Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada Clinical Trials Group.

Abstract

PURPOSE:

To determine the response rate and toxicity of flavopiridol in patients with previously untreated or relapsed mantle-cell lymphoma.

PATIENTS AND METHODS:

Adult patients with previously untreated or in first or second relapse of previously responsive mantle-cell lymphoma were given flavopiridol 50 mg/m2/d by intravenous bolus for 3 consecutive days every 21 days with antidiarrheal prophylaxis. Flavopiridol was continued until disease progression, unacceptable toxicity, or stable disease for four cycles. Disease was reassessed every two cycles.

RESULTS:

From 33 registered patients, 30 were eligible after pathology review, 30 were assessable for toxicity, and 28 were assessable for response. A median of four cycles of treatment was administered; 90% of patients received at least 90% of planned dose-intensity. No complete responses were seen; three patients had a partial response (11%), 20 patients had stable disease (71%), and five patients had progressive disease (18%). The median duration of response was 3.3 months (range, 2.8 to 13.2 months). The most common toxicities were diarrhea (97%), fatigue (73%), nausea (47%), and vomiting (27%). At least one nonhematologic grade 3 or 4 toxicity was seen in 14 patients (47%). Hematologic toxicity was modest.

CONCLUSIONS:

Flavopiridol given as a daily bolus for 3 consecutive days every 3 weeks has modest activity as a single agent for mantle-cell lymphoma. The number of stable and partial responses that was seen indicates that it is biologically active and may delay progression. Future studies in mantle-cell lymphoma should test this agent with other active agents and using different schedules.

• Authors: C Tom Kouroukis, Andrew Belch, Michael Crump, Elizabeth Eisenhauer, Randy D Gascoyne, Ralph Meyer, Reinhard Lohmann, Pedro Lopez, Jean Powers, Robert Turner, Joseph M Connors, National Cancer Institute of Canada Clinical Trials Group
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 21 Issue 9 Pg. 1740-5 (May 01 2003) ISSN: 0732-183X [Print] United States
• PMID: 12735303 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Flavonoids
• Piperidines
• alvocidib

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage, adverse effects, pharmacology)
• Diarrhea (chemically induced)
• Disease Progression
• Fatigue (chemically induced)
• Female
• Flavonoids (administration & dosage, adverse effects, pharmacology)
• Humans
• Injections, Intravenous
• Lymphoma, Mantle-Cell (drug therapy, pathology)
• Male
• Middle Aged
• Nausea (chemically induced)
• Piperidines (administration & dosage, adverse effects, pharmacology)
• Treatment Outcome
• Vomiting (chemically induced)