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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

1424 - EXPRESS study - A Multicenter, Prospective Trial In Progress Exploring The Association Between Low Level Of Genomic Alteration And Exceptional And Unexpected Response To Targeted Therapies In Patients With Solid Tumors

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Translational Research

Presenters

Antoine Italiano

Citation

Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269

Authors

A. Italiano1, O. Le Saux2, F. André3, T. Filleron4, D. Spaeth5, P. Heudel6, L. Albiges7, T. Bachelot6, A. Gonçalves8, J. Pierga9, F. Barlesi10, V. Boige11, C. Lebbé12, L. Mortier13, J. Frenel14, O. Tredan15, M. Jimenez16, F. Legrand17, C. Ferté18

Author affiliations

  • 1 Early Phase Trials Unit, Institute Bergonié, 33076 - Bordeaux/FR
  • 2 Service D'oncologie Médicale, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
  • 3 Breast Cancer Unit, Department Of Medical Oncology, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 4 Statistique, Centre Claudius-Regaud, 31052 - Toulouse/FR
  • 5 Service D'oncologie, Centre d'Oncologie de Gentilly, 54100 - Nancy/FR
  • 6 Service D'oncologie Médicale, Centre Léon Bérard, 69008 - Lyon/FR
  • 7 Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 8 Service D'oncologie Médicale, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 9 Service D'oncologie Médicale, Institut Curie, 75248 cedex5 - Paris/FR
  • 10 Service D'oncologie Médicale, Aix-Marseille University - Faculté de Médecine Nord, 13015 - Marseille/FR
  • 11 Département De Médecine / Comité 040, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 12 Paris, Hôpital St. Louis, 75010 - Paris/FR
  • 13 Department Of Dermatology, Hôpital Huriez, Lille University Hospital, lille/FR
  • 14 Service D'oncologie Médicale, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 15 Département D'oncologie Médicale, Centre Léon Bérard, 69008 - Lyon/FR
  • 16 R&d, Unicancer, Paris/FR
  • 17 R&d, UNICANCER, 75654 - Paris/FR
  • 18 Département De Médecine Oncologique, Institut Gustave Roussy, 94800 - Villejuif/FR
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Resources

Abstract 1424

Background

Most anticancer drugs are approved by making marginal improvements in terms of tumor response or survival in non-selected populations, and are highly heterogeneous at the molecular level. Studying patients who present an exceptional and unexpected response (ER) to these drugs could enable the rapid identification of novel treatment response biomarkers, accelerate drug development and, more broadly, lead to a better understanding of the biology of cancer cells. Several studies are currently recruiting to build cohorts of patients, in order to subsequently analyze their tumors and reveal in detail the molecular anomalies associated with exceptional response.

Trial design

This is an exploratory, multicenter, multicohort, prospective trial conducted in 264 adult patients, with advanced breast, lung, colorectal, ovarian, kidney cancers and melanoma, having presented an ER to an approved antineoplastic targeted therapy. ER is defined using the definition chosen by the NCI which combines the three criteria: -complete or partial response -lasting > 6 months -and not expected in > 10% of the patients in this drug – organ situation. The primary objective is to assess whether ER can be associated with a low level of genomic instability in the tumor. Low genomic instability is defined by the presence of less than the 5th quantile of genomic alterations (mutations, amplifications, deletions) to be expected in the given tumor type as per TCGA database. For each tumor type, the null hypothesis H0: π = 0.05 will be tested, against the one-sided alternative hypothesis π > 0.05. For each of the 6 cohorts, a sample size of 44 patients is necessary to achieve 80% power at π = 15 with a one-sided level 5% test. Patients presenting an ER will be identified retrospectively, in a nationwide manner, then monthly reviewed and validated for inclusion by a panel of pathology experts. As of May 2018, 56 patients have been included. The identification of molecular traits associated with ER might serve the development of predictive classifiers for precision medicine. This study also represents a unique opportunity to better understand cancer biology.

Clinical trial identification

NCT02701907.

Legal entity responsible for the study

UNICANCER R&D.

Funding

Fondation ARC.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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