403P - Phase II study evaluating oral vinorelbine as a single-agent as first-line chemotherapy for metastatic breast cancer patients with bone metastases...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Breast Cancer
Biological Therapy
Presenter Guenther Steger
Citation Annals of Oncology (2014) 25 (suppl_4): iv116-iv136. 10.1093/annonc/mdu329
Authors G.G. Steger1, A. Dominguez2, O. Switsers3, N. Dobrovolskaya4, F. Giotta5, I. Glogowska6, N. Tubiana-Mathieu7, M. Pecherstorfer8, A. Ardizzoia9, P. Bougnoux10, M. Blasinska-Morawiec11, C. Veyret12, S. Garcia13, J. Dorca14, C. Marth15, A. Manikhas16, M. Benasso17, S. Protsenko18, G.R. Villanova19, E. Espinosa20
  • 1Department Of Medicine I, Vienna General Hospital (AKH) - Medizinische Universität Wien, 1090 - Vienna/AT
  • 2Medical Oncology, CANCEROLOGIA DE QUERETARO, Queretaro/MX
  • 3Medical Oncology, Centre F. Baclesse, Caen/FR
  • 4Medical Oncology, Russian Research Centre of Roentgenoradiology, Moscow/RU
  • 5Medical Oncology Unit, NCRC Istituto Tumori “Giovanni Paolo II, 70124 - Bari/IT
  • 6Medical Oncology, Oncology Center Marie Curie, Warsaw/PL
  • 7Medical Oncology, CHU Limoges - Hopital Dupuytren, 87042 - Limoges/FR
  • 8Hämatologisch-onkologischer Dienst, Landesklinikum Krems, 3500 - Krems an der Donau/AT
  • 9Medical Oncology, Ospedale A. Manzoni, Lecco/IT
  • 10Medical Oncology, CHU Bretonneau, Tours/FR
  • 11Oddzial Chorob Rozrostowych, Kopernik Memory Hospital Lodz, Lodz/PL
  • 12Medical Oncology, Centre Henri Becquerel, Rouen/FR
  • 13Medical Oncology, Hospital J. Graham Casas, Villahermosa/MX
  • 14Medical Oncology, Hospital J. Trueta, Girona/ES
  • 15Department Obstetrics And Gynecology, University Hospital Innsbruck, 6020 - Innsbruck/AT
  • 16Oncology, Oncology Hospital of St. Petersburg, St. Petersburg/RU
  • 17Medical Oncology, Hospital San Paolo, Savona/IT
  • 18Biotherapy & Bone Marrow Transplantation, N.N.Petrov Research Inst. of Oncology, RU-197758 - St. Petersburg/RU
  • 19Medical Affairs Oncology, Institut de Recherche Pierre Fabre, 92654 - Boulogne Billancourt/FR
  • 20Medical Oncology, Hospital Universitario La Paz, 28046 - Madrid/ES



Background: Oral chemotherapy (CT) is a widely recognized treatment option for hormone receptor positive, metastatic breast cancer (MBC) patients (pts) pretreated by hormone therapy (HT). In this phase II study, we evaluated the efficacy and safety of single-agent Oral Vinorelbine (OV) as first-line CT in pts presenting bone metastases without visceral involvement.


Main eligibility criteria included: age ≥18 years, documented bone disease previously untreated by CT, hormone receptor positive disease previously treated by at least one HT, HER2-negative disease, Karnofsky PS ≥70 and absence of visceral metastases. All pts received a bisphosphonate during the study. Study treatment (until progression): OV 80 mg/m2 weekly (following a first cycle at 60 mg/m2 and dose escalation to 80 in the absence of grade 3 or 4 toxicity). One cycle was defined as four weeks of treatment


Between April 2010 and April 2012, 70 patients have been included. Main pts characteristics: median age: 60.6 years (34% ≥65 years); median Karnofsky PS 90%. Prior HT 100% (80% in adjuvant setting, 53% in advanced setting); prior (neo)adjuvant CT 63%; prior anthracyclines/taxanes 59/24%; prior palliative radiotherapy 41%. Bone involvement 100%; other metastatic sites: lymph nodes 14%, soft tissue 3%. Median duration of treatment 5.8 months (range 0.9-18.4), median number of cycles: 6 (range: 1-18); median relative dose intensity: 83.0%. Efficacy: with a median follow up of 26.1 months, median progression-free survival (primary endpoint) was 8.2 months (95% CI [5.5-10.3]). Clinical benefit was observed in 55.7% of pts. Median duration of clinical benefit was 11.1 months (95% CI [8.6-14.7]). Overall survival results are not mature yet, at cut off date 63% of pts being alive. Safety: grade 3/4 adverse events per pt: neutropenia 37%, anemia 4%, neutropenic infection 3%, diarrhoea 3%, nausea 3%, asthenia 1%, liver toxicity 1%, non-neutropenic infection 1%. Grade 2 alopecia was reported in 6% of pts.


Conclusion: For this particular population of metastatic pts, with hormone receptor positive disease progressing to HT and bone involvement, OV is an active and safe first-line CT option.


G.G. Steger: Honoraria and Travel Grants from Pierre Fabre Medicament; G.R. Villanova: Employee of Pierre Fabre Medicament. All other authors have declared no conflicts of interest.