Abstract
Assessing tumour response using a traditional phase I, II and III trial approach is not without limitations, particularly when targeted therapies are involved. Window of opportunity trials, performed presurgically but differing from neoadjuvant studies, were developed in an attempt to overcome the limitations of the traditional approach. A recent window of opportunity trial, the EORTC 90111-24111-NOCI-HNCG study, evaluated afatinib in treatment-naive patients with squamous cell carcinoma of the head and neck. While this study was the first to demonstrate the activity of afatinib in this setting and to define its potential predictive biomarkers, it also highlighted the challenges associated with the window of opportunity trial design, including the impact of patient selection, tumour site, and other organisational issues. This report details the key learnings from the EORTC 90111-24111-NOCI-HNCG study and provides recommendations to overcome the challenges of this particular trial design.
| Original language | English |
|---|---|
| Pages (from-to) | 219-223 |
| Number of pages | 5 |
| Journal | European Journal of Cancer |
| Volume | 104 |
| DOIs | |
| Publication status | Published - Nov 2018 |
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Perspectives on window of opportunity trials in head and neck cancer : lessons from the EORTC 90111-24111-NOCI-HNCG study. / Schmitz, Sandra; Caballero, Carmela; Locati, Laura D.
In: European Journal of Cancer, Vol. 104, 11.2018, p. 219-223.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Perspectives on window of opportunity trials in head and neck cancer
T2 - lessons from the EORTC 90111-24111-NOCI-HNCG study
AU - Schmitz, Sandra
AU - Caballero, Carmela
AU - Locati, Laura D
N1 - Copyright © 2018 Elsevier Ltd. All rights reserved.
PY - 2018/11
Y1 - 2018/11
N2 - Assessing tumour response using a traditional phase I, II and III trial approach is not without limitations, particularly when targeted therapies are involved. Window of opportunity trials, performed presurgically but differing from neoadjuvant studies, were developed in an attempt to overcome the limitations of the traditional approach. A recent window of opportunity trial, the EORTC 90111-24111-NOCI-HNCG study, evaluated afatinib in treatment-naive patients with squamous cell carcinoma of the head and neck. While this study was the first to demonstrate the activity of afatinib in this setting and to define its potential predictive biomarkers, it also highlighted the challenges associated with the window of opportunity trial design, including the impact of patient selection, tumour site, and other organisational issues. This report details the key learnings from the EORTC 90111-24111-NOCI-HNCG study and provides recommendations to overcome the challenges of this particular trial design.
AB - Assessing tumour response using a traditional phase I, II and III trial approach is not without limitations, particularly when targeted therapies are involved. Window of opportunity trials, performed presurgically but differing from neoadjuvant studies, were developed in an attempt to overcome the limitations of the traditional approach. A recent window of opportunity trial, the EORTC 90111-24111-NOCI-HNCG study, evaluated afatinib in treatment-naive patients with squamous cell carcinoma of the head and neck. While this study was the first to demonstrate the activity of afatinib in this setting and to define its potential predictive biomarkers, it also highlighted the challenges associated with the window of opportunity trial design, including the impact of patient selection, tumour site, and other organisational issues. This report details the key learnings from the EORTC 90111-24111-NOCI-HNCG study and provides recommendations to overcome the challenges of this particular trial design.
U2 - 10.1016/j.ejca.2018.07.315
DO - 10.1016/j.ejca.2018.07.315
M3 - Article
C2 - 30301582
VL - 104
SP - 219
EP - 223
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
ER -