PaSION (Patient Symptoms in Immuno-Oncology) is a nurse-led study designed as an exploratory, longitudinal and observational research in a single center (Department of Oncology at the Lausanne University Hospital, DO-CHUV). Using semi-structured interviews, self-reported questionnaires, health-related personal data, and newly sampled blood, we aim to gain a more complete understanding of patients’ experience during the first months of immune-checkpoint inhibitors (ICI) therapy. In addition, we investigate potential associations between symptoms reported by the patient and immune-related biomarkers that might predict and prevent adverse events.
ICIs have shown significant clinical benefit in a growing number of different tumor types. Because ICI drugs target cells of the immune system, this therapy can lead to toxicities associated with inflammatory or autoimmune responses, known as immune-related adverse events (irAEs). Importantly, up to 85% of patients experience irAEs of any grade. Although rare, even fatal toxicities may occur, and therefore, prompt recognition and management is important. Taking the increasing use of these therapies in the clinical practice into account, it has been of urgent interest to achieve a comprehensive understanding of the overall patients' experience during ICI therapy, including symptomatic toxicities and quality of life.
Patient-Reported Outcomes (PROs) allow the identification of benefits or deficiencies related to the disease or treatment that are only detectable by the patient and can be collected through questionnaires, diaries or interviews. For instance, PROs permit to quantify symptom severity and frequency, or their impact on patient's function, but also more complex concepts such as quality of life (QoL). Studies show that PROs are more concordant with the patient’s overall health status and result in earlier detection of toxicity/symptom occurrence and severity compared to clinician reports. Thus, given the importance of early detection in irAEs, PRO assessment could serve as a complementary indicator for ICI toxicities before the presentation of any severe clinical manifestation. Furthermore, evidence has proven the association of cytokine levels with several symptoms and their use as therapy-related toxicity predictors before treatment initiation.
In order to achieve the overall objective, four major research questions were proposed through a series of independent, yet complementary aims.
AIM 1: To identify and examine instruments currently used to measure PROs in ICI therapy.
AIM 2: To describe the treatment experience of patients undergoing ICI therapy.
AIM 3: To explore potential associations between selected immune-related biomarkers and the most frequent symptoms reported by patients undergoing ICI therapy.
AIM 4: To adapt an existing PRO instrument or develop a novel immune oncology (IO)-specific measure.
