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Poster display session

3021 - Hope for salivary gland cancer (SGC): EORTC HNCG/UKCRN 1206 randomized phase II study to evaluate the efficacy and safety of Chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic androgen receptor (AR) expressing SGC

Date

10 Sep 2017

Session

Poster display session

Presenters

Laura Locati

Citation

Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374

Authors

L.D. Locati1, C. Caballero2, C. Fortpied2, F. Perrone3, S. Pilotti4, K.J. Harrington5, V. Grégoire6, L. Licitra7

Author affiliations

  • 1 Head And Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Medical, EORTC, 1200 - Brussels/BE
  • 3 Molecular Pathology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
  • 4 Anatomic Pathology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 5 Radiotherapy And Imaging, Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, London/GB
  • 6 Dept. Radiation Oncology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 7 Head And Neck Medical Oncology Unit, Fondazione Irccs Istituto Nazionale Tumori Milano, 20133 - Milan/IT
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Resources

Abstract 3021

Background

SGCs are rare and heterogenous tumors (

Trial design

In this multicenter, randomized, phase II intergroup study a total of 76 treatment naïve patients (Cohort A) are planned to be randomized to receive ADT or platinum-based chemotherapy. Previously treated patients will be enrolled in a separate Cohort B to receive ADT. Patients from Cohort A randomized to chemotherapy can also enter Cohort B at disease progression. The primary endpoint is PFS for Cohort A and best overall response for Cohort B. Central testing of AR expression is based on staining intensity (0 = negative to 3 = strong) and percentage of positive nuclear stained cells (0 = ≤10% to 3 = ≥70%). AR overexpression requires a maximum score of 3 on both scales. Mechanisms of AR activation and resistance will be studied. This study is led by EORTC Head and Neck Cancer Group with UNICANCER/REFCOR, International Rare Cancer Initiative UK Salivary Gland Cancer Group and RARECARENet. It will run in 35 sites in 10 countries: Austria, Belgium, France, Germany, Greece, Hungary, Italy, Portugal, The Netherlands, and United Kingdom. Sites from the EURACAN European Reference Network are participating. Currently, 36 patients are registered; 20 have AR overexpression, of which 16 have been randomized in Cohort A. Identification of AR as a treatment target in SGC can be practice changing.

Clinical trial identification

EORTC 1206 HNCG http://clinicaltrials.gov/ct/show/NCT01969578

Legal entity responsible for the study

European Organization for Research and Treatment of Cancer

Funding

EORTC ICR RARECAREnet Fondazione IRCCS Istituto Nazionale dei Tumori

Disclosure

All authors have declared no conflicts of interest.

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