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

• Published in: American journal of hematology Vol. 92; no. 10; pp. E575 - E583
• Main Authors: Witzig, Thomas E, Luigi Zinzani, Pier, Habermann, Thomas M, Tuscano, Joseph M, Drach, Johannes, Ramchandren, Radhakrishnan, Kalayoglu Besisik, Sevgi, Takeshita, Kenichi, Casadebaig Bravo, Marie-Laure, Zhang, Lei, Fu, Tommy, Goy, Andre
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-10-2017
• Subjects: Administration, Oral; Adult; Aged; Aged, 80 and over; Anemia - chemically induced; Anemia - epidemiology; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Bortezomib; Disease-Free Survival; Drug Administration Schedule; Female; Humans; Immunomodulation; Immunotherapy; Kaplan-Meier Estimate; Lymphoma; Lymphoma, Mantle-Cell - drug therapy; Male; Mantle cell lymphoma; Middle Aged; Myelosuppression; Neoplasm Staging; Neutropenia - chemically induced; Neutropenia - epidemiology; Non-Hodgkin's lymphoma; Patients; Recurrence; Remission; Targeted cancer therapy; Thalidomide - administration & dosage; Thalidomide - adverse effects; Thalidomide - analogs & derivatives; Thalidomide - therapeutic use; Thrombocytopenia - chemically induced; Thrombocytopenia - epidemiology
• ISSN: 0361-8609; 1096-8652
• DOI: 10.1002/ajh.24854

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.