Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin's lymphoma: a randomized controlled trial

Blood ◽  
1992 ◽  
Vol 80 (6) ◽  
pp. 1430-1436 ◽  
Author(s):  
R Pettengell ◽  
H Gurney ◽  
JA Radford ◽  
DP Deakin ◽  
R James ◽  
...  
Keyword(s):  
Relative Risk ◽  
Controlled Trial ◽  
Dose Intensity ◽  
Cytotoxic Chemotherapy ◽  
Control Group ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Weekly Chemotherapy ◽  
To Receive ◽  
Stimulating Factor

Abstract The effect of granulocyte colony-stimulating factor (G-CSF) on neutropenia, infection, and cytotoxic chemotherapy administration was studied in a randomized trial in patients receiving intensive weekly chemotherapy for non-Hodgkinxybs lymphoma (NHL). Eighty patients (aged 16 to 71 years) with high-grade NHL (Kiel) of any stage were randomized to receive VAPEC-B chemotherapy alone (39 patients) or with G-CSF administered as a daily subcutaneous dose of 230 micrograms/m2 (41 patients). Prophylactic ketoconazole and cotrimoxazole were administered to all patients throughout treatment. The protocol specified identical dose modification and antibiotic treatment criteria bor both groups. Neutropenia (absolute neutrophil count [ANC] less than 1.0 x 10(9)/L) occurred in 15 of 41 (37%) of the G-CSF-treated patients and in 33 of 39 (85%) of the controls, giving a relative risk for control patients of 2.31 (95% confidence interval [CI], [1.51, 3.54]; P = .00001). Fever (greater than or equal to 37.5 degrees C) with neutropenia (ANC less than 1.0 x 10(9)/L) occurred in 9 of 41 (22%) of the G-CSF group and in 17 of 39 (44%) of the controls (relative risk for control, 2.26; 95% CI [1.01, 5.06]; P = .04). There were fewer treatment delays, with shorter duration (P = .01) in patients receiving G-CSF. Chemotherapy doses were reduced in 4 of 41 (10%) of the G-CSF patients and 13 of 39 (33%) of the controls (P = .01). The dose intensity of cytotoxic chemotherapy was significantly increased in patients receiving G-CSF (median of 95% in G-CSF group compared with 83% in control patients). Three vascular deaths occurred in the G-CSF group. Delays in the control group most commonly resulted from neutropenia (19 patients, compared with 2 patients in the G-CSF-treated group, P = .000007). Severe mucositis was the major dose-limiting toxicity in G-CSF-treated patients, but did not occur more frequently than in controls (15 patients in each group). Overall, patients randomized to receive G-CSF achieved a greater dose intensity than control patients, but this did not result in significant differences in drug toxicity (other than neutropenia), intravenous antibiotic usage, or hospitalization between the two groups.

scholarly journals Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin's lymphoma: a randomized controlled trial

Blood ◽  
1992 ◽  
Vol 80 (6) ◽  
pp. 1430-1436 ◽  
Author(s):  
R Pettengell ◽  
H Gurney ◽  
JA Radford ◽  
DP Deakin ◽  
R James ◽  
...  
Keyword(s):  
Relative Risk ◽  
Controlled Trial ◽  
Dose Intensity ◽  
Cytotoxic Chemotherapy ◽  
Control Group ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Weekly Chemotherapy ◽  
To Receive ◽  
Stimulating Factor

The effect of granulocyte colony-stimulating factor (G-CSF) on neutropenia, infection, and cytotoxic chemotherapy administration was studied in a randomized trial in patients receiving intensive weekly chemotherapy for non-Hodgkinxybs lymphoma (NHL). Eighty patients (aged 16 to 71 years) with high-grade NHL (Kiel) of any stage were randomized to receive VAPEC-B chemotherapy alone (39 patients) or with G-CSF administered as a daily subcutaneous dose of 230 micrograms/m2 (41 patients). Prophylactic ketoconazole and cotrimoxazole were administered to all patients throughout treatment. The protocol specified identical dose modification and antibiotic treatment criteria bor both groups. Neutropenia (absolute neutrophil count [ANC] less than 1.0 x 10(9)/L) occurred in 15 of 41 (37%) of the G-CSF-treated patients and in 33 of 39 (85%) of the controls, giving a relative risk for control patients of 2.31 (95% confidence interval [CI], [1.51, 3.54]; P = .00001). Fever (greater than or equal to 37.5 degrees C) with neutropenia (ANC less than 1.0 x 10(9)/L) occurred in 9 of 41 (22%) of the G-CSF group and in 17 of 39 (44%) of the controls (relative risk for control, 2.26; 95% CI [1.01, 5.06]; P = .04). There were fewer treatment delays, with shorter duration (P = .01) in patients receiving G-CSF. Chemotherapy doses were reduced in 4 of 41 (10%) of the G-CSF patients and 13 of 39 (33%) of the controls (P = .01). The dose intensity of cytotoxic chemotherapy was significantly increased in patients receiving G-CSF (median of 95% in G-CSF group compared with 83% in control patients). Three vascular deaths occurred in the G-CSF group. Delays in the control group most commonly resulted from neutropenia (19 patients, compared with 2 patients in the G-CSF-treated group, P = .000007). Severe mucositis was the major dose-limiting toxicity in G-CSF-treated patients, but did not occur more frequently than in controls (15 patients in each group). Overall, patients randomized to receive G-CSF achieved a greater dose intensity than control patients, but this did not result in significant differences in drug toxicity (other than neutropenia), intravenous antibiotic usage, or hospitalization between the two groups.

Can cytotoxic dose-intensity be increased by using granulocyte colony-stimulating factor? A randomized controlled trial of lenograstim in small-cell lung cancer.

1995 ◽  
Vol 13 (3) ◽  
pp. 652-659 ◽  
Author(s):  
P J Woll ◽  
J Hodgetts ◽  
L Lomax ◽  
F Bildet ◽  
V Cour-Chabernaud ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Survival Rate ◽  
Dose Intensity ◽  
Small Cell ◽  
Control Group ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Small Cell Lung ◽  
To Receive ◽  
Stimulating Factor

PURPOSE The use of granulocyte colony-stimulating factor (G-CSF) to increase cytotoxic dose-intensity was assessed in a randomized trial in better-prognosis small-cell lung cancer (SCLC). Both control and G-CSF arms were subject to the same dose-intensification strategy. PATIENTS AND METHODS Patients with newly diagnosed SCLC and either no or one adverse prognostic factor were randomized to receive vincristine, ifosfamide, carboplatin, and etoposide (VICE) alone or with recombinant human (rHu)G-CSF (lenograstim) 5 micrograms/kg/d between cycles. Six chemotherapy cycles were given, with prophylactic cranial irradiation after cycle 1 and thoracic irradiation after cycle 3. There was no fixed dose interval. In both arms, patients were eligible for re-treatment when the WBC count was > or = 3 x 10(9)/L and platelet count was > or = 100 x 10(9)/L. No dose reductions were permitted. Dose-intensity was expressed relative to standard every-4-weeks VICE. RESULTS Sixty-five consecutive patients in one institution were randomized to control (n = 31) or G-CSF (n = 34). WBC and neutrophil counts were consistently higher in G-CSF patients than in the control group, but there were no significant differences in the incidence of febrile neutropenia, antibiotic or transfusion requirements, or days in hospital. In both treatment arms, the median dose-intensity was greater than one for each cycle (control group, P = .0009; G-CSF group, P = .0001). The G-CSF group received a significantly higher dose-intensity than the control group, with the greatest difference in the first three cycles (1.34 v 1.17, P = .001). There were more chemotherapy-related deaths in the G-CSF group than in the control group (six v one), but this group had a better 2-year survival rate (32% with G-CSF, 95% confidence interval [CI], 16 to 48; 15% with controls, 95% CI, 2 to 27). CONCLUSION The dose-intensity of VICE chemotherapy was increased in both groups. Patients randomized to receive G-CSF achieved a significantly higher dose-intensity than controls. Despite early toxicity, they had a better 2-year survival rate.

Received dose-intensity: a randomized trial of weekly chemotherapy with and without granulocyte colony-stimulating factor in small-cell lung cancer.

1994 ◽  
Vol 12 (1) ◽  
pp. 77-82 ◽  
Author(s):  
D W Miles ◽  
O Fogarty ◽  
C M Ash ◽  
R M Rudd ◽  
C W Trask ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Dose Intensity ◽  
Small Cell ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Small Cell Lung ◽  
Weekly Chemotherapy ◽  
Treatment Delays ◽  
Stimulating Factor ◽  
Dose Reductions

PURPOSE A prospective randomized trial to determine if granulocyte colony-stimulating factor (G-CSF) could increase the received dose-intensity (RDI) of weekly chemotherapy in patients with small-cell lung cancer (SCLC). PATIENTS AND METHODS Forty patients with SCLC with good prognostic features (all patients with limited disease [LD], and extensive-disease [ED] patients with Eastern Cooperative Oncology Group [ECOG] 0 or 1 and plasma alkaline phosphatase levels < 1.5 times the upper limit of normal) were randomized to receive weekly chemotherapy with or without G-CSF. G-CSF (5 micrograms/kg) was self-administered subcutaneously on days when chemotherapy was not given. Chemotherapy consisted of cisplatin 50 mg/m2 intravenously (IV) on day 1 and etoposide 75 mg/m2 IV on days 1 and 2 alternating weekly with ifosfamide 2 g/m2 IV (with mesna) and doxorubicin 25 mg/m2 on day 1, for a total of 12 courses. Dose modifications (dose reductions and treatment delays) were made according to defined hematologic criteria. RESULTS Dose reductions were made at some point during treatment in 12 of 17 patients in the control arm and in 11 of 23 patients in the G-CSF arm (P = .20). The proportion of patients experiencing dose reductions due to leukopenia was significantly higher in the control arm (nine of 17) compared with the G-CSF arm (four of 23, P < .04). Cycle delays due to leukopenia were similar in both arms of the study. The RDI was 82% of projected in the control arm (95% confidence interval [CI], 79% to 84%) and 84% in patients receiving G-CSF (95% CI, 82% to 87%) (P value not significant). CONCLUSION In this randomized trial, G-CSF significantly decreased dose reductions due to neutropenia. However, administration of G-CSF did not decrease dose reductions or treatment delays to a level that would allow an increase in received dose-intensity. Nonhematologic toxicities such as increased creatinine concentration also prevented an increase in the RDI in the G-CSF arm.

scholarly journals Therapeutic effects of coronary granulocyte colony-stimulating factor on rats with chronic ischemic heart disease

2020 ◽  
Vol 15 (1) ◽  
pp. 742-752
Author(s):  
Pengcheng Ren ◽  
Ming Zhang ◽  
Shuren Dai
Keyword(s):  
Heart Disease ◽  
Myocardial Perfusion ◽  
Ischemic Heart Disease ◽  
Left Ventricular ◽  
Control Group ◽  
Therapeutic Effects ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Chronic Ischemic Heart Disease ◽  
Stimulating Factor

AbstractBackgroundThe aim of this study was to evaluate the therapeutic effects of coronary granulocyte colony-stimulating factor (G-CSF) on rats with chronic ischemic heart disease (CIHD).MethodsThirty healthy rats were randomly divided into control, subcutaneous and intracoronary G-CSF injection groups (n = 10) after the CIHD model was established. Left ventricular ejection fraction (LVEF), myocardial injury area, myocardial perfusion area and viable myocardium were observed by coronary angiography, dual-isotopic myocardial imaging and first-pass delayed myocardial perfusion magnetic resonance imaging (MRI) before modeling as well as 2 and 4 weeks after surgery.ResultsThe peak times of peripheral blood and subcutaneous G-CSF levels were 3 and 5 days after mobilization, respectively. The peripheral blood CD34+/CD133+ cell ratio of subcutaneous or intracoronary G-CSF injection group significantly exceeded that of the control group (P < 0.05). The distal stenosis degrees of target lesions in subcutaneous and intracoronary G-CSF injection groups were significantly lower than that of the control group (P < 0.05). Compared with the situation before mobilization, LVEF was significantly improved after 2 weeks in intracoronary and subcutaneous G-CSF injection groups (P < 0.01). Their infarcted myocardial areas were reduced, the left ventricular remodeling was relieved, the percentage of viable myocardium was increased, angiogenesis was promoted and cardiomyocyte apoptosis was inhibited.ConclusionIntracoronary G-CSF injection is safe and effective as subcutaneous injection, improving the cardiac function of CIHD rats.

Neuroprotective effects of granulocyte colony-stimulating factor and relationship to promotion of angiogenesis after spinal cord injury in rats

2011 ◽  
Vol 15 (4) ◽  
pp. 414-421 ◽  
Author(s):  
Junko Kawabe ◽  
Masao Koda ◽  
Masayuki Hashimoto ◽  
Takayuki Fujiyoshi ◽  
Takeo Furuya ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Treated Group ◽  
Control Group ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Neuroprotective Effects ◽  
Cord Injury ◽  
Bone Marrow Derived Cells ◽  
Stimulating Factor ◽  
Angiogenic Cytokines

Object Granulocyte colony-stimulating factor (G-CSF) has neuroprotective effects on the CNS. The authors have previously demonstrated that G-CSF also exerts neuroprotective effects in experimental spinal cord injury (SCI) by enhancing migration of bone marrow–derived cells into the damaged spinal cord, increasing glial differentiation of bone marrow–derived cells, enhancing antiapoptotic effects on both neurons and oligodendrocytes, and by reducing demyelination and expression of inflammatory cytokines. Because the degree of angiogenesis in the subacute phase after SCI correlates with regenerative responses, it is possible that G-CSF's neuroprotective effects after SCI are due to enhancement of angiogenesis. The aim of this study was to assess the effects of G-CSF on the vascular system after SCI. Methods A contusive SCI rat model was used and the animals were randomly allocated to either a G-CSF–treated group or a control group. Integrity of the blood–spinal cord barrier was evaluated by measuring the degree of edema in the cord and the volume of extravasation. For histological evaluation, cryosections were immunostained with anti–von Willebrand factor and the number of vessels was counted to assess revascularization. Real-time reverse transcriptase polymerase chain reaction was performed to assess expression of angiogenic cytokines, and recovery of motor function was assessed with function tests. Results In the G-CSF–treated rats, the total number of vessels with a diameter > 20 μm was significantly larger and expression of angiogenic cytokines was significantly higher than those in the control group. The G-CSF–treated group showed significantly greater recovery of hindlimb function than the control group. Conclusions These results suggest that G-CSF exerts neuroprotective effects via promotion of angiogenesis after SCI.

Effect of Granulocyte Colony-Stimulating Factor Combined with Erythropoietin on Chronic Granulocytic Leukemia with Anemia and Its Effect on Nutritional Status

2021 ◽  
Vol 7 (5) ◽  
pp. 3150-3154
Author(s):  
GeLe Tong ◽  
Liusha Xu ◽  
Yanqi Leng ◽  
Pang Wu
Keyword(s):  
Nutritional Status ◽  
Immune Function ◽  
Control Group ◽  
Observation Group ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Chronic Granulocytic Leukemia ◽  
Cd8 Cells ◽  
Stimulating Factor ◽  
Granulocytic Leukemia

Objective: To investigate the clinical effect of granulocyte colony-stimulating factor combined with erythropoietin on chronic granulocytic leukemia with anemia and its effect on nutritional status. Methods: 60 patients of chronic granulocytic leukemia of our hospital with anemia induced by maintenance chemotherapy were randomly divided into two groups. Patients in the control group received routine treatment, while patients in the observation group received basal treatment with granulocyte colony-stimulating factor and erythropoietin. The nutritional status before and after treatment as well as the immune function and the incidence of blood transfusion and adverse events were compared between the two groups. Results: There was no significant difference in hemoglobin, hematocrit, nutritional status and immune function between the two groups before treatment (P>0.05). Those after treatment were significantly higher than that before treatment (P<0.05). After treatment, the percentage of CD4* cells in the control group was significantly higher than that before treatment (P<0.05), but the percentage of CD8* cells and CD47/CD8* cells did not change significantly (P>0.05). After treatment, the concentrations of IgA, IgM and IgG in the observation group were significantly higher than those before treatment (P<0.05), but only the concentrations of IgA and IgM in the control group were significantly higher than those in the observation group after treatment (P<0.05). The incidence of adverse reactions in the observation group was significantly lower than that in the control group. Conclusion: Granulocyte colony-stimulating factor combined with erythropoietin can effectively correct anemia, improve nutritional status and improve immune function in patients with chronic myelogenous leukemia.

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