Breast Cancer Research and Treatment

, Volume 125, Issue 1, pp 127–136 | Cite as

Benefits of early and prolonged fulvestrant treatment in 848 postmenopausal advanced breast cancer patients

  • Mathias Warm
  • Ronald Kates
  • Friedrich Overkamp
  • Anke Thomas
  • Nadia Harbeck
Clinical trial


Response to fulvestrant and survival in postmenopausal hormone-sensitive advanced breast cancer was investigated within a non-randomized, In-Practice Evaluation Program, with the aim of optimizing treatment decisions. 848 patients (median age 64 years; 52% co-morbidity; 78% prior palliative therapy; median 4 prior regimens) received monthly fulvestrant injections (250 mg/month) and were followed-up three-monthly for 9 months. Clinical benefit (PFS ≥ 24 weeks) occurred in 532/848 (62.7%); stable disease (SD) in 627/848 patients (74%), including 62 complete and 177 partial responses. Best response was delayed in 115 patients. Estimated 9-month overall survival (OS) was 89%; 9-month event-free survival (EFS) was 71%. Indicators of disease aggressiveness affected response and survival, but number of fulvestrant cycles was the key OS and EFS determinant. The patients with SD at 3 months benefitted from continued fulvestrant. Excluding deaths, 7 serious adverse events occurred (none attributable to fulvestrant). No new or unexpected safety issues arose; 90% of the patients and physicians rated fulvestrant tolerability as “very good” or “good”. In the largest prospective, fulvestrant-treated cohort to date, advanced breast cancer patients achieving SD or better after 3 months of treatment gained survival benefit by prolonging fulvestrant therapy—independent of disease and treatment history.


Advanced breast cancer Fulvestrant Progesterone receptor Therapy response 



The authors would like to thank Silke Zaun MD, PhD from AstraZeneca for supplying the patient data, for very useful discussions, and for editing support. Dawn Batty, PhD from Complete Medical Communications provided editing support, funded by AstraZeneca. Approval of the final manuscript rested with the authors, who are responsible for all scientific content.


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Copyright information

© Springer Science+Business Media, LLC. 2010

Authors and Affiliations

  • Mathias Warm
    • 1
    • 2
  • Ronald Kates
    • 3
  • Friedrich Overkamp
    • 4
  • Anke Thomas
    • 5
  • Nadia Harbeck
    • 1
  1. 1.Breast CenterUniversity of CologneCologneGermany
  2. 2.Breast CenterClinics of the City of CologneCologneGermany
  3. 3.REK ConsultingOtterfingGermany
  4. 4.Day Clinic for Hematology and OncologyRecklinghausenGermany
  5. 5.Department of GynecologyUniversity Berlin CharitéBerlinGermany

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