title: A randomised study comparing granulocyte-colony stimulating factor (G-CSF) with G-CSF plus thymostimulin in the treatment of haematological toxicity in patients with advanced breast cancer after high dose mitoxantrone therapy.
abstract: 54 patients with advanced breast cancer were randomised into a prospective, non-blinded, controlled trial to receive: mitoxantrone 28 mg/m2 intravenous day 1 and granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg/day subcutaneously days 2 to 16 (n = 27) or the same regimen plus thymostimulin (TS) 50 mg/day intramuscular at days 2 to 16 (n = 27). The median time to reach a neutrophil count greater than 0.5 x 10(9)/l was lower in the G-CSF+TS treated group (9.13 versus 3.24 days; P < 0.0005). More patients experienced neutropenic fever in the G-CSF group than in the G-CSF+TS group (59.3% versus 22.2%, P = 0.0119). The incidence, duration and severity of clinically or bacteriologically documented infection were lower in patients who received TS. 16 patients (59.3%) in the G-CSF group contracted infection, and 4 patients (14.8%) receiving G-CSF+TS (P = 0.0016). These data indicate that the combination of G-CSF and TS is well-tolerated and may enhance haematological recovery following myelosuppressive chemotherapy in patients with advanced breast cancer.
authors.affiliation: Centre de Radioterapia i Oncologia, Clinica Platón, Barcelona, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Sanchiz
authors.forename: A
authors.initials: A
authors.lastname: Milla
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006402:Hematologic Diseases / Q000139:chemically induced / Q000517:prevention & control*; D006801:Humans; D007369:Interferon Inducers / Q000627:therapeutic use*; D008875:Middle Aged; D008942:Mitoxantrone / Q000009:adverse effects / Q000627:therapeutic use; D009894:Opportunistic Infections / Q000517:prevention & control; D011446:Prospective Studies; D013949:Thymus Extracts / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D007369:Interferon Inducers; D013949:Thymus Extracts; C031407:thymostimulin; D016179:Granulocyte Colony-Stimulating Factor; D008942:Mitoxantrone