A Dose-Escalation Study of Pegylated Liposomal Doxorubicin and Oxaliplatin in Patients with Advanced Solid Tumors
| Autor: | Sophia Agelaki, D. Mavroudis, Antonia Kalykaki, A. Kotsakis, Aristidis Polyzos, Ch. Kouroussis, L. Vamvakas, V. Georgoulias, N. Vardakis, Kostas Kalbakis, Nikos Androulakis |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Maximum Tolerated Dose Organoplatinum Compounds Liposomal Doxorubicin Antineoplastic Agents Polyethylene Glycols Pegylated Liposomal Doxorubicin Neoplasms Internal medicine medicine Dose escalation Humans Doxorubicin In patient Aged business.industry General Medicine Middle Aged Surgery Oxaliplatin Phase i study enzymes and coenzymes (carbohydrates) Maximum tolerated dose Female lipids (amino acids peptides and proteins) business medicine.drug |
| Zdroj: | Oncology. 71:190-196 |
| ISSN: | 1423-0232 0030-2414 |
| DOI: | 10.1159/000106068 |
| Popis: | Purpose: A phase I study was conducted to determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of the pegylated liposomal doxorubicin (PLD) and oxaliplatin combination in patients with advanced solid tumors. Patients and Methods: Forty-five patients with advanced-stage solid tumors received escalating doses of PLD 25–50 mg/m2 as 60-min intravenous (i.v.) infusion and oxaliplatin 80–130 mg/m2 as 2- to 4-hour i.v. infusion on day 1 every 3 weeks without growth factors. Results: MTD was defined at PLD 45 mg/m2 and oxaliplatin 130 mg/m2. Eleven dose levels were evaluated and DLTs were grade 2–3 neutropenia resulting in treatment delays, grade 3 neurotoxicity and nausea/vomiting. A total of 187 cycles were administered with two episodes of febrile neutropenia and one toxic death due to sepsis. Two (4%) and 6 (13%) patients developed grade 4 and 3 neutropenia, respectively, 2 (4%) and 1 (2%) grade 4 and 3 thrombocytopenia, and 1 (2%) grade 4 anemia. The most common nonhematological toxicities were grade 2–3 nausea/vomiting and asthenia observed in 27 (60%) and 16 (36%) of patients, respectively. One complete and eight partial responses were observed. Conclusion: The combination of PLD and oxaliplatin has an acceptable toxicity profile with promising activity and merits further evaluation in phase II studies. |
| Databáze: | OpenAIRE |
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