Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma

Thomas Elmer Witzig, Pier Luigi Zinzani, Thomas Matthew Habermann, Joseph M. Tuscano, Johannes Drach, Radhakrishnan Ramchandren, Sevgi Kalayoglu Besisik, Kenichi Takeshita, Marie Laure Casadebaig Bravo, Lei Zhang, Tommy Fu, Andre Goy

Research output: Contribution to journalArticle

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Abstract

Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) with aggressive disease characteristics resulting in multiple relapses after initial treatment. Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib). The purpose of this report is to provide longer follow-up on the MCL-001 study (follow-ups were 6.8 [NHL-002], 7.6 [NHL-003], and 52.2 [MCL-001] months). The 206 relapsed MCL patients treated with single-agent lenalidomide (25 mg/day PO, days 1 to 21 every 28-days) had a median age of 67 years (63% ≥65 years), 91% with stage III/IV disease, and 50% with ≥4 previous treatment regimens. With a median follow-up of X, the combined best overall response rate (ORR) was 33% (including 11% with complete remission [CR]/CR unconfirmed CRu). Lenalidomide produced rapid and durable responses with a median time to response of 2.2 months and median duration of response (DOR) of 16.6 months (95% CI: 11.1%-29.8%). The safety profile was consistent and manageable; myelosuppression was the most common adverse event (AE). Overall, single-agent lenalidomide showed consistent efficacy and safety in multiple phase II studies of heavily pretreated patients with relapsed/refractory MCL, including those previously treated with bortezomib.

Original languageEnglish (US)
Pages (from-to)E575-E583
JournalAmerican Journal of Hematology
Volume92
Issue number10
DOIs
StatePublished - Oct 1 2017

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Mantle-Cell Lymphoma
Non-Hodgkin's Lymphoma
Safety
lenalidomide
Recurrence
Therapeutics

ASJC Scopus subject areas

  • Hematology

Cite this

Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. / Witzig, Thomas Elmer; Luigi Zinzani, Pier; Habermann, Thomas Matthew; Tuscano, Joseph M.; Drach, Johannes; Ramchandren, Radhakrishnan; Kalayoglu Besisik, Sevgi; Takeshita, Kenichi; Casadebaig Bravo, Marie Laure; Zhang, Lei; Fu, Tommy; Goy, Andre.

In: American Journal of Hematology, Vol. 92, No. 10, 01.10.2017, p. E575-E583.

Research output: Contribution to journalArticle

Witzig, TE, Luigi Zinzani, P, Habermann, TM, Tuscano, JM, Drach, J, Ramchandren, R, Kalayoglu Besisik, S, Takeshita, K, Casadebaig Bravo, ML, Zhang, L, Fu, T & Goy, A 2017, 'Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma', American Journal of Hematology, vol. 92, no. 10, pp. E575-E583. https://doi.org/10.1002/ajh.24854
Witzig, Thomas Elmer ; Luigi Zinzani, Pier ; Habermann, Thomas Matthew ; Tuscano, Joseph M. ; Drach, Johannes ; Ramchandren, Radhakrishnan ; Kalayoglu Besisik, Sevgi ; Takeshita, Kenichi ; Casadebaig Bravo, Marie Laure ; Zhang, Lei ; Fu, Tommy ; Goy, Andre. / Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. In: American Journal of Hematology. 2017 ; Vol. 92, No. 10. pp. E575-E583.
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abstract = "Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) with aggressive disease characteristics resulting in multiple relapses after initial treatment. Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib). The purpose of this report is to provide longer follow-up on the MCL-001 study (follow-ups were 6.8 [NHL-002], 7.6 [NHL-003], and 52.2 [MCL-001] months). The 206 relapsed MCL patients treated with single-agent lenalidomide (25 mg/day PO, days 1 to 21 every 28-days) had a median age of 67 years (63{\%} ≥65 years), 91{\%} with stage III/IV disease, and 50{\%} with ≥4 previous treatment regimens. With a median follow-up of X, the combined best overall response rate (ORR) was 33{\%} (including 11{\%} with complete remission [CR]/CR unconfirmed CRu). Lenalidomide produced rapid and durable responses with a median time to response of 2.2 months and median duration of response (DOR) of 16.6 months (95{\%} CI: 11.1{\%}-29.8{\%}). The safety profile was consistent and manageable; myelosuppression was the most common adverse event (AE). Overall, single-agent lenalidomide showed consistent efficacy and safety in multiple phase II studies of heavily pretreated patients with relapsed/refractory MCL, including those previously treated with bortezomib.",
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AU - Drach, Johannes

AU - Ramchandren, Radhakrishnan

AU - Kalayoglu Besisik, Sevgi

AU - Takeshita, Kenichi

AU - Casadebaig Bravo, Marie Laure

AU - Zhang, Lei

AU - Fu, Tommy

AU - Goy, Andre

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N2 - Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) with aggressive disease characteristics resulting in multiple relapses after initial treatment. Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib). The purpose of this report is to provide longer follow-up on the MCL-001 study (follow-ups were 6.8 [NHL-002], 7.6 [NHL-003], and 52.2 [MCL-001] months). The 206 relapsed MCL patients treated with single-agent lenalidomide (25 mg/day PO, days 1 to 21 every 28-days) had a median age of 67 years (63% ≥65 years), 91% with stage III/IV disease, and 50% with ≥4 previous treatment regimens. With a median follow-up of X, the combined best overall response rate (ORR) was 33% (including 11% with complete remission [CR]/CR unconfirmed CRu). Lenalidomide produced rapid and durable responses with a median time to response of 2.2 months and median duration of response (DOR) of 16.6 months (95% CI: 11.1%-29.8%). The safety profile was consistent and manageable; myelosuppression was the most common adverse event (AE). Overall, single-agent lenalidomide showed consistent efficacy and safety in multiple phase II studies of heavily pretreated patients with relapsed/refractory MCL, including those previously treated with bortezomib.

AB - Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) with aggressive disease characteristics resulting in multiple relapses after initial treatment. Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib). The purpose of this report is to provide longer follow-up on the MCL-001 study (follow-ups were 6.8 [NHL-002], 7.6 [NHL-003], and 52.2 [MCL-001] months). The 206 relapsed MCL patients treated with single-agent lenalidomide (25 mg/day PO, days 1 to 21 every 28-days) had a median age of 67 years (63% ≥65 years), 91% with stage III/IV disease, and 50% with ≥4 previous treatment regimens. With a median follow-up of X, the combined best overall response rate (ORR) was 33% (including 11% with complete remission [CR]/CR unconfirmed CRu). Lenalidomide produced rapid and durable responses with a median time to response of 2.2 months and median duration of response (DOR) of 16.6 months (95% CI: 11.1%-29.8%). The safety profile was consistent and manageable; myelosuppression was the most common adverse event (AE). Overall, single-agent lenalidomide showed consistent efficacy and safety in multiple phase II studies of heavily pretreated patients with relapsed/refractory MCL, including those previously treated with bortezomib.

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