General Review Publications: IND

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

Recent experience with targeted anticancer drugs and immunotherapies suggest the traditional approach of using the maximal tolerated dose (MTD) is not ideal. Project Optimus recommends optimizing the dosage of oncology drugs to ensure they are both effective and tolerable. MDICT developed practical recommendations for the design and conduct of phase I oncology trials.

Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, Ivy P, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Oncology phase I trial design and conduct: time for a change - MDICT Guidelines 2022 (ONLINE). Ann Oncol 2022.
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Results: Test-retest repeatability of percentage fluctuations for all three types of SUV measurement (max, mean and peak) improved with higher FDG uptake levels. Repeatability in all three SUV measurements varied for different lesion locations. Worse repeatability in SUVmean was also associated with higher tumor volumes.

Conclusions: Recommendations regarding SUV measurements for assessing minimal detectable changes based on repeatability and reproducibility are proposed and should be applied to differentiate between response categories for FDG-PET-based criteria.

Shankar LK, Huang E, Litière S, Hoekstra OS, Schwartz L, Collette S, Boellaard R, Bogaerts J, Seymour L, de Vries EGE. Meta-Analysis of the Test-Retest Repeatability of [18F]-Fluorodeoxyglucose Standardized Uptake Values: Implications for Assessment of Tumor Response (ONLINE). Clin Cancer Res 2022.