Clinical trial design for systemic agents in patients with brain metastases from solid tumours: a guideline by the Response Assessment in Neuro-Oncology Brain Metastases working group

The Lancet Oncology
D Ross CamidgePatrick Y Wen

Abstract

Patients with active CNS disease are often excluded from clinical trials, and data regarding the CNS efficacy of systemic agents are usually obtained late in the drug development process or not at all. In this guideline from the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group, we provide detailed recommendations on when patients with brain metastases from solid tumours should be included or excluded in clinical trials of systemic agents. We also discuss the limitations of retrospective studies in determining the CNS efficacy of systemic drugs. Inclusion of patients with brain metastases early on in the clinical development of a drug or a regimen is needed to generate appropriate CNS efficacy or non-efficacy signals. We consider how to optimally incorporate or exclude such patients in systemic therapy trials depending on the likelihood of CNS activity of the agent by considering three scenarios: drugs that are considered very unlikely to have CNS antitumour activity or efficacy; drugs that are considered very likely to have CNS activity or efficacy; and drugs with minimal baseline information on CNS activity or efficacy. We also address trial design issues unique to patients with brain metastases, ...Continue Reading

Citations

Mar 23, 2018·Neuro-oncology·Rute M S M PedrosaJohan M Kros
May 17, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·D Ross CamidgeScott N Gettinger
Jun 30, 2018·Future Oncology·Riccardo SoffiettiRoberta Rudà
Feb 4, 2019·Pigment Cell & Melanoma Research·Zeynep ErogluKeiran S M Smalley
Jan 8, 2019·Neuro-oncology·Norbert GalldiksJörg C Tonn
Jun 9, 2019·Neuro-oncology·Eudocia Q LeePatrick Y Wen
Aug 16, 2019·Current Opinion in Oncology·Riccardo SoffiettiRoberta Rudà
Jan 19, 2019·Nature Reviews. Disease Primers·Achal Singh AchrolSteven D Chang
Jan 5, 2020·Neuro-oncology·Roshal R PatelEthan B Ludmir
Sep 16, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paul W SperdutoMinesh P Mehta
Sep 24, 2019·Biomedical Papers of the Medical Faculty of the University Palacký, Olomouc, Czechoslovakia·Renata BelanovaTomas Kazda
Oct 16, 2018·Frontiers in Oncology·Suneel D Kamath, Priya U Kumthekar
Mar 3, 2020·Frontiers in Neurology·Philipp LohmannNorbert Galldiks
Sep 3, 2020·Nature Reviews. Neurology·Riccardo SoffiettiRoberta Rudà
May 16, 2020·Future Oncology·Clemence HenonLizza El Hendriks
Jul 7, 2018·Therapeutic Advances in Medical Oncology·Nuria KoteckiAhmad Awada
Jan 17, 2020·Pharmaceutics·Marco CavacoVera Neves
May 12, 2020·Frontiers in Oncology·Elizabeth PanJorge Nieva
Aug 30, 2020·Journal for Immunotherapy of Cancer·Florian CamyMichel Peoc'h
Dec 1, 2020·British Journal of Cancer·Caroline BailleuxThomas Bachelot
Oct 13, 2020·The Canadian Journal of Neurological Sciences. Le Journal Canadien Des Sciences Neurologiques·Philip J O'HalloranPaul Kongkham
Jan 27, 2021·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·David Chun Cheong Tsui, D Ross Camidge
Nov 23, 2019·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Rudolf M HuberD Ross Camidge
Feb 1, 2021·Neurosurgery·Philip C De Witt HamerMitchel S Berger
Jul 3, 2021·Current Treatment Options in Oncology·Eudocia Q Lee
Aug 29, 2021·Critical Reviews in Oncology/hematology·Janna Josephus Anna Oda SchoenmaekersLizza Elisabeth Lucia Hendriks
Aug 30, 2021·Annals of Oncology : Official Journal of the European Society for Medical Oncology·S Popat, L Welsh
Jul 12, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·N U Lin

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.