The Austrian fulvestrant registry: results from a prospective observation of fulvestrant in postmenopausal patients with metastatic breast cancer

Bartsch, Rupert; Mlineritsch, Brigitte; Gnant, Michael; Niernberger, T.; Pluschnig, Ursula; Greil, Richard; Wenzel, Catharina; Sevelda, P.; Thaler, Josef; Rudas, Margaretha; Pober, Michael; Zielinski, Christoph; Steger, Guenther G.

doi:10.1007/s10549-008-0132-0

Cited by 10 publications

(4 citation statements)

References 32 publications

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“…In phase III clinical trials, treatment with fulvestrant has been observed to result in a clinical benefit rate (i.e., complete response, partial response, and stable disease C24 weeks) of 54.3% in the first-line metastatic setting [6], and between 32.2 and 44.6% for subsequent lines of therapy [7][8][9]. Additionally, phase IV studies involving the review of compassionate use databases and including over 1,100 patients have observed clinical benefit rates of approximately 37% [10][11][12][13][14][15][16]. In these trials, the study population was quite heterogeneous, and complete clinical information was not available for all patients.…”

Section: Introductionmentioning

confidence: 99%

Predicting benefit from fulvestrant in pretreated metastatic breast cancer patients

Freedman

Amir

Dranitsaris

et al. 2009

Breast Cancer Res Treat

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Fulvestrant use in pretreated metastatic breast cancer patients is associated with variable response rates. This study aimed to characterize these responses and to develop a prediction model to identify those patients who could potentially derive the most clinical benefit. A nationwide review of patients enrolled in a Canadian compassionate use program from 1999 to 2006 was performed. Prior therapy with tamoxifen, steroidal, and nonsteroidal aromatase inhibitors was mandatory. The dependent variable in the analysis was the proportion of patients requiring chemotherapy at 3 months following the start of fulvestrant. General Linear Mixed modeling was used to identify factors significantly associated with this dependant variable and to subsequently develop the prediction model. Three hundred and five women received at least one dose of fulvestrant; 207 went on to receive chemotherapy (68%). Median duration of fulvestrant treatment was 4.1 months (range 0.8-63.1). Factors predictive of being chemotherapy free at 3 months included older age, no prior adjuvant hormonal therapy, and the absence of lung or brain metastases at the start of therapy. A receiver operating characteristic (ROC) curve analysis had an area under the curve of 0.70 (95% CI 0.60-0.80). This model was able to identify risk information that could be helpful in assessing which patients would most likely benefit from fulvestrant as an intervention with the objective being a delay in chemotherapy.

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Section: Introductionmentioning

confidence: 99%

Predicting benefit from fulvestrant in pretreated metastatic breast cancer patients

Freedman

Amir

Dranitsaris

et al. 2009

Breast Cancer Res Treat

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“…They observed that TTP was significantly higher for fulvestrant when compared to anastrozole (median TTP not reached for fulvestrant against 12.5 months for anastrozole (P = 0.0496). Ingle et al [14] observed a TTP of 3 months, whereas Mlineritsch et al [15] observed a median TTP of 6.4 months and Bartsch et al [9] of 7 months, all of them while studying postmenopausal women with metastatic breast cancer.…”

Section: Discussionmentioning

confidence: 99%

“…Fulvestrant has been studied as both first-and secondline therapy for locally advanced and metastatic breast cancer, but few studies [8][9][10] exist showing its effect as third-line therapy alone. In this study, we correlated the disease time to progression (TTP) obtained with fulvestrant when used on metastatic breast cancer as first-, second-, and also third-line therapy.…”

Section: Introductionmentioning

confidence: 99%

Prolonged time to progression with fulvestrant for metastatic breast cancer

et al. 2010

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Although the incidence of breast cancer has been declining in recent years, the disease is still one of the leading causes of cancer deaths in women. Recently, breast cancer has been treated with innovative approaches that use hormone-sensitive therapies. This is because in at least one-third of breast cancers, estrogens mediated via the estrogen receptor pathway act as endocrine growth factors. Fulvestrant has been studied as both first- and second-line therapy for locally advanced and metastatic breast cancer, but few studies have shown its effect as third-line therapy alone. To observe the disease time to progression (TTP) obtained with fulvestrant when used on metastatic breast cancer as first-, second-, and also third-line therapy. We also aimed to correlate the TTP obtained with fulvestrant with hormone receptor, HER2 expression, and metastatic site. This was a cohort study that retrospectively examined medical records of 73 postmenopausal women with advanced breast cancer who were treated with fulvestrant (250 mg/month i.m. injection) and followed at the Department of Medical Oncology at Hospital do Cancer A. C. Camargo in São Paulo, Brazil from August 2003 to December 2006. The median TTP with fulvestrant was about 11 months. When used as the first-line therapy, TTP was about 13 months; when used as second-line, TTP was about 6 months; and when used as third-line, it was about 12 months. No statistically significant difference was observed regarding the therapy line. In patients with positive ER tumors, TTP was 11 months. No significant difference in TTP was observed in negative ER tumors (TTP = 10 months). In patients with positive PgR tumors, TTP was 13 months and for negative PgR, TTP was 6 months (P = 0.008). According to the HER2 status, the TTP was 5 months for HER2+ and 10 months for HER2-. Our findings indicate that fulvestrant is an effective alternative for treatment of metastatic breast cancer.

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“…In phase III trials, fulvestrant was active and well-tolerated in patients who failed tamoxifen [24] or non-steroidal AI therapy [25,26], and is recommended in the second-line setting by clinical guidelines [5,6]. Recent evidence also indicates that fulvestrant may be useful in the first-line setting [27]. Ongoing trials will help to elucidate the full potential of this agent in patients with MBC.…”

Section: Endocrine Therapy For Mbcmentioning

confidence: 99%

Optimal treatment strategies in postmenopausal women with hormone-receptor-positive and HER2-negative metastatic breast cancer

Gligorov

Lotz

2008

Breast Cancer Res Treat

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Metastatic breast cancer (MBC) is unfortunately still considered incurable; treatment aims to prolong progression-free and overall survival, relieve disease symptoms, and maintain quality of life. Treatment can include endocrine therapy, radiotherapy, chemotherapy, bisphosphonates, and/or targeted therapy; which is used depends on the characteristics of the disease [e.g., hormone receptor status, disease site(s), and response to previous treatment] and the patient (age, comorbidity, and personal preferences). For most patients with hormone-receptor-positive tumors, the first choice of treatment is further endocrine therapy, but endocrine resistance is a common problem in advanced disease. Several novel anticancer agents have been developed with the aim of overcoming endocrine resistance, many of which target intracellular signaling pathways implicated in disease progression or resistance. Among these, inhibitors of growth factor receptor tyrosine kinases and of mammalian target of rapamycin have shown the most promise in clinical trials. Chemotherapy is the cornerstone of MBC treatment in most women. Important considerations when choosing chemotherapy include the choice of agents, and whether to use single-agent or combination therapy. Anthracyclines are one of the most active cytotoxic agents currently used for the treatment of breast cancer, and for many women, further anthracycline therapy at progression or relapse would be the preferred option. However, lifetime exposure to anthracyclines is limited by cumulative cardiotoxicity, which often prevents rechallenge in later lines of therapy. Newer anthracycline formulations have been developed with lower cardiotoxicity than the conventional anthracycline doxorubicin, but these agents still impair cardiac function, and have maximum recommended lifetime doses. Recently, the concomitant use of cardioprotective agents, such as dexrazoxane, has emerged as an effective approach to reducing the cardiotoxic effects of anthracyclines, thus permitting retreatment. Bisphosphonates, which are not associated with the acute toxicities of cytotoxic chemotherapy drugs, are the established standard of care for patients with metastatic bone disease, and have greatly improved outcomes over the last decade. The search is ongoing for novel agents that will, hopefully, bring a cure closer to reality.

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The Austrian fulvestrant registry: results from a prospective observation of fulvestrant in postmenopausal patients with metastatic breast cancer

Cited by 10 publications

References 32 publications

Predicting benefit from fulvestrant in pretreated metastatic breast cancer patients

Predicting benefit from fulvestrant in pretreated metastatic breast cancer patients

Prolonged time to progression with fulvestrant for metastatic breast cancer

Optimal treatment strategies in postmenopausal women with hormone-receptor-positive and HER2-negative metastatic breast cancer

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