Presurgical window of opportunity trial design as a platform for testing anticancer drugs: Pros, cons and a focus on breast cancer

Ruggero De Maria Marchiano, Marcello Maugeri-Saccà, Maddalena Barba, Patrizia Vici, Laura Pizzuti, Domenico Sergi, Teresa Catenaro, Luigi Di Lauro, Marcella Mottolese, Daniele Santini, Michele Milella

Risultato della ricerca: Contributo in rivistaArticolo in rivista

6 Citazioni (Scopus)

Abstract

The high attrition rate is a major issue in anticancer drug development. Among the alternative trial designs, presurgical window of opportunity trials envision a short course treatment in the time window between diagnostic biopsy and surgery in a moderately-sized patient population. This approach allows testing therapeutics when pre- and post-treatment tumor tissues are available for comprehensive molecular analyses. The emerging evidence may help define the ability of a given agent to modulate its target(s) and help obtain a broader picture of the molecular changes operated by the treatment. The resulting gain may outweigh the potential harms for patients in the early disease setting. Window of opportunity trials have been extensively applied to breast cancer. Overall, a wider use of these trial designs might lead to the identification of potential responders, ineffective drugs or combinations, and ultimately contribute to enhance the efficiency of the clinical developmental process.
Lingua originaleEnglish
pagine (da-a)132-142
Numero di pagine11
RivistaCRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
Volume106
DOI
Stato di pubblicazionePubblicato - 2016

Keywords

  • Antineoplastic Agents
  • Attrition rate
  • Breast Neoplasms
  • Breast cancer
  • Cancer therapeutics
  • Clinical Trials as Topic
  • Female
  • Geriatrics and Gerontology
  • Hematology
  • Humans
  • Oncology
  • Preoperative Period
  • Window of opportunity trials

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