ABSTRACT

The development of Herceptin needs to be situated in the highly charged world of cancer treatment research. At its launch, Herceptin was hailed for pointing the way towards better cancer treatments, which other firms should follow by developing other treatments targeted at tumours with particular expression profiles. Trials of Herceptin took place in the mid-1990s and recruited only women with tumours that overexpressed HER-2 identified by immunohistochemical (IHC) staining. Herceptin is only indicated as a monotherapy either as a frontline or adjuvant treatment when chemotherapy has also been tried in patients, otherwise it is used alongside standard chemotherapy. Patients therefore are likely to experience many of the side effects associated with these drugs. Furthermore, since its clinical development, evidence that Herceptin itself produces adverse reactions in patients has grown. The Food and Drug Administration (FDA) label warns in particular about the increased risk of cardiomyopathy and pulmonary toxicity reported in patients on Herceptin regimes compared to standard chemotherapy.