[HTML][HTML] Perspectives on window of opportunity trials in head and neck cancer: lessons from the EORTC 90111-24111-NOCI-HNCG study

S Schmitz, C Caballero, LD Locati - European Journal of Cancer, 2018 - Elsevier
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 …

Activity of afatinib administered in a window pre-operative study in squamous cell carcinoma of the head and neck (SCCHN): EORTC-90111.

JPH Machiels, J Menis, M Lia, C Fortpied, R Lhommel… - 2016 - ascopubs.org
6049 Background: Targeted agents (TA) are often investigated in unselected end-stage
cancer patients (pts), making difficult to fully evaluate their activity and impairing translational …

PREDICTOR (UNICANCER GEP11): Randomized phase II study of preoperative afatinib in untreated head and neck squamous cell carcinoma (HNSCC) patients.

C Le Tourneau, JP Delord, G Dolivet, O Malard… - 2017 - ascopubs.org
6021 Background: Afatinib, a pan-HER irreversible tyrosine kinase inhibitor, demonstrated
limited antitumor activity compared to methotrexate in unselected recurrent and/or metastatic …

[HTML][HTML] Activity and safety of afatinib in a window preoperative EORTC study in patients with squamous cell carcinoma of the head and neck (SCCHN)

JP Machiels, P Bossi, J Menis, M Lia, C Fortpied… - Annals of …, 2018 - Elsevier
Background To investigate the activity and safety of afatinib in the preoperative treatment of
squamous cell carcinoma of the head and neck (SCCHN). Patients and methods This study …

Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically …

B Burtness, JP Bourhis, JB Vermorken, KJ Harrington… - Trials, 2014 - Springer
Background Over 50% of patients with head and neck squamous cell carcinoma (HNSCC)
present with locoregionally advanced disease. Those at intermediate-to-high risk of …

Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck: a randomized clinical trial

B Burtness, R Haddad, J Dinis, J Trigo, T Yokota… - JAMA …, 2019 - jamanetwork.com
Importance Locoregionally advanced head and neck squamous cell cancer (HNSCC) is
treated curatively; however, risk of recurrence remains high among some patients. The …

A phase 1 study of afatinib in combination with postoperative radiation therapy with and without weekly docetaxel in intermediate-and high-risk patients with resected …

DN Margalit, RI Haddad, RB Tishler, NG Chau… - International Journal of …, 2019 - Elsevier
Purpose To determine the maximum tolerated dose and tolerability of (1) afatinib in
combination with postoperative radiation therapy (PORT) for patients with intermediate-risk …

Tumor Microenvironment Modifications Induced by Afatinib in Squamous Cell Carcinoma of the Head and Neck: A Window-of-Opportunity Study (EORTC-90111 …

SP Beyaert, AE Loriot, ND Huyghe, RM Goebbels… - Clinical Cancer …, 2023 - AACR
Abstract Purpose: The EORTC-90111–24111 phase II window study evaluated afatinib
versus no preoperative treatment in patients with primary squamous cell carcinoma of the …

LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected …

B Burtness, J Bourhis, JB Vermorken, L Dai, C Lind… - 2012 - ascopubs.org
TPS5599 Background: Locally advanced squamous cell cancer of the head and neck
(SCCHN) is treated with curative intent, but recurrence and death are common. SCCHN …

LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected …

B Burtness, RI Haddad, J Dinis, JM Trigo Perez… - 2017 - ascopubs.org
6001 Background: Locally advanced HNSCC is treated curatively, but recurrence is
common. In HNSCC, EGFR is richly expressed and EGFR inhibition is validated treatment …