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.
| Original language | English |
|---|---|
| Pages (from-to) | 132-142 |
| Number of pages | 11 |
| Journal | Critical Reviews in Oncology/Hematology |
| Volume | 106 |
| DOIs | |
| Publication status | Published - Oct 1 2016 |
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Keywords
- Attrition rate
- Breast cancer
- Cancer therapeutics
- Window of opportunity trials
ASJC Scopus subject areas
- Hematology
- Oncology
- Geriatrics and Gerontology
Cite this
Presurgical window of opportunity trial design as a platform for testing anticancer drugs : Pros, cons and a focus on breast cancer. / Maugeri-Saccà, Marcello; Barba, Maddalena; Vici, Patrizia; Pizzuti, Laura; Sergi, Domenico; Catenaro, Teresa; Di Lauro, Luigi; Mottolese, Marcella; Santini, Daniele; Milella, Michele; De Maria, Ruggero.
In: Critical Reviews in Oncology/Hematology, Vol. 106, 01.10.2016, p. 132-142.Research output: Contribution to journal › Review article
}
TY - JOUR
T1 - Presurgical window of opportunity trial design as a platform for testing anticancer drugs
T2 - Pros, cons and a focus on breast cancer
AU - Maugeri-Saccà, Marcello
AU - Barba, Maddalena
AU - Vici, Patrizia
AU - Pizzuti, Laura
AU - Sergi, Domenico
AU - Catenaro, Teresa
AU - Di Lauro, Luigi
AU - Mottolese, Marcella
AU - Santini, Daniele
AU - Milella, Michele
AU - De Maria, Ruggero
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
KW - Attrition rate
KW - Breast cancer
KW - Cancer therapeutics
KW - Window of opportunity trials
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UR - http://www.scopus.com/inward/citedby.url?scp=84994860524&partnerID=8YFLogxK
U2 - 10.1016/j.critrevonc.2016.08.004
DO - 10.1016/j.critrevonc.2016.08.004
M3 - Review article
AN - SCOPUS:84994860524
VL - 106
SP - 132
EP - 142
JO - Critical Reviews in Oncology/Hematology
JF - Critical Reviews in Oncology/Hematology
SN - 1040-8428
ER -