Prospective subgroup analyses of the randomized MCL-002 (SPRINT) study: lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma

Luca Arcaini, Thierry Lamy, Jan Walewski, David Belada, Jiri Mayer, John Radford, Wojciech Jurczak, Franck Morschhauser, Julia Alexeeva, Simon Rule, José Cabeçadas, Elias Campo, Stefano A. Pileri, Tsvetan Biyukov, Meera Patturajan, Marie Laure Casadebaig Bravo, Marek Trnĕný, the SPRINT Trial Investigators

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Abstract

In the mantle cell lymphoma (MCL)-002 study, lenalidomide demonstrated significantly improved median progression-free survival (PFS) compared with investigator's choice (IC) in patients with relapsed/refractory MCL. Here we present the long-term follow-up data and results of preplanned subgroup exploratory analyses from MCL-002 to evaluate the potential impact of demographic factors, baseline clinical characteristics and prior therapies on PFS. In MCL-002, patients with relapsed/refractory MCL were randomized 2:1 to receive lenalidomide (25 mg/day orally on days 1–21; 28-day cycles) or single-agent IC therapy (rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine). The intent-to-treat population comprised 254 patients (lenalidomide, n = 170; IC, n = 84). Subgroup analyses of PFS favoured lenalidomide over IC across most characteristics, including risk factors, such as high MCL International Prognostic Index score, age ≥65 years, high lactate dehydrogenase (LDH), stage III/IV disease, high tumour burden, and refractoriness to last prior therapy. By multivariate Cox regression analysis, factors associated with significantly longer PFS (other than lenalidomide treatment) included normal LDH levels (P < 0·001), nonbulky disease (P = 0·045), <3 prior antilymphoma treatments (P = 0·005), and ≥6 months since last prior treatment (P = 0·032). Overall, lenalidomide improved PFS versus single-agent IC therapy in patients with relapsed/refractory MCL, irrespective of many demographic factors, disease characteristics and prior treatment history.

Original languageEnglish
Pages (from-to)224-235
Number of pages12
JournalBritish Journal of Haematology
Volume180
Issue number2
DOIs
Publication statusPublished - Jan 1 2018

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Keywords

  • lenalidomide
  • mantle cell lymphoma
  • non-Hodgkin lymphoma

ASJC Scopus subject areas

  • Hematology

Cite this

Arcaini, L., Lamy, T., Walewski, J., Belada, D., Mayer, J., Radford, J., Jurczak, W., Morschhauser, F., Alexeeva, J., Rule, S., Cabeçadas, J., Campo, E., Pileri, S. A., Biyukov, T., Patturajan, M., Casadebaig Bravo, M. L., Trnĕný, M., & the SPRINT Trial Investigators (2018). Prospective subgroup analyses of the randomized MCL-002 (SPRINT) study: lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma. British Journal of Haematology, 180(2), 224-235. https://doi.org/10.1111/bjh.15025