title: A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND.150.
abstract: BACKGROUND
  We evaluated the activity and toxic effects of bortezomib in patients with mantle cell lymphoma.
  
  
  METHODS
  Thirty patients, including 29 eligible patients, were enrolled; 13 had received no prior chemotherapy. The dose of bortezomib was 1.3 mg/m2 given on days 1, 4, 8 and 11 every 21 days. Response was assessed according to the International Workshop Criteria for non-Hodgkin's lymphoma and toxicity graded using the National Cancer Institute Common Toxicity Criteria version 2.0.
  
  
  RESULTS
  There were 13 responding patients (46.4%; 95% confidence interval=27.5% to 66.1%), including one unconfirmed complete remission. The median response duration was 10 months. Response rates were similar in previously untreated (46.2%) and treated (46.7%) patients. Neurological toxicity and myalgia led to treatment discontinuation in 10 patients after two to seven treatment cycles. Five serious adverse events (including two deaths) associated with fluid retention were observed in the first 12 patients. We subsequently excluded patients with baseline effusions, dyspnea or edema; no further events were seen.
  
  
  CONCLUSIONS
  Bortezomib is active in treating patients with mantle cell lymphoma. While cumulative neuromuscular toxic effects limited therapy duration and specific issues related to fluid retention require further evaluation, continued study of this drug in combination regimens is warranted.
authors.affiliation: Department of Medical Oncology, Cross Cancer Institute, Edmonton, Alberta.
authors.forename: A
authors.initials: A
authors.lastname: Belch
authors.affiliation: Juravinski Cancer Centre, Hamilton, Ontario.
authors.forename: C T
authors.initials: CT
authors.lastname: Kouroukis
authors.affiliation: University Health Network, Princess Margaret Hospital, Toronto, Ontario.
authors.forename: M
authors.initials: M
authors.lastname: Crump
authors.affiliation: BC Cancer Agency, Vancouver Clinic, Vancouver, British Columbia.
authors.forename: L
authors.initials: L
authors.lastname: Sehn
authors.affiliation: BC Cancer Agency, Vancouver Clinic, Vancouver, British Columbia.
authors.forename: R D
authors.initials: RD
authors.lastname: Gascoyne
authors.affiliation: BC Cancer Agency, Vancouver Clinic, Vancouver, British Columbia.
authors.forename: R
authors.initials: R
authors.lastname: Klasa
authors.affiliation: National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Powers
authors.affiliation: Cancer Therapy Evaluation Program, National Cancer Institute United States, Bethesda, MD, USA.
authors.forename: J
authors.initials: J
authors.lastname: Wright
authors.affiliation: National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ontario, Canada. Electronic address: eeisenhauer@ctg.queensu.ca.
authors.forename: E A
authors.initials: EA
authors.lastname: Eisenhauer
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001897:Boronic Acids / Q000627:therapeutic use*; D000069286:Bortezomib; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011379:Prognosis; D011719:Pyrazines / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib