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. 2024 May 20;42(15):1734-1737.
doi: 10.1200/JCO.23.01241. Epub 2024 Mar 14.

How Can Radiopharmaceutical Therapies Reach Their Full Potential? Improving Dose Reporting and Phase I Clinical Trial Design

Collaborators, Affiliations

How Can Radiopharmaceutical Therapies Reach Their Full Potential? Improving Dose Reporting and Phase I Clinical Trial Design

Ana P Kiess et al. J Clin Oncol. .
No abstract available

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Conflict of interest statement

Last year, we organized a gathering of RPT expert physicians and scientists from academia and industry. The objective of the workshop was to propose how to replace existing absorbed dose constraints adopted from EBRT with new constraints and strategies derived from recent RPT experience. We aim to create normal tissue complication probability (NTCP) curves similar to those in Figure 1D for specific toxicities and types of RPT. However, in our examination of the literature, we found that most clinical trial reports unfortunately provide little or no information regarding tissue absorbed doses and insufficient detail regarding toxicities.6,13,23-25 We are actively collecting available patient-level data through data sharing and use agreements with our industry and academic partners, including coauthors and others, and we will analyze the data independently to limit potential bias and conflict of interest. We believe that routine reporting of estimates of absorbed dose delivered to tumors and organs at risk (eg, using single-photon emission computed tomography [SPECT]/computed tomography imaging-based methods) would improve analysis of the factors that might affect the efficacy of RPT agents for a given indication. Beyond this, it would provide the data needed for analysis of absorbed dose versus response or toxicity to better compare different agents and regimens.

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