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

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.
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https://hal.univ-lille.fr/hal-03196163
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Soumis le : lundi 12 avril 2021 - 15:13:00
Dernière modification le : mercredi 6 octobre 2021 - 09:40:02
Archivage à long terme le : : mardi 13 juillet 2021 - 18:55:50

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Luca Arcaini, Thierry Lamy, Jan Walewski, David Belada, Jiri Mayer, et al.. 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, 2018, British journal of haematology, 180, pp.224-235. ⟨10.1111/bjh.15025⟩. ⟨hal-03196163⟩

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