[Assessment of the clinical efficacy and safety of fulvestrant in heavily pretreated patients with hormone-receptor positive metastatic breast cancer-a single-institution experience].
Masaya HattoriAkiyo HorioMasataka SawakiNaoto KondoTakashi FujitaAya UshioNaomi GondoAi IdotaMari IchikawaHiroji Iwata
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Abstract:
Fulvestrant, a pure estrogen receptor antagonist with no known agonist effects, was approved in September 2011 for the treatment of hormone-receptor positive metastatic breast cancer(MBC)in postmenopausal women in Japan. Here, we present a retrospective review of data from 73 heavily pretreated patients who received a high-dose regimen of fulvestrant in our hospital. Patients received a median of 3 endocrine therapies(range: 1-7)prior to the fulvestrant regimen. Partial response was observed in 4 patients, and 10 patients experienced stable disease for more than 6 months(objective response rate: 5.5%; clinical benefit rate: 19.2%). The median time to progression was 2.8 months. Fulvestrant was well tolerated; however, Grade 3 neuropathy at the injection site was observed in 2 patients. Of 12 patients, 3 responded to endocrine therapy following fulvestrant treatment. Our clinical experience indicates that fulvestrant can be administered to patients pretreated with several lines of endocrine therapy, although its efficacy as first- or second-line endocrine therapy has been demonstrated in clinical trial settings.Keywords:
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e12537 Background: Fulvestrant is a selective estrogen receptor degrader approved as monotherapy for postmenopausal women with estrogen-receptor-positive metastatic breast cancer (MBC) who progress following anti-estrogen therapy. The recent Phase 3 FALCON study for hormone therapy (HT) naïve women showed increased median progression-free survival (PFS) (16.6 months) in fulvestrant treated patients (pts) compared with anastrozole (13.8 months), but real-world data are lacking. This study examined the real-world effectiveness of fulvestrant monotherapy as first (L1) or second line (L2) treatment after MBC diagnosis. Methods: This was a retrospective medical record review from 10 US community oncology practices. Female pts initiated fulvestrant monotherapy as the first HT after MBC diagnosis, administered as L1 or as L2 treatment following L1 chemotherapy. Fulvestrant was initiated between 1/1/2011 and 12/31/2015. Pts were classified as HT naïve; and HT relapse status: early relapse (≤12 months of adjuvant HT completion), late relapse (>12 months). Time to first chemotherapy (TTC), PFS, and overall survival (OS) were evaluated using Kaplan-Meier analyses. Results: The study included 121 pts: mean (SD) age 65.7 (11.4) years, 81.8% Caucasian, 94.2% postmenopausal/undocumented, and 92.0% HER2-/undocumented. Overall, 15.7% were de novo metastatic and 86.0% initiated fulvestrant in L1. At the start of fulvestrant, 40.5% had visceral metastasis. The study results (Table 1) suggest better outcomes (TTC, PFS, OS) in HT naïve and late relapse pts, than early relapse pts. Conclusions: First line fulvestrant in the real-world setting demonstrates comparable PFS benefit to clinical trial results and appeared successful in delaying chemotherapy initiation in HT naïve and late relapse pts. This finding supports the use of fulvestrant monotherapy as the first hormonal therapy in a metastatic setting. [Table: see text]
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Background: Endocrine therapy was recommended as the preferred first-line treatment for hormone receptor-positive (HR+, i.e., ER+ and/or PgR+), human epidermal growth factor receptor-2-negative (HER2−) postmenopausal advanced breast cancer (ABC), but which endocrine monotherapy is optimal lacks consensus. We aimed to identify the optimal endocrine monotherapy with a network meta-analysis. Methods: We performed a network meta-analysis for a comprehensive analysis of 6 first-line endocrine monotherapies (letrozole, anastrozole, exemestane, tamoxifen, fulvestrant 250 mg and 500 mg) for HR+ HER2− metastatic or locally advanced breast cancer in postmenopausal patients. The main outcomes were objective response rate (ORR), time to progression (TTP), and progression-free survival (PFS). Secondary outcomes were adverse events. Results: We identified 27 articles of 8 randomized controlled trials including 3492 patients in the network meta-analysis. For ORR, the treatments ranked in descending order of effectiveness were letrozole > exemestane > anastrozole > fulvestrant 500 mg > tamoxifen > fulvestrant 250 mg. For TTP/PFS, the order was fulvestrant 500 mg > letrozole > anastrozole > exemestane > tamoxifen > fulvestrant 250 mg. We directly compared adverse events and found that tamoxifen produced more hot flash events than fulvestrant 250 mg. Conclusions: Fulvestrant 500 mg and letrozole might be optimal first-line endocrine monotherapy choices for HR+ HER2− ABC because of efficacious ORR and TTP/PFS, with a favorable tolerability profile. However, direct comparisons among endocrine monotherapies in the first-line therapy setting are still required to robustly demonstrate any differences among these endocrine agents. Clinical choices should also depend on the specific disease situation and duration of endocrine therapy.
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Metastatic hormone receptor (HR)-positive, HER2-negative breast cancer is an important cause of cancer mortality. Endocrine treatment with or without additional targeted therapies has been the mainstay of treatment. This trial was designed to evaluate the combination of fulvestrant plus everolimus versus fulvestrant, everolimus, and anastrozole compared with fulvestrant alone in the first-line treatment of advanced HR-positive, HER2-negative breast cancer.This randomized placebo-controlled trial included postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had received no prior systemic therapy for metastatic disease. Participants were randomized to one of three treatment arms and the primary outcome was progression-free survival (PFS), comparing combinations of fulvestrant and everolimus with or without anastrozole with fulvestrant alone. Circulating tumor cells (CTC), as measured with two different methods, and circulating tumor DNA (ctDNA) were evaluated serially prior to treatment and the beginning of the second cycle of therapy.Due in part to changes in clinical practice, the study was closed after accruing only 37 participants. There was no evidence that everolimus-containing combination treatment improved PFS or overall survival relative to fulvestrant alone. When modeled continuously, an association was observed of baseline CTC and ctDNA with poorer survival.Although power of the study was limited, the findings were unable to support the routine use of everolimus combination endocrine therapy in the first-line treatment of advanced hormone-sensitive breast cancer. Prognostic impact of baseline ctDNA and copy-number variations in CTC was demonstrated.
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