Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study.

Abstract

PURPOSE:

Although dose-intensive strategies or high-dose therapy induction followed by autologous stem-cell transplantation have improved the outcome for patients with mantle-cell lymphoma (MCL), most eventually relapse and subsequently respond poorly to additional therapy. Bortezomib (in the United States) and temsirolimus (in Europe) are currently the only two treatments approved for relapsed disease. Lenalidomide is an immunomodulatory agent with proven tumoricidal and antiproliferative activity in MCL. The MCL-001 (EMERGE) trial is a global, multicenter phase II study examining the safety and efficacy of lenalidomide in patients who had relapsed or were refractory to bortezomib.

PATIENTS AND METHODS:

Lenalidomide 25 mg orally was administered on days 1 through 21 every 28 days until disease progression or intolerance. Primary end points were overall response rate (ORR) and duration of response (DOR); secondary end points included complete response (CR) rate, progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

In all, 134 patients were enrolled with a median age of 67 years and a median of four prior therapies (range, two to 10 prior therapies). The ORR was 28% (7.5% CR/CR unconfirmed) with rapid time to response (median, 2.2 months) and a median DOR of 16.6 months (95% CI, 7.7 to 26.7 months). Median PFS was 4.0 months (95% CI, 3.6 to 5.6 months), and median OS was 19.0 months (95% CI, 12.5 to 23.9 months). The most common grade 3 to 4 adverse events were neutropenia (43%), thrombocytopenia (28%), anemia (11%), pneumonia (8%), and fatigue (7%).

CONCLUSION:

The MCL-001 study demonstrated durable efficacy of lenalidomide with a predictable safety profile in heavily pretreated patients with MCL who had all relapsed or progressed after or were refractory to bortezomib.

• Authors: Andre Goy, Rajni Sinha, Michael E Williams, Sevgi Kalayoglu Besisik, Johannes Drach, Radhakrishnan Ramchandren, Lei Zhang, Sherri Cicero, Tommy Fu, Thomas E Witzig
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 31 Issue 29 Pg. 3688-95 (Oct 10 2013) ISSN: 1527-7755 [Electronic] United States
• PMID: 24002500 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Angiogenesis Inhibitors
• Antineoplastic Agents
• Boronic Acids
• Pyrazines
• Thalidomide
• Bortezomib
• Lenalidomide

Topics

• Adult
• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Boronic Acids (therapeutic use)
• Bortezomib
• Disease Progression
• Female
• Humans
• Lenalidomide
• Lymphoma, Mantle-Cell (drug therapy, mortality)
• Male
• Middle Aged
• Pyrazines (therapeutic use)
• Recurrence
• Thalidomide (adverse effects, analogs & derivatives, therapeutic use)