarcinoma. Partial responses were observed in 15 patients. All patients were evaluated for response and toxicity. The overall response rate was 18.5% (95% confidence interval, 5-33%) and the median response duration was 17 (range, 7.4 to 49+) weeks. The median time to progression was 10 (range, 7 to 34+) weeks. The median overall survival for all patients was 38 (range, 10 to 122+) weeks. During a total of 87 cycles, granulocytopenia greater than CTC grade 2 occurred in 7%, thrombocytopenia in 1% and anemia in 24% of case. Non-hematologic toxicities were minor and easily controlled. Conclusion: This study confirms the activity and safety of the single-agent gemcitabine as a second-line therapy in pretreated patients with advanced NSCLC. © 2006 Foundation for Promotion of Cancer Research.
- KSP Keywords
- Cancer research, Non-small cell Lung cancer, Overall survival, confidence Interval, performance status, response rate, squamous cell carcinoma