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)
| Autor: | Kazushige Futsuhara, Tsuyoshi Saito, Shiori Kaneko, Kenichi Inoue, Satoshi Hata, Satoko Nakano, Takashi Sakurai, Hirofumi Yamada, Masafumi Kurosumi, Kei Kimizuka, Shigenori Nagai |
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| Rok vydání: | 2019 |
| Předmět: |
Oncology
medicine.medical_specialty Time Factors Antineoplastic Agents Hormonal medicine.medical_treatment Breast Neoplasms Cohort Studies 03 medical and health sciences 0302 clinical medicine Breast cancer Asian People Internal medicine medicine Clinical endpoint Humans Endocrine system Prospective Studies Adverse effect Fulvestrant Aged Retrospective Studies Aged 80 and over Chemotherapy business.industry General Medicine Middle Aged medicine.disease Combined Modality Therapy Metastatic breast cancer Postmenopause Treatment Outcome Receptors Estrogen 030220 oncology & carcinogenesis Female 030211 gastroenterology & hepatology Estrogen Receptor Antagonists Neoplasm Recurrence Local business Cohort study medicine.drug |
| Zdroj: | Journal of Nippon Medical School. 86:165-171 |
| ISSN: | 1347-3409 1345-4676 |
| DOI: | 10.1272/jnms.jnms.2019_86-305 |
| Popis: | 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 non-fulvestrant 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. |
| Databáze: | OpenAIRE |
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