title: Intravenous busulfan plus melphalan is a highly effective, well-tolerated preparative regimen for autologous stem cell transplantation in patients with advanced lymphoid malignancies.
abstract: We investigated the administration of intravenous (i.v.) busulfan (Bu) combined with melphalan (Mel) in patients with advanced lymphoid malignancies undergoing autologous stem cell transplantation. Bu 130 mg/m(2) was infused daily for 4 days, either as a fixed dose per body surface area (BSA), or to target an average daily area under the curve of 5000 μmol-min, determined by a test dose of i.v. Bu at 32 mg/m(2) given 48 hours prior to the high-dose regimen, followed by a rest day, followed by 2 daily doses of Mel at 70 mg/m(2). Stem cells were infused the following day. Eighty patients had i.v. Bu delivered per test dose guidance. The median daily systemic Bu exposure was 4867 μmol-min. One hundred two patients (Hodgkin lymphoma n = 49, non-Hodgkin lymphoma n = 12, multiple myeloma = 41) with a median age of 44 years (range: 19-65 years) were treated. The 2-year overall survival and progression-free survival rates were 85% and 57%, respectively, for patients with Hodgkin lymphoma, 67% and 64%, respectively, for patients with non-Hodgkin lymphoma, and 82% and 42%, respectively, for patients with multiple myeloma. The regimen was very well tolerated with treatment-related mortality at 100 days, 1 year, and 2 years of 1%, 3%, and 3%, respectively. Intravenous Bu-Mel was well tolerated. Disease control wa encouraging, and should be explored in larger phase II studies.
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, USA. pkebriae@mdanderson.org
authors.forename: Partow
authors.initials: P
authors.lastname: Kebriaei
authors.forename: Timothy
authors.initials: T
authors.lastname: Madden
authors.forename: Reza
authors.initials: R
authors.lastname: Kazerooni
authors.forename: Xuemei
authors.initials: X
authors.lastname: Wang
authors.forename: Peter F
authors.initials: PF
authors.lastname: Thall
authors.forename: Celina
authors.initials: C
authors.lastname: Ledesma
authors.forename: Yago
authors.initials: Y
authors.lastname: Nieto
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Shpall
authors.forename: Chitra
authors.initials: C
authors.lastname: Hosing
authors.forename: Muzaffar
authors.initials: M
authors.lastname: Qazilbash
authors.forename: Uday
authors.initials: U
authors.lastname: Popat
authors.forename: Issa
authors.initials: I
authors.lastname: Khouri
authors.forename: Richard E
authors.initials: RE
authors.lastname: Champlin
authors.forename: Roy B
authors.initials: RB
authors.lastname: Jones
authors.forename: Borje S
authors.initials: BS
authors.lastname: Andersson
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002066:Busulfan / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000188:drug therapy / Q000628:therapy; D006801:Humans; D007262:Infusions, Intravenous; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000628:therapy; D008232:Lymphoproliferative Disorders / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy / Q000628:therapy; D012720:Severity of Illness Index; D016019:Survival Analysis; D019172:Transplantation Conditioning / Q000009:adverse effects*; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D002066:Busulfan; D008558:Melphalan