Oral Metronomic Vinorelbine (OMV) in elderly or pretreated patients with advanced non small cell lung cancer: outcome and pharmacokinetics in the real world

Summary Background Oral metronomic therapy (OMV) is particularly suitable for palliative care, and schedules adapted for unfit patients are advisable. This study investigated the effects of oral vinorelbine given every other day without interruption and its pharmacokinetic profile in patients with a...

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Published in:Investigational new drugs 2018-10, Vol.36 (5), p.927-932
Main Authors: Pasini, Felice, Barile, Carmen, Caruso, Donatella, Modena, Yasmina, Fraccon, Anna Paola, Bertolaso, Laura, Menon, Daniela, La Russa, Francesca, Crepaldi, Giorgio, Bononi, Antonio, Spezzano, Roberto, Padrini, Roberto, Corona, Giuseppe, Gusella, Milena
Format: Article
Language:English
Subjects:
Blood
Cancer
Geriatrics
Histology
Interruption
Lung cancer
Medicine
Medicine & Public Health
Older people
Oncology
Patients
Pharmacokinetics
Pharmacology
Pharmacology/Toxicology
Phase II Studies
Schedules
Studies
Survival
Toxicity
Vinorelbine
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Summary:Summary Background Oral metronomic therapy (OMV) is particularly suitable for palliative care, and schedules adapted for unfit patients are advisable. This study investigated the effects of oral vinorelbine given every other day without interruption and its pharmacokinetic profile in patients with advanced lung cancer. Materials and Methods Ninety-two patients received OMV at doses of 20, 30 or 50 mg. Toxic events, clinical benefit and overall survival were analysed. Blood pharmacokinetics were evaluated in 82 patients. Results Median treatment duration and overall survival were 15 (range 1.3–144) and 32.3 weeks, respectively; fourty-eight (60%) patients experienced clinical benefit. Outcomes were unrelated to previous therapies, age, histology or comorbidities. Toxicity was associated with higher blood concentrations of the drug. Pharmacokinetics were stable for up to two years, and were not influenced by treatment line or age. Conclusions OMV produced non-negligible survival in patients and also showed stable long-term blood concentrations. The schedule of 20–30 mg every other day without interruption gave good tolerability and clinical benefit.
ISSN:0167-6997
1573-0646
DOI:10.1007/s10637-018-0631-8