Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma

• Published in: British journal of haematology Vol. 145; no. 3; pp. 344 - 349
• Main Authors: Habermann, Thomas M., Lossos, Izidore S., Justice, Glen, Vose, Julie M., Wiernik, Peter H., McBride, Kyle, Wride, Kenton, Ervin‐Haynes, Annette, Takeshita, Kenichi, Pietronigro, Dennis, Zeldis, Jerome B., Tuscano, Joseph M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.05.2009; Blackwell
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Disease-Free Survival; Drug Administration Schedule; efficacy; Female; Hematologic and hematopoietic diseases; Humans; Kaplan-Meier Estimate; lenalidomide; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Leukopenia - chemically induced; Lymphoma, B-Cell - drug therapy; Lymphoma, B-Cell - mortality; Lymphoma, Mantle-Cell - drug therapy; Lymphoma, Mantle-Cell - mortality; Male; mantle cell lymphoma; Medical sciences; Middle Aged; Neutropenia - chemically induced; non‐Hodgkin lymphoma; Recurrence; safety; Thalidomide - administration & dosage; Thalidomide - adverse effects; Thalidomide - analogs & derivatives; Thalidomide - therapeutic use; Thrombocytopenia - chemically induced; Treatment Outcome; Antineoplastic agent; Human; Relapse; Treatment resistance; Hematology; Lenalidomide; Treatment efficiency; Response rate; B cell neoplasm; Malignant hemopathy; B-Lymphocyte; non-Hodgkin lymphoma; Non Hodgkin lymphoma; efficacy; Lymphoproliferative syndrome; safety; Mantle cell lymphoma; Monotherapy; Cancer
• ISSN: 0007-1048; 1365-2141
• DOI: 10.1111/j.1365-2141.2009.07626.x

Summary Mantle cell lymphoma (MCL) is an aggressive non‐Hodgkin lymphoma with a poor prognosis following first relapse. We present a subgroup analysis of an open‐label phase II trial investigating the efficacy and safety of lenalidomide in patients with relapsed or refractory MCL. Oral lenalidomide 25 mg was self‐administered once daily on days 1–21 every 28 d for up to 52 weeks, according to tolerability or until disease progression. The primary endpoint was overall response rate (ORR) and secondary endpoints were duration of response, progression‐free survival (PFS) and safety. Among 15 patients with MCL with a median disease duration of 5·1 years and a median of four prior treatments, the ORR was 53%. Three patients (20%) had a complete response and 5 (33%) had a partial response. The median duration of response was 13·7 months and median PFS was 5·6 months. Four of five patients who relapsed after transplantation and two of five patients who previously received bortezomib responded to lenalidomide. The most common grade 4 adverse event was thrombocytopenia (13%) and the most common grade 3 adverse events were neutropenia (40%), leucopenia (27%) and thrombocytopenia (20%). In conclusion, oral lenalidomide monotherapy is well tolerated and active in relapsed or refractory MCL.