Oncology phase I trial design and conduct: time for a change - MDICT Guidelines 2022.

Autor:	Araujo D; Hospital de Base, Sao Jose do Rio Preto, Brazil., Greystoke A; Northern Centre for Cancer Care, Newcastle, UK., Bates S; Division of Hematology and Oncology, Department of Medicine, Columbia University, New York, USA., Bayle A; Institut Gustave Roussy, Paris, France., Calvo E; START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain., Castelo-Branco L; European Society for Medical Oncology (ESMO), Lugano, Switzerland., de Bono J; Institute of Cancer Research, University of London, London; The Royal Marsden Hospital, London, UK., Drilon A; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA., Garralda E; Vall d'Hebron Institute of Oncology, Barcelona, Spain., Ivy P; National Cancer Institute, USA Cancer Therapy Evaluation Program Investigational Drug Branch (NCI/CTEP/IDB), Bethesda, USA., Kholmanskikh O; European Medicines Agency, Amsterdam, Netherlands; Federal Agency for Medicines and Health Products, Brussels, Belgium., Melero I; CUN and CIMA, University of Navarra, Pamplona, Spain., Pentheroudakis G; European Society for Medical Oncology (ESMO), Lugano, Switzerland., Petrie J; Canadian Cancer Trials Group, Queen's University, Kingston., Plummer R; Northern Centre for Cancer Care, Newcastle, UK., Ponce S; Institut Gustave Roussy, Paris, France., Postel-Vinay S; Institut Gustave Roussy, Paris, France., Siu L; Princess Margaret Cancer Centre, Toronto, Canada., Spreafico A; Princess Margaret Cancer Centre, Toronto, Canada., Stathis A; Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland., Steeghs N; The Netherlands Cancer Institute, Amsterdam, The Netherlands., Yap C; Institute of Cancer Research, University of London, London., Yap TA; Department of Investigational Cancer Therapeutics, University of Texas, MD Anderson Cancer Center, Houston., Ratain M; Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, USA., Seymour L; Canadian Cancer Trials Group, Queen's University, Kingston. Electronic address: lseymour@ctg.queensu.ca.
Jazyk:	angličtina
Zdroj:	Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2023 Jan; Vol. 34 (1), pp. 48-60. Date of Electronic Publication: 2022 Sep 29.
DOI:	10.1016/j.annonc.2022.09.158
Abstrakt:	In 2021, the Food and Drug Administration Oncology Center of Excellence announced Project Optimus focusing on dose optimization for oncology drugs. The Methodology for the Development of Innovative Cancer Therapies (MDICT) Taskforce met to review and discuss the optimization of dosage for oncology trials and to develop a practical guide for oncology phase I trials. Defining a single recommended phase II dose based on toxicity may define doses that are neither the most effective nor the best tolerated. MDICT recommendations address the need for robust non-clinical data which are needed to inform trial design, as well as an expert team including statisticians and pharmacologists. The protocol must be flexible and adaptive, with clear definition of all endpoints. Health authorities should be consulted early and regularly. Strategies such as randomization, intrapatient dose escalation, and real-world eligibility criteria are encouraged whereas serial tumor sampling is discouraged in the absence of a strong rationale and appropriately validated assay. Endpoints should include consideration of all longitudinal toxicity. The phase I dose escalation trial should define the recommended dose range for later testing in randomized phase II trials, rather than a single recommended phase II dose, and consider scenarios where different populations may require different dosages. The adoption of these recommendations will improve dosage selection in early clinical trials of new anticancer treatments and ultimately, outcomes for patients. (Copyright © 2022 European Society for Medical Oncology. All rights reserved.)
Databáze:	MEDLINE
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