title: A phase 2 study of lenalidomide monotherapy in patients with deletion 5q acute myeloid leukemia: Southwest Oncology Group Study S0605.
abstract: Older acute myeloid leukemia (AML) patients with a chromosome 5q deletion have poor outcomes with conventional chemotherapy. This phase 2 study explored the safety and efficacy of single-agent lenalidomide in previously untreated older AML patients with del(5q) who declined standard chemotherapy. Patients were treated with lenalidomide 50 mg daily for 28 days as induction therapy and 10 mg daily for 21 days of a 28-day cycle as maintenance until disease progression or unacceptable toxicity. Among 37 evaluable patients, the median age was 74 years (range, 60-94), 21 (57%) were female, 19 (51%) had prior myelodysplastic syndrome, and 30 (81%) had pretreatment cytogenetic studies evaluated centrally. Six had isolated del(5q), 1 had del(5q) and +8, 23 had complex cytogenetics, and 7 others had del(5q) identified locally. Fourteen patients (38%) completed induction therapy: 7 patients died during induction therapy, 8 had disease progression, 7 had nonfatal adverse events, and 1 entered hospice. Eight patients started maintenance therapy. Five patients (14%) achieved a partial or complete response, 2 with isolated del(5q) and 3 with complex cytogenetics. Relapse-free survival was 5 months (range, 0-19). Median overall survival was 2 months for the entire population. In conclusion, lenalidomide as a single agent has modest activity in older del(5q) AML patients. Southwest Oncology Group Study S0605 is registered at www.clinicaltrials.gov as NCT00352365.
authors.affiliation: Leukemia Program, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH 44195, USA. sekerem@ccf.org
authors.forename: Mikkael A
authors.initials: MA
authors.lastname: Sekeres
authors.forename: Holly
authors.initials: H
authors.lastname: Gundacker
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Lancet
authors.forename: Anjali
authors.initials: A
authors.lastname: Advani
authors.forename: Stephen
authors.initials: S
authors.lastname: Petersdorf
authors.forename: Jane
authors.initials: J
authors.lastname: Liesveld
authors.forename: Deborah
authors.initials: D
authors.lastname: Mulford
authors.forename: Tom
authors.initials: T
authors.lastname: Norwood
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Willman
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Appelbaum
authors.forename: Alan F
authors.initials: AF
authors.lastname: List
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002872:Chromosome Deletion; D002895:Chromosomes, Human, Pair 5; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000235:genetics*; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide