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

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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.

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Acknowledgments

We thank patients for contributing to this research. The Lega Italiana per la Lotta contro i Tumori- LILT, sezione di Rovigo financed the study.

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Authors and Affiliations

  1. Servizio di Oncologia, Ospedale Pederzoli, Peschiera del Garda, Verona, Italy

    Felice Pasini & Anna Paola Fraccon

  2. Dipartimento Oncologico, Ospedale Santa Maria della Misericordia, Viale Tre Martiri 140, 45100, Rovigo, Italy

    Carmen Barile, Yasmina Modena, Laura Bertolaso, Daniela Menon, Francesca La Russa, Giorgio Crepaldi, Antonio Bononi & Milena Gusella

  3. Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milan, Italy

    Donatella Caruso & Roberto Spezzano

  4. Servizio di Farmacologia Clinica, Dipartimento di Medicina, Università di Padova, Padua, Italy

    Roberto Padrini

  5. Dipartimento di Ricerca Traslazionale, IRCCS Centro di Riferimento Oncologico, Aviano, Italy

    Giuseppe Corona

Authors
  1. Felice Pasini
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  2. Carmen Barile
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  3. Donatella Caruso
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  4. Yasmina Modena
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  5. Anna Paola Fraccon
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  6. Laura Bertolaso
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  7. Daniela Menon
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  8. Francesca La Russa
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  9. Giorgio Crepaldi
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  10. Antonio Bononi
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  11. Roberto Spezzano
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  12. Roberto Padrini
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  13. Giuseppe Corona
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  14. Milena Gusella
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Contributions

Pasini, Gusella, Bononi and Corona planned and designed the study;

Barile, Modena, Fraccon, Menon, La Russa and Crepaldi recruited patients and collected clinical data;

Bertolaso, Caruso and Spezzano analysed biological samples;

Pasini, Padrini, Gusella and Caruso participated in data analysis;

Pasini, Gusella, Padrini and Corona wrote the manuscript;

All authors critically reviewed the final version.

Corresponding author

Correspondence to Milena Gusella.

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Competing interests

The authors declare no competing interests.

Informed consent

This research involved Human Participants, who gave their informed consent.

Ethical approval

All procedures were carried out in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments.

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Pasini, F., Barile, C., Caruso, D. et al. Oral Metronomic Vinorelbine (OMV) in elderly or pretreated patients with advanced non small cell lung cancer: outcome and pharmacokinetics in the real world. Invest New Drugs 36, 927–932 (2018). https://doi.org/10.1007/s10637-018-0631-8

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  • DOI: https://doi.org/10.1007/s10637-018-0631-8

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