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
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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.
KeywordsStem cells Neoplasm Bismuth Gender Cytotoxicity
We wish to acknowledge the clinical research unit and the nurses of the Department of Hematology for their assistance.
Compliance with ethical standards
The study was approved by relevant boards including the ethics committee and the Danish National Board of Health. This study is registered with EudraCT number 2007-007652-34.
Conflict of interest
The authors declare that they have no conflict of interest.
The study was funded by means of our institutions at the time of investigation (the Department of Hematology and the University of Copenhagen) and by grants from Herlev Hospital (PBH), Lægeforeningens Forskningsfond (MP) and Mimi og Viktor Larsens Fond (MP).
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