title: A phase II study of single agent gemcitabine in relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphomas: a Hoosier Oncology Group Study.
abstract: 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.
authors.affiliation: Hematology/Oncology Department, Indiana University Medical Center, Indianapolis, Indiana, USA. knganjoo@yahoo.com
authors.forename: Kristen N
authors.initials: KN
authors.lastname: Ganjoo
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Robertson
authors.forename: William
authors.initials: W
authors.lastname: Fisher
authors.forename: Sin-Ho
authors.initials: SH
authors.lastname: Jung
authors.forename: John
authors.initials: J
authors.lastname: McClean
authors.forename: Sang Yoon
authors.initials: SY
authors.lastname: Huh
authors.forename: Jose
authors.initials: J
authors.lastname: Bufill
authors.forename: Sheron
authors.initials: S
authors.lastname: Williams
authors.forename: Larry D
authors.initials: LD
authors.lastname: Cripe
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008224:Lymphoma, Follicular / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine