title: Therapy with bortezomib plus lenalidomide for relapsed/refractory mantle cell lymphoma: final results of a phase II trial (CALGB 50501).
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.
authors.affiliation: University of Minnesota and VAMC , Minneapolis, MN , USA.
authors.forename: Vicki A
authors.initials: VA
authors.lastname: Morrison
authors.forename: Sin-Ho
authors.initials: SH
authors.lastname: Jung
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Johnson
authors.forename: Ann
authors.initials: A
authors.lastname: LaCasce
authors.forename: Kristie A
authors.initials: KA
authors.lastname: Blum
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
authors.forename: Brandelyn N
authors.initials: BN
authors.lastname: Pitcher
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077269:Lenalidomide; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy*; D008231:Lymphopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009422:Nervous System Diseases / Q000139:chemically induced; D012008:Recurrence; D012074:Remission Induction; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D000069286:Bortezomib; D000077269:Lenalidomide
keywords: Mantle cell lymphoma; bortezomib; lenalidomide