The ideal chemotherapeutic agent for use in a first-line trastuzumab-based combination therapy regimen for HER2-positive breast cancer remains under debate. Therefore, to maximize therapeutic effectiveness, it is important to maintain the patient's quality of life (QOL) and ensure the long-term administration of therapy to the extent possible. The National Comprehensive Cancer Network (NCCN) guidelines ( 5) recommend the administration of a preoperative trastuzumab-containing chemotherapy regimen for more than nine weeks before the surgical treatment of HER2-positive breast cancer and suggest a trastuzumab + pertuzumab + taxane or trastuzumab ± other chemotherapy regimen as a first-line treatment.ĭespite the existence of these multiple guidelines and consensus regarding the initial treatment of HER2-positive advanced and recurrent breast cancers, no single standard treatment has been identified and currently available options mainly focus on “care” rather than “cure”. The American Society of Clinical Oncology (ASCO) guideline ( 4) recommends a combination regimen comprising trastuzumab + pertuzumab + taxane for the first-line treatment of HER2-positive recurrent breast cancer. The Physician Data Query (PDQ) ( 3) recommends that a standard first-line treatment for stage IIIB, IIIC, and IV progressive and relapse HER2-positive breast cancers should comprise single-agent chemotherapy + trastuzumab. This response rate can be enhanced by combining trastuzumab with other chemotherapeutic drugs. However, the reported response rates following trastuzumab monotherapy was 19% ( 2). Currently, human epidermal growth factor receptor-2 (HER2)-positive tumors account for approximately 15% of all breast cancers, and HER2 overexpression has been identified as a poor prognosticator.Ĭurrently, the molecular targeted drug trastuzumab is recommended as a standard therapy for HER2-positive metastatic breast cancer. In Japan, more than 90,000 patients are newly diagnosed with breast cancer each year, and the annual number of deaths due to breast cancer currently exceeds 13,000 ( 1). 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.īreast cancer is the most common cancer among women, and the numbers of affected patients and related deaths continue to increase annually. No symptomatic congestive heart failure was observed. The patient with osteonecrosis received denosumab, too. 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. Grade 3/4 adverse events were observed in 12 (42.9%) patients. Results: The RR was 53.6% with a median PFS of 344 days. Twenty-eight patients (median age: 62.5 years) received a median of 12 (range: 2–53) cycles of eribulin plus trastuzumab. The secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety. The primary endpoint was the response rate (RR). Patients and Methods: Enrolled patients received eribulin (1.4 mg/m 2 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 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. Background/Aim: Eribulin mesylate has been approved for advanced or metastatic breast cancers subjected to at least two previous chemotherapy regimens.
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