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A Limited Sampling Strategy for Therapeutic Drug Monitoring of Mycophenolate Mofetil for Prophylaxis of Acute Graft-Versus-Host Disease in Allogeneic Stem Cell Transplantation.

التفاصيل البيبلوغرافية
العنوان: A Limited Sampling Strategy for Therapeutic Drug Monitoring of Mycophenolate Mofetil for Prophylaxis of Acute Graft-Versus-Host Disease in Allogeneic Stem Cell Transplantation.
المؤلفون: Gota V; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India.; Homi Bhabha National Institute, Mumbai, Maharastra, India., Purohit V; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Gurjar M; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Nayak L; Homi Bhabha National Institute, Mumbai, Maharastra, India.; Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Punatar S; Homi Bhabha National Institute, Mumbai, Maharastra, India.; Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Gokarn A; Homi Bhabha National Institute, Mumbai, Maharastra, India.; Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Bonda A; Homi Bhabha National Institute, Mumbai, Maharastra, India.; Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Bagal B; Homi Bhabha National Institute, Mumbai, Maharastra, India.; Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Vora CS; Homi Bhabha National Institute, Mumbai, Maharastra, India.; Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Patil A; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Nookala M; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India., Khattry N; Homi Bhabha National Institute, Mumbai, Maharastra, India.; Bone Marrow Transplant Unit, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, Maharashtra, India.
المصدر: Cell transplantation [Cell Transplant] 2020 Jan-Dec; Vol. 29, pp. 963689720912925.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: SAGE Publishing Country of Publication: United States NLM ID: 9208854 Publication Model: Print Cited Medium: Internet ISSN: 1555-3892 (Electronic) Linking ISSN: 09636897 NLM ISO Abbreviation: Cell Transplant Subsets: MEDLINE
أسماء مطبوعة: Publication: 2017- : Thousand Oaks, CA : SAGE Publishing
Original Publication: Elmsford, New York : Pergamon Press, c1992-
مواضيع طبية MeSH: Cyclosporine/*pharmacology , Graft vs Host Disease/*prevention & control , Immunosuppressive Agents/*pharmacology , Mycophenolic Acid/*pharmacology, Cyclosporine/administration & dosage ; Drug Monitoring/methods ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Immunosuppressive Agents/administration & dosage
مستخلص: A universally accepted strategy for therapeutic drug monitoring (TDM) of mycophenolate mofetil (MMF) in the prevention of acute graft-versus-host disease (aGVHD) in allogenic hematopoietic stem cell transplantation (alloHSCT) does not exist. We explored the feasibility of developing a limited sampling strategy (LSS) for TDM of MMF in this setting. Patients undergoing alloHSCT received standard MMF-cyclosporine prophylaxis, with MMF administered twice daily (BD) for matched transplant recipients or thrice daily (TID) in haploidentical transplantation. Intensive blood sampling was carried out on day 7 and area under the concentration-time curve (AUC) of mycophenolic acid (MPA), the active metabolite, was estimated using noncompartmental analysis. The ability of MPA exposure defined by AUC 0-12 to discriminate between responders (patients who did not develop GVHD) and nonresponders (patients who developed GVHD) was determined by receiver operating characteristic curve analysis. Patients were divided into training and validation sets within BD and TID groups. Mathematical equations were developed from the training set to predict AUC 0-12 from an abbreviated AUC involving a limited number of sampling points. The equations were validated in the validation set by comparing the MPA AUC 0-12 predicted from LSS with the observed AUC 0-12 . It was observed that patients with AUC 0-12 ≤18.99 mg*h/L had a higher risk of developing aGVHD [odds ratio (OR) = 2.63 (1.17 to 5.87), P = 0.06]. The benefit was more in matched transplant recipients [OR = 3.5 (1.30 to 9.49), P = 0.05] as compared to haploindentical transplant [OR = 2.8 (0.49 to 15.91), P = NS]. Using the mathematical equations, the observed AUC 0-12 was predicted with 92.31% accuracy in the BD subset and 100% accuracy in the TID subset for a combined accuracy of 94.76%. A set of just three samples that constituted the abbreviated AUC 1-4 was used to develop the predictive models. The LSS could be employed for the therapeutic monitoring of MMF particularly in patients undergoing matched hematopoietic stem cell transplantation.
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فهرسة مساهمة: Keywords: graft-versus-host disease; hematopoietic stem cell transplantation; mycophenolate mofetil; therapeutic drug monitoring
المشرفين على المادة: 0 (Immunosuppressive Agents)
83HN0GTJ6D (Cyclosporine)
HU9DX48N0T (Mycophenolic Acid)
تواريخ الأحداث: Date Created: 20200605 Date Completed: 20210608 Latest Revision: 20210608
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC7444217
DOI: 10.1177/0963689720912925
PMID: 32495641
قاعدة البيانات: MEDLINE
الوصف
تدمد:1555-3892
DOI:10.1177/0963689720912925