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Schilder RJ , Johnson S , Gallo J , Kindsfather S , Rogers B , Bookman MA , Millenson MM , Boente M , Rosenblum N , Litwin S , Ozols RF
Phase I trial of multiple cycles of high-dose chemotherapy supported by autologous peripheral-blood stem cells
Journal of Clinical Oncology. 1999 Jul;17(7) :2198-2207
AbstractPurpose: To determine the safety and feasibility of delivering multiple cycles of front-line high-dose carboplatin and paclitaxel with hematopoietic peripheral-blood stem cell (PBSC) support, Patients and Methods: Patients were required to have a malignant solid tumor for which they had received no prior chemotherapy. Mobilization of PBSC was achieved with cyclophosphamide, etoposide, and granulocyte-macrophage colony- stimulating factor (GM-CSF). After one cycle of conventional- dose carboplatin and cyclophosphamide with GM-CSF, patients received multiple cycles of high dose carboplatin (area under the concentration-lime curve [AUC], 12 to 20) and paclitaxel (250 mg/m(2)) with PBSC and GM-CSF repeated every 28 days. Results: Twenty-four of 28 patients were assessable for toxicity and clinical outcome. Dose-limiting toxicities were dehydration, diarrhea, and electrolyte imbalances, The maximum- tolerated dose of carboplatin was AUC 16 (equivalent to a median of 1,189 mg/m(2)). The relationship of target AUC to measured AUC was linear (r(2) = .29; P = .0011), The overall response rate was 96%, with a complete clinical response rate of 67%, The median time to progression from the first PBSC reinfusion was 49.5 weeks (range, 8 to 156+ weeks). Conclusion: Multiple cycles of high-dose carboplatin (AUC 16) and paclitaxel (250 mg/m(2)) can be safely administered with GM-CSF and PBSC support, Although this regimen is safe, feasible, and active, the use of multiple cycles of high-dose chemotherapy as front-line treatment remains experimental and should only be used in the context of a clinical trial. (C) 1999 by American Society of Clinical Oncology.
NotesTimes Cited: 10 English Article 213GL J CLIN ONCOL