Salivary gland cancer, a type of head and neck cancer, is a rare cancer with less than 1,000 patients newly diagnosed annually in Japan1. The standard therapy is primarily surgery, and there is no established chemotherapy for this cancer. Unlike other head and neck cancers, salivary gland cancer includes many histological types, associated with diversity in genomic alterations and prognosis. Less than 15% of all salivary cancers in
'We are very pleased that Herceptin has become a new treatment option as the first personalized medicine for salivary gland cancer, for which no standard chemotherapy has been established so far. I'd like to thank everyone who strongly supported us toward the approval based on evidence from
The approval is based on a Japanese investigator-initiated phase II clinical study (HUON-003-01 study) with 16 patients with HER2-positive advanced or recurrent salivary gland cancer. The study investigated the efficacy and safety of Herceptin in combination with docetaxel. The primary endpoint was the response rate. 60% of 15 patients in the efficacy analysis population showed response (95%Cl: 32.3 - 83.7). Major adverse events included neutropenia, leukopenia, alopecia, anemia, stomatitis, and hypoalbuminemia.
HER2 protein overexpression and gene amplification should be determined with the pathological testing kit
Indications
Breast cancer overexpressing HER2
Advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection
Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection
Dosage and administration
Use either Regimen A or Regimen B for breast cancer overexpressing HER2.
Use Regimen B for advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection, in combination with other antineoplastic agents.
Use Regimen B in combination with docetaxel formulation for advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection.
Regimen A: The usual adult dosage is a loading dose of 4 mg/kg (body weight) trastuzumab (genetical recombination) and subsequent doses of 2 mg/kg once a week, each administered by intravenous infusion over at least 90 minutes.
Regimen B: The usual adult dosage is a loading dose of 8 mg/kg (body weight) trastuzumab (genetical recombination) and subsequent doses of 6 mg/kg every 3 weeks, each administered by intravenous infusion over at least 90 minutes.
If the first infusion is well tolerated, subsequent infusions may be administered over a shorter time of at least 30 minutes.
About Herceptin
Herceptin is a humanized monoclonal antibody that targets human epidermal growth factor receptor type 2 (HER2), which is involved in the growth of tumor cells. Herceptin was launched in 2001 for metastatic breast cancer overexpressing HER2. In 2011, it was approved for the treatment of patients with advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection.
About Salivary Gland Cancer
Salivary gland cancer is a type of head and neck cancer2,3 and develops in the cells that form salivary gland tissues. It is characterized by a variety of histological patterns as classified into 21 types4, making pathological diagnosis difficult5. Recently, gene expression and abnormalities that define features of each histological type have become increasingly clear6. About 80% of salivary gland tumors are in the parotid gland, of which about 20% are malignant2. Standard therapy includes surgery, radiation therapy, and pharmacological treatment, and no standard chemotherapy has been established for advanced or recurrent salivary gland cancer7.
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4. WHO Classification of Head and Neck Tumors. Fourth edition, 2017
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