title: Phase I dose escalation study of bortezomib in combination with lenalidomide in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).
abstract: We conducted a phase I dose escalation study to determine the maximal tolerated dose of bortezomib that could be combined with standard dose lenalidomide in patients with MDS or AML. Treatment consisted of bortezomib (IV) on Days 1, 4, 8, and 11 and lenalidomide 10mg daily (PO) days 1-21 in 28 day cycles for up to 9 cycles. 23 patients (14 MDS/CMML, 9 AML) were enrolled. The maximally tested dose of bortezomib, 1.3mg/m(2), was tolerable in this regimen. Responses were seen in patients with MDS and AML. Further testing of this regimen is planned.
authors.affiliation: Center for Leukemia, Massachusetts General Hospital Cancer Center, Boston, MA, USA. eattar@partners.org
authors.forename: Eyal C
authors.initials: EC
authors.lastname: Attar
authors.forename: Philip C
authors.initials: PC
authors.lastname: Amrein
authors.forename: James W
authors.initials: JW
authors.lastname: Fraser
authors.forename: Amir T
authors.initials: AT
authors.lastname: Fathi
authors.forename: Steven
authors.initials: S
authors.lastname: McAfee
authors.forename: Martha
authors.initials: M
authors.lastname: Wadleigh
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Deangelo
authors.forename: David P
authors.initials: DP
authors.lastname: Steensma
authors.forename: Richard M
authors.initials: RM
authors.lastname: Stone
authors.forename: Julia
authors.initials: J
authors.lastname: Foster
authors.forename: Donna
authors.initials: D
authors.lastname: Neuberg
authors.forename: Karen K
authors.initials: KK
authors.lastname: Ballen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077269:Lenalidomide; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000401:mortality; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis; D011719:Pyrazines / Q000008:administration & dosage; D012074:Remission Induction; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D000077269:Lenalidomide
keywords: Bortezomib and lenalidomide in MDS and AML