A dose-finding study of lenograstim (glycosylated rHuG-CSF) for peripheral blood stem cell mobilization during postoperative adjuvant chemotherapy in patients with breast cancer

Masaru Narabayashi, Kunihiko Takeyama, Takashi Fukutomi, Yutaka Tokuda, Tomoo Tajima, Akira Okumura, Takaaki Chou, Muneaki Sano, Haruhiko Makino, Tadahiko Igarashi, Yasutsuna Sasaki, Shigeru Imoto, Michinori Ogura, Yasuo Morishima, Hiroshi Murai, Shinichiro Okamoto, Tadashi Ikeda, Masaharu Kasai, Toshiya Yokozawa, Kensei Tobinai

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Abstract

Background: The optimum dose of granulocyte colony-stimulating factor (G-CSF) for peripheral blood stem cell (PBSC) mobilization after disease-oriented, conventional-dose chemotherapy remains unknown. Methods: A multicenter dose-finding study of glycosylated G-CSF (lenograstim) for the mobilization of PBSCs following adjuvant CAF chemotherapy (cyclophosphamide, doxorubicin and 5-fluorouracil) was performed in 38 patients with postoperative breast cancer. Each 10, ten and eight patients were sequentially allocated to one of the three dose groups (2, 5 and 10 μg/kg, respectively) of lenograstim. Lenograstim was administered subcutaneously (s.c.) daily from day 8 to the day of the last apheresis and CD34+ cells and colony-forming units-granulocyte macrophage (CFU-GMs) in peripheral blood were measured serially. Additionally, 10 patients who received adjuvant CAF chemotherapy alone also participated in the study, as a control. Results: Lenograstim was well tolerated up to 10 μg/kg, except for one patient given 10 μg/kg who developed transient grade 3 hepatic enzyme elevation. The peak levels of CD34+ cells and CFU-GMs in peripheral blood showed dose-response relationships. The median peak CD34+ cells for the 0, 2, 5 and 10 μg/kg dose groups were 5.4, 34.3, 55.0 and 127.6 cells/μl, respectively, and those of CFU-GMs for the 0, 2, 5 and 10 μg/kg dose groups were 0.01, 0.33, 1.32 and 3.30 CFU-GMs/μl, respectively. Conclusions: Considering the previous reports suggesting that a pre-apheresis number of 40-50 CD34+ cells/μl in peripheral blood is highly predictive for achievement of more than 2.5 × 106 CD34+ cells/kg in a standard apheresis procedure of 10 litres, the optimum dose of lenograstim for PBSC mobilization following CAF chemotherapy in patients with postoperative breast cancer is 5 μg/kg/day s.c.

Original languageEnglish
Pages (from-to)285-290
Number of pages6
JournalJapanese Journal of Clinical Oncology
Volume29
Issue number6
Publication statusPublished - 1999 Jun

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Hematopoietic Stem Cell Mobilization
Adjuvant Chemotherapy
Granulocyte-Macrophage Progenitor Cells
Breast Neoplasms
Blood Component Removal
Granulocyte Colony-Stimulating Factor
Drug Therapy
Fluorouracil
Doxorubicin
Cyclophosphamide
lenograstim
Peripheral Blood Stem Cells
Liver
Enzymes

Keywords

  • Breast cancer
  • Granulocyte colony-stimulating factor
  • Lenograstim
  • Mobilization
  • Peripheral blood stem cell

ASJC Scopus subject areas

  • Oncology

Cite this

A dose-finding study of lenograstim (glycosylated rHuG-CSF) for peripheral blood stem cell mobilization during postoperative adjuvant chemotherapy in patients with breast cancer. / Narabayashi, Masaru; Takeyama, Kunihiko; Fukutomi, Takashi; Tokuda, Yutaka; Tajima, Tomoo; Okumura, Akira; Chou, Takaaki; Sano, Muneaki; Makino, Haruhiko; Igarashi, Tadahiko; Sasaki, Yasutsuna; Imoto, Shigeru; Ogura, Michinori; Morishima, Yasuo; Murai, Hiroshi; Okamoto, Shinichiro; Ikeda, Tadashi; Kasai, Masaharu; Yokozawa, Toshiya; Tobinai, Kensei.

In: Japanese Journal of Clinical Oncology, Vol. 29, No. 6, 06.1999, p. 285-290.

Research output: Contribution to journalArticle

Narabayashi, M, Takeyama, K, Fukutomi, T, Tokuda, Y, Tajima, T, Okumura, A, Chou, T, Sano, M, Makino, H, Igarashi, T, Sasaki, Y, Imoto, S, Ogura, M, Morishima, Y, Murai, H, Okamoto, S, Ikeda, T, Kasai, M, Yokozawa, T & Tobinai, K 1999, 'A dose-finding study of lenograstim (glycosylated rHuG-CSF) for peripheral blood stem cell mobilization during postoperative adjuvant chemotherapy in patients with breast cancer', Japanese Journal of Clinical Oncology, vol. 29, no. 6, pp. 285-290.
Narabayashi, Masaru ; Takeyama, Kunihiko ; Fukutomi, Takashi ; Tokuda, Yutaka ; Tajima, Tomoo ; Okumura, Akira ; Chou, Takaaki ; Sano, Muneaki ; Makino, Haruhiko ; Igarashi, Tadahiko ; Sasaki, Yasutsuna ; Imoto, Shigeru ; Ogura, Michinori ; Morishima, Yasuo ; Murai, Hiroshi ; Okamoto, Shinichiro ; Ikeda, Tadashi ; Kasai, Masaharu ; Yokozawa, Toshiya ; Tobinai, Kensei. / A dose-finding study of lenograstim (glycosylated rHuG-CSF) for peripheral blood stem cell mobilization during postoperative adjuvant chemotherapy in patients with breast cancer. In: Japanese Journal of Clinical Oncology. 1999 ; Vol. 29, No. 6. pp. 285-290.
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abstract = "Background: The optimum dose of granulocyte colony-stimulating factor (G-CSF) for peripheral blood stem cell (PBSC) mobilization after disease-oriented, conventional-dose chemotherapy remains unknown. Methods: A multicenter dose-finding study of glycosylated G-CSF (lenograstim) for the mobilization of PBSCs following adjuvant CAF chemotherapy (cyclophosphamide, doxorubicin and 5-fluorouracil) was performed in 38 patients with postoperative breast cancer. Each 10, ten and eight patients were sequentially allocated to one of the three dose groups (2, 5 and 10 μg/kg, respectively) of lenograstim. Lenograstim was administered subcutaneously (s.c.) daily from day 8 to the day of the last apheresis and CD34+ cells and colony-forming units-granulocyte macrophage (CFU-GMs) in peripheral blood were measured serially. Additionally, 10 patients who received adjuvant CAF chemotherapy alone also participated in the study, as a control. Results: Lenograstim was well tolerated up to 10 μg/kg, except for one patient given 10 μg/kg who developed transient grade 3 hepatic enzyme elevation. The peak levels of CD34+ cells and CFU-GMs in peripheral blood showed dose-response relationships. The median peak CD34+ cells for the 0, 2, 5 and 10 μg/kg dose groups were 5.4, 34.3, 55.0 and 127.6 cells/μl, respectively, and those of CFU-GMs for the 0, 2, 5 and 10 μg/kg dose groups were 0.01, 0.33, 1.32 and 3.30 CFU-GMs/μl, respectively. Conclusions: Considering the previous reports suggesting that a pre-apheresis number of 40-50 CD34+ cells/μl in peripheral blood is highly predictive for achievement of more than 2.5 × 106 CD34+ cells/kg in a standard apheresis procedure of 10 litres, the optimum dose of lenograstim for PBSC mobilization following CAF chemotherapy in patients with postoperative breast cancer is 5 μg/kg/day s.c.",
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T1 - A dose-finding study of lenograstim (glycosylated rHuG-CSF) for peripheral blood stem cell mobilization during postoperative adjuvant chemotherapy in patients with breast cancer

AU - Narabayashi, Masaru

AU - Takeyama, Kunihiko

AU - Fukutomi, Takashi

AU - Tokuda, Yutaka

AU - Tajima, Tomoo

AU - Okumura, Akira

AU - Chou, Takaaki

AU - Sano, Muneaki

AU - Makino, Haruhiko

AU - Igarashi, Tadahiko

AU - Sasaki, Yasutsuna

AU - Imoto, Shigeru

AU - Ogura, Michinori

AU - Morishima, Yasuo

AU - Murai, Hiroshi

AU - Okamoto, Shinichiro

AU - Ikeda, Tadashi

AU - Kasai, Masaharu

AU - Yokozawa, Toshiya

AU - Tobinai, Kensei

PY - 1999/6

Y1 - 1999/6

N2 - Background: The optimum dose of granulocyte colony-stimulating factor (G-CSF) for peripheral blood stem cell (PBSC) mobilization after disease-oriented, conventional-dose chemotherapy remains unknown. Methods: A multicenter dose-finding study of glycosylated G-CSF (lenograstim) for the mobilization of PBSCs following adjuvant CAF chemotherapy (cyclophosphamide, doxorubicin and 5-fluorouracil) was performed in 38 patients with postoperative breast cancer. Each 10, ten and eight patients were sequentially allocated to one of the three dose groups (2, 5 and 10 μg/kg, respectively) of lenograstim. Lenograstim was administered subcutaneously (s.c.) daily from day 8 to the day of the last apheresis and CD34+ cells and colony-forming units-granulocyte macrophage (CFU-GMs) in peripheral blood were measured serially. Additionally, 10 patients who received adjuvant CAF chemotherapy alone also participated in the study, as a control. Results: Lenograstim was well tolerated up to 10 μg/kg, except for one patient given 10 μg/kg who developed transient grade 3 hepatic enzyme elevation. The peak levels of CD34+ cells and CFU-GMs in peripheral blood showed dose-response relationships. The median peak CD34+ cells for the 0, 2, 5 and 10 μg/kg dose groups were 5.4, 34.3, 55.0 and 127.6 cells/μl, respectively, and those of CFU-GMs for the 0, 2, 5 and 10 μg/kg dose groups were 0.01, 0.33, 1.32 and 3.30 CFU-GMs/μl, respectively. Conclusions: Considering the previous reports suggesting that a pre-apheresis number of 40-50 CD34+ cells/μl in peripheral blood is highly predictive for achievement of more than 2.5 × 106 CD34+ cells/kg in a standard apheresis procedure of 10 litres, the optimum dose of lenograstim for PBSC mobilization following CAF chemotherapy in patients with postoperative breast cancer is 5 μg/kg/day s.c.

AB - Background: The optimum dose of granulocyte colony-stimulating factor (G-CSF) for peripheral blood stem cell (PBSC) mobilization after disease-oriented, conventional-dose chemotherapy remains unknown. Methods: A multicenter dose-finding study of glycosylated G-CSF (lenograstim) for the mobilization of PBSCs following adjuvant CAF chemotherapy (cyclophosphamide, doxorubicin and 5-fluorouracil) was performed in 38 patients with postoperative breast cancer. Each 10, ten and eight patients were sequentially allocated to one of the three dose groups (2, 5 and 10 μg/kg, respectively) of lenograstim. Lenograstim was administered subcutaneously (s.c.) daily from day 8 to the day of the last apheresis and CD34+ cells and colony-forming units-granulocyte macrophage (CFU-GMs) in peripheral blood were measured serially. Additionally, 10 patients who received adjuvant CAF chemotherapy alone also participated in the study, as a control. Results: Lenograstim was well tolerated up to 10 μg/kg, except for one patient given 10 μg/kg who developed transient grade 3 hepatic enzyme elevation. The peak levels of CD34+ cells and CFU-GMs in peripheral blood showed dose-response relationships. The median peak CD34+ cells for the 0, 2, 5 and 10 μg/kg dose groups were 5.4, 34.3, 55.0 and 127.6 cells/μl, respectively, and those of CFU-GMs for the 0, 2, 5 and 10 μg/kg dose groups were 0.01, 0.33, 1.32 and 3.30 CFU-GMs/μl, respectively. Conclusions: Considering the previous reports suggesting that a pre-apheresis number of 40-50 CD34+ cells/μl in peripheral blood is highly predictive for achievement of more than 2.5 × 106 CD34+ cells/kg in a standard apheresis procedure of 10 litres, the optimum dose of lenograstim for PBSC mobilization following CAF chemotherapy in patients with postoperative breast cancer is 5 μg/kg/day s.c.

KW - Breast cancer

KW - Granulocyte colony-stimulating factor

KW - Lenograstim

KW - Mobilization

KW - Peripheral blood stem cell

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