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Phase II study of single agent oral vinorelbine as first-line treatment in patients with HER-2 negative metastatic breast cancer

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Abstract

Purpose

Previous studies indicated that oral chemotherapy is convenient and preferred by many patients. We hereby report the efficacy and safety of oral vinorelbine as first-line chemotherapy for metastatic breast cancer (MBC).

Methods

Thirty-one patients with HER-2 negative MBC were enrolled between January 2007 and December 2010 in a prospective phase II trial. Patients were treated every 3 weeks with oral vinorelbine 60 mg/m² Days 1 and 8 for the 1st cycle and thereafter 80 mg/m² Days 1 and 8 every 3 weeks. Treatment was administered until disease progression or unexpected adverse event or patient refusal to continue. Primary endpoint was objective response rate (ORR); secondary endpoints were time-to-progression (TTP), overall survival (OS) and safety. Follow-up results until October 2012 are reported.

Results

Median age was 42 years (range 33–75). 26 (84 %) patients had 2 or more metastatic sites. A median of 6 cycles were administered (range 2–20). ORR was achieved in 9 (29 %) patients including 1 complete and 8 partial responses. 12 (39 %) patients had stable disease, resulting in a disease control rate of 68 %. Median TTP was 5.2 months [95 % CI 2.8–7.5]. Median OS was 16 months [95 % CI 11.3–20.7]. 3 (10 %) patients developed Grade 3–4 neutropenia. No events of febrile neutropenia, cardiac, renal toxicities or alopecia were recorded. Grade 3 thrombocytopenia and nausea-vomiting were reported in 2 (6 %) and 5 (16 %) patients, respectively.

Conclusion

Results show a good efficacy and tolerance profile of oral vinorelbine as first-line chemotherapy for HER-2 negative MBC patients.

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Acknowledgments

We thank all our patients and their families.

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Authors and Affiliations

  1. Clinical Oncology and Nuclear Medicine Department (NEMROCK), Faculty of Medicine, Cairo University, Cairo, Egypt

    Maged Mansour

  2. Medical Affairs Department, Pierre Fabre Médicament, Beirut, Lebanon

    Cynthia Mourad

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  1. Maged Mansour
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Correspondence to Maged Mansour.

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Mansour, M., Mourad, C. Phase II study of single agent oral vinorelbine as first-line treatment in patients with HER-2 negative metastatic breast cancer. Cancer Chemother Pharmacol 72, 429–435 (2013). https://doi.org/10.1007/s00280-013-2216-8

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  • DOI: https://doi.org/10.1007/s00280-013-2216-8

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