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Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY)

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 f...

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Detalles Bibliográficos
Autores principales: Ohtani, Shoichiro, Nakayama, Takahiro, Yoshinami, Tetsuhiro, Watanabe, Ken-ichi, Hara, Fumikata, Sagara, Yasuaki, Kawaguchi, Hidetoshi, Higaki, Kenji, Matsunami, Nobuki, Hasegawa, Yoshie, Takahashi, Masato, Mizutani, Makiko, Morimoto, Takashi, Sato, Masako, Itoh, Mitsuya, Morita, Satoshi, Masuda, Norikazu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Japan 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5996009/
https://www.ncbi.nlm.nih.gov/pubmed/29435730
http://dx.doi.org/10.1007/s12282-018-0843-y
Descripción
Sumario: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/m(2) on days 1 and 8 of a 21-day cycle) in the first cycle; change of dosing schedule (1.4 mg/m(2) 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.