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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-11-02

AUTHORS

Michael Wang, Stephen J. Schuster, Tycel Phillips, Izidore S. Lossos, Andre Goy, Simon Rule, Mehdi Hamadani, Nilanjan Ghosh, Craig B. Reeder, Evelyn Barnett, Marie-Laure Casadebaig Bravo, Peter Martin

ABSTRACT

BackgroundThe observational MCL-004 study evaluated outcomes in patients with relapsed/refractory mantle cell lymphoma who received lenalidomide-based therapy after ibrutinib failure or intolerance.MethodsThe primary endpoint was investigator-assessed overall response rate based on the 2007 International Working Group criteria.ResultsOf 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.ConclusionLenalidomide-based treatment showed clinical activity, with no unexpected toxicities, in patients with relapsed/refractory mantle cell lymphoma who previously failed ibrutinib therapy.Trial registrationClinicaltrials.gov identifier NCT02341781. Date of registration: January 14, 2015 More... »

PAGES

171

References to SciGraph publications

  • 2016-03-09. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor in JOURNAL OF HEMATOLOGY & ONCOLOGY
  • 2016-03-03. SOX11 is a biomarker for cyclin D1-negative mantle cell lymphoma in BIOMARKER RESEARCH
  • 2016-09-02. Second-generation inhibitors of Bruton tyrosine kinase in JOURNAL OF HEMATOLOGY & ONCOLOGY
  • Identifiers

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    http://scigraph.springernature.com/pub.10.1186/s13045-017-0537-5

    DOI

    http://dx.doi.org/10.1186/s13045-017-0537-5

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1092508548

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29096668


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