Clinical trial of low-dose rHuG-CSF in neutropenic cancer patients following anti-cancer chemotherapy

Ming Chih Chang, Gi Ming Lai, Kun Wu Tsan, Ruen Sheng Wang, Ji Hong Wu

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Low-dose, subcutaneous recombinant human granulocyte colony-stimulating factor (rHuG-CSF, Lenograstim®) was administered to 40 cancer patients (17 men, 23 women) enrolled from two medical centers to verify its clinical effectiveness and safety. The patient's mean age was 50.3 ± 14.9 years. In this study, there were 20 patients with non-Hodgkin's lymphoma, 10 with breast cancer and 10 with various other solid tumors. The patients first received a course of chemotherapy without rHuG-CSF (control cycle). All patients had at least one episode of neutropenia or leukopenia during the control cycle. rHuG-CSF (2 μg/kg/day) was given subcutaneously for 10 days during the study cycle starting on the fourth day of chemotherapy. The nadirs of absolute neutrophil counts (ANC) were 1.8 ± 0.25 x 109/L and 0.27 ± 0.05 x 109/L for the rHuG-CSF cycle and pre-rHuG-CSF control cycle, respectively. The number of days of ANC <1 x 109/L were 1.03 ± 0.29 and 7.38 ± 0.58 for rHuG-CSF and control cycles, respectively. The duration from nadir to recovery of ANC (≤ 2 x 109/L) was 9.68 ± 1.15 days in the rHuG-CSF cycle, vs 22.53 ± 1.03 days in control cycle (p <0.0001). No patient withdrew from the study. Adverse events were mild, with 12.5% to 40% of patients developing myalgia, general malaise, back pain, anorexia or fever. These side-effects were tolerable in all cases. The biochemical abnormalities were subtle and negligible. rHuG-CSF 2μg/kg/day given subcutaneously for 10 days beginning on the fourth day of chemotherapy is very effective (90%), safe and convenient.

Original languageEnglish
Pages (from-to)845-850
Number of pages6
JournalJournal of the Formosan Medical Association = Taiwan yi zhi
Volume95
Issue number11
Publication statusPublished - Nov 1996
Externally publishedYes

Fingerprint

Clinical Trials
Drug Therapy
Neoplasms
Neutrophils
Myalgia
Leukopenia
Anorexia
Granulocyte Colony-Stimulating Factor
Back Pain
Granulocyte-Macrophage Colony-Stimulating Factor
Neutropenia
Non-Hodgkin's Lymphoma
Fever
Breast Neoplasms
Safety

Keywords

  • (rHuG-CSF)
  • cancer chemotherapy
  • neutropenia
  • recombinant human granulocyte colony-stimulating factor

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Clinical trial of low-dose rHuG-CSF in neutropenic cancer patients following anti-cancer chemotherapy. / Chang, Ming Chih; Lai, Gi Ming; Tsan, Kun Wu; Wang, Ruen Sheng; Wu, Ji Hong.

In: Journal of the Formosan Medical Association = Taiwan yi zhi, Vol. 95, No. 11, 11.1996, p. 845-850.

Research output: Contribution to journalArticle

@article{47f165d0fa664d8183ac1b3effa5181c,
title = "Clinical trial of low-dose rHuG-CSF in neutropenic cancer patients following anti-cancer chemotherapy",
abstract = "Low-dose, subcutaneous recombinant human granulocyte colony-stimulating factor (rHuG-CSF, Lenograstim{\circledR}) was administered to 40 cancer patients (17 men, 23 women) enrolled from two medical centers to verify its clinical effectiveness and safety. The patient's mean age was 50.3 ± 14.9 years. In this study, there were 20 patients with non-Hodgkin's lymphoma, 10 with breast cancer and 10 with various other solid tumors. The patients first received a course of chemotherapy without rHuG-CSF (control cycle). All patients had at least one episode of neutropenia or leukopenia during the control cycle. rHuG-CSF (2 μg/kg/day) was given subcutaneously for 10 days during the study cycle starting on the fourth day of chemotherapy. The nadirs of absolute neutrophil counts (ANC) were 1.8 ± 0.25 x 109/L and 0.27 ± 0.05 x 109/L for the rHuG-CSF cycle and pre-rHuG-CSF control cycle, respectively. The number of days of ANC <1 x 109/L were 1.03 ± 0.29 and 7.38 ± 0.58 for rHuG-CSF and control cycles, respectively. The duration from nadir to recovery of ANC (≤ 2 x 109/L) was 9.68 ± 1.15 days in the rHuG-CSF cycle, vs 22.53 ± 1.03 days in control cycle (p <0.0001). No patient withdrew from the study. Adverse events were mild, with 12.5{\%} to 40{\%} of patients developing myalgia, general malaise, back pain, anorexia or fever. These side-effects were tolerable in all cases. The biochemical abnormalities were subtle and negligible. rHuG-CSF 2μg/kg/day given subcutaneously for 10 days beginning on the fourth day of chemotherapy is very effective (90{\%}), safe and convenient.",
keywords = "(rHuG-CSF), cancer chemotherapy, neutropenia, recombinant human granulocyte colony-stimulating factor",
author = "Chang, {Ming Chih} and Lai, {Gi Ming} and Tsan, {Kun Wu} and Wang, {Ruen Sheng} and Wu, {Ji Hong}",
year = "1996",
month = "11",
language = "English",
volume = "95",
pages = "845--850",
journal = "Journal of the Formosan Medical Association",
issn = "0929-6646",
publisher = "Elsevier Science Publishers B.V.",
number = "11",

}

TY - JOUR

T1 - Clinical trial of low-dose rHuG-CSF in neutropenic cancer patients following anti-cancer chemotherapy

AU - Chang, Ming Chih

AU - Lai, Gi Ming

AU - Tsan, Kun Wu

AU - Wang, Ruen Sheng

AU - Wu, Ji Hong

PY - 1996/11

Y1 - 1996/11

N2 - Low-dose, subcutaneous recombinant human granulocyte colony-stimulating factor (rHuG-CSF, Lenograstim®) was administered to 40 cancer patients (17 men, 23 women) enrolled from two medical centers to verify its clinical effectiveness and safety. The patient's mean age was 50.3 ± 14.9 years. In this study, there were 20 patients with non-Hodgkin's lymphoma, 10 with breast cancer and 10 with various other solid tumors. The patients first received a course of chemotherapy without rHuG-CSF (control cycle). All patients had at least one episode of neutropenia or leukopenia during the control cycle. rHuG-CSF (2 μg/kg/day) was given subcutaneously for 10 days during the study cycle starting on the fourth day of chemotherapy. The nadirs of absolute neutrophil counts (ANC) were 1.8 ± 0.25 x 109/L and 0.27 ± 0.05 x 109/L for the rHuG-CSF cycle and pre-rHuG-CSF control cycle, respectively. The number of days of ANC <1 x 109/L were 1.03 ± 0.29 and 7.38 ± 0.58 for rHuG-CSF and control cycles, respectively. The duration from nadir to recovery of ANC (≤ 2 x 109/L) was 9.68 ± 1.15 days in the rHuG-CSF cycle, vs 22.53 ± 1.03 days in control cycle (p <0.0001). No patient withdrew from the study. Adverse events were mild, with 12.5% to 40% of patients developing myalgia, general malaise, back pain, anorexia or fever. These side-effects were tolerable in all cases. The biochemical abnormalities were subtle and negligible. rHuG-CSF 2μg/kg/day given subcutaneously for 10 days beginning on the fourth day of chemotherapy is very effective (90%), safe and convenient.

AB - Low-dose, subcutaneous recombinant human granulocyte colony-stimulating factor (rHuG-CSF, Lenograstim®) was administered to 40 cancer patients (17 men, 23 women) enrolled from two medical centers to verify its clinical effectiveness and safety. The patient's mean age was 50.3 ± 14.9 years. In this study, there were 20 patients with non-Hodgkin's lymphoma, 10 with breast cancer and 10 with various other solid tumors. The patients first received a course of chemotherapy without rHuG-CSF (control cycle). All patients had at least one episode of neutropenia or leukopenia during the control cycle. rHuG-CSF (2 μg/kg/day) was given subcutaneously for 10 days during the study cycle starting on the fourth day of chemotherapy. The nadirs of absolute neutrophil counts (ANC) were 1.8 ± 0.25 x 109/L and 0.27 ± 0.05 x 109/L for the rHuG-CSF cycle and pre-rHuG-CSF control cycle, respectively. The number of days of ANC <1 x 109/L were 1.03 ± 0.29 and 7.38 ± 0.58 for rHuG-CSF and control cycles, respectively. The duration from nadir to recovery of ANC (≤ 2 x 109/L) was 9.68 ± 1.15 days in the rHuG-CSF cycle, vs 22.53 ± 1.03 days in control cycle (p <0.0001). No patient withdrew from the study. Adverse events were mild, with 12.5% to 40% of patients developing myalgia, general malaise, back pain, anorexia or fever. These side-effects were tolerable in all cases. The biochemical abnormalities were subtle and negligible. rHuG-CSF 2μg/kg/day given subcutaneously for 10 days beginning on the fourth day of chemotherapy is very effective (90%), safe and convenient.

KW - (rHuG-CSF)

KW - cancer chemotherapy

KW - neutropenia

KW - recombinant human granulocyte colony-stimulating factor

UR - http://www.scopus.com/inward/record.url?scp=0030450452&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030450452&partnerID=8YFLogxK

M3 - Article

C2 - 8990772

AN - SCOPUS:0030450452

VL - 95

SP - 845

EP - 850

JO - Journal of the Formosan Medical Association

JF - Journal of the Formosan Medical Association

SN - 0929-6646

IS - 11

ER -