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Clinical and Epidemiological Investigations

Dose Escalation Study of Recombinant Human Granulocyte-Colony-stimulating Factor (KRN8601) in Patients with Advanced Malignancy

Kenji Eguchi, Satoru Sasaki, Tomohide Tamura, Yasutsuna Sasaki, Tetsu Shinkai, Kouzou Yamada, Yoshifumi Soejima, Masaaki Fukuda, Yasuhiro Fujihara, Hideo Kunitou, Kensei Tobinai, Tomoko Ohtsu, Keiichi Suemasu, Fumimaro Takaku and Nagahiro Saijo
Kenji Eguchi
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Satoru Sasaki
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Tomohide Tamura
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Yasutsuna Sasaki
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Tetsu Shinkai
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Kouzou Yamada
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Yoshifumi Soejima
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Masaaki Fukuda
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Yasuhiro Fujihara
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Hideo Kunitou
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Kensei Tobinai
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Tomoko Ohtsu
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Keiichi Suemasu
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Fumimaro Takaku
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Nagahiro Saijo
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DOI:  Published September 1989
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Abstract

To evaluate the toxicity and efficacy of recombinant human granulocyte-colony-stimulating factor (rh G-CSF) administered with intensive chemotherapy, 39 patients with advanced pulmonary cancers were enrolled in a dose escalation trial of rh G-CSF. Three days after initiation of chemotherapy rh G-CSF was administered i.v. for 14 consecutive days at five dose levels (50–800 µg/m2).

Absolute neutrophil counts showed a dose-dependent increase with an increasing dose of rh G-CSF and the durations of neutropenia (less than 1000/mm3) shortened significantly at doses of 200, 400, and 800 µg/m2 compared to those at 50 µg/m2 (P < 0.01). The duration of neutropenia was shortened significantly at all five dose levels following treatment with rh G-CSF compared to treatment without rh G-CSF (P < 0.05).

Adverse side effects associated with rh G-CSF administration were fever higher than 38°C (21%), chest pain, and low back pain (13%). No intolerable side effects were experienced. It can be concluded that rh G-CSF is effective in shortening the duration of neutropenia following intensive chemotherapy at a dose level of 100 to 200 µg/m2 i.v. a 400-µg/m2 dose of rh G-CSF is recommended in patients with prior treatment because of the possibility of a lower bone marrow response.

Footnotes

  • ↵1 Supported partly by Grant for Aid of the Comprehensive 10 Year Strategy for Cancer Control Japan.

  • ↵2 To whom requests for reprints should be addressed.

  • Received January 4, 1989.
  • Revision received May 23, 1989.
  • Accepted June 20, 1989.
  • ©1989 American Association for Cancer Research.
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September 1989
Volume 49, Issue 18
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Dose Escalation Study of Recombinant Human Granulocyte-Colony-stimulating Factor (KRN8601) in Patients with Advanced Malignancy
Kenji Eguchi, Satoru Sasaki, Tomohide Tamura, Yasutsuna Sasaki, Tetsu Shinkai, Kouzou Yamada, Yoshifumi Soejima, Masaaki Fukuda, Yasuhiro Fujihara, Hideo Kunitou, Kensei Tobinai, Tomoko Ohtsu, Keiichi Suemasu, Fumimaro Takaku and Nagahiro Saijo
Cancer Res September 15 1989 (49) (18) 5221-5224;

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Dose Escalation Study of Recombinant Human Granulocyte-Colony-stimulating Factor (KRN8601) in Patients with Advanced Malignancy
Kenji Eguchi, Satoru Sasaki, Tomohide Tamura, Yasutsuna Sasaki, Tetsu Shinkai, Kouzou Yamada, Yoshifumi Soejima, Masaaki Fukuda, Yasuhiro Fujihara, Hideo Kunitou, Kensei Tobinai, Tomoko Ohtsu, Keiichi Suemasu, Fumimaro Takaku and Nagahiro Saijo
Cancer Res September 15 1989 (49) (18) 5221-5224;
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