title: Treating patients with metastatic renal carcinoma: an escape from Phase III.
abstract: The wide availability of drugs for the treatment of advanced renal cell carcinoma has recently provided many alternatives for patients historically treated with immunotherapy alone. The six drugs currently available for the treatment of metastatic renal cell carcinoma became available to physicians after the approval processes performed by regulatory agencies, based mainly on the results of Phase III studies. Owing to the stringent entry criteria of the studies, patients are not representative of the entire population. Results of Phase III studies are extrapolated to all renal cell carcinoma populations without taking into account patients with different comorbidities. The purpose of this review is to analyze and weigh the safety data available for the drugs approved for metastatic renal cell carcinoma and to suggest the best therapy in terms of both efficacy and safety based on the multiplicity of features of each patient in relation to the main characteristics of each agent.
authors: IRCCS Istituto Oncologico Veneto, Medical Oncology, Via Gattamelata, 64-35128 Padua, Italy. fable.zustovich@ioveneto.it
authors: Fable
authors: F
authors: Zustovich
authors: Giuseppe
authors: G
authors: Lombardi
authors: Patrizia
authors: P
authors: Farina
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D054715:Cardiotoxins / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D051379:Mice; D051381:Rats; D051437:Renal Insufficiency / Q000139:chemically induced; D058570:TOR Serine-Threonine Kinases / Q000037:antagonists & inhibitors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D054715:Cardiotoxins; C546842:MTOR protein, human; D058570:TOR Serine-Threonine Kinases