Abstract 1847: Closed-loop drug delivery system to personalize chemotherapy dosing

While most oncologists know that many chemotherapies are dosed on a body surface area (BSA) basis, fewer know that the equations used to estimate BSA are based on a study done over 100 years ago using data from just 9 people. Moreover, two patients with the same BSA can have many factors, such as body composition and genetics, which can impact a drug’s pharmacokinetics and pharmacodynamics, resulting in worse therapeutic outcomes. To solve this problem, we developed a medical device that can personalize the dose of chemotherapy to the patient during an infusion center visit. Our medical device, which we call CLAUDIA (the Closed-Loop AUtomated Drug Infusion regulator) is a closed-loop drug delivery system that measures the concentration of drug and changes the infusion rate in real time to keep the concentration of drug within the therapeutic window. CLAUDIA uses high performance liquid chromatography-mass spectrometry (HPLC-MS) as the sensor, which allows it to be relatively easily translated to control many different drugs, either individually or in a combination chemotherapy regimen. We demonstrate CLAUDIA can control the concentration of 5-fluorouracil (5-FU) in rabbits, which were manipulated to capture the pharmacokinetic variability observed clinically. We then adapted CLAUDIA to also control the concentration of irinotecan, demonstrating its ability to be rapidly translated to additional chemotherapies. Finally, we perform a cost-effectiveness analysis that demonstrates that CLAUDIA is cost-effective compared to the current standard of care for drug dosing of 5-FU (i.e., BSA). Overall, CLAUDIA presents promising medical device that can personalize the dosing of chemotherapy, which may be able to improve the therapeutic outcomes for multiple chemotherapies. Citation Format: Louis DeRidder, Kyle Hare, Ted Smierciak, Mia Chao, Aaron Lopes, Josh Jenkins, Nina Fitzgerald, Emmeline MacPherson, Niora Fabian, Josh Morimoto, Jacqueline Chu, Ameya Kirtane, Wiam Madani, Keiko Ishida, Johannes Kuosmanen, Naomi Zecharias, Christopher Colangelo, Hen-Wei Huang, Makaya Chilekwa, Nikhil Lal, Shriya Srinivasan, Alison Hayward, Brian Wolpin, David Trumper, Troy Quast, Douglas Rubinson, Robert Langer, Giovanni Traverso. Closed-loop drug delivery system to personalize chemotherapy dosing [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 1847.