Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting
| Autor: | Hiroki Ikezawa, Chiyomi Egawa, Junji Tsurutani, Toshiyuki Matsuoka, Kenichi Inoue, Hirofumi Mukai, Yukinori Sakata, Masato Takahashi, Takashi Yamanaka |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Adult medicine.medical_specialty Neutropenia Receptor ErbB-2 Phase II Studies Antineoplastic Agents Breast Neoplasms Kaplan-Meier Estimate 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Japan Asian People Post-marketing study Diabetes mellitus Internal medicine medicine Product Surveillance Postmarketing Humans Pharmacology (medical) Overall survival Eribulin Furans Aged Pharmacology Aged 80 and over business.industry Proportional hazards model Cancer Ketones Middle Aged medicine.disease Confidence interval 030104 developmental biology Peripheral neuropathy Treatment Outcome Oncology chemistry 030220 oncology & carcinogenesis Observational study Female business |
| Zdroj: | Investigational New Drugs |
| ISSN: | 1573-0646 0167-6997 |
| Popis: | SummaryBackground Data on eribulin as the first- or second-line treatment in a clinical setting, especially the overall survival (OS) of patients, are scarce. Therefore, we assessed the effectiveness and safety of eribulin as the first-, second-, and third- or later-line treatments in patients with human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in Japan. Methods This multicenter, prospective, post-marketing, observational study enrolled patients from September 2014 to February 2016 in Japan and followed them for 2 years. Patients were categorized by eribulin use into the first-, second-, and third- or later-line treatment groups. Results Of 651 registered patients, 637 patients were included in the safety and effectiveness analysis. In all, first-, second-, and third or later-line treatment groups, median OS (95% confidence interval) were 15.6 (13.8–17.6), 22.8 (17.3–31.0), 16.3 (12.4–19.9), and 12.6 (11.2–15.1) months and time to treatment failure (TTF) (95% confidence interval) were 4.2 (3.7–4.4), 5.2 (3.7–5.9), 4.2 (3.7–5.1), and 3.8 (3.5–4.2) months, respectively. Prolonged TTF was associated with complications of diabetes and the development of peripheral neuropathy after eribulin treatment, according to multivariate Cox regression analysis. Grade ≥ 3 adverse drug reactions (ADRs) were reported in 61.7% of the patients. Neutropenia (49.5%) was the most common grade ≥ 3 ADR in all groups. Conclusions The effectiveness and safety results of eribulin as the first- or second-line treatment were favorable. Thus, these suggest eribulin may be a first-line treatment candidate for patients with HER2-negative advanced breast cancer in Japan. |
| Databáze: | OpenAIRE |
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