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
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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