Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY)
| Autor: | Masako Sato, Hidetoshi Kawaguchi, Satoshi Morita, Makiko Mizutani, Yoshie Hasegawa, Ken-ichi Watanabe, Yasuaki Sagara, Fumikata Hara, Takashi Morimoto, Takahiro Nakayama, Norikazu Masuda, Mitsuya Itoh, Shoichiro Ohtani, Nobuki Matsunami, Kenji Higaki, Masato Takahashi, Tetsuhiro Yoshinami |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
0301 basic medicine Oncology medicine.medical_specialty Bi-weekly schedule Antineoplastic Agents Breast Neoplasms Drug Administration Schedule 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Breast cancer Internal medicine medicine Clinical endpoint Humans Pharmacology (medical) Radiology Nuclear Medicine and imaging Prospective Studies Eribulin Furans Adverse effect Prospective cohort study Aged Aged 80 and over Taxane business.industry General Medicine Ketones Middle Aged medicine.disease Metastatic breast cancer Treatment Outcome 030104 developmental biology chemistry 030220 oncology & carcinogenesis Absolute neutrophil count Female Original Article business Schedule modification |
| Zdroj: | Breast Cancer (Tokyo, Japan) |
| ISSN: | 1340-6868 |
| Popis: | Background This study aimed to investigate whether schedule modification is safe and effective in patients intolerant to the standard eribulin dose and schedule. Methods Patients with metastatic breast cancer (MBC) treated with both anthracycline and taxane and ≤ 3 prior regimens of chemotherapy for MBC received eribulin at the standard dose and schedule (1.4 mg/m2 on days 1 and 8 of a 21-day cycle) in the first cycle; change of dosing schedule (1.4 mg/m2 on days 1 and 15 of a 28-day cycle) was determined by change in neutrophil count, platelet count, aspartate aminotransferase, alanine aminotransferase, total bilirubin, serum creatinine, and non-hematological toxicity on day 8 of the first cycle or day 1 of the second cycle. Clinical benefit rate (CBR; primary endpoint), time to treatment failure (TTF), overall survival (OS), and safety were evaluated. Results Of the 88 patients who were enrolled and received standard eribulin therapy in the first cycle, 42 patients were moved to the bi-weekly therapy group and 40 continued standard therapy. In the bi-weekly and standard therapy groups, mean relative dose intensity was 62.7 and 90.9%, CBR was 31.0 and 25.0%, median TTF was 81.5 and 75 days, and OS was 523 and 412 days, respectively. Neither group reported severe adverse events. Conclusion This is the first study to show that a bi-weekly eribulin schedule is tolerable and has comparable efficacy in patients intolerant to the standard eribulin schedule. Clinical trial registration University Hospital Medical Information Network (UMIN) Center (ID: UMIN 000008491). Electronic supplementary material The online version of this article (10.1007/s12282-018-0843-y) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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