Herceptin (trastuzumab) 150mg ROCHE Switzerland

testimony

Mammary cancer

Patients must be proven to have HER2 overexpression in tumor tissue before initiating Herceptin®, either by immunohistochemistry (staining should score 3+) or by molecular biology techniques (detection of HER2 gene amplification by fluorescence in situ hybridization [FISH ] or chromogenic in situ hybridizations [CISH]).

Metastatic breast cancer with tumor overexpression of HER2:

as monotherapy if patients have already received one or more chemotherapy regimens for the metastatic stage of the disease

in combination with paclitaxel or docetaxel if patients have not yet received chemotherapy for metastatic disease

in combination with an aromatase inhibitor in postmenopausal patients with hormone-positive metastatic breast cancer who have not yet received chemotherapy for the metastatic stage of the disease.

There are no data on patients with breast cancer who received adjuvant therapy with Herceptin® at an early stage of the disease.

Breast cancer with tumor overexpression of HER2 (early stages):

after surgery completion of chemotherapy (neoadjuvant or adjuvant) and, if applicable, radiation therapy

in combination with paclitaxel or docetaxel after adjuvant chemotherapy with doxorubicin and cyclophosphamide;

in combination with adjuvant chemotherapy, which includes docetaxel and carboplatin;

in combination with neoadjuvant chemotherapy followed by Herceptin® as adjuvant therapy for the treatment of locally (including inflammatory) breast cancer or tumors > 2 cm in diameter.

Metastatic gastric cancer or cancer of the gastroesophageal junction

Herceptin in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not previously received chemotherapy for metastatic disease. Herceptin® should only be used in patients with metastatic gastric cancer with tumor overexpression of HER2, i.e. an expression level of 2+ as determined by immunohistochemistry (IHC) and a positive FISH or in situ silver hybridization (SISH) test or expression level 3+ according to the results of a validated IHC analysis.