Current drug development and trial designs in neuro-oncology: report from the first American Society of Clinical Oncology and Society for Neuro-Oncology Clinical Trials Conference - 28/03/23

Doi : 10.1016/S1470-2045(23)00005-0

Rifaquat Rahman, MD ^a,⁎^{*
Contributed equally} , Mei-Yin C Polley, PhD ^e,^{*
Contributed equally}, Laura Alder, MD ^f, Priscilla K Brastianos, MD ^b,^g, Carey K Anders, ProfMD ^f, Hussein A Tawbi, ProfMD PhD ^h, Minesh Mehta, ProfMD ⁱ, Patrick Y Wen, ProfMD ^c,^j, Susan Geyer, PhD ^k, John de Groot, ProfMD ^m, Gelareh Zadeh, ProfMD PhD ⁿ, Steven Piantadosi, ProfMD PhD ^d, Evanthia Galanis, ProfMD ^l,^{*
Contributed equally}, Mustafa Khasraw, ProfMD ^f,^{*
Contributed equally}

^a Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

^b Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

^c Centre for Neuro-Oncology, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

^d Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

^e Department of Public Health Sciences, University of Chicago, Chicago, IL, USA

^f Duke Cancer Institute, Duke University Medical Center, Durham, NC, USA

^g Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

^h MD Anderson Cancer Center, Houston, TX, USA

ⁱ Miami Cancer Institute, Baptist Hospital, Miami, FL, USA

^j Center for Neuro-Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA

^k Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA

^l Department of Oncology, Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA

^m University of California San Francisco Brain Tumor Center, San Francisco, CA, USA

ⁿ Department of Neurological Surgery University of Toronto, Toronto, ON, Canada

^* Correspondence to: Dr Rifaquat Rahman, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115, USA Department of Radiation Oncology Dana-Farber Cancer Institute Brigham and Women’s Hospital Harvard Medical School Boston MA 02115 USA

Summary

Successful drug development for people with cancers of the CNS has been challenging. There are multiple barriers to successful drug development including biological factors, rarity of the disease, and ineffective use of clinical trials. Based upon a series of presentations at the First Central Nervous System Clinical Trials Conference hosted by the American Society of Clinical Oncology and the Society for Neuro-Oncology, we provide an overview on drug development and novel trial designs in neuro-oncology. This Review discusses the challenges of therapeutic development in neuro-oncology and proposes strategies to improve the drug discovery process by enriching the pipeline of promising therapies, optimising trial design, incorporating biomarkers, using external data, and maximising efficacy and reproducibility of clinical trials.

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Plan

Introduction

The gap between molecular advances and clinical advances

Precision oncology clinical trial designs that integrate biomarker evaluation

Enrichment design

All-comers design

Biomarker-stratified design

Basket, umbrella, and platform trials

Basket trials

Umbrella trials

Platform trials

External data for trial design and analysis

Externally controlled single arm trials

Hybrid EACT and RCT designs

Data quality and data sharing

Future of EACT designs

Special considerations for CNS tumour trials

Conclusion

Search strategy and selection criteria

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Vol 24 - N° 4

P. e161-e171 - avril 2023 Retour au numéro

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Current drug development and trial designs in neuro-oncology: report from the first American Society of Clinical Oncology and Society for Neuro-Oncology Clinical Trials Conference - 28/03/23

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