Phase II Clinical Trial of First-line Eribulin Plus Trastuzumab for Advanced or Recurrent HER2-positive Breast Cancer
| Autor: | Takayuki Matsuda, Hiroshi Koyama, Nobuyuki Tsunoda, Koichi Sakaguchi, Kazuyoshi Onishi, Akira Sakuyama, Katsuhiko Nakatsukasa, Hiroki Tanaka, Tetsuya Taguchi, Masahide Yamaguchi, Yuji Yoshino, Makoto Kato, Takashi Kikuchi, Ikuya Fujiwara, Mie Onishi |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
0301 basic medicine Oncology Eribulin Mesylate Cancer Research medicine.medical_specialty Receptor ErbB-2 medicine.medical_treatment Breast Neoplasms Neutropenia 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Breast cancer Recurrence Trastuzumab Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Furans Aged Aged 80 and over Chemotherapy business.industry General Medicine Ketones Middle Aged medicine.disease Survival Analysis Regimen Treatment Outcome 030104 developmental biology chemistry 030220 oncology & carcinogenesis Female business Eribulin medicine.drug |
| Zdroj: | Anticancer Research. 38:4073-4081 |
| ISSN: | 1791-7530 0250-7005 |
| DOI: | 10.21873/anticanres.12697 |
| Popis: | Background/aim Eribulin 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 methods Enrolled 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. Results The 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. Conclusion Combination 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. |
| Databáze: | OpenAIRE |
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