title: Metabolic and toxicological considerations of botanicals in anticancer therapy.
abstract: BACKGROUND
  Cancer is a complex disease, characterized by redundant aberrant signaling pathways as a result of genetic perturbations at different levels. Botanicals consist of a complex mixture of constituents and exhibit pharmacological effects by the interaction of many phytochemicals. The multitarget nature of botanicals could, therefore, be a relevant strategy to address the biological complexity that characterizes tumors.
  
  
  METHODS
  This article reviews the current status of botanicals in the oncological field and the challenges associated with their complex nature.
  
  
  CONCLUSIONS
  Botanicals are an important new pharmacological strategy, which are potentially exploitable in the oncological area but are characterized by a number of problems still unresolved. Content variation of products is one of the primary problems with botanicals and, consequently, there is a concern about the therapeutic consistency in marketed batches. Furthermore, metabolic interactions with antineoplastic drugs and the genotoxic potential of botanicals need to be properly addressed throughout the various phases of botanical drug development. These issues not only pose a serious problem to the approvability of those botanical products as new drugs but also present as a limitation to their post-approval clinical use.
authors.affiliation: Alma Mater Studiorum-University of Bologna, Department of Pharmacology, Via Irnerio 48, 40126 Bologna, Italy. carmela.fimognari@unibo.it
authors.forename: Carmela
authors.initials: C
authors.lastname: Fimognari
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Ferruzzi
authors.forename: Eleonora
authors.initials: E
authors.lastname: Turrini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Carulli
authors.forename: Monia
authors.initials: M
authors.lastname: Lenzi
authors.forename: Patrizia
authors.initials: P
authors.lastname: Hrelia
authors.forename: Giorgio
authors.initials: G
authors.lastname: Cantelli-Forti
mesh_terms: D000818:Animals; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D004249:DNA Damage / Q000187:drug effects; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical / Q000379:methods; D004347:Drug Interactions; D015507:Drugs, Investigational; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D008517:Phytotherapy; D018675:Toxicity Tests / Q000379:methods
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D015507:Drugs, Investigational