392 - Phase II study of single agent oral vinorelbine (OV) as first-line chemotherapy (CT) in patients (pts) with HER-2 negative metastatic breast cancer...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Breast Cancer
Biological therapy
Presenter A.R. Maged Mansour
Authors A.R. Maged Mansour1, C. Mourad2
  • 1Oncology, Erfan Hospital, Jeddah/SA
  • 2Pierre Fabre Medicament, 11072100 - Beirut/LB



Quality of life and pts' preferences play an important role in treatment decision-making in the metastatic setting. Previous studies indicated that Oral CT is convenient and a preferred option by many pts. We hereby report the efficacy and safety of OV as first-line CT for MBC.

Patients and methods

31 pts were enrolled between January 2007 and December 2010. All pts had measurable disease, a majority (84%) relapsing after anthracyclines (ANT) and/or taxanes (TXN) adjuvant treatment, WHO PS ≤ 2, adequate bone marrow, hepatic and renal functions and no adjuvant CT within the last 6 months. Pts were treated every 3 weeks with OV 60 mg/m2 D1 and D8 for the 1st cycle and thereafter 80 mg/m2 D1 and D8 every 3 weeks in the absence of G4 neutropenia and/or febrile neutropenia. Treatment was administered until disease progression or unexpected adverse event or pt refusal to continue. Primary endpoint (EP) was Objective Response Rate (ORR); secondary EPs were TTP, OS and safety. Follow-up results until April 2012 are reported.


Median age was 42 years (range, 33 -75); median WHO PS 1 (range, 0-2). Previous adjuvant therapy: ANT-based alone: 29%, TXN-based alone: 19%, ANT plus TXN: 36%, other: 16%. Median disease-free interval from end of previous CT was 7 months. 26 pts (84%) had 2 or more metastatic sites, liver (61%), bone (58%), lung (58%) being the most frequent sites. A median of 6 cycles were administered (range, 2-20). ORR was achieved in 9 pts (29%), including 1 complete and 8 partial responses. 12 pts (39%) had stable disease, resulting in a clinical benefit rate (CBR) of 68%. In pts pretreated by ANT, ORR was 35% and CBR was 70%. Median TTP was 3.7 months [95% CI: 2.2-5.2]. Median survival was 16 months [95% CI: 11.4-20.6]. 3 pts (10%) developed G 3-4 neutropenia. No events of febrile neutropenia, cardiac, renal toxicities or alopecia were recorded. G 3 thrombocytopenia was reported in 2 pts (6%). 5 pts (16%) developed G 3 nausea-vomiting.

Conclusions: Results show a good efficacy and tolerance profile of OV as first line CT for HER-2 negative MBC pts. Similar activity was observed in the sub-group of pts pretreated by ANT.


All authors have declared no conflicts of interest.