Phase II trial of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2–positive salivary duct carcinoma
Journal of Clinical Oncology Nov 23, 2018
Takahashi H, et al. - In patients with locally advanced and/or recurrent or metastatic human epidermal growth factor receptor 2–positive salivary duct carcinoma (SDC), the efficacy and toxicity of trastuzumab plus docetaxel was investigated. In the given patient population, trastuzumab plus docetaxel therapy demonstrated encouraging efficacy and a manageable toxicity profile.
Methods
- Researchers performed this single-center, single-arm, open-label, phase II study in Japan, wherein, they administered trastuzumab at a loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks, to patients.
- They administered docetaxel 70 mg/m2 every 3 weeks.
- The overall response rate was primarly assessed, in addition, the clinical benefit rate, progression-free survival, overall survival, and toxicity were also evaluated.
Results
- This study included 57 eligible patients with SDC.
- The overall response rate and the clinical benefit rate was 70.2% (95% CI, 56.6% to 81.6%) and 84.2% (95% CI, 72.1% to 92.5%), respectively.
- The reported median progression-free survival time was 8.9 months (95% CI, 7.8 to 9.9 months) and median overall survival time was 39.7 months (95% CI, not reached).
- Anemia (52 patients [91%]) was documented as the most frequently experienced adverse event, followed by a decreased WBC count which was seen in 51 patients (89%) and neutropenia in 50 patients (88%).
- Among grade 4 adverse events, a decreased neutrophil count (34 patients [60%]) occurred most frequently.
- Eight patients (14%) were found to have grade 3 febrile neutropenia.
- Findings demonstrated that no grade 2 or greater adverse events of heart failure or left ventricular ejection fraction decline to less than 50% occurred.
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