Fulvestrant 500 mg in postmenopausal patients with metastatic breast cancer: the initial clinical experience

Ishida, Naoko; Araki, Kazuhiro; Sakai, Takehiko; Kobayashi, Kokoro; Kobayashi, Takayuki; Fukada, Ippei; Hosoda, Mitsuchika; Yamamoto, Misazō; Ichinokawa, Kazuomi; Takahashi, Shunji; Iwase, Takuji; Ito, Yoshiaki; Yamashita, Hiroko

doi:10.1007/s12282-015-0612-0

Cited by 11 publications

(11 citation statements)

References 18 publications

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“…In the retrospective trial from Ishida and co-authors, 117 patients were treated with HD fulvestrant. In this cohort, CBR was 42% and median time to progression (TTP) was 6 months; previous endocrine sensitivity and absence of liver metastasis correlated with TTP [ 29 ]. In our prospective trial, we evaluated the efficacy of fulvestrant in the clinical daily practice.…”

Section: Discussionmentioning

confidence: 99%

Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial

et al. 2017

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The observational prospective trial herein presented aimed at evaluating the efficacy of fulvestrant 500 mg in the treatment of endocrine sensitive advanced breast cancer patients from the real world setting. The primary end point was clinical benefit rate (CBR). Secondary end points were overall survival (OS), progression free survival (PFS) and tolerability. One hundred sixty three patients were enrolled. At a median follow up of 20 months, the 61% of patients reached CBR, whose median duration was 10.8 months. Median PFS and OS were 7 and 35 months, respectively. Endocrine sensitive patients showed better PFS and OS. No relevant toxicity appeared when analyzing safety data. In multivariate analysis, visceral involvement, endocrine sensitivity and previous endocrine therapy were prognostic factor for PFS, whereas endocrine sensitivity and metastasis at diagnosis had prognostic relevance for OS. Estrogen receptor expression >50%, single metastatic site, and no prior endocrine therapy for advanced disease were predictive of CBR. In this prospective trial, fulvestrant 500 mg appeared to be a safe and active treatment and confirmed its efficacy in the daily clinical practice. A high percent expression of estrogen receptors (above 50%) was associated with higher CBR. Treatment was very well tolerated. Endocrine sensitivity had a major impact on treatment outcome. As expected, patients who had received first-line endocrine therapy for advanced disease exhibited worse outcome and a lower CBR.

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Section: Discussionmentioning

confidence: 99%

Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial

et al. 2017

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“…In two studies on Japanese women with advanced breast cancer treated with fulvestrant were reported that PFS was 5.4-5.5 months [13,14]. In another study by Ishida et al [15], fulvestrant in Japanese women with metastatic breast cancer that progressed after endocrine therapy was found that the median time to progression was 6.1 months.…”

Section: Discussionmentioning

confidence: 98%

The effects of fulvestrant treatment on hormone receptor-positive metastatic breast cancer

Arıcı

Geredeli

Seçmeler

et al. 2020

The European Research Journal

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Objectives: To determine fulvestrant efficacy and tolerability in Turkish patients with hormone receptor-positive metastatic breast cancer. Methods: Patients who developed metastasis while taking tamoxifen or aromatase inhibitors in the adjuvant period or metastatic disease at the diagnosis. Fulvestrant 500 mg was administered intramuscularly every 28 days. Progression-free survival (PFS) and overall survival (OS) durations were calculated. Results: In this particular research, totally 137 patients were participated. Median PFS was 9 months (95% CI, 5.7-10.3). The 12-month PFS rate was calculated as 42%, and the 36-month PFS rate was 17%. The median PFS was not reached in the first line use of fulvestrant in the metastatic period but 9 months and 7 months in the second and subsequent lines respectively. Results indicated that this difference was statistically significant (p = 0.002). It was shown that patients with liver and brain metastasis had lower PFS compared patients with no liver and no brain metastasis. The estimated median OS was 38 months after fulvestrant started. The 12month OS rate was calculated as 82.4%, and the 36-month OS rate was 50%. Conclusions: Fulvestrant contributes both PFS and OS in patients with hormone receptor-positive metastatic breast cancer and this effect is more clear in using fulvestrant as first-line treatment.

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“…Several cohort studies focusing on fulvestrant have been reported both in Japan and abroad 8,9 . In a cohort study As to subsequent therapy after fulvestrant, the response to chemotherapy was significantly higher than that to endocrine therapy.…”

Section: Discussionmentioning

confidence: 99%

“…To date, no data have been reported from clinical trials in which fulvestrant was administered first, for progressive cancer, versus treatment with a CDK 4/6 inhibitor added to fulvestrant. However, in cases in which the duration of previous endocrine therapy is long and there is no liver metastasis, it may be an option to start treatment with fulvestrant alone 8 .…”

Section: Discussionmentioning

confidence: 99%

Multicenter Observational Study of Fulvestrant 500 mg in Postmenopausal Japanese Women with Estrogen Receptor-Positive Advanced or Recurrent Breast Cancer after Prior Endocrine Treatment (SBCCSG29 Study)

Kimizuka¹,

Inoue

Nagai

et al. 2019

J Nippon Med Sch

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Background: Fulvestrant 500 mg has been an option for endocrine therapy for advanced or recurrent breast cancer after prior endocrine treatment since November 2011 in Japan. This study aimed to clarify the effectiveness and safety of fulvestrant 500 mg in clinical settings. Methods: This was a multicenter, both prospective and retrospective, observational study of 132 postmenopausal women (median age 66) with locally advanced or metastatic breast cancer, who had been treated with fulvestrant. Information from medical records was retrospectively obtained from 9 hospitals (Saitama Breast Cancer Clinical Study Group: SBCCSG) in Saitama prefecture, Japan, from October 2012 to April 2014. The primary end point was time to treatment failure (TTF). The secondary end points were overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), and adverse events (AE) (CTCAE ver. 4). The choice of subsequent therapy after fulvestrant was also evaluated. Results: The median TTF was 6.1 months. Median OS was 28.5 months (the starting date was the first day of fulvestrant). ORR was 12.9% and CBR was 45.5%. The most common AEs were injection site reactions (9.1%). The rate of grade 3 AE was only 2.3% (3/132). The number of patients who underwent subsequent therapy after fulvestrant were 54 (55.7%) receiving chemotherapy, 42 (43.3%) receiving nonfulvestrant endocrine therapy, and 1 (1%) receiving mammalian target of rapamycin inhibitor (mTORi) + endocrine therapy (ET). Conclusion: Fulvestrant 500 mg is an effective and safe treatment for patients with advanced or recurrent breast cancer after prior endocrine treatment.

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Fulvestrant 500 mg in postmenopausal patients with metastatic breast cancer: the initial clinical experience

Abstract: Background: Fulvestrant 500 mg is currently approved for the treatment of postmenopausal

Cited by 11 publications

References 18 publications

Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial

Fulvestrant 500 milligrams as endocrine therapy for endocrine sensitive advanced breast cancer patients in the real world: the Ful500 prospective observational trial

The effects of fulvestrant treatment on hormone receptor-positive metastatic breast cancer

Multicenter Observational Study of Fulvestrant 500 mg in Postmenopausal Japanese Women with Estrogen Receptor-Positive Advanced or Recurrent Breast Cancer after Prior Endocrine Treatment (SBCCSG29 Study)

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