Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors.
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Authors
Piccart, MJ
Hilbers, FS
Bliss, JM
Caballero, C
Frank, ES
Renault, P
Naït Kaoudjt, R
Schumacher, E
Spears, PA
Regan, MM
Gelber, RD
Davidson, NE
Norton, L
Winer, EP
BIG-NABCG Collaboration,
Hilbers, FS
Bliss, JM
Caballero, C
Frank, ES
Renault, P
Naït Kaoudjt, R
Schumacher, E
Spears, PA
Regan, MM
Gelber, RD
Davidson, NE
Norton, L
Winer, EP
BIG-NABCG Collaboration,
Document Type
Journal Article
Date
2020-12-01
Date Accepted
2020-08-18
Abstract
An important challenge in the field of cancer is finding the balance between delivering effective treatments and avoiding adverse effects and financial toxicity caused by innovative, yet expensive, drugs. To address this, several treatment de-escalation trials have been conducted, but only a few of these have provided clear answers. A few trials had poor accrual or had design flaws that led to conflicting results. Members of the Breast International Group (BIG) and North American Breast Cancer Group (NABCG) believe the way forward is to understand the lessons from these trials and listen more carefully to what truly matters to our patients. We reviewed several adjuvant trials of different cancer types and developed a road map for improving the design and implementation of future de-escalation trials. The road map incorporates patients' insights obtained through focused group discussions across the BIG-NABCG networks. Considerations for the development of de-escalation trials for systemic adjuvant treatment, including noninferiority trial design, choice of end points, and prioritization of a patient's perspectives, are presented in this consensus article.
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020, 38 (34), pp. 4120 - 4129
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Source Title
Publisher
LIPPINCOTT WILLIAMS & WILKINS
ISSN
0732-183X
eISSN
1527-7755
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Research Team
Clinical Trials & Statistics Unit