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A Phase II Study of Single Agent Gemcitabine in Relapsed or Refractory Follicular or Small Lymphocytic Non-Hodgkin Lymphomas

A Hoosier Oncology Group Study

Ganjoo, Kristen N., MD*; Robertson, Michael J., PhD*; Fisher, William, MD; Jung, Sin-Ho, PhD; McClean, John, MD; Huh, Sang Yoon, MD; Bufill, Jose, MD; Williams, Sheron, MD; Cripe, Larry D., MD*

American Journal of Clinical Oncology: April 2005 - Volume 28 - Issue 2 - p 169-172
doi: 10.1097/01.coc.0000144812.74663.d0
Original Article: Hematologic/Lymphatic
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Gemcitabine is a pyrimidine analog that is active in patients with aggressive lymphomas and Hodgkin disease. This study assessed tumor response in patients with previously treated follicular or small lymphocytic non-Hodgkin lymphoma. This was a 2-stage phase II trial with the first stage requiring 2 of 13 responses to proceed to the second stage. Gemcitabine was given as a single agent to patients with previously treated follicular or small lymphocytic lymphomas. Gemcitabine was administered at 1250 mg/m2 over 30 minutes on days 1 and 8 of a 21-day cycle for a maximum of 6 cycles. Thirteen patients were treated with 1 to 6 cycles of chemotherapy. Two patients experienced grade 4 toxicity with neutropenia. No grade 4 nonhematologic toxicity was seen. There was 1 partial response and 8 patients (61%) had either minimal response or stable disease. Single-agent gemcitabine administered at this dose and schedule produced 1 partial remission and half the patients had stable disease. However, the study had to be stopped early because of lack of meaningful response.

From the *Hematology/Oncology Department; Indiana University Medical Center, Indianapolis, Indiana; the †Hoosier Oncology Group, a program of the Walther Cancer Institute, Indiana; and the ‡Department of Biostatistics & Bioinformatics, Duke University Medical Center, Durham, North Carolina.

Reprints: Kristen N. Ganjoo, MD, 535 Barnhill Dr. RT 473, Indianapolis, IN. 46202. E-mail: knganjoo@yahoo.com.

© 2005 Lippincott Williams & Wilkins, Inc.