title: Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.
abstract: High-dose chemotherapy prior to autologous stem cell transplantation (ASCT) leads to adverse effects including mucositis, neutropenia and bacteremia. To reduce the toxicity, we treated myeloma and lymphoma patients with peroral bismuth as an adjuvant to chemotherapy to convey cytoprotection in non-malignant cells.
  
  
  
  This trial was a prospective, randomised, double-blind, placebo-controlled pilot study of hematological inpatients (n = 50) receiving bismuth or placebo tablets, in order to identify any potential superiority of bismuth on toxicity from chemotherapy.
  
  
  
  We show for the first time that bismuth significantly reduces grade 2 stomatitis, febrile neutropenia and infections caused by melphalan in multiple myeloma, where adverse effects also were significantly linked to gender. In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo. Also, lymphoma patients' adverse effects were linked to gender. For the first time, bismuth is demonstrated as a safe strategy against chemotherapy's toxicity without interfering with intentional anti-cancer efficiency. Also, we show how gender significantly influences various adverse effects and response to treatment in both multiple myeloma and malignant lymphomas.
  
  
  
  These results may impact clinical prevention of chemotherapy's cytotoxicity in certain patient groups, and also, this study may direct further attention towards the impact of gender during the course and treatment outcome of malignant disorders.
authors.affiliation: Department of Hematology, Herlev Hospital, University of Copenhagen, 2720, Herlev, Denmark. pbhn@regionsjaelland.dk.|Department of Hematology, University Hospital of Roskilde, DK-4000, Roskilde, Denmark. pbhn@regionsjaelland.dk.
authors.forename: Per Boye
authors.identifier: http://orcid.org/0000-0002-8857-8143
authors.initials: PB
authors.lastname: Hansen
authors.affiliation: Section for Neuroprotection, Hjerneeksperten, 1718, Copenhagen, Denmark.
authors.forename: Milena
authors.initials: M
authors.lastname: Penkowa
mesh_terms: D000368:Aged; D001729:Bismuth / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D011446:Prospective Studies; D019172:Transplantation Conditioning / Q000379:methods*; D014182:Transplantation, Autologous / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D001729:Bismuth
keywords: Bismuth; Cytotoxicity; Gender; Neoplasm; Stem cells