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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...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Japan
2018
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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 |
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author | 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 |
author_facet | 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 |
author_sort | Ohtani, Shoichiro |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5996009 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer Japan |
record_format | MEDLINE/PubMed |
spelling | pubmed-59960092018-06-25 Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY) 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 Breast Cancer Original Article 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. Springer Japan 2018-02-12 2018 /pmc/articles/PMC5996009/ /pubmed/29435730 http://dx.doi.org/10.1007/s12282-018-0843-y Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Article 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 Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY) |
title | Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY) |
title_full | Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY) |
title_fullStr | Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY) |
title_full_unstemmed | Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY) |
title_short | Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY) |
title_sort | bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase ii prospective study (just-study) |
topic | Original Article |
url | 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 |
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