Clinical trial design and end points for epidermal growth factor receptor-targeted therapies: implications for drug development and practice.

Introduction There is an increased perception that current chemotherapeutic drugs have almost reached a ceiling as systemic anticancer therapies. In great part because of their unpredictable side effects, the development of these cytotoxic drugs followed certain patterns and principles that may not necessarily apply to modern molecule-targeted antineoplastic strategies. In the following commentary, some of these differences will be highlighted. Using the EGFR network as a model of a therapeutic target in cancer, key aspects that apply to the clinical development of EGFR-directed drugs will be discussed. These issues may well apply to many other molecule-targeted strategies in preclinical and clinical development.