| Herceptin®: a well-tolerated treatment option
Data from pivotal clinical trials and extensive clinical experience in over 500,000 patients have demonstrated that Herceptin® is generally well tolerated and has a predictable safety profile in both EBC and MBC. Herceptin® can be given in combination with a wide range of chemotherapies and other agents, such as hormonal therapy, with minimal addition to the toxicity of these other treatments.1-5 Furthermore, Herceptin® is not metabolised by cytochrome P450 and is not subject to pharmacokinetic drug–drug interactions,6 so it can be given irrespective of co-medications.
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| Table 1.1 Herceptin® adds little to the toxicity of chemotherapy: non-haematological adverse events reported in >20% of patients in trial M770017 (reprinted with permission from the American Society of Clinical Oncology) |
Cardiac dysfunction and infusion-related reactions can occur with Herceptin® treatment. However, these events arise relatively infrequently. In addition, cardiac events are generally reversible, manageable with standard therapeutic interventions and patients potentially at risk can mostly be identified prior to initiation of Herceptin.
The safety of prolonged use of Herceptin® in MBC has been demonstrated8 and in four large Phase III trials of adjuvant Herceptin® in EBC, 1 year of Herceptin® therapy did not increase the overall severity of non-cardiac adverse events associated with the chemotherapeutic regimens.9-13
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