title: Toxicity of high-dose busulphan and cyclophosphamide as conditioning therapy for allogeneic bone marrow transplantation in adults with haematological malignancies.
abstract: The toxicity of the conditioning regimen high-dose busulfan (BU) 16 mg/kg followed by cyclophosphamide (CY) 200 mg/kg has been analysed in 60 adult patients (mean age 36 +/- 9 years) with haematological malignancies, a third of whom had advanced disease, all received the graft from fully HLA-identical siblings. Significant nausea and vomiting were rare during BU administration but occurred in 44% of the patients with CY. Severe mucositis occurred in 30% of patients. Haemorrhagic cystitis occurred in 16% of patients; interstitial pneumonia occurred in 3 patients and was fatal in one. Veno-occlusive disease of the liver occurred in 2 patients and was fatal in one: however, increase of bilirubin of at least twice the baseline value and/or isolated weight gain > 5% of pre-transplant value occurred in 28% of patients. These signs of liver toxicity disappeared in all patients after appropriate therapy. Normalisation of bilirubin levels took twice as long as normalisation of body weight: median 35 and 18 days, respectively. Hyperpigmentation of the skin, mainly involving flexural and pressure areas, occurred in 47% of patients and was manageable topically. Eight patients died of relapsed disease; 15 died of transplant complications but in six the original malignancy persisted or had recurred at the time of death. Overall transplant-related mortality was 15%. We conclude that the toxicity of this regimen has not been high, with the liver being the most seriously affected organ. A longer follow-up is necessary to assess long-term consequences.
authors.affiliation: Institute of Haematology Lorenzo e Ariosto Seràgnoli, St. Orsola University Hospital, Bologna, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Bandini
authors.forename: A
authors.initials: A
authors.lastname: Belardinelli
authors.forename: G
authors.initials: G
authors.lastname: Rosti
authors.forename: E
authors.initials: E
authors.lastname: Calori
authors.forename: M R
authors.initials: MR
authors.lastname: Motta
authors.forename: S
authors.initials: S
authors.lastname: Rizzi
authors.forename: C
authors.initials: C
authors.lastname: Benini
authors.forename: S
authors.initials: S
authors.lastname: Tura
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D016026:Bone Marrow Transplantation; D002066:Busulfan / Q000008:administration & dosage / Q000009:adverse effects*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006504:Hepatic Veno-Occlusive Disease / Q000209:etiology; D006801:Humans; D007938:Leukemia / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D014184:Transplantation, Homologous
chemical_list: D003520:Cyclophosphamide; D002066:Busulfan