Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma.

Abstract

Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) with aggressive disease characteristics resulting in multiple relapses after initial treatment. Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib). The purpose of this report is to provide longer follow-up on the MCL-001 study (follow-ups were 6.8 [NHL-002], 7.6 [NHL-003], and 52.2 [MCL-001] months). The 206 relapsed MCL patients treated with single-agent lenalidomide (25 mg/day PO, days 1 to 21 every 28-days) had a median age of 67 years (63% ≥65 years), 91% with stage III/IV disease, and 50% with ≥4 previous treatment regimens. With a median follow-up of X, the combined best overall response rate (ORR) was 33% (including 11% with complete remission [CR]/CR unconfirmed CRu). Lenalidomide produced rapid and durable responses with a median time to response of 2.2 months and median duration of response (DOR) of 16.6 months (95% CI: 11.1%-29.8%). The safety profile was consistent and manageable; myelosuppression was the most common adverse event (AE). Overall, single-agent lenalidomide showed consistent efficacy and safety in multiple phase II studies of heavily pretreated patients with relapsed/refractory MCL, including those previously treated with bortezomib.

• Authors: Thomas E Witzig, Pier Luigi Zinzani, Thomas M Habermann, Joseph M Tuscano, Johannes Drach, Radhakrishnan Ramchandren, Sevgi Kalayoglu Besisik, Kenichi Takeshita, Marie-Laure Casadebaig Bravo, Lei Zhang, Tommy Fu, Andre Goy
• Journal: American journal of hematology (Am J Hematol) Vol. 92 Issue 10 Pg. E575-E583 (Oct 2017) ISSN: 1096-8652 [Electronic] United States
• PMID: 28699256 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © 2017 Wiley Periodicals, Inc.

Chemical References

• Antineoplastic Agents
• Thalidomide
• Lenalidomide

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Anemia (chemically induced, epidemiology)
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Humans
• Kaplan-Meier Estimate
• Lenalidomide
• Lymphoma, Mantle-Cell (drug therapy)
• Male
• Middle Aged
• Neoplasm Staging
• Neutropenia (chemically induced, epidemiology)
• Recurrence
• Thalidomide (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Thrombocytopenia (chemically induced, epidemiology)