Optimización del beneficio clínico en pacientes con tumores sólidos avanzados tratados en ensayos clínicos precoces a través del desarrollo de una herramienta pronóstica online y caracterización del patrón de respuesta hiperprogresor

Abstract

Early drug development refers generally to the first studies of a compound in humans and it is also known as phase 1 trials. The main objectives of these studies are to determine the safety, tolerability and the recommended dose of the new compounds for the next trials. However, the therapeutic intent with the patient should always drive this medical act. Therefore, increase the clinical benefit for the patients involve in these studies is still a challenge. Two aspects are fundamental to achieve it: i) patient selection process and ii) response assessment with the new drugs. With the common objective of improving these process, in order to increase the potential benefit of patients in early clinical trials, we have develop two applications in this Thesis: i) PIPO, an interactive prognostic tool, which is able to determine a specific survival probability for each patient before enrolling the patient in a phase 1 trials; and ii) a new hyperprogressive disease criteria base on RECIST for patients treated with immune checkpoint inhibitors, that is associated with an impact in overall survival.