Multicentre, phase II study of eribulin in combination with S-1 in patients with advanced breast cancer
Autor: | Shoichiro Ohtani, Nobuki Matsunami, Yuko Tanabe, Toshimi Takano, Takashi Morimoto, Tsutomu Takashima, Yoshifumi Komoike, Jun Yamamura, Ryoji Kato, Junji Tsurutani, Yutaka Mizuno, Satomi Watanabe, Yasuyuki Kojima, Tsutomu Iwasa, Tetsuhiro Yoshinami, Kazuhiko Nakagawa |
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Rok vydání: | 2019 |
Předmět: |
0301 basic medicine
Oncology Cancer Research Receptor ErbB-2 Phase II study Phases of clinical research chemistry.chemical_compound Breast cancer 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Anthracyclines S-1 Ketones Middle Aged lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens Drug Combinations Receptors Estrogen 030220 oncology & carcinogenesis Female Taxoids TNBC Research Article Eribulin Adult Bridged-Ring Compounds Antimetabolites Antineoplastic medicine.medical_specialty Combination therapy Anthracycline Breast Neoplasms lcsh:RC254-282 Disease-Free Survival 03 medical and health sciences Internal medicine Genetics medicine Humans Furans Aged Tegafur Taxane business.industry Cancer medicine.disease Oxonic Acid 030104 developmental biology chemistry business |
Zdroj: | BMC Cancer, Vol 19, Iss 1, Pp 1-8 (2019) BMC Cancer |
ISSN: | 1471-2407 |
Popis: | 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. |
Databáze: | OpenAIRE |
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