• Koichi Sakaguchi, Katsuhiko Nakatsukasa, Hiroshi Koyama, Makoto Kato, Akira Sakuyama, Takayuki Matsuda, Nobuyuki Tsunoda, Ikuya Fujiwara, Masahide Yamaguchi, Hiroki Tanaka, Kazuyoshi Onishi, Mie Onishi, Yuji Yoshino, Takashi Kikuchi, and Tetsuya Taguchi.
• Kyoto Prefectural University of Medicine, Kyoto, Japan ksak@koto.kpu-m.ac.jp.
• Anticancer Res. 2018 Jul 1; 38 (7): 4073-4081.

Background/AimEribulin mesylate has been approved for advanced or metastatic breast cancers subjected to at least two previous chemotherapy regimens. The present multicenter, phase II, single-arm study assessed the efficacy and safety of a first-line regimen of eribulin plus trastuzumab for untreated advanced or metastatic HER2-positive breast cancer.Patients And MethodsEnrolled patients received eribulin (1.4 mg/m2 intravenously; I.V.) on days 1 and 8 of each 21-day cycle, an initial trastuzumab dose (8 mg/kg I.V.) on day 1, and 6 mg/kg of trastuzumab on day 1 of each subsequent cycle. The primary endpoint was the response rate (RR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety. Twenty-eight patients (median age: 62.5 years) received a median of 12 (range: 2-53) cycles of eribulin plus trastuzumab.ResultsThe RR was 53.6% [complete response (CR), 4; partial response (PR), 11] with a median PFS of 344 days. The clinical benefit rate was 64.0%. Grade 3/4 adverse events were observed in 12 (42.9%) patients. For details, neutropenia in 8 (28.6%) patients, peripheral neuropathy in 2 (7.1%) patients, interstitial pneumonia in 1 (3.6%) patient, ALT elevation in 1 (3.6%) patient, osteonecrosis of the jaw in 1 (3.6%) patient, and fatigue in 1 (3.6%) patient. The patient with osteonecrosis received denosumab, too. No symptomatic congestive heart failure was observed.ConclusionCombination therapy of eribulin plus trastuzumab is acceptable in efficacy and safety, and a capable option for first-line advanced or recurrent HER2-positive breast cancer.Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

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