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J Hematol Oncol. 2017 Nov 2;10(1):171. doi: 10.1186/s13045-017-0537-5.

Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004).

Author information

1
Department of Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, USA. miwang@mdanderson.org.
2
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
3
University of Michigan, Ann Arbor, MI, USA.
4
Sylvester Comprehensive Cancer Center, Division of Hematology Oncology, University of Miami, Miami, FL, USA.
5
John Theurer Cancer Center at HUMC, Hackensack, NJ, USA.
6
Department of Haematology, Derriford Hospital and Plymouth University Medical School, Plymouth, UK.
7
Medical College of Wisconsin & CIBMTR, Milwaukee, WI, USA.
8
Carolinas HealthCare System, Levine Cancer Institute, Charlotte, NC, USA.
9
Mayo Clinic Scottsdale/Phoenix, Scottsdale, AZ, USA.
10
Celgene Corporation, Summit, NJ, USA.
11
Celgene International Sàrl, Boudry, Switzerland.
12
Weill Cornell Medical College, New York, NY, USA.

Abstract

BACKGROUND:

The observational MCL-004 study evaluated outcomes in patients with relapsed/refractory mantle cell lymphoma who received lenalidomide-based therapy after ibrutinib failure or intolerance.

METHODS:

The primary endpoint was investigator-assessed overall response rate based on the 2007 International Working Group criteria.

RESULTS:

Of 58 enrolled patients (median age, 71 years; range, 50-89), 13 received lenalidomide monotherapy, 11 lenalidomide plus rituximab, and 34 lenalidomide plus other treatment. Most patients (88%) had received ≥ 3 prior therapies (median 4; range, 1-13). Median time from last dose of ibrutinib to the start of lenalidomide was 1.3 weeks (range, 0.1-21.7); 45% of patients had partial responses or better to prior ibrutinib. Primary reasons for ibrutinib discontinuation were lack of efficacy (88%) and ibrutinib toxicity (9%). After a median of two cycles (range, 0-11) of lenalidomide-based treatment, 17 patients responded (8 complete responses, 9 partial responses), for a 29% overall response rate (95% confidence interval, 18-43%) and a median duration of response of 20 weeks (95% confidence interval, 2.9 to not available). Overall response rate to lenalidomide-based therapy was similar for patients with relapsed/progressive disease after previous response to ibrutinib (i.e., ≥PR) versus ibrutinib-refractory (i.e., ≤SD) patients (30 versus 32%, respectively). The most common all-grade treatment-emergent adverse events after lenalidomide-containing therapy (n = 58) were fatigue (38%) and cough, dizziness, dyspnea, nausea, and peripheral edema (19% each). At data cutoff, 28 patients have died, primarily due to mantle cell lymphoma.

CONCLUSION:

Lenalidomide-based treatment showed clinical activity, with no unexpected toxicities, in patients with relapsed/refractory mantle cell lymphoma who previously failed ibrutinib therapy.

TRIAL REGISTRATION:

Clinicaltrials.gov identifier NCT02341781 . Date of registration: January 14, 2015.

KEYWORDS:

Ibrutinib failure; Lenalidomide; Mantle cell lymphoma

PMID:
29096668
PMCID:
PMC5668956
DOI:
10.1186/s13045-017-0537-5
[Indexed for MEDLINE]
Free PMC Article

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