Annals of oncology : official journal of the European Society for Medical Oncology
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Multicenter Study Clinical Trial
Phase I and pharmacokinetic study of the topoisomerase I inhibitor, exatecan mesylate (DX-8951f), using a weekly 30-minute intravenous infusion, in patients with advanced solid malignancies.
The topoisomerase I inhibitor exatecan mesylate (DX-8951f ) is a water-soluble hexacyclic analogue of camptothecin that does not require enzymatic activation. This study determined the toxicity, maximum tolerated dose (MTD), pharmacokinetics and pharmacodynamics of a weekly intravenous (i.v.) schedule of DX-8951f. ⋯ The dose-limiting toxicity of DX-8951f is neutropenia for MP patients and neutropenia and thrombocytopenia for HP patients. Evidence for clinical activity was seen, suggesting phase II study of the drug is indicated. Using this schedule the recommended dose is 2.75 mg/m(2)/week for MP patients and 2.10 mg/m(2)/week for HP patients.
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After decades of irradiation as standard therapy for clinical stage I testicular seminoma, alternative treatment approaches have emerged including postorchiectomy surveillance and adjuvant chemotherapy. This study was performed to assess a dual policy of surveillance and selective single-agent carboplatin (for high-risk cases) in a multicenter setting. ⋯ This dual treatment policy is feasible in a multicenter setting and preserves 70% of patients from adjuvant chemotherapy. Single-agent carboplatin is effective in reducing the relapse rate in patients with high-risk stage I seminoma. A better definition of local risk features would probably improve patient selection, thus minimizing the incidence of recurrences on surveillance.