Busulfex (i.v. BU) and CY regimen before SCT: Japanese-targeted phase II pharmacokinetics combined study

S. W. Kim, S. J. Mori, Ryuji Tanosaki, T. Fukuda, M. Kami, H. Sakamaki, T. Yamashita, Y. Kodera, S. Terakura, S. Taniguchi, S. Miyakoshi, N. Usui, S. Yano, Y. Kawano, Y. Nagatoshi, M. Harada, Y. Morishima, Shinichiro Okamoto, A. M. Saito, Y. OhashiR. Ueda, Y. Takaue

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Abstract

To evaluate the toxicity and efficacy of an i.v. preparation of BU (12.8 mg/kg), combined with CY (120 mg/kg), a prospective study was performed on 30 Japanese patients (median age, 30 years) with hematologic malignancies undergoing hematopoietic SCT (28 allogeneic transplants from an HLA-matched donor and 2 autologous transplants). There were no significant toxicities, and all but one patient showed evidence of granulocyte engraftment at a median of 14 days for allogeneic and 11 days for autologous transplantation. Grades II-IV acute and chronic GVHD occurred in 9 (9/27, 33%) and 16 patients (16/27, 59%), respectively. Non-relapse mortality at days 100 and 365 was 3 and 17%, respectively. The pharmacokinetics of i.v. BU showed close inter- and intrapatient consistency; the area under the plasma concentration-time curve of the first administration remained at less than 1500 μmol min/l in 27 of the 29 patients (93%), and between 900 and 1350 μmol min/l in 22 patients (73%). As all of the profiles overlap with data from non-Japanese patients, we conclude that racial factors may not seriously influence the bioactivity of i.v. BU.

Original languageEnglish
Pages (from-to)611-617
Number of pages7
JournalBone Marrow Transplantation
Volume43
Issue number8
DOIs
Publication statusPublished - 2009

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Busulfan
Pharmacokinetics
Autologous Transplantation
Autografts
Hematologic Neoplasms
Granulocytes
Tissue Donors
Prospective Studies
Transplants
Mortality

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

Busulfex (i.v. BU) and CY regimen before SCT : Japanese-targeted phase II pharmacokinetics combined study. / Kim, S. W.; Mori, S. J.; Tanosaki, Ryuji; Fukuda, T.; Kami, M.; Sakamaki, H.; Yamashita, T.; Kodera, Y.; Terakura, S.; Taniguchi, S.; Miyakoshi, S.; Usui, N.; Yano, S.; Kawano, Y.; Nagatoshi, Y.; Harada, M.; Morishima, Y.; Okamoto, Shinichiro; Saito, A. M.; Ohashi, Y.; Ueda, R.; Takaue, Y.

In: Bone Marrow Transplantation, Vol. 43, No. 8, 2009, p. 611-617.

Research output: Contribution to journalArticle

Kim, SW, Mori, SJ, Tanosaki, R, Fukuda, T, Kami, M, Sakamaki, H, Yamashita, T, Kodera, Y, Terakura, S, Taniguchi, S, Miyakoshi, S, Usui, N, Yano, S, Kawano, Y, Nagatoshi, Y, Harada, M, Morishima, Y, Okamoto, S, Saito, AM, Ohashi, Y, Ueda, R & Takaue, Y 2009, 'Busulfex (i.v. BU) and CY regimen before SCT: Japanese-targeted phase II pharmacokinetics combined study', Bone Marrow Transplantation, vol. 43, no. 8, pp. 611-617. https://doi.org/10.1038/bmt.2008.372
Kim, S. W. ; Mori, S. J. ; Tanosaki, Ryuji ; Fukuda, T. ; Kami, M. ; Sakamaki, H. ; Yamashita, T. ; Kodera, Y. ; Terakura, S. ; Taniguchi, S. ; Miyakoshi, S. ; Usui, N. ; Yano, S. ; Kawano, Y. ; Nagatoshi, Y. ; Harada, M. ; Morishima, Y. ; Okamoto, Shinichiro ; Saito, A. M. ; Ohashi, Y. ; Ueda, R. ; Takaue, Y. / Busulfex (i.v. BU) and CY regimen before SCT : Japanese-targeted phase II pharmacokinetics combined study. In: Bone Marrow Transplantation. 2009 ; Vol. 43, No. 8. pp. 611-617.
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abstract = "To evaluate the toxicity and efficacy of an i.v. preparation of BU (12.8 mg/kg), combined with CY (120 mg/kg), a prospective study was performed on 30 Japanese patients (median age, 30 years) with hematologic malignancies undergoing hematopoietic SCT (28 allogeneic transplants from an HLA-matched donor and 2 autologous transplants). There were no significant toxicities, and all but one patient showed evidence of granulocyte engraftment at a median of 14 days for allogeneic and 11 days for autologous transplantation. Grades II-IV acute and chronic GVHD occurred in 9 (9/27, 33{\%}) and 16 patients (16/27, 59{\%}), respectively. Non-relapse mortality at days 100 and 365 was 3 and 17{\%}, respectively. The pharmacokinetics of i.v. BU showed close inter- and intrapatient consistency; the area under the plasma concentration-time curve of the first administration remained at less than 1500 μmol min/l in 27 of the 29 patients (93{\%}), and between 900 and 1350 μmol min/l in 22 patients (73{\%}). As all of the profiles overlap with data from non-Japanese patients, we conclude that racial factors may not seriously influence the bioactivity of i.v. BU.",
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AU - Kim, S. W.

AU - Mori, S. J.

AU - Tanosaki, Ryuji

AU - Fukuda, T.

AU - Kami, M.

AU - Sakamaki, H.

AU - Yamashita, T.

AU - Kodera, Y.

AU - Terakura, S.

AU - Taniguchi, S.

AU - Miyakoshi, S.

AU - Usui, N.

AU - Yano, S.

AU - Kawano, Y.

AU - Nagatoshi, Y.

AU - Harada, M.

AU - Morishima, Y.

AU - Okamoto, Shinichiro

AU - Saito, A. M.

AU - Ohashi, Y.

AU - Ueda, R.

AU - Takaue, Y.

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N2 - To evaluate the toxicity and efficacy of an i.v. preparation of BU (12.8 mg/kg), combined with CY (120 mg/kg), a prospective study was performed on 30 Japanese patients (median age, 30 years) with hematologic malignancies undergoing hematopoietic SCT (28 allogeneic transplants from an HLA-matched donor and 2 autologous transplants). There were no significant toxicities, and all but one patient showed evidence of granulocyte engraftment at a median of 14 days for allogeneic and 11 days for autologous transplantation. Grades II-IV acute and chronic GVHD occurred in 9 (9/27, 33%) and 16 patients (16/27, 59%), respectively. Non-relapse mortality at days 100 and 365 was 3 and 17%, respectively. The pharmacokinetics of i.v. BU showed close inter- and intrapatient consistency; the area under the plasma concentration-time curve of the first administration remained at less than 1500 μmol min/l in 27 of the 29 patients (93%), and between 900 and 1350 μmol min/l in 22 patients (73%). As all of the profiles overlap with data from non-Japanese patients, we conclude that racial factors may not seriously influence the bioactivity of i.v. BU.

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