Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies: The SACHA-France Experience.

Fiche publication

Date publication

novembre 2024

Journal

Pediatric blood & cancer

Auteurs

Membres identifiés du Cancéropôle Est :
Pr CHASTAGNER Pascal , Pr ENTZ-WERLE Natacha

Tous les auteurs :
Berlanga P, Aerts I, Corradini N, Ndounga-Diakou LA, Entz-Werle N, Ducassou S, André N, Sevrin F, Chastagner P, Puiseux C, Cleirec M, Plantaz D, De Carli E, Gambart M, Khanfar C, Thouvenin S, Petit A, Klein S, Briandet C, Millot F, Pluchart C, Reguerre Y, Schneider P, Serre J, Halfon-Domenech C, Carausu L, Piguet C, Saumet L, Benadiba J, Abbou S, Laghouati S, Geoerger B, Vassal G

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/39558828

Résumé

SACHA-France (NCT04477681) is a prospective real-world study that collects clinical safety and efficacy data of novel anticancer therapies prescribed off-label or on compassionate use to patients <25 years. From March 2020 until February 2024, 640 patients with solid tumors or lymphomas were included, with 176 (28%) reported objective tumor responses. Centralized medical monitoring of local radiological/functional imaging reports by the SACHA coordinating investigator led to response modification in 45 out of 176 cases (26%), highlighting the relevance of the medical review of study data. We suggest this pragmatic approach for improving clinical trial data when centralized radiological review is not performed.