Association between symptoms and health-related quality of life in patients with cancer with prior or ongoing immune checkpoint inhibitor therapy exposure.

e24085 Background: There is a growing appreciation that patients exposed to immune checkpoint inhibitors (ICI) may experience long-term symptoms that impact health-related quality of life (HRQoL). We conducted an app-based, electronic patient reported outcomes (ePRO) study to explore the relationship between the symptom experience and HRQoL in a population of patients with cancer exposed to ICI therapy. Methods: Eligible patients had a history of advanced skin cancer or kidney cancer treated with ICI (adjuvant or metastatic) with ongoing, clinician-assessed disease control. Patients may have completed a course of ICI or continued on therapy if ≥ 6 months had passed since initiation. We conducted a single-center, observational, prospective cohort study where participants completed ePRO assessments via smartphone (ImmunoWave) measuring eleven symptoms (PRO-CTCAE) and HRQoL (PROMIS-29) weekly for 12 weeks. We used generalized estimating equations to assess the changes in PROMIS scores over study and to test the association of PRO-CTCAE symptoms with PROMIS scores and subdomains. Results: Forty-seven patients (77% melanoma, 15% renal cell carcinoma, 8% non-melanoma skin cancer) consented to the study. 70% were on active therapy while 30% had completed therapy. Most (62%) were treated in the metastatic setting. 43 patients who completed questionnaires were included in the analysis. Among subdomains of HRQoL at the study population level, social function was observed to have a significant linear trend (p = 0.013) and potentially meaningful (3.9 points overall) increase over the 12 weeks. Other subdomains were felt to have no clinically meaningful change at the population level over the 12 wk study period. Several PRO-CTCAE symptoms were significantly associated with health-related quality of life (PROMIS) subdomains (Table). Joint pain was significantly associated with fatigue (B = 1.006, p = 0.045), pain interference (B = 2.579, p = 0.002) and physical function (B = -1.532, p = 0.042). Itch was associated with anxiety (B = 1.017, p = 0.007) and social function (B = -1.136, p = 0.030). Numbness and tingling was associated with fatigue (B = 0.891, p = 0.027) and sleep disturbance (B = 1.436, p < 0.001). Conclusions: We observed high concordance between patient symptom report by PRO-CTCAE and corresponding PROMIS HRQoL subdomains. Addressing specific symptoms such as itch, numbness/tingling and joint pain in patients with current or prior ICI exposure could improve HRQoL. [Table: see text]