Long-term follow-up of lenalidomide in relapsed/ refractory mantle cell lymphoma

Subset analysis of the NHL-003 study

P. L. Zinzani, Julie Marie Vose, M. S. Czuczman, C. B. Reeder, C. Haioun, J. Polikoff, H. Tilly, L. Zhang, K. Prandi, J. Li, T. E. Witzig

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Abstract

Background: Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II multicenter study of single-agent lenalidomide in patients with aggressive lymphoma Design: Lenalidomide was administered orally 25 mg daily on days 1-21 every 28 days until progressive disease (PD) or intolerability. The primary end point was overall response rate (ORR). Results: Fifty-seven patients with relapsed/refractory, advanced-stage MCL had a median of three prior therapies. The ORR was 35% [complete response (CR)/CR unconfirmed (CRu) 12%], with a median duration of response (DOR) of 16.3 months (not yet reached in patients with CR/CRu) by blinded independent central review. The median time to first response was 1.9 months. Median progression-free survival was 8.8 months, and overall survival had not yet been reached. The most common grade 3/4 adverse events (AEs) were neutropenia (46%), thrombocytopenia (30%), and anemia (13%). Conclusions: These results show the activity of lenalidomide in heavily pretreated, relapsed/refractory MCL. Responders had a durable response with manageable side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036.

Original languageEnglish (US)
Article numbermdt366
Pages (from-to)2892-2897
Number of pages6
JournalAnnals of Oncology
Volume24
Issue number11
DOIs
StatePublished - Nov 1 2013

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Mantle-Cell Lymphoma
Neutropenia
Thrombocytopenia
Antineoplastic Agents
Non-Hodgkin's Lymphoma
Multicenter Studies
Disease-Free Survival
Anemia
Lymphoma
lenalidomide
Clinical Trials
Survival
Therapeutics

Keywords

  • Lenalidomide
  • Mantle cell lymphoma
  • Non-Hodgkin lymphoma

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Zinzani, P. L., Vose, J. M., Czuczman, M. S., Reeder, C. B., Haioun, C., Polikoff, J., ... Witzig, T. E. (2013). Long-term follow-up of lenalidomide in relapsed/ refractory mantle cell lymphoma: Subset analysis of the NHL-003 study. Annals of Oncology, 24(11), 2892-2897. [mdt366]. https://doi.org/10.1093/annonc/mdt366

Long-term follow-up of lenalidomide in relapsed/ refractory mantle cell lymphoma : Subset analysis of the NHL-003 study. / Zinzani, P. L.; Vose, Julie Marie; Czuczman, M. S.; Reeder, C. B.; Haioun, C.; Polikoff, J.; Tilly, H.; Zhang, L.; Prandi, K.; Li, J.; Witzig, T. E.

In: Annals of Oncology, Vol. 24, No. 11, mdt366, 01.11.2013, p. 2892-2897.

Research output: Contribution to journalArticle

Zinzani, PL, Vose, JM, Czuczman, MS, Reeder, CB, Haioun, C, Polikoff, J, Tilly, H, Zhang, L, Prandi, K, Li, J & Witzig, TE 2013, 'Long-term follow-up of lenalidomide in relapsed/ refractory mantle cell lymphoma: Subset analysis of the NHL-003 study', Annals of Oncology, vol. 24, no. 11, mdt366, pp. 2892-2897. https://doi.org/10.1093/annonc/mdt366
Zinzani, P. L. ; Vose, Julie Marie ; Czuczman, M. S. ; Reeder, C. B. ; Haioun, C. ; Polikoff, J. ; Tilly, H. ; Zhang, L. ; Prandi, K. ; Li, J. ; Witzig, T. E. / Long-term follow-up of lenalidomide in relapsed/ refractory mantle cell lymphoma : Subset analysis of the NHL-003 study. In: Annals of Oncology. 2013 ; Vol. 24, No. 11. pp. 2892-2897.
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abstract = "Background: Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II multicenter study of single-agent lenalidomide in patients with aggressive lymphoma Design: Lenalidomide was administered orally 25 mg daily on days 1-21 every 28 days until progressive disease (PD) or intolerability. The primary end point was overall response rate (ORR). Results: Fifty-seven patients with relapsed/refractory, advanced-stage MCL had a median of three prior therapies. The ORR was 35{\%} [complete response (CR)/CR unconfirmed (CRu) 12{\%}], with a median duration of response (DOR) of 16.3 months (not yet reached in patients with CR/CRu) by blinded independent central review. The median time to first response was 1.9 months. Median progression-free survival was 8.8 months, and overall survival had not yet been reached. The most common grade 3/4 adverse events (AEs) were neutropenia (46{\%}), thrombocytopenia (30{\%}), and anemia (13{\%}). Conclusions: These results show the activity of lenalidomide in heavily pretreated, relapsed/refractory MCL. Responders had a durable response with manageable side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036.",
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