title: A phase II study of bortezomib and gemcitabine in relapsed mantle cell lymphoma from the National Cancer Institute of Canada Clinical Trials Group (IND 172).
abstract: Bortezomib and gemcitabine have each shown activity as single agents in mantle cell lymphoma (MCL), which is incurable. The purpose of this phase II study was to determine the efficacy and safety of the previously unstudied combination of bortezomib and gemcitabine in patients with relapsed or refractory MCL. Patients were eligible if they had relapsed MCL with 1-3 prior therapies. Patients were treated with gemcitabine 1000 mg/m(2) on days 1 and 8 and bortezomib 1.0 mg/m(2) IV on days 1, 4, 8, and 11, on a 21-day schedule. Twenty-six patients were evaluable for toxicity and 25 for response. The overall response rate was 60% and the median progression free survival was 11.4 months. The main adverse effects were hematological, with 40% and 48% of patients experiencing grade 3/4 thrombocytopenia and granulocytopenia, respectively. Bortezomib and gemcitabine is an active combination in relapsed and refractory MCL with clinically meaningful results. It offers a chemotherapy backbone to which other agents, less myelosuppressive, may be added.
authors.affiliation: Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada. tom.kouroukis@jcc.hhsc.ca
authors.forename: C Tom
authors.initials: CT
authors.lastname: Kouroukis
authors.forename: Louis A V
authors.initials: LA
authors.lastname: Fernandez
authors.forename: Michael
authors.initials: M
authors.lastname: Crump
authors.forename: Randy D
authors.initials: RD
authors.lastname: Gascoyne
authors.forename: Neil Sun
authors.initials: NS
authors.lastname: Chua
authors.forename: Rena
authors.initials: R
authors.lastname: Buckstein
authors.forename: Robert
authors.initials: R
authors.lastname: Turner
authors.forename: Sarit
authors.initials: S
authors.lastname: Assouline
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Klasa
authors.forename: Wendy
authors.initials: W
authors.lastname: Walsh
authors.forename: Jean
authors.initials: J
authors.lastname: Powers
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Eisenhauer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D000069286:Bortezomib; D002170:Canada; D002986:Clinical Trials as Topic; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008495:Medical Oncology / Q000458:organization & administration; D008875:Middle Aged; D009313:National Health Programs; D011719:Pyrazines / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D012955:Societies, Medical; D000093542:Gemcitabine
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D003841:Deoxycytidine; D000069286:Bortezomib; D000093542:Gemcitabine