<b>Granulocyte Colony-Stimulating Factors
[for increasing White Blood Cells]</b>

See &&url at the American Society of Clinical Oncology

J Clin Oncol 2000 Jul;18(14):2676-84 
<b>Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group.</b> 
Le Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, et. al., Institut Gustave Roussy, Villejuif, London, United Kingdom. lecesne@igr.fr 

“… This randomized multicenter study was designed to compare the activity of a high-dose doxorubicin-containing chemotherapy regimen with a conventional standard-dose regimen in adult patients with advanced soft tissue sarcomas … 314 patients were randomized to receive a standard-dose regimen (arm A), containing doxorubicin (50 mg/m(2) on day 1) and ifosfamide (5 g/m(2) on day 1), or an intensified regimen (arm B), combining doxorubicin (75 mg/m(2) on day 1), the same ifosfamide dose, and <b>recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF; sargramostim, 250 microgram/m(2) on days 3 to 16)</b>; all courses were repeated every 3 weeks.”

“ … Thirty-eight percent and 23% of patients presented with leiomyosarcomas and liver metastases, respectively. Objective responses were observed in 31 (21%) of 147 assessable patients in arm A and in 31 (23.3%) of 133 in arm B (P =.65). No change was observed in 41.6% and 46.2% of patients in arm A and B, respectively. Progression-free survival (PFS) was significantly longer in the intensive arm (P =.03). The median duration of the time to progression was 19 weeks in the conventional arm and 29 weeks in the intensified arm. <b>There was no difference in overall survival (P =.98) between the two therapeutic arms. Toxicities were manageable in both arms.</b> A grade 3/4 neutropenia and infection occurred in 92% and 4.6% of patients in arm A, respectively, and in 90% and 16.6% in arm B, respectively. Grade 3/4 thrombocytopenia was more frequent in arm B. <b>CONCLUSION: The use of rhGM-CSF allowed safe escalation of chemotherapy doses.</b> Despite a 50% increase of the doxorubicin dose-intensity, the high-dose regimen failed to demonstrate any impact on survival in patients with ASTS. The low complete response rate, <b>the high incidence of leiomyosarcomas</b>, and liver metastases may in part explain these results. However, the lengthening of the PFS in the intensive arm, because of the quality of stable disease and inappropriate tumor evaluation policies that potentially lead to an underestimation of antitumor activity, does not definitively refute the use of a high-dose chemotherapy regimen in selected patients with ASTS. Clinical trial, phase iii Multicenter study Randomized controlled trial “
&&url PMID: 10894866 

Ann Pharmacother 2001 Jan;35(1):92-108 Comment in: Ann Pharmacother. 2001 Jan;35(1):120-2
<b>Efficacy of colony-stimulating factors in acute leukemia.</b> 
Holdsworth MT, Mathew P. College of Pharmacy and Department of Pediatrics, University of New Mexico, Albuquerque, NM 87131-5691, USA. markt@unm.edu 

A comprehensive medical literature search was done “… to evaluate the literature describing the safety and efficacy of the hematopoietic colony-stimulating factors (CSFs) for the management of treatment-related adverse effects in patients with acute leukemia.”

“ … <b>The published studies document a decrease in the time to recovery from neutropenia when patients with acute leukemia are treated with a CSF.</b> However, a consistent reduction in infectious complications or in the duration of hospitalization has not been demonstrated when a CSF is used for either pediatric or adult patients. Very limited data exist to support the premise that CSFs meet the criteria established by the American Society of Clinical Oncology for demonstrating the value of these agents. Further careful study focused on resource utilization and pharmacoeconomics may help to elucidate how healthcare institutions may most effectively employ CSFs to treat patients with acute leukemia.”  
&&url PMID: 11197591

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