Dados do Trabalho

Título

QUALITY OF LIFE IN ONCOLOGY TRIALS: AN UNDERSTUDIED ENDPOINT IN THE ERA OF IMMUNOTHERAPY

Introdução

Introduction: In oncology, the primary goal when designing clinical trials (CT) is to assess whether a new treatment extends a patient's life (overall survival-OS) or enhances their quality of life (QoL). However, evaluating these endpoints is difficult. Accessing OS often takes years, while QoL, being a subjective concept, is inherently difficult to quantify. Due to these challenges, the FDA (Food and Drug Administration) sometimes approves drugs based on surrogate endpoints-intermediate outcomes- often used to accelerate research and decision-making. However, the correlation between surrogate endpoints and actual improvements in OS and QoL is not always clear. This has sparked a significant debate within the oncology community regarding the FDA's accelerated drug approval process. Additionally, many CTs are now being structured to use immunotherapy as an interventional drug. In light of this ongoing debate, this research aims to explore CT that evaluated QoL as an endpoint in oncology research in a setting with immunotherapy as an interventional protocol

Objetivo e Método

Methodology: Systematic review in the Clinical Trials database with the keywords “cancer”, “quality of life” and “immunotherapy”. Were included trials with the primary endpoint QoL and excluded trials without immunotherapy as drug intervention.

Resultados

Results: Our search identified 528 trials, but only 10 met the inclusion criteria. The studies were initiated between 2018 and 2024. The majority of studies originated from the USA (60%), followed by France (20%). Most studies employed a phase II design (40%), and the number of patients enrolled ranged from 19 to 300, with a mean of 67. The cancer types investigated included melanoma (20%), lung cancer (20%), head and neck cancer (10%), pleural mesothelioma (10%), glioblastoma (10%), and a pan-cancer cohort (30%). Only two studies focused on an early-stage setting. Eight studies reported their method for evaluating QoL, with the most common instruments being the EORTC QLQ-C30 (5 studies) and the FACT-G (2 studies).

Conclusão/Considerações finais

Conclusion: This review highlights a lack of focus on QoL in cancer clinical trials, particularly those with immunotherapy. Most studies focused on advanced stages, overlooking QoL in the early phases. This emphasizes the need for increased emphasis on QoL assessment in future oncology research.

Palavras Chave

Quality of Life; Clinical Trial; Immunotherapy