Abstract CN66
Background
While randomized clinical trials on immune-checkpoint inhibitors (ICI) show promising results regarding quality of life, real-world data demonstrate a high symptom burden. We investigated the evolution of symptoms reported by advanced cancer patients over the first 6 months of ICI treatment.
Methods
From 2019-2021, melanoma (Mel, n=17) or lung cancer (Lung, n=29) patients starting ICI treatment alone or +Chemotherapy (ICI+CHT) were recruited and followed for 25 weeks. Patients filled the EORTC QLQ-C30 questionnaire at baseline (BL) and every 6 weeks and reported on 50 items from the PRO-CTCAE library biweekly. PRO-CTCAE composite scores were analyzed by fitting cumulative link mixed models (CLMM).
Results
Mean Global Health Status (GHS) score at BL was 73(SD 18.5) in patients with melanoma and 67(SD 19.7) in lung cancer patients with a trend towards improvement (Mel) or stabilization (Lung) over time. Comparison of composite scores at BL and week 25 to the mean of the lowest score (0), identified 9 (Mel) and 28 (Lung) symptoms (8 symptoms in Lung adj p val<0.05). While 11 persisted at week 25 in lung cancer patients, only fatigue showed a tendency towards significance in Melanoma (p<0.06, adj p val ns). CLMM revealed (i) symptoms that can be predicted from individual scores at BL (fatigue, skin dryness, joint pain), (ii) symptoms for which time is an important score predictor (dizziness), and (iii) symptoms for which individual variation adds to the importance of time (constipation and insomnia in Lung patients, and diarrhea or itchiness in Melanoma). Gender, age (<65 vs >65) and treatment (ICI vs ICI+CHT) were considered as covariates in the models and found to explain several of these distinct observations. For instance, age is a significant predictor of general pain in lung patients, and high discourage scores were shown in patients treated with ICI alone compared to ICI+CHT.
Conclusions
Results from this exploratory study reveal that although GHS remains stable, some symptoms persist and can be predicted based on patient characteristics, treatment, BL scores, and/or time. These results warrant further research, and encourage supportive care interventions and close follow-up of these specific symptoms.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Institute of Higher Education and Research in Healthcare – IUFRS-UNIL-CHUV.
Funding
European Commission H2020-EU.1.3.2; MSCA-IF-2017 ID:793592; Brystol-Myers Squibb; Roche.
Disclosure
S. Colomer-Lahiguera: Financial Interests, Institutional, Funding: BMS, Roche. M. Eicher: Financial Interests, Institutional, Funding: BMS, Roche. All other authors have declared no conflicts of interest.