CN72Patient reported outcomes during immunotherapy: Symptom burden in daily clinical practice

Abstract Background PD(L)1-inhibitors can cause immune-related adverse events (irAEs.). IrAEs may be under-recognized and their influence on health-related quality of life (HRQL) underestimated. At this point, insight into patient-reported symptom prevalence and intensity is limited. Methods In this cohort study, patients with melanoma or lung carcinoma treated with PD(L)1-inhibitors - as per standard of care - between February 2016 and December 2018, were included. Patient characteristics, patient-reported symptoms and well-being, influence of (ir)AEs on HRQL were prospectively obtained, just as irAEs from professional perspectives and treatment decisions. Used instruments were the patient-scored Utrecht Symptom Diary (USD) and the professional-scored Common Terminology Criteria for AEs v4.03. Patients completed the USD as part of routine care. Results 162 patients with melanoma (55%) or lung carcinoma (45%) were included. 59% were men, median age was 66 years. Most patients (89%) were treated with nivolumab or pembrolizumab. Preliminary analysis shows that at baseline patients reported a median of 4 symptoms with an USD-score ≥3 (11-point numeric rating scale). Symptom burden caused by anorexia (p=.035), cough (p=.000), dyspnea (p=.002) and fatigue (p=.012) differed significantly between tumor types. CTCAE grade 3 toxicity occurred in 20 patients (12%) and significantly more often in patients with melanoma (p=.004) and in patients previously treated with immunotherapy (p=.000). At time of grade 3 toxicity occurrence, patients experienced a median of six clinically relevant symptoms (USD ≥3), which was not significantly different from baseline. The median USD-score of influence of AEs on HRQL was 3 (NRS 0-7). Conclusions This study shows that the use of patient-reported outcomes (PROs) as standard of care provides insight into symptom burden from patient perspectives in patients with melanoma or lung carcinoma during immunotherapy. As a result, PROs can add additional information to the objectified severity of symptoms as scored by professionals, just as to effect evaluation of interventions performed. Final results will be presented at the conference. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure J.J. Koldenhof: Honoraria (institution), Advisory / Consultancy: Novartis. K.P.M. Suijkerbuijk: Honoraria (institution), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (institution), Advisory / Consultancy: Novartis; Honoraria (institution), Advisory / Consultancy: MSD; Honoraria (institution), Advisory / Consultancy: Roche; Honoraria (institution), Advisory / Consultancy: Pierre Fabre. All other authors have declared no conflicts of interest.