Comparing comparators: a look at control arms in kidney cancer studies over the years.
In the past decade, an increasing number of frequently positive randomised clinical trials have been completed, allowing new consideration of the present therapeutic armamentarium for advanced renal cell carcinoma. These studies were predominantly designed to compare the experimental drugs with 1 of 2 active control arms: interferon alpha-2a or sorafenib. Different from expectations, the final results of some of these studies were not in line with the predictions, and the reasons have not been fully investigated. Consequently, there is a great need for careful analysis of the studies carried out so far, chiefly the role and validity of the control arms. In this regard, the examination of patient baseline characteristics and other factors of potential interest seems fundamental for a correct analysis of the results of these trials and consequent optimal use of the available targeted agents.
Department of Medical Oncology, Ospedale San Donato, Istituto Toscano Tumori, Arezzo, Italy.
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Bracarda
Department of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.
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Porta
Department of Medical Oncology, Ospedale San Donato, Istituto Toscano Tumori, Arezzo, Italy.
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Sisani
Department of Medical Oncology, Ospedale San Donato, Istituto Toscano Tumori, Arezzo, Italy.
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Marrocolo
Department of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.
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Paglino
Department of Medical Oncology, Ospedale San Donato, Istituto Toscano Tumori, Arezzo, Italy.
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Hamzaj
Department of Medical Oncology, Ospedale San Donato, Istituto Toscano Tumori, Arezzo, Italy.
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D Buono
Department of Medical Oncology, Ospedale San Camillo Forlanini, Rome, Italy.
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Sternberg
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D007680:Kidney Neoplasms / Q000188:drug therapy*; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives; D010671:Phenylurea Compounds / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D011994:Recombinant Proteins / Q000008:administration & dosage; D000077157:Sorafenib
D000970:Antineoplastic Agents; D016898:Interferon-alpha; D010671:Phenylurea Compounds; D011994:Recombinant Proteins; D009536:Niacinamide; D011092:Polyethylene Glycols; D000077157:Sorafenib; C100416:peginterferon alfa-2a