Abstract
In attempt to develop a new chemotherapeutic regimen including carboplatin (CBDCA), epirubicin (EPI), and VP-16 in extensive small cell lung cancer, with a higher dose intensity compared with previous experience of our group, we determined the maximum tolerated dose (MTD) of VP-16 when administered in association with CBDCA (300 mg/ m2, i.v., day 1) and EPI (75 mg/m2, i.v., day 1), recycling chemotherapy every 3 weeks, with the support of granulocyte-colony-stimulating factor (G-CSF). A total of 15 patients received three dose levels of VP-16 (mg/m2, i.v., daily on days 1-3): 100 (three patients), 120 (six), and 140 (six). G-CSF was administered subcutaneously at the dose of 5 micrograms/kg/day on days 6-15 of each chemotherapy course. The MTD was established at 140 mg/m2 and myelotoxicity, grade 4 neutropenia with death for sepsis in one case and grade 3 thrombocytopenia in three cases, was dose limiting. The recommended dose of VP-16 for a phase II study is 140 mg/m2.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
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Comparative Study
MeSH terms
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Adult
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Aged
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Antibiotics, Antineoplastic / administration & dosage*
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Antibiotics, Antineoplastic / adverse effects
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Antineoplastic Agents / administration & dosage*
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents, Phytogenic / administration & dosage*
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Antineoplastic Agents, Phytogenic / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Bone Marrow / drug effects
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Carboplatin / administration & dosage*
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Carboplatin / adverse effects
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Carcinoma, Small Cell / drug therapy*
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Cause of Death
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Dose-Response Relationship, Drug
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Drug Tolerance
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Epirubicin / administration & dosage*
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Epirubicin / adverse effects
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Etoposide / administration & dosage*
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Etoposide / adverse effects
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Female
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Granulocyte Colony-Stimulating Factor / administration & dosage
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Granulocyte Colony-Stimulating Factor / therapeutic use*
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Humans
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Lung Neoplasms / drug therapy*
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Male
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Middle Aged
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Neutropenia / chemically induced
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Neutropenia / prevention & control
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Sepsis / etiology
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Thrombocytopenia / chemically induced
Substances
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Antibiotics, Antineoplastic
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Antineoplastic Agents
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Antineoplastic Agents, Phytogenic
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Granulocyte Colony-Stimulating Factor
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Epirubicin
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Etoposide
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Carboplatin