Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group

F Mosele; J Remon; J Mateo; C B Westphalen; F Barlesi; M P Lolkema; N Normanno; A Scarpa; M Robson; F Meric-Bernstam; N Wagle; A Stenzinger; J Bonastre; A Bayle; S Michiels; I Bièche; E Rouleau; S Jezdic; J-Y Douillard; J S Reis-Filho; R Dienstmann; F André

doi:10.1016/j.annonc.2020.07.014

Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group

Ann Oncol. 2020 Nov;31(11):1491-1505. doi: 10.1016/j.annonc.2020.07.014. Epub 2020 Aug 24.

Authors

F Mosele¹, J Remon², J Mateo³, C B Westphalen⁴, F Barlesi¹, M P Lolkema⁵, N Normanno⁶, A Scarpa⁷, M Robson⁸, F Meric-Bernstam⁹, N Wagle¹⁰, A Stenzinger¹¹, J Bonastre¹², A Bayle¹³, S Michiels¹², I Bièche¹⁴, E Rouleau¹⁵, S Jezdic¹⁶, J-Y Douillard¹⁶, J S Reis-Filho¹⁷, R Dienstmann¹⁸, F André¹⁹

Affiliations

¹ Department of Medical Oncology, Gustave Roussy, Villejuif, France.
² Department of Medical Oncology, Centro Integral Oncológico Clara Campal (HM-CIOCC), Hospital HM Delfos, HM Hospitales, Barcelona, Spain.
³ Clinical Research Program, Vall Hebron Institute of Oncology (VHIO) and Vall d'Hebron University Hospital, Barcelona, Spain.
⁴ Comprehensive Cancer Center Munich and Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.
⁵ Department of Medical Oncology, Erasmus MC Cancer Center, Rotterdam, the Netherlands.
⁶ Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori, 'Fondazione G. Pascale' - IRCCS, Naples, Italy.
⁷ ARC-Net Research Centre and Department of Diagnostics and Public Health - Section of Pathology, University of Verona, Verona, Italy.
⁸ Breast Medicine and Clinical Genetics Services, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
⁹ Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, USA.
¹⁰ Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, USA.
¹¹ Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany.
¹² Department of Biostatistics and Epidemiology, Gustave Roussy, University Paris-Saclay, Villejuif, France; Oncostat U1018, Inserm, University Paris-Saclay, labeled Ligue Contre le Cancer, Villejuif, France.
¹³ Department of Medical Oncology, Gustave Roussy, Villejuif, France; Department of Biostatistics and Epidemiology, Gustave Roussy, University Paris-Saclay, Villejuif, France; Oncostat U1018, Inserm, University Paris-Saclay, labeled Ligue Contre le Cancer, Villejuif, France.
¹⁴ Department of Genetics, Institut Curie, Paris Descartes University, Paris, France.
¹⁵ Cancer Genetic Laboratories, Department of Medical Biology and Pathology, Gustave Roussy Cancer Campus, Villejuif, France.
¹⁶ Scientific and Medical Division, European Society for Medical Oncology, Lugano, Switzerland.
¹⁷ Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, USA.
¹⁸ Oncology Data Science Group, Molecular Prescreening Program, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
¹⁹ Department of Medical Oncology, Gustave Roussy, Villejuif, France; Inserm, Gustave Roussy Cancer Campus, UMR981, Villejuif, France; Paris Saclay University, Orsay, France. Electronic address: education@esmo.org.

PMID: 32853681
DOI: 10.1016/j.annonc.2020.07.014

Abstract

Next-generation sequencing (NGS) allows sequencing of a high number of nucleotides in a short time frame at an affordable cost. While this technology has been widely implemented, there are no recommendations from scientific societies about its use in oncology practice. The European Society for Medical Oncology (ESMO) is proposing three levels of recommendations for the use of NGS. Based on the current evidence, ESMO recommends routine use of NGS on tumour samples in advanced non-squamous non-small-cell lung cancer (NSCLC), prostate cancers, ovarian cancers and cholangiocarcinoma. In these tumours, large multigene panels could be used if they add acceptable extra cost compared with small panels. In colon cancers, NGS could be an alternative to PCR. In addition, based on the KN158 trial and considering that patients with endometrial and small-cell lung cancers should have broad access to anti-programmed cell death 1 (anti-PD1) antibodies, it is recommended to test tumour mutational burden (TMB) in cervical cancers, well- and moderately-differentiated neuroendocrine tumours, salivary cancers, thyroid cancers and vulvar cancers, as TMB-high predicted response to pembrolizumab in these cancers. Outside the indications of multigene panels, and considering that the use of large panels of genes could lead to few clinically meaningful responders, ESMO acknowledges that a patient and a doctor could decide together to order a large panel of genes, pending no extra cost for the public health care system and if the patient is informed about the low likelihood of benefit. ESMO recommends that the use of off-label drugs matched to genomics is done only if an access programme and a procedure of decision has been developed at the national or regional level. Finally, ESMO recommends that clinical research centres develop multigene sequencing as a tool to screen patients eligible for clinical trials and to accelerate drug development, and prospectively capture the data that could further inform how to optimise the use of this technology.

Keywords: genomic alterations; metastatic cancers; next-generation sequencing (NGS).

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Carcinoma, Non-Small-Cell Lung*
High-Throughput Nucleotide Sequencing
Humans
Lung Neoplasms*
Male
Medical Oncology
Practice Guidelines as Topic
Precision Medicine