Breast Cancer Research and Treatment

, Volume 123, Issue 2, pp 463–469 | Cite as

Multicenter phase II randomized trial evaluating antiangiogenic therapy with sunitinib as consolidation after objective response to taxane chemotherapy in women with HER2-negative metastatic breast cancer

  • H. Wildiers
  • C. Fontaine
  • P. Vuylsteke
  • M. Martens
  • J. L. Canon
  • W. Wynendaele
  • C. Focan
  • J. De Greve
  • P. Squifflet
  • R. Paridaens
Clinical trial

Abstract

The aim of this study is to test the hypothesis that antiangiogenic treatment with sunitinib consolidation can prolong remissions induced by taxane-based chemotherapy in women with metastatic breast cancer. The method involves a two-arm open-label (2:1 randomization) multicenter, randomized phase II trial evaluating the efficacy of sunitinib (arm A) versus no therapy (arm B) in patients with HER-2-negative metastatic breast cancer who achieved an objective response to taxane-based chemotherapy. The results of this study indicates that the primary endpoint of progression-free survival (PFS) ≥5 months was achieved in 10 of 36 patients (28%) in arm A and 4 of 19 patients (21%) in arm B. The median PFS was 2.8 and 3.1 months, respectively. A protocol amendment to the sunitinib dosing schedule was made because 53% (17/32) of patients treated at a starting dose of 50 mg (4 weeks on/2 weeks off) required dose reduction. Changing the starting dose to sunitinib 37.5 mg continuously resulted in dose reductions in 44% (7/16) of patients. Grades III–IV toxicity occurred in 69% of patients in arm A (fatigue 31%, musculoskeletal pain 11%, neutropenia and thrombopenia 8%) and 11% in arm B. The proof-of-principle study does not confirm the hypothesis that sunitinib consolidation therapy can lead to a predefined clinically relevant proportion of patients with PFS of ≥5 months after an objective response to taxanes. Furthermore, toxicity was significant.

Keywords

Breast cancer Angiogenesis Sunitinib Consolidation Taxanes 

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Copyright information

© Springer Science+Business Media, LLC. 2010

Authors and Affiliations

  • H. Wildiers
    • 1
  • C. Fontaine
    • 2
  • P. Vuylsteke
    • 3
  • M. Martens
    • 4
  • J. L. Canon
    • 5
  • W. Wynendaele
    • 6
  • C. Focan
    • 7
  • J. De Greve
    • 2
  • P. Squifflet
    • 8
  • R. Paridaens
    • 1
  1. 1.Department of General Medical Oncology/Multidisciplinary Breast CentreUniversity Hospitals LeuvenLeuvenBelgium
  2. 2.Department of Medical OncologyOncologisch Centrum, UZBrusselBrusselsBelgium
  3. 3.Department of OncologySint-Elisabeth HospitalNamurBelgium
  4. 4.Department of Oncology-RadiologySint-Elisabeth HospitalTurnhoutBelgium
  5. 5.Department of Oncology-Hematology and RadiologyGrand Hopital de CharleroiCharleroiBelgium
  6. 6.Department of Oncology-RadiotherapyImelda HospitalBonheidenBelgium
  7. 7.Department of Oncology-Hemato-ImmunologyCHC HospitalLiègeBelgium
  8. 8.IDDILouvain-la-NeuveBelgium

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