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Cancer Chemother Pharmacol. 2013 Aug;72(2):429-35. doi: 10.1007/s00280-013-2216-8. Epub 2013 Jun 26.

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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Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt.



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).


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.


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.


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

[Indexed for MEDLINE]

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