Phase II trial of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2–positive salivary duct carcinoma
Journal of Clinical Oncology Jan 12, 2019
Takahashi H, et al. - In this single-center, single-arm, open-label, phase 2 study in Japan with 57 salivary duct carcinoma (SDC) patients, the overall response rate, the clinical benefit rate, progression-free survival, overall survival, and toxicity were assessed following treatment with trastuzumab plus docetaxel. Patients with locally advanced and/or recurrent or metastatic human epidermal growth factor receptor 2–positive SDC were administered trastuzumab at a loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks, and docetaxel 70 mg/m2 every 3 weeks. A manageable toxicity profile and encouraging efficacy were demonstrated by trastuzumab plus docetaxel therapy in this patient population, with a 70.2% overall response rate, an 84.2% clinical benefit rate, and median progression-free and overall survival times of 8.9 months and 39.7 months, respectively. Anemia (91%) was the most frequently reported adverse event, followed by a decreased WBC count (89%) and neutropenia (88%). A decreased neutrophil count (60%) was documented as most frequently detected grade 4 adverse event. Grade 3 febrile neutropenia was reported in eight patients (14%).
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