title: Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who had well-defined taxane resistance.
abstract: No clinical evidence on the efficacy and safety of eribulin monotherapy has been obtained by a prospective clinical study in patients with metastatic breast cancer (MBC) who had well-defined taxane resistance. The present Phase II, multicenter, single-arm, open-label study aimed to obtain the evidence. Japanese female patients, aged 33-74 years who had the metastasis of taxane-resistant and histopathologically confirmed breast cancer, received eribulin mesylate 1.4 mg/m(2) (equivalent to eribulin 1.23 mg/m(2) [expressed as free base]) as a 2- to 5-min intravenous infusion on days 1 and 8 of each 21-day cycle. The primary endpoint was the clinical benefit rate (CBR) [complete response (CR), partial response (PR), and long-term stable disease (LSD) ≥24 weeks]. A total of 51 patients underwent chemotherapy cycles (median 4; range 1-42 cycles). The CBR was 39.2 % (CR 2.0 %; PR 23.5 %; and LSD 13.7 %), and the rate of progressive disease was 49.0 %. The median progression-free survival and the median overall survival were 3.6 months [95 % confidence interval (CI) 2.6-4.6 months] and 11.7 months (95 % CI 9.2-14.2 months), respectively. Grade 3 or greater adverse events were leukopenia (23.5 %), neutropenia (35.3 %), anemia (5.9 %), and febrile neutropenia (7.8 %). The incidences of grade 3 and 4 peripheral sensory neuropathy were 2.0 and 0 %, respectively. Eribulin showed a clinically manageable tolerability profile by dose adjustments or symptomatic treatment. Eribulin was effective and well tolerated in heavily pretreated patients with MBC who had well-defined taxane resistance, thus providing a potential therapeutic option in the clinical settings.
authors.affiliation: Division of Breast Oncology, Saitama Cancer Center, 780 Komuro, Ina-machi, Kita-adachi-gun, Saitama, 362-0806, Japan. ino.bad.ken@gmail.com.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Department of Breast Surgery, Saitama Red Cross Hospital, Saitama, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Saito
authors.affiliation: Department of Breast Unit, Toda Central General Hospital, Saitama, Japan.
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Okubo
authors.affiliation: Department of Breast Surgery, Kasukabe Municipal Hospital, Saitama, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Kimizuka
authors.affiliation: Department of Surgery, Sekishindo Hospital, Saitama, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yamada
authors.affiliation: Division of Surgery, JCHO Saitama Medical Center, Saitama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sakurai
authors.affiliation: Breast Center, Dokkyo Medical University Koshigaya Hospital, Saitama, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Ishizuna
authors.affiliation: Breast Center, Mitsui Hospital, Saitama, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hata
authors.affiliation: Shintoshin Ladies' Mammo Clinic, Saitama, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Kai
authors.affiliation: Department of Pathology, Saitama Cancer Center, Saitama, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kurosumi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005663:Furans / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D007659:Ketones / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D000095662:Polyether Polyketides
chemical_list: D000970:Antineoplastic Agents; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Eribulin mesylate; Estrogen receptor; Human epidermal growth factor receptor 2-negative; Metastatic breast cancer; Taxane resistance; Triple-negative