title: What are the reasons for negative phase III trials of molecular-target-based drugs?
abstract: The results of molecular-biological studies of cancer are changing the way we diagnose and treat cancer. Target-based drug discovery selects agents for development based on their mechanisms of action. The interaction between target-based drugs and their targets can be described by classical drug-receptor theory. Clinical trials have demonstrated that some effective target-based drugs induce apoptosis, even though they are considered to be cytostatic. Numerous phase III trials of target-based drugs have been conducted. Although some have yielded strongly positive results, the majority of the results have been negative. This article seeks to clarify the value of molecular-target-based therapy and to discuss the reasons for negative results in phase III trials. The importance of proof-of-principle studies is stressed throughout preclinical and clinical trials of molecular-target-based drugs.
authors.affiliation: National Cancer Center Hospital East, Kashiwa-shi, Chiba 277-8577, Japan. nsaijo@east.ncc.go.jp
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000970:Antineoplastic Agents / Q000145:classification / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017326:Clinical Trials, Phase III as Topic; D016503:Drug Delivery Systems; D015195:Drug Design; D006801:Humans; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents