title: Four different regimens of farnesyltransferase inhibitor tipifarnib in older, untreated acute myeloid leukemia patients: North American Intergroup Phase II study SWOG S0432.
abstract: We report on 348 patients ≥ 70 years (median age 78 years) with acute myeloid leukemia (>50% with secondary AML) randomized to receive either 600 mg or 300 mg of tipifarnib orally twice daily on days 1-21 or days 1-7 and 15-21, repeated every 28 days (4 treatment regimens). Responses were seen in all regimens, with overall response rate (CR + CRi + PR) highest (20%) among patients receiving tipifarnib 300 mg twice daily on days 1-21. Toxicities were acceptable. Unless predictors of response to tipifarnib are identified, further study as a single agent in this population is unwarranted.
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; SWOG Headquarters, Ann Arbor, MI, USA. Electronic address: herba@uabmc.edu.
authors.forename: Harry P
authors.initials: HP
authors.lastname: Erba
authors.affiliation: SWOG Statistical Center, Seattle, WA, USA.
authors.forename: Megan
authors.initials: M
authors.lastname: Othus
authors.affiliation: SWOG Headquarters, Ann Arbor, MI, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Roland B
authors.initials: RB
authors.lastname: Walter
authors.affiliation: SWOG Headquarters, Ann Arbor, MI, USA; Department of Hematology & Hematopoietic Cell Transplantation, City of Hope Cancer Center, Duarte, CA, USA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Kirschbaum
authors.affiliation: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Eastern Cooperative Oncology Group, Boston, MA, USA.
authors.forename: Martin S
authors.initials: MS
authors.lastname: Tallman
authors.affiliation: Department of Medicine, University of Chicago, Chicago, IL, USA; Cancer and Leukemia Group B, Chicago, IL, USA.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Larson
authors.affiliation: SWOG Headquarters, Ann Arbor, MI, USA; Department of Hematology & Hematopoietic Cell Transplantation, City of Hope Cancer Center, Duarte, CA, USA; Cytogenetics Laboratory, Sonora Quest Diagnostics Nichols Institute, Chantilly, VA, USA.
authors.forename: Marilyn L
authors.initials: ML
authors.lastname: Slovak
authors.affiliation: SWOG Statistical Center, Seattle, WA, USA.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Kopecky
authors.affiliation: SWOG Statistical Center, Seattle, WA, USA.
authors.forename: Holly M
authors.initials: HM
authors.lastname: Gundacker
authors.affiliation: SWOG Headquarters, Ann Arbor, MI, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Appelbaum
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D051231:Farnesyltranstransferase / Q000037:antagonists & inhibitors* / Q000378:metabolism; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D015363:Quinolones / Q000627:therapeutic use*; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D015363:Quinolones; D051231:Farnesyltranstransferase; C402769:tipifarnib
keywords: Acute myeloid leukemia; Farnesyltransferase inhibitor; Older; Tipifarnib; Untreated