Lani

The following are articles discussing the use of Faslodex (which is usually given as part of a “compassionate use” program and which is, by the way, given as an injection) and Herceptin:


1: Eur J Cancer. 2005 Oct 14; [Epub ahead of print]
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Fulvestrant ('Faslodex') in pre-treated patients with advanced breast cancer: A single-centre experience.

Steger GG, Bartsch R, Wenzel C, Pluschnig U, Hussian D, Sevelda U, Locker GJ, Gnant MF, Jakesz R, Zielinski CC.

Division of Oncology, Department of Internal Medicine I, Medical University of Vienna, 18-20 wahringer Gurtel, A-1090 Vienna, Austria.

Fulvestrant ('Faslodex') is a new oestrogen receptor (ER) antagonist with no agonist effects. This report describes the experience of a single centre including 126 postmenopausal women with advanced breast cancer (ABC) in a fulvestrant Compassionate Use Programme. All patients had previously received endocrine treatment for early or ABC. Patients received fulvestrant as first- (n=7), second- (n=51), third- (n=50) or fourth-line endocrine therapy (n=18) for ABC (median duration of treatment: 4 months [range 3-27(+) months], follow-up: 13 months [range 1-38(+) months]). Twelve patients had partial responses (PR) and 43 patients experienced stable disease (SD) 6 months (objective response rate: 9.5%; clinical benefit [CB] rate: 43.6%). Ten of 12 patients with a PR had HER2-negative tumours, and 9/12 had ER-positive and progesterone receptor (PgR)-positive disease (two patients had unknown HER2 status and one had unknown ER and PgR status). Nine of the 18 patients with HER2-positive tumours experienced CB with fulvestrant. Although CB rates were similar when fulvestrant was given as first- to fourth-line endocrine treatment, the proportion of those experiencing CB who had a PR appeared to decrease when fulvestrant was used later in the sequence. Fulvestrant was well tolerated; six patients experienced adverse events (all grade I/II). These data demonstrate that fulvestrant is an effective and well-tolerated therapy for patients with ABC progressing on prior therapies.

PMID: 16230005 [PubMed - as supplied by publisher]


1: Cancer Treat Rev. 2005;31 Suppl 2:S17-25. Epub 2005 Sep 29.
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Case studies of fulvestrant ('Faslodex') in postmenopausal women with advanced breast cancer.

Abram P, Maass N, Rea D, Simon SD, Steger GG.

Belvoir Park Hospital, Hospital Road, Belfast, Northern Ireland, UK.

Fulvestrant is a new oestrogen receptor (ER) antagonist that is licensed for the treatment of postmenopausal women with advanced breast cancer progressing following antioestrogen treatment and may also be effective in those progressing after non-steroidal aromatase inhibitors. The use of fulvestrant in a Compassionate Use Programme (CUP) in a 'real-life' setting has permitted its activity and tolerability profile in patients with different disease characteristics to be observed. Here, we present five case reports of fulvestrant use in postmenopausal women with advanced breast cancer progressing after prior endocrine therapy. Clinical experience from the CUP supports the published clinical trial data and suggests that fulvestrant is a valuable new treatment for postmenopausal women with advanced breast cancer, including those with visceral metastases and human epidermal growth factor receptor 2-positive disease.

PMID: 16199128 [PubMed - in process]


1: Cancer Treat Rev. 2005;31 Suppl 2:S10-6. Epub 2005 Sep 28.
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Fulvestrant ('Faslodex'): Clinical experience from the Compassionate Use Programme.

Steger GG, Gips M, Simon SD, Lluch A, Vinholes J, Kaufman B, Wardley A, Mauriac L.

Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, 18-20 Wahringer Gurtel, A-1090 Vienna, Austria.

Fulvestrant ('Faslodex') is a new oestrogen receptor (ER) antagonist with no agonist effects that is licensed in the USA, Brazil, Europe and elsewhere for the treatment of advanced breast cancer (ABC) in postmenopausal women following progression on other endocrine agents. This report consolidates clinical experience from the 'Faslodex' Compassionate Use Programme, including a total of 339 patients treated at eight cancer centres. Patients received fulvestrant as first- (n=22), second- (n=125), third- (n=105), fourth- (n=58), fifth- (n=22) or sixth-line (n=5) hormonal treatment for ABC, with two patients receiving fulvestrant after more than six other endocrine therapies. Objective response was achieved by 40 patients and stable disease lasting 6 months by 92 patients, giving overall clinical benefit (CB) in 132/339 patients (39%). The CB rate decreased as fulvestrant was used later in the sequence of endocrine treatments, from 46% (10/22) with first-line fulvestrant to 27% (6/22) with fifth-line fulvestrant. Increased benefit was found in patients with tumours expressing both ER and progesterone receptor (PgR) compared with other combinations, although good activity was reported in patients expressing either ER or PgR as well as in tumours expressing human epidermal growth factor receptor 2. Fulvestrant was well tolerated; adverse events were noted in 18/339 patients (5%). These findings concur with data from the clinical-trial setting and further support the assertion that greater benefit is derived when fulvestrant is used early in the treatment sequence.

PMID: 16198057 [PubMed - in process]
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1: Cancer Treat Rev. 2005;31 Suppl 2:S26-33. Epub 2005 Sep 28.
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The future of fulvestrant ('Faslodex').

Howell A.

CRUK Department of Medical Oncology, University of Manchester, Christie Hospital NHS Trust, Wilmslow Road, Manchester M20 4BX, UK.

Changes in clinical practice regarding favoured first-line and adjuvant treatments for postmenopausal women with advanced breast cancer (ABC) mean that it is becoming increasingly important to identify agents that are effective following aromatase inhibitor (AI) failure as well as tamoxifen failure. Fulvestrant ('Faslodex') is a new oestrogen receptor (ER) antagonist with no agonist effects that binds, blocks and degrades the ER. Fulvestrant is at least as effective as anastrozole following tamoxifen failure and also shows activity after progression on AIs. Its very good tolerability profile and novel mode of action, might offer potential for the use of fulvestrant in combination regimens, and there is also scope for investigating the use of loading and higher dose regimens in an attempt to further enhance efficacy. Here, the rationale and evidence for the efficacy of fulvestrant following AI failure and its combination with AIs and novel agents such as gefitinib and trastuzumab will be reviewed. The ongoing clinical development programme for fulvestrant will more fully the role of this valuable new agent in the treatment of postmenopausal ABC.

PMID: 16198056 [PubMed - in process]



1: Cancer Treat Rev. 2005;31 Suppl 2:S3-9. Epub 2005 Sep 28.
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Clinical development of fulvestrant ('Faslodex').

Howell A, Abram P.

CRUK Department of Medical Oncology, University of Manchester, Christie Hospital NHS Trust, Wilmslow Road, Manchester M20 4BX, UK.

This paper outlines the development of fulvestrant, the first in a new class of antioestrogen agents with no agonist effects, to be used for the treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. The role of the oestrogen receptor in breast cancer growth and development and the evolution of pharmacological strategies to manipulate it are also discussed. Preclinical and clinical evidence for the efficacy of fulvestrant are also reviewed, along with the tolerability profile of this agent in relation to other endocrine therapies. Further research will define the role of this exciting new agent in the endocrine treatment of breast cancer.

PMID: 16198055 [PubMed - in process]

As you can see, these are hot off the press. AND IN FACT TWO MORE ARTICLES ON FULVESTRANT CAME in the last 2 WEEKs