Benefits of early and prolonged fulvestrant treatment in 848 postmenopausal advanced breast cancer patients.
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.
Breast Center, University of Cologne, Kerpener Strasse 62, 50924 Cologne, Germany. WarmM@kliniken-koeln.de
Mathias
M
Warm
Ronald
R
Kates
Friedrich
F
Overkamp
Anke
A
Thomas
Nadia
N
Harbeck
D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016009:Chi-Square Distribution; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000077267:Fulvestrant; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009367:Neoplasm Staging; D017698:Postmenopause; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D020847:Estrogen Receptor Modulators; D000077267:Fulvestrant; D004958:Estradiol