Prospective subgroup analyses of the randomized MCL-002 (SPRINT) study: lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
29193019
PubMed Central
PMC5814930
DOI
10.1111/bjh.15025
Knihovny.cz E-resources
- Keywords
- lenalidomide, mantle cell lymphoma, non-Hodgkin lymphoma,
- MeSH
- Drug Resistance, Neoplasm MeSH
- Kaplan-Meier Estimate MeSH
- Lenalidomide MeSH
- Middle Aged MeSH
- Humans MeSH
- Lymphoma, Mantle-Cell drug therapy mortality pathology MeSH
- Follow-Up Studies MeSH
- Retreatment MeSH
- Proportional Hazards Models MeSH
- Antineoplastic Agents administration & dosage adverse effects therapeutic use MeSH
- Recurrence MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Neoplasm Staging MeSH
- Thalidomide administration & dosage adverse effects analogs & derivatives therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Lenalidomide MeSH
- Antineoplastic Agents MeSH
- Thalidomide MeSH
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.
Clinical Research and Development Celgene Corporation Summit NJ USA
Clinical Research and Development Celgene Sàrl Boudry Switzerland
Department of Haematology Charles University Hospital Prague Czech Republic
Department of Haematology Derriford Hospital Plymouth United Kingdom
Department of Haematology Hôpital Claude Huriez EA 7365 GRITA Lille France
Department of Haematology Hôpital Pontchaillou Rennes France
Department of Haematology Jagiellonian University Medical College Kraków Poland
Department of Haematology Oncology Fondazione IRCCS Policlinico San Matteo Pavia Italy
Department of Haematology Research Federal Medical Research Centre Saint Petersburg Russia
Department of Molecular Medicine University of Pavia Pavia Italy
Haematopathology Unit Hospital Clinic University of Barcelona Barcelona Spain
Unit of Haematopathology European Institute of Oncology Milan Italy
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