TY - JOUR
T1 - High-dose carboplatin and recombinant granulocyte-macrophage colony-stimulating factor in advanced-stage recurrent ovarian cancer
AU - Reed, Eddie
AU - Janik, John
AU - Bookman, Michael A.
AU - Rothenberg, Mace
AU - Smith, John
AU - Young, Robert C.
AU - Ozols, Robert F.
AU - Vandermolen, Louis
AU - Kohn, Elise
AU - Jacob, Joan L.
AU - Cornelison, Terri L.
PY - 1993
Y1 - 1993
N2 - Purpose: We investigated whether carboplatin myelosuppression could be favorably modulated by the administration of recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF) in patients with advanced-stage ovarian cancer. Patients and Methods: Thirty-four patients with advanced-stage recurrent ovarian cancer were treated with high-dose carboplatin (800 mg/m2 per 35-day cycle) and rGM-CSF. rGM-CSF was administered as a daily subcutaneous injection starting 72 hours after the carboplatin dose and continuing until 7 days beyond the WBC nadir. rGM-CSF was administered in a phase I fashion. Seven patients were treated at an rGM-CSF dose of 3 μg/kg, 11 at 5 μg/kg, 10 at 10 μg/kg, and six at 20 μg/kg. Results: rGM-CSF-related toxicities that were not dose-related included nonneutropenic fever, rib pain, acute hypersensitivity reaction, and pericarditis. At the rGM-CSF dose of 20 μg/kg, debilitating malaise was seen in four of six patients and this was the dose-limiting tox-icity. Patient tolerance of the 3-μg/kg and 5-μg/kg doses was good, but tolerance was limited for the 10-μg/kg dose. Febrile neutropenia was seen in four of seven patients at 3 μg/kg, two of 11 at 5 μg/kg, two of 10 at 10 μg/kg, and one of six at 20 μg/kg. Cumulative carboplatin myelotoxicity was blunted only in respect to WBC count, and not for platelets or RBCs. Gastrointestinal bleeding was seen in seven patients. The administered dose-intensity of carboplatin averaged 134 mg/m2/wk for the cohort, or 670 mg/m2 per 35-day cycle. There were two clinical complete responses and eleven partial responses, for a response rate of 38%. Conclusion: rGM-CSF appears to be effective and tolerable at 5 μg/kg/d administered subcutaneously, if given with carboplatin doses up to approximately 600 mg/m2 over 35 days. The use of rGM-CSF with high-dose carboplatin is associated with a substantial response rate in poor-prognosis ovarian cancer patients.
AB - Purpose: We investigated whether carboplatin myelosuppression could be favorably modulated by the administration of recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF) in patients with advanced-stage ovarian cancer. Patients and Methods: Thirty-four patients with advanced-stage recurrent ovarian cancer were treated with high-dose carboplatin (800 mg/m2 per 35-day cycle) and rGM-CSF. rGM-CSF was administered as a daily subcutaneous injection starting 72 hours after the carboplatin dose and continuing until 7 days beyond the WBC nadir. rGM-CSF was administered in a phase I fashion. Seven patients were treated at an rGM-CSF dose of 3 μg/kg, 11 at 5 μg/kg, 10 at 10 μg/kg, and six at 20 μg/kg. Results: rGM-CSF-related toxicities that were not dose-related included nonneutropenic fever, rib pain, acute hypersensitivity reaction, and pericarditis. At the rGM-CSF dose of 20 μg/kg, debilitating malaise was seen in four of six patients and this was the dose-limiting tox-icity. Patient tolerance of the 3-μg/kg and 5-μg/kg doses was good, but tolerance was limited for the 10-μg/kg dose. Febrile neutropenia was seen in four of seven patients at 3 μg/kg, two of 11 at 5 μg/kg, two of 10 at 10 μg/kg, and one of six at 20 μg/kg. Cumulative carboplatin myelotoxicity was blunted only in respect to WBC count, and not for platelets or RBCs. Gastrointestinal bleeding was seen in seven patients. The administered dose-intensity of carboplatin averaged 134 mg/m2/wk for the cohort, or 670 mg/m2 per 35-day cycle. There were two clinical complete responses and eleven partial responses, for a response rate of 38%. Conclusion: rGM-CSF appears to be effective and tolerable at 5 μg/kg/d administered subcutaneously, if given with carboplatin doses up to approximately 600 mg/m2 over 35 days. The use of rGM-CSF with high-dose carboplatin is associated with a substantial response rate in poor-prognosis ovarian cancer patients.
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U2 - 10.1200/JCO.1993.11.11.2118
DO - 10.1200/JCO.1993.11.11.2118
M3 - Article
C2 - 8229126
AN - SCOPUS:0027428038
SN - 0732-183X
VL - 11
SP - 2118
EP - 2126
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 11
ER -
