title: A multicenter phase I trial of metronomic oral vinorelbine plus cisplatin in patients with NSCLC.
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(2) 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(2) 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.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, PO Box 1352, 711 10 Heraklion, Crete, Greece.
authors.forename: Athanasios G
authors.initials: AG
authors.lastname: Pallis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Chandrinos
authors.forename: Georgia
authors.initials: G
authors.lastname: Pavlakou
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Xenidis
authors.forename: Ioannis
authors.initials: I
authors.lastname: Varthalitis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vardakis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Emmanouel
authors.initials: E
authors.lastname: Kontopodis
authors.forename: Maria
authors.initials: M
authors.lastname: Rovithi
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine