Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's lymphoma

Thomas E. Witzig, Peter H. Wiernik, Timothy Eisdell Moore, Craig Reeder, Craig Cole, Glen Justice, Henry Kaplan, Michael Voralia, Dennis Pietronigro, Kenichi Takeshita, Annette Ervin-Haynes, Jerome B. Zeldis, Julie Marie Vose

Research output: Contribution to journalArticle

187 Citations (Scopus)

Abstract

Purpose: Lenalidomide is a novel immunomodulatory agent with antiproliferative activities. Given its efficacy in a wide range of hematologic malignancies, we conducted a phase II trial (NHL-001) of single-agent lenalidomide in indolent non-Hodgkin's lymphoma (NHL). Patients and Methods: Patients with relapsed/refractory indolent NHL were eligible, with no limit on the number of previous therapies. Oral lenalidomide 25 mg was self-administered once daily on days 1 to 21 of every 28-day cycle for up to 52 weeks as tolerated, or until disease progression. The primary end point was objective response rate (ORR), with secondary end points of duration of response (DR), progression-free survival (PFS), and safety. Results: Forty-three enrolled patients were assessable for response and safety. Patients received a median of three prior systemic therapies (range, 1 to 17) and half were refractory to last therapy. ORR was 23% (10 of 43), including a 7% complete response (CR) or unconfirmed CR rate. Twenty-seven percent (six of 22) of patients with follicular lymphoma grade 1 or 2, and 22% (four of 18) with small lymphocytic lymphoma responded to therapy. Median DR was not reached, but was longer than 16.5 months with seven of 10 responses ongoing at 15 to 28 months. Median PFS for the whole group was 4.4 months (95% CI, 2.5 to 10.4 months). Adverse events were predictable and manageable; the most common grade 3 or 4 adverse events were neutropenia (30% and 16%, respectively) and thrombocytopenia (14% and 5%, respectively). Conclusion: Oral lenalidomide monotherapy produces durable responses with manageable adverse events in patients with relapsed/refractory indolent NHL, warranting further investigation of treatment for indolent NHL.

Original languageEnglish (US)
Pages (from-to)5404-5409
Number of pages6
JournalJournal of Clinical Oncology
Volume27
Issue number32
DOIs
StatePublished - Nov 10 2009

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Non-Hodgkin's Lymphoma
Follicular Lymphoma
Disease-Free Survival
Therapeutics
Safety
Hematologic Neoplasms
B-Cell Chronic Lymphocytic Leukemia
Neutropenia
Thrombocytopenia
Disease Progression
lenalidomide

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's lymphoma. / Witzig, Thomas E.; Wiernik, Peter H.; Moore, Timothy Eisdell; Reeder, Craig; Cole, Craig; Justice, Glen; Kaplan, Henry; Voralia, Michael; Pietronigro, Dennis; Takeshita, Kenichi; Ervin-Haynes, Annette; Zeldis, Jerome B.; Vose, Julie Marie.

In: Journal of Clinical Oncology, Vol. 27, No. 32, 10.11.2009, p. 5404-5409.

Research output: Contribution to journalArticle

Witzig, TE, Wiernik, PH, Moore, TE, Reeder, C, Cole, C, Justice, G, Kaplan, H, Voralia, M, Pietronigro, D, Takeshita, K, Ervin-Haynes, A, Zeldis, JB & Vose, JM 2009, 'Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's lymphoma', Journal of Clinical Oncology, vol. 27, no. 32, pp. 5404-5409. https://doi.org/10.1200/JCO.2008.21.1169
Witzig, Thomas E. ; Wiernik, Peter H. ; Moore, Timothy Eisdell ; Reeder, Craig ; Cole, Craig ; Justice, Glen ; Kaplan, Henry ; Voralia, Michael ; Pietronigro, Dennis ; Takeshita, Kenichi ; Ervin-Haynes, Annette ; Zeldis, Jerome B. ; Vose, Julie Marie. / Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's lymphoma. In: Journal of Clinical Oncology. 2009 ; Vol. 27, No. 32. pp. 5404-5409.
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abstract = "Purpose: Lenalidomide is a novel immunomodulatory agent with antiproliferative activities. Given its efficacy in a wide range of hematologic malignancies, we conducted a phase II trial (NHL-001) of single-agent lenalidomide in indolent non-Hodgkin's lymphoma (NHL). Patients and Methods: Patients with relapsed/refractory indolent NHL were eligible, with no limit on the number of previous therapies. Oral lenalidomide 25 mg was self-administered once daily on days 1 to 21 of every 28-day cycle for up to 52 weeks as tolerated, or until disease progression. The primary end point was objective response rate (ORR), with secondary end points of duration of response (DR), progression-free survival (PFS), and safety. Results: Forty-three enrolled patients were assessable for response and safety. Patients received a median of three prior systemic therapies (range, 1 to 17) and half were refractory to last therapy. ORR was 23{\%} (10 of 43), including a 7{\%} complete response (CR) or unconfirmed CR rate. Twenty-seven percent (six of 22) of patients with follicular lymphoma grade 1 or 2, and 22{\%} (four of 18) with small lymphocytic lymphoma responded to therapy. Median DR was not reached, but was longer than 16.5 months with seven of 10 responses ongoing at 15 to 28 months. Median PFS for the whole group was 4.4 months (95{\%} CI, 2.5 to 10.4 months). Adverse events were predictable and manageable; the most common grade 3 or 4 adverse events were neutropenia (30{\%} and 16{\%}, respectively) and thrombocytopenia (14{\%} and 5{\%}, respectively). Conclusion: Oral lenalidomide monotherapy produces durable responses with manageable adverse events in patients with relapsed/refractory indolent NHL, warranting further investigation of treatment for indolent NHL.",
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T1 - Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's lymphoma

AU - Witzig, Thomas E.

AU - Wiernik, Peter H.

AU - Moore, Timothy Eisdell

AU - Reeder, Craig

AU - Cole, Craig

AU - Justice, Glen

AU - Kaplan, Henry

AU - Voralia, Michael

AU - Pietronigro, Dennis

AU - Takeshita, Kenichi

AU - Ervin-Haynes, Annette

AU - Zeldis, Jerome B.

AU - Vose, Julie Marie

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N2 - Purpose: Lenalidomide is a novel immunomodulatory agent with antiproliferative activities. Given its efficacy in a wide range of hematologic malignancies, we conducted a phase II trial (NHL-001) of single-agent lenalidomide in indolent non-Hodgkin's lymphoma (NHL). Patients and Methods: Patients with relapsed/refractory indolent NHL were eligible, with no limit on the number of previous therapies. Oral lenalidomide 25 mg was self-administered once daily on days 1 to 21 of every 28-day cycle for up to 52 weeks as tolerated, or until disease progression. The primary end point was objective response rate (ORR), with secondary end points of duration of response (DR), progression-free survival (PFS), and safety. Results: Forty-three enrolled patients were assessable for response and safety. Patients received a median of three prior systemic therapies (range, 1 to 17) and half were refractory to last therapy. ORR was 23% (10 of 43), including a 7% complete response (CR) or unconfirmed CR rate. Twenty-seven percent (six of 22) of patients with follicular lymphoma grade 1 or 2, and 22% (four of 18) with small lymphocytic lymphoma responded to therapy. Median DR was not reached, but was longer than 16.5 months with seven of 10 responses ongoing at 15 to 28 months. Median PFS for the whole group was 4.4 months (95% CI, 2.5 to 10.4 months). Adverse events were predictable and manageable; the most common grade 3 or 4 adverse events were neutropenia (30% and 16%, respectively) and thrombocytopenia (14% and 5%, respectively). Conclusion: Oral lenalidomide monotherapy produces durable responses with manageable adverse events in patients with relapsed/refractory indolent NHL, warranting further investigation of treatment for indolent NHL.

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