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.

• Authors: 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, SPRINT Trial Investigators
• Journal: British journal of haematology (Br J Haematol) Vol. 180 Issue 2 Pg. 224-235 (01 2018) ISSN: 1365-2141 [Electronic] England
• PMID: 29193019 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2017 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

Chemical References

• Antineoplastic Agents
• Thalidomide
• Lenalidomide

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Drug Resistance, Neoplasm
• Female
• Follow-Up Studies
• Humans
• Kaplan-Meier Estimate
• Lenalidomide
• Lymphoma, Mantle-Cell (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Neoplasm Staging
• Proportional Hazards Models
• Recurrence
• Retreatment
• Thalidomide (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Treatment Outcome