Bibliographic Details
Title: |
Multicentre, phase II study of eribulin in combination with S-1 in patients with advanced breast cancer |
Authors: |
Tsutomu Iwasa, Junji Tsurutani, Satomi Watanabe, Ryoji Kato, Yutaka Mizuno, Yasuyuki Kojima, Tsutomu Takashima, Nobuki Matsunami, Takashi Morimoto, Jun Yamamura, Shoichiro Ohtani, Yuko Tanabe, Tetsuhiro Yoshinami, Toshimi Takano, Yoshifumi Komoike, Kazuhiko Nakagawa |
Source: |
BMC Cancer, Vol 19, Iss 1, Pp 1-8 (2019) |
Publisher Information: |
BMC, 2019. |
Publication Year: |
2019 |
Collection: |
LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
Subject Terms: |
Eribulin, S-1, Phase II study, Breast cancer, TNBC, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
More Details: |
Abstract Background We previously reported the synergistic effect of S-1 and eribulin in preclinical models. In addition, our phase I study revealed the recommended dose for the phase II study of the combination therapy in advanced breast cancer (ABC) patients pre-treated with anthracycline and taxane. Our current study reports on the efficacy and safety of the combined use of eribulin and S-1 in patients with ABC and poor prognosis. Methods Patients with breast cancer who received prior anthracycline- and/or taxane-based therapy were assigned to receive a combination therapy of eribulin (1.4 mg/m2 on days 1 and 8, every 21 days) and S-1 (65 mg/m2, on days 1 to 14, every 21 days) for advanced/metastatic disease. All patients had at least one clinicopathological factor such as being oestrogen receptor negative, Human Epidermal Growth Factor Receptor 2 (HER2) receptor negative, presence of visceral involvement, presence of three or more metastatic sites, or having a disease-free interval shorter than 2 years. The primary endpoint was the independent-reviewer assessed objective response rate (ORR). Secondary endpoints were clinical benefit rate, disease control rate, progression-free survival (PFS), and overall survival (OS). Results This study enrolled 33 patients. Confirmed ORR was 33.3% (95% CI: 17.3 to 52.8). Median PFS was 7.5 months (95% CI: 4.0 to 14.3). Median OS time was not reached during the current experimental periods. The most common grade 3/4 adverse event was neutropenia (68.8%). Conclusions The combination of eribulin and S-1 is safe and effective for treatment in patients with ABC and poor prognosis. Trial registration Current Controlled Trials UMIN000015049, date of registration: September 5th 2014. |
Document Type: |
article |
File Description: |
electronic resource |
Language: |
English |
ISSN: |
1471-2407 |
Relation: |
http://link.springer.com/article/10.1186/s12885-019-6200-5; https://doaj.org/toc/1471-2407 |
DOI: |
10.1186/s12885-019-6200-5 |
Access URL: |
https://doaj.org/article/0a03588daea444e08474b844baa4c3b0 |
Accession Number: |
edsdoj.0a03588daea444e08474b844baa4c3b0 |
Database: |
Directory of Open Access Journals |
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