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Phase I study of the combination of nedaplatin and gemcitabine in previously untreated advanced squamous cell lung cancer.
- Source :
- Cancer Chemotherapy & Pharmacology; Feb2011, Vol. 67 Issue 2, p325-330, 6p
- Publication Year :
- 2011
-
Abstract
- Purpose: The objectives of this phase I trial were to evaluate the toxicity of the nedaplatin/gemcitabine regimen, determine the maximum tolerated doses (MTDs) of these agents, and observe the anti-tumor effects of this regimen on advanced squamous cell lung cancer. Methods: Patients with previously untreated advanced squamous cell lung cancer were eligible if they had a performance status of 0 or 1 with adequate organ function. The doses of gemcitabine (days 1 and 8) and nedaplatin (day 8) studied were 800/70, 1,000/80, 1,000/90, and 1,000/100 (mg/m), repeated every 3 weeks. Results: Toxicity and response could be assessed in all 13 patients enrolled. The patients included 12 men and one woman with a median age of 69 years (range 57-81 years). Three patients had stage IIIB disease and 10 patients had stage IV disease. The MTDs were reached at 1,000 mg/m gemcitabine and 80 mg/m nedaplatin. The most frequent toxic effects were thrombocytopenia and neutropenia; grade 3 or 4 thrombocytopenia was observed in 23% of patients, and grade 3 or 4 neutropenia was seen in 46% of patients. Non-hematologic toxicities were mild. Grade 3 fatigue, nausea/vomiting, and appetite loss occurred in two patients. The overall response rate was 62%. Conclusions: We recommend doses of 800 mg/m gemcitabine and 70 mg/m nedaplatin for phase II study. This combination chemotherapeutic regimen is active and well tolerated. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 03445704
- Volume :
- 67
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- Cancer Chemotherapy & Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 57552488
- Full Text :
- https://doi.org/10.1007/s00280-010-1321-1