Format

Send to

Choose Destination
See comment in PubMed Commons below
Ann Oncol. 2007 Jan;18(1):116-21. Epub 2006 Sep 13.

A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND.150.

Author information

  • 1Department of Medical Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.

Abstract

BACKGROUND:

We evaluated the activity and toxic effects of bortezomib in patients with mantle cell lymphoma.

PATIENTS AND 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.

PMID:
16971665
DOI:
10.1093/annonc/mdl316
[PubMed - indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for HighWire
    Loading ...
    Support Center