Abstract Cancer and Leukemia Group B designed a phase II trial of lenalidomide + bortezomib for relapsed/refractory mantle cell lymphoma (MCL). Induction therapy was lenalidomide (days 1-14) plus bortezomib (days 1/4/8/11), every 21 days for eight cycles. Complete/partial responders (CR, PR) received maintenance lenalidomide (days 1-14) and bortezomib (days 1/8), every 21 days. Primary endpoint was overall response rate; secondary endpoints were CR rate, progression-free (PFS), event-free (EFS) and overall survival (OS). Fifty-three eligible patients, median age 67 years, were accrued. Median number of cycles received was 4 (range, 1-82). Median followup was 46 (range, 12-67) months. Best response was CR 15%, PR 25%. 5/8 CR, and 4/13 PR patients received maintenance. Six CR and one PR patient remain in remission (median, 3.2 years). Thirty-three (62%) patients have died. One-year PFS, EFS and OS are 40%, 25% and 68%, respectively. This combination will not be pursued further.
Bibliographical noteFunding Information:
The research for CALGB 50501 (Alliance) was supported, in part, by grants from the National Cancer Institute (CA31946) to the Alliance for Clinical Trials in Oncology (Monica M. Bertagnolli, MD, Chair) and to the Alliance Statistics and Data Center (Daniel J. Sargent, PhD, CA33601). The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.
The following Alliance/CALGB institutions participated in this study: Christiana Care Health Services, Inc. CCOP, Wilmington, DE, Stephen Grubbs, MD, supported by CA45418 Dana-Farber Cancer Institute, Boston, MA, Harold J. Burstein, MD, PhD, supported by CA32291 Dartmouth Medical School-Norris Cotton Cancer Center, Lebanon, NH, Konstantin Dragnev, MD, supported by CA04326 Georgetown University Medical Center, Washington, DC, Bruce Cheson, MD, supported by CA77597 Grand Rapids Clinical Oncology Program, Grand Rapids, MI, Martin J. Bury, MD Massachusetts General Hospital, Boston, MA, Jeffrey W. Clark, MD, supported by CA32291 Southeast Cancer Control Consortium, Inc. CCOP, Goldsboro, NC, James N. Atkins, MD, supported by CA45808
- Mantle cell lymphoma