1. A multicenter phase I trial of metronomic oral vinorelbine plus cisplatin in patients with NSCLC.
- Author
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Pallis, Athanasios, Chandrinos, Vassilis, Pavlakou, Georgia, Xenidis, Nikolaos, Varthalitis, Ioannis, Vardakis, Nikolaos, Vamvakas, Lambros, Kontopodis, Emmanouel, Rovithi, Maria, and Georgoulias, Vassilis
- Subjects
VINORELBINE ,LUNG cancer treatment ,ORAL drug administration ,CISPLATIN ,METASTASIS ,CANCER chemotherapy ,DRUG toxicity - Abstract
The purpose of the present study was to determine the maximum-tolerated doses (MTDs) and the dose-limiting toxicities of a metronomic administration of oral vinorelbine and cisplatin in patients with advanced/metastatic NSCLC. Twenty-six patients with advanced/metastatic NSCLC were enrolled. Escalating doses of vinorelbine (40-70 mg p.o./trice per week) and cisplatin (70-85 mg/m intravenous infusion) were administered on day 1 every 3 weeks. ΜΤDs were reached at 60 mg thrice/week p.o. for vinorelbine and 85 mg/m for cisplatin. Grade 4 neutropenia, febrile neutropenia and grade 4 diarrhea were the dose-limiting events during the first cycle of chemotherapy. The most common grade III-IV hematologic toxicity was neutropenia occurring in seven (27%) patients, while non-hematological toxicities were relatively infrequent and mostly of grade I or II. Objective responses were observed in 20.8% of patients with measurable disease. The regimen of metronomic administration and cisplatin is feasible and active in patients with NSCLC. [ABSTRACT FROM AUTHOR]
- Published
- 2011
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