A phase II study of gemcitabine in patients with relapsed or refractory low-grade non-Hodgkin lymphoma.
Autor: | Larson BJ; Division of Hematology/Oncology, Department of Medicine, University of Florida College of Medicine, Shands/UF Cancer Center, Gainesville, Florida, USA., Waples JM, Pusateri A, Mendenhall NP, Lynch JW Jr |
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Jazyk: | angličtina |
Zdroj: | American journal of clinical oncology [Am J Clin Oncol] 2005 Apr; Vol. 28 (2), pp. 165-8. |
DOI: | 10.1097/01.coc.0000143015.66143.22 |
Abstrakt: | Purpose: The purpose of this study was to determine the tolerability, clinical response rate, and time to disease progression of gemcitabine treatment in patients with low-grade non-Hodgkin lymphoma. (NHL) PATIENTS AND METHODS: Twenty patients with low-grade NHL and progression of disease after at least 1 prior treatment regimen were prospectively enrolled. The treatment regimen consisted of 1200 mg/m2 gemcitabine intravenously administered weekly for 7 weeks followed by a 1-week rest. Subsequent treatment was given weekly for 3 weeks followed by a 1-week rest and repeated for a maximal treatment of 6 cycles until disease progression or unacceptable toxicity. Results: The predominant histologic subtypes among our patients were small lymphocytic (8 of 20) and follicular (7 of 20). Grade III/IV hematologic toxicity was observed in 15 of 20 patients and dose reductions or treatment delays occurred in 19 of 20 patients. Fatigue and asthenia were treatment-limiting in many patients. There were no complete or partial responses observed and only 2 patients had stable disease after 12 weeks of treatment. The average time to progression or off-study status was 2.3 months (95% confidence interval, 1.7-2.9) with 8 patients showing progression of disease. Twelve patients were taken off the study as a result of unacceptable toxicity before observed progression of disease. No patient completed the planned course of therapy. With a median follow up of 10.2 months, 10 of 20 patients remained alive. Conclusion: Gemcitabine as a single agent, in this dosage and schedule, has minimal clinical activity in relapsed or refractory low-grade lymphomas and was associated with considerable toxicity. Therefore, further study of gemcitabine in this setting is not justified. |
Databáze: | MEDLINE |
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