Neutropenia.
Conditions
Interventions
Invention was granlocyte-colony stimulating factor as recombinant product made by AryaTinaGene Biopharm Co namely Filgrastim-ATG for group A and Neupogen (Amgen) for group B as standard treatment. Adm
Treatment - Drugs
Sponsors
AryaTinaGene Biopharm Co.
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: The study population consisted of women = 18 years of age with metastatic or localized histopathologically proven breast cancer. Patients with localized cancer were required to have = stage II disease with = 1 positive regional node. Additional inclusion criteria included: Karnofsky performance status = 70% for patients = 70 years of age and = 90% for patients > 70 years of age; adequate hematologic function (absolute neutrophil count [ANC] =3000 cells/µL, platelet count >100,000/µL, hemoglobin [Hb] = 8 g/dL); adequate hepatic function (bilirubin = 1.5 × upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase = 2.5 × ULN, alkaline phosphatase = 5 × ULN); creatinine = 2.0 × ULN; and normal cardiac function as determined by MUGA (multiple-gated acquisition) scan or echocardiography. All hematologic, renal, and hepatic valueshad to be within institutional normal limits in patients > 70 years of age. All women who had received prior chemotherapy must have completed treatment at least 3 weeks prior to study drug administration, and women of child-bearing age had to agree to comply with effective contraception and have done so since their last menses. Patients who had received radiotherapy within 4 weeks of entry required special permission from the study sponsors to enroll. Patients were excluded if they had received a cumulative lifetime dose of doxorubicin > 240 mg/m2 or epirubicin > 432 mg/m2, prior treatment with mitomycin-C or busulfan, or > 2 prior regimens of chemotherapy (excluding hormonal treatment). Additional exclusion criteria included a history of significant cardiac disease, arrhythmias, uncontrolled hypertension, recent myocardial infarction, or ischemia. Patients with human immunodeficiency virus infection, active hepatitis, or a history of a serious comorbid condition, uncontrolled metabolic disease, or psychiatric condition that would impair tolerance or evaluation of the study drug were also excluded.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days of severe neuropenia (ANC>200 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood).;Days of minor neuropenia (ANC>500-1000 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood).;Days of moderate neuropenia (ANC>200-500 per ul). Timepoint: Every chemotherapy cycle. Method of measurement: Absolute neutrophil count (per ul of blood). | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurance of febrile neutropenia. Timepoint: every chemotherapy cycle. Method of measurement: Fever of 38.5 C for at least 1 h and neutropenia less than 500 per ul.;Occurance of sepsis related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Blood analysis.;Occurance of increased hepatic enzymes related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Blood analysis.;Occurance of musculoskeletal pain related to filgrastim. Timepoint: every chemotherapy cycle. Method of measurement: Patient questionery. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Amini
Golestan University of Medical sciences
Outcome results
None listed