A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND.150.
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.
Belch
A
A
Department of Medical Oncology, Cross Cancer Institute, Edmonton, Alberta.
Kouroukis
C T
CT
Juravinski Cancer Centre, Hamilton, Ontario.
Crump
M
M
University Health Network, Princess Margaret Hospital, Toronto, Ontario.
Sehn
L
L
BC Cancer Agency, Vancouver Clinic, Vancouver, British Columbia.
Gascoyne
R D
RD
BC Cancer Agency, Vancouver Clinic, Vancouver, British Columbia.
Klasa
R
R
BC Cancer Agency, Vancouver Clinic, Vancouver, British Columbia.
Powers
J
J
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.
Wright
J
J
Cancer Therapy Evaluation Program, National Cancer Institute United States, Bethesda, MD, USA.
Eisenhauer
E A
EA
National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ontario, Canada. Electronic address: eeisenhauer@ctg.queensu.ca.
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
D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib