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Herceptin in patients with advanced or metastatic salivary gland carcinomas. A phase II study
Robert Haddad1, A Dimitrios Colevas, Jeffrey F Krane
1Dana Farber Cancer Institute, Department of Adult Oncology, SW430G, 44 Binney Street, Boston, MA 02115, USA. robert_haddad@dfci.harvard.edu
Abstract:
Phase II study of Herceptin (Trastuzumab) in patients with advanced salivary gland tumors overexpressing Her2/neu. Patients with advanced, incurable salivary gland tumors and 2(+) or 3(+) Her2/neu expression in their tumors were enrolled in the study. After an initial dose of 4 mg/kg, patients received 2 mg/kg weekly. Patients were treated until they experienced progression of disease or unacceptable toxicity. The study was closed early when it has become clear that the majority of tumors screened did not overexpress Her2/neu. Fourteen patients were enrolled in the study. A total of 86 cycles of Herceptin were delivered with a median of three cycles per patient (range 1-40). Median time to progression was 4.2 months. One patient with metastatic mucoepidermoid carcinoma has received 40 cycles of Herceptin to date with a documented partial response. Herceptin given as a single agent has a low activity in salivary gland tumors overexpressing Her2/neu. New agents are still needed.
Insights
This study investigated Herceptin (Trastuzumab) for advanced salivary gland tumors. Herceptin showed limited activity in Her2/neu-overexpressing tumors, indicating a need for new therapeutic agents.
Area of Science:
- Oncology
- Medical Research
Background:
- Salivary gland tumors are rare and often aggressive.
- Overexpression of Human Epidermal growth factor Receptor 2 (Her2/neu) is found in some cancers, making it a target for therapy.
Purpose of the Study:
- To evaluate the efficacy of Herceptin (Trastuzumab) as a single agent in patients with advanced salivary gland tumors that overexpress Her2/neu.
Main Methods:
- A Phase II study enrolled patients with advanced, incurable salivary gland tumors and Her2/neu expression (2+ or 3+).
- Patients received Herceptin intravenously: an initial dose of 4 mg/kg followed by 2 mg/kg weekly until disease progression or toxicity.
- The study was terminated early due to a low rate of Her2/neu overexpression in screened tumors.
Main Results:
- Fourteen patients were enrolled, receiving a median of three cycles of Herceptin.
- The median time to disease progression was 4.2 months.
- One patient with metastatic mucoepidermoid carcinoma achieved a partial response and received 40 cycles.
Conclusions:
- Herceptin as a single agent demonstrated low activity in salivary gland tumors with Her2/neu overexpression.
- The findings suggest that novel therapeutic strategies are required for this patient population.
