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Cisplatin in combination with metronomic vinorelbine as front-line treatment in advanced non-small cell lung cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG)

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Abstract

Purpose

To evaluate the safety and efficacy of metronomic vinorelbine in combination with cisplatin as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC).

Patients and methods

A total of 41 patients with inoperable stage IIIb or stage IV NSCLC (14 with adenocarcinomas, 19 with squamous cell carcinoma and eight with other types), PS = 0–2, were treated with cisplatin (80 mg/m2) in combination with oral metronomic vinorelbine (60 mg total dose, every other day) in cycles of 21 days.

Results

A total of 35 patients who received at least one cycle of chemotherapy were evaluable for toxicity and response. Partial response was achieved in 13 patients (ORR 37.1 %; CI 21.1–53.1 %) and stable disease in 10 (28.6 %). After a median follow-up period of 26.2 months (range 0.5–33.4 months), the median progression-free survival was 4.2 months and the median overall survival 12.0 months. The 1-year survival rate was 52.6 %. Myelosuppression was the main adverse event with grade 3 and 4 neutropenia occurring in five (14.3 %) and six (17.1 %) patients, respectively. Three of these patients presented with febrile neutropenia and there was one death due to sepsis. Non-hematologic toxicities were mild.

Conclusion

Cisplatin in combination with metronomic vinorelbine is an active, although myelotoxic, therapeutic option in the first-line setting for the treatment of patients with locally advanced and metastatic non-small cell lung cancer, which merits further evaluation in randomized trials.

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Acknowledgments

This work was partially supported by a research grant from the Cretan Association for Biomedical Research (CABR).

Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Hellenic Oncology Research Group (HORG), 55 Lombardou Str, 11470, Athens, Greece

    P. Katsaounis, A. Kotsakis, S. Agelaki, E. Kontopodis, A. Agelidou, N. Kentepozidis, L. Vamvakas, A. Christopoulou, N. Karachaliou, D. Hatzidaki & V. Georgoulias

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  1. P. Katsaounis
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  2. A. Kotsakis
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  3. S. Agelaki
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Correspondence to V. Georgoulias.

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Katsaounis, P., Kotsakis, A., Agelaki, S. et al. Cisplatin in combination with metronomic vinorelbine as front-line treatment in advanced non-small cell lung cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG). Cancer Chemother Pharmacol 75, 821–827 (2015). https://doi.org/10.1007/s00280-015-2707-x

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  • DOI: https://doi.org/10.1007/s00280-015-2707-x

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