Herceptin therapy

Leyland-Jones B. Maximizing the response to Herceptin therapy through optimal use and patient selection. Anticancer Drugs 2001 12(suppl 4) S11- S17. 

Suter TM, Cook-Brunsb, Bartonc C. Cardiotoxicity associated with trastuzumab (Herceptin) therapy in the treatment of metastatic breast cancer. The Breast. 2004 13(3) 173-183. 

The fourth broad use of a test result is concerned with patient management. In a patient with a chronic disease, the result may be used to select the type of intervention and assess the effectiveness of an intervention, and the action will be to change or continue the treatment. In women with metastatic breast cancer, the HER-2/ e status is used to assess the potential usefulness of Herceptin therapy. In a person with diabetes, hemoglobin (Hb) Ai measurements are used to assess glyceraic control and thus the effectiveness of therapy. 

Sample preparation has emerged as a key issue in recent years, in large part due to use of IHC assays for HER2 to qualify patients for Herceptin therapy in clinical trials. 

HER2 Testing as a Prerequisite for Herceptin Therapy Development of Commercially Available and Validated Testing Methodologies... 

Fig. 5.5 HER2 testing algorithm for identifying patients eligible for Herceptin therapy [58].

Help to determine the optimal duration of adjuvant Herceptin therapy. 

Standardization of IHC/ICC has been a critical issue for more than three decades, especially with the advances in targeted therapy such as the development of trastuzumab (Herceptin) for advanced breast cancer.51 Nevertheless, standardization is a difficult issue because numerous factors may influence the consistency and reliability of immunostaining results, including fixatives, fixation time, AR, antibody clones, detection system, and interpretation (see Part II). In cytopathology, the situation is even worse due to its variable cell sample preparation techniques. Cytopreparation is. .. the foundation of cytomorphology. 52 We believe it is also the foundation of ICC. Therefore, standardization of ICC needs to start with uniform and reliable cytopreparation. 

Herceptin is the only approved HER2 therapy designed to bind to HER2-h tumor cells and flag ttiem for destruction by the immune system... 

F. Role in therapy In untreated HER2-overexpressing metastatic breast cancer, the addition of Herceptin to paclitaxel increases response rates and time to progression it... 

While no biopharmaceutical is approved with the requirement of genotyping as a part of its therapeutic indication, a recently approved monoclonal antibody therapy against breast cancer, trastuzumab (Herceptin), is indicated only for those tumors measurably expressing the protein expressed by the gene erbB-2. Because the oncogene product of erbB-2 is elevated... 

BOX 14.1. HOW HERCEPTIN NAS APPROVED AS A THERAPY THAT REQUIRES HER2 EXPRESSION TESTS ON PATIENT TUMOR TISSUES BEFORE USE... 

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