Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors.

Piccart, Martine J, Hilbers, Florentine S, Bliss, Judith M, Caballero, Carmela, Frank, Elizabeth S, Renault, Patrick, Naït Kaoudjt, Rachida, Schumacher, Eva, Spears, Patricia A, Regan, Meredith M, Gelber, Richard D, Davidson, Nancy E, Norton, Larry, Winer, Eric P, BIG-NABCG Collaboration (December 2020) Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors. Journal of Clinical Oncology, 38 (34). pp. 4120-4129. ISSN 0732-183X

DOI: 10.1200/JCO.20.01382


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.

Item Type: Paper
Subjects: diseases & disorders > cancer
diseases & disorders
diseases & disorders > neoplasms
diseases & disorders > cancer > cancer types > breast cancer
diseases & disorders > cancer > drugs and therapies > chemotherapy
diseases & disorders > cancer > drugs and therapies
CSHL Authors:
Communities: CSHL labs > Wigler lab
SWORD Depositor: CSHL Elements
Depositing User: CSHL Elements
Date: 1 December 2020
Date Deposited: 01 Jun 2021 19:38
Last Modified: 01 Feb 2024 16:51

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