Abstract 5193
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.
Clinical trial identification
Editorial acknowledgement
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.
Resources from the same session
4543 - Long-term real-world (RW) outcomes in patients with advanced melanoma (MEL) treated with ipilimumab (IPI) and non-IPI therapies: IMAGE study
Presenter: Stéphane Dalle
Session: Poster Display session 3
Resources:
Abstract
4523 - Prognostic Factors for efficacy of Ipilimumab used after AntiPD1 and/or BRAF+MEK inhibitors in Melanoma Patients: an Italian Melanoma Intergroup study
Presenter: Riccardo Marconcini
Session: Poster Display session 3
Resources:
Abstract
3632 - Rechallenge with combination ipilimumab and anti-PD-1 (IPI+PD1) in metastatic melanoma after acquired resistance to IPI+PD1 immunotherapy
Presenter: Adriana Hepner
Session: Poster Display session 3
Resources:
Abstract
3732 - Clinicopathologic characteristics of immune colitis in melanoma patients treated with combination ipilimumab and anti-PD1 (IPI+PD1) and PD1 monotherapy.
Presenter: Kazi Nahar
Session: Poster Display session 3
Resources:
Abstract
5005 - Real-world outcomes of ipilimumab plus nivolumab for advanced melanoma in the Netherlands
Presenter: Michiel van Zeijl
Session: Poster Display session 3
Resources:
Abstract
5524 - Utilization of Real-World Data to Assess the Effectiveness of Immune Checkpoint Inhibitors (ICIs) in Elderly Patients with Metastatic Melanoma
Presenter: D Scott Ernst
Session: Poster Display session 3
Resources:
Abstract
5884 - Tumor mutational burden and response to PD-1 inhibitors: an analysis of 89 cases of metastatic melanoma.
Presenter: Léa Dousset
Session: Poster Display session 3
Resources:
Abstract
3120 - Increase in S100B and LDH as early outcome predictors for non-responsiveness to anti-PD-1 monotherapy in advanced melanoma.
Presenter: Elisa Rozeman
Session: Poster Display session 3
Resources:
Abstract
2157 - Immune status defined by molecular information layers predicts response to pembrolizumab treatment in advanced melanoma
Presenter: Guillermo Prado-Vázquez
Session: Poster Display session 3
Resources:
Abstract
2553 - Interim analysis of a phase Ib study of cobimetinib plus atezolizumab in patients with advanced BRAFV600 wild type melanoma progressing on prior anti-PD-L1 therapy
Presenter: Shahneen Sandhu
Session: Poster Display session 3
Resources:
Abstract