PURPOSE: A phase Ib/II clinical study was undertaken to assess the efficacy of recombinant human (rh) granulocyte-macrophage colony-stimulating (GM-CSF) factor in attenuating neutropenia and associated morbidity caused by high-dose anticancer chemotherapy administered in the presence or absence of autologous bone marrow support. PATIENTS AND METHODS: Twenty-two patients with various solid tumors and lymphoid neoplasias were treated with a single daily subcutaneous dose of rh GM-CSF (250 micrograms/m2) 48 hours after receiving a second cycle of highly myelotoxic chemotherapy for a period of 10 days. Within-subject comparisons on neutropenia-related clinical and laboratory variables were made with data obtained from the same patients after they received the first neutropenia-inducing cycle of identical chemotherapy in the absence of GM-CSF. RESULTS: GM-CSF was active in neutropenic patients because it significantly increased the neutrophilic nadir, reduced the time of relevant neutropenia, and reduced the duration of a patient's hospital stay and the necessity for parenteral antibiotics. No significant toxicity was encountered with subcutaneous GM-CSF treatment. CONCLUSION: Although GM-CSF was shown to significantly reduce chemotherapy-associated morbidity in patients receiving myelotoxic cancer chemotherapy, additional studies are needed to assess whether the use of GM-CSF in anticancer chemotherapy will allow an increase in the dosage level, leading to improved response rates and survival among cancer patients.
PURPOSE: A phase Ib/II clinical study was undertaken to assess the efficacy of recombinant human (rh) granulocyte-macrophage colony-stimulating (GM-CSF) factor in attenuating neutropenia and associated morbidity caused by high-dose anticancer chemotherapy administered in the presence or absence of autologous bone marrow support. PATIENTS AND METHODS: Twenty-two patients with various solid tumors and lymphoid neoplasias were treated with a single daily subcutaneous dose of rh GM-CSF (250 micrograms/m2) 48 hours after receiving a second cycle of highly myelotoxic chemotherapy for a period of 10 days. Within-subject comparisons on neutropenia-related clinical and laboratory variables were made with data obtained from the same patients after they received the first neutropenia-inducing cycle of identical chemotherapy in the absence of GM-CSF. RESULTS:GM-CSF was active in neutropenicpatients because it significantly increased the neutrophilic nadir, reduced the time of relevant neutropenia, and reduced the duration of a patient's hospital stay and the necessity for parenteral antibiotics. No significant toxicity was encountered with subcutaneous GM-CSF treatment. CONCLUSION: Although GM-CSF was shown to significantly reduce chemotherapy-associated morbidity in patients receiving myelotoxic cancer chemotherapy, additional studies are needed to assess whether the use of GM-CSF in anticancer chemotherapy will allow an increase in the dosage level, leading to improved response rates and survival among cancerpatients.
Authors: K Eguchi; J Kabe; S Kudo; K Mano; H Morinari; K Nakada; K Noda; Y Saito; T Tanaka; T Uzawa Journal: Cancer Chemother Pharmacol Date: 1994 Impact factor: 3.333