| Title: |
Improving the response to lenvatinib in partial responders using a Constrained-Disorder-Principle-based second-generation artificial intelligence-therapeutic regimen: a proof-of-concept open-labeled clinical trial |
| Authors: |
Sigawi, Tal; Gelman, Ram; Maimon, Ofra; Yossef, Amal; Hemed, Nila; Agus, Samuel; Berg, Marc; Ilan, Yaron; Popovtzer, Aron |
| Source: |
Frontiers in Oncology ; volume 14 ; ISSN 2234-943X |
| Publisher Information: |
Frontiers Media SA |
| Publication Year: |
2024 |
| Collection: |
Frontiers (Publisher - via CrossRef) |
| Description: |
Introduction The main obstacle in treating cancer patients is drug resistance. Lenvatinib treatment poses challenges due to loss of response and the common dose-limiting adverse events (AEs). The Constrained-disorder-principle (CDP)-based second-generation artificial intelligence (AI) systems introduce variability into treatment regimens and offer a potential strategy for enhancing treatment efficacy. This proof-of-concept clinical trial aimed to assess the impact of a personalized algorithm-controlled therapeutic regimen on lenvatinib effectiveness and tolerability. Methods A 14-week open-label, non-randomized trial was conducted with five cancer patients receiving lenvatinib—an AI-assisted application tailored to a personalized therapeutic regimen for each patient, which the treating physician approved. The study assessed changes in tumor response through FDG-PET-CT and tumor markers and quality of life via the EORTC QLQ-THY34 questionnaire, AEs, and laboratory evaluations. The app monitored treatment adherence. Results At 14 weeks of follow-up, the disease control rate (including the following outcomes: complete response, partial response, stable disease) was 80%. The FDG-PET-CT scan-based RECIST v1.1 and PERCIST criteria showed partial response in 40% of patients and stable disease in an additional 40% of patients. One patient experienced a progressing disease. Of the participants with thyroid cancer, 75% showed a reduction in thyroglobulin levels, and 60% of all the participants showed a decrease in neutrophil-to-lymphocyte ratio during treatment. Improvement in the median social support score among patients utilizing the system supports an ancillary benefit of the intervention. No grade 4 AEs or functional deteriorations were recorded. Summary The results of this proof-of-concept open-labeled clinical trial suggest that the CDP-based second-generation AI system-generated personalized therapeutic recommendations may improve the response to lenvatinib with manageable AEs. Prospective controlled studies are ... |
| Document Type: |
article in journal/newspaper |
| Language: |
unknown |
| DOI: |
10.3389/fonc.2024.1426426 |
| DOI: |
10.3389/fonc.2024.1426426/full |
| Availability: |
https://doi.org/10.3389/fonc.2024.1426426; https://www.frontiersin.org/articles/10.3389/fonc.2024.1426426/full |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.77094506 |
| Database: |
BASE |