A multicenter phase I trial of metronomic oral vinorelbine plus cisplatin in patients with NSCLC

Athanasios G. Pallis (1) , Vassilis Chandrinos (2) , Georgia Pavlakou (3) , Nikolaos Xenidis (4) , Ioannis Varthalitis (5) , Nikolaos Vardakis (1) , Lambros Vamvakas (1) , Emmanouel Kontopodis (1) , Maria Rovithi (1) , Vassilis Georgoulias (1)

1 Department of Medical Oncology
2 2nd Department of Pulmonary Diseases
3 8th Department of Pulmonary Diseases
4 Department of Medical Oncology
5 Department of Medical Oncology

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.

Mots clés: Metronomic; Oral Vinorelbine; Cisplatin; NSCLC; Phase I; Maximum-tolerated doses; Dose-limiting toxicities

Athanasios G. Pallis, Vassilis Chandrinos, Georgia Pavlakou, Nikolaos Xenidis, Ioannis Varthalitis, et al.. A multicenter phase I trial of metronomic oral vinorelbine plus cisplatin in patients with NSCLC. Cancer Chemotherapy and Pharmacology, 2010, 67 (6), pp.1239-1245. ⟨10.1007/s00280-010-1415-9⟩. ⟨hal-00615338⟩