title: A phase II, multicenter, single-arm trial of eribulin as first-line chemotherapy for HER2-negative locally advanced or metastatic breast cancer.
abstract: The treatment goals for metastatic breast cancer (MBC) are prolonging survival and improving the quality of life. Eribulin, a non-taxane tubulin inhibitor, demonstrated improved survival in previous studies and also showed mild toxicity when used in late-line therapy for MBC. We conducted a phase II study to investigate the efficacy of eribulin mesylate as the first-line chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative MBC. This was a phase II, open-label, single-arm, multicenter trial conducted in Japan. Patients with HER2-negative MBC received intravenous eribulin (1.4 mg/m(2) on days 1 and 8 of each 21-day cycle). The primary efficacy outcome was overall response rate (ORR). Secondary outcomes included time to treatment failure, progression-free survival (PFS), overall survival (OS), and safety. A total of 35 patients were enrolled and received a median of 8 (range 1-21) cycles of eribulin therapy. ORR and clinical benefit rate were 54.3 and 62.9 %, respectively. Median PFS was 5.8 months and median OS was 35.9 months. Grade 3 or 4 neutropenia was observed in 63 % of patients. The majority of non-hematological adverse events were mild in severity. The present trial demonstrated that eribulin has antitumor activity comparable with other key established cytotoxic agents with acceptable safety and tolerability. Thus, eribulin as first-line chemotherapy might be beneficial for patients with HER2-negative MBC.
authors.affiliation: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abeno, Osaka, 5458585 Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takashima
authors.affiliation: Osaka City General Hospital, Osaka, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Tokunaga
authors.affiliation: Seichokai Fuchu Hospital, Izumi, Japan.
authors.forename: Seika
authors.initials: S
authors.lastname: Tei
authors.affiliation: Sumitomo Hospital, Osaka, Japan.
authors.forename: Shigehiko
authors.initials: S
authors.lastname: Nishimura
authors.affiliation: Ishikiri Seiki Hospital, Higashi-Osaka, Japan.
authors.forename: Hidemi
authors.initials: H
authors.lastname: Kawajiri
authors.affiliation: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abeno, Osaka, 5458585 Japan.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Kashiwagi
authors.affiliation: Sumitomo Hospital, Osaka, Japan.
authors.forename: Shigehito
authors.initials: S
authors.lastname: Yamagata
authors.affiliation: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abeno, Osaka, 5458585 Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Noda
authors.affiliation: Ikuwakai Memorial Hospital, Osaka, Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Nishimori
authors.affiliation: Ohno Memorial Hospital, Osaka, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Mizuyama
authors.affiliation: Izumi Municipal Hospital, Izumi, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Sunami
authors.affiliation: Kinki-Cho Chest Medical Center, Sakai, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Tezuka
authors.affiliation: Osaka City General Hospital, Osaka, Japan.
authors.forename: Katsumi
authors.initials: K
authors.lastname: Ikeda
authors.affiliation: Osaka City General Hospital, Osaka, Japan.
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Ogawa
authors.affiliation: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abeno, Osaka, 5458585 Japan.
authors.forename: Naoyoshi
authors.initials: N
authors.lastname: Onoda
authors.affiliation: Kashiwara Municipal Hospital, Kashiwara, Japan.
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Ishikawa
authors.affiliation: Osaka Socio-Medical Center Hospital, Osaka, Japan.
authors.forename: Shinzoh
authors.initials: S
authors.lastname: Kudoh
authors.affiliation: Hanwa Daini Senboku Hospital, Sakai, Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Takada
authors.affiliation: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abeno, Osaka, 5458585 Japan.
authors.forename: Kosei
authors.initials: K
authors.lastname: Hirakawa
keywords: Eribulin mesylate; HER2-negative breast cancer; Metastatic breast cancer; Objective response rate; Survival