Follow-up assessment of quality of life in patients with recurrent glioblastoma undergoing investigational immune therapy

Aims
Assessment of subjective Quality of life (QOL) in longitudinal interventional studies is imperative but challenging because of relativity biases. A new treatment with axitinib and avelumab for recurrent glioblastoma (recGB), the most frequent malignant tumor of the brain, may result in a significant antitumor effect which is expected to improve QOL.
Methods
Together with medical-oncological and neuro-cognitive follow-up, QOL of experimentally treated patients with recGB is recorded at baseline (week 1, before start of treatment), week 9 and every 12 weeks thereafter. Patients are stratified into 2 cohorts according to their baseline need for treatment with corticosteroids to reduce edema (1=none, 2=steroid treatment). The EORTC QLQ-C30 is complemented by the Hospital Anxiety and Depression Scale (HADS), the Anamnestic Comparative Self-Assessment (ACSA), a personalized uniscale of subjective wellbeing (SWB) and a newly developed uniscale questionnaire for SWB.
Results
In this ongoing study we have, at time of writing, baseline results for 42 patients (23 cohort 1, 19 cohort 2). Comparing the baseline results with follow up results at week 9, the novel questionnaire indicates that patients in cohort 2 are less pleased with their daily activities (t(6)=2, p=.046) while no such change occurs in cohort 1. Patients in cohort 1 report more depressive symptoms at week 9 than at baseline (t(10)=2.368, p=.020) without depassing the HADS cut-off score (M=6.73, SD= 4.25). Whereas the EORTC QLQ-C30 does not seem to detect a change in QOL, our novel question indicates improved SWB at week 9 in cohort 1 (t(10)=4.633, p=.0005). This finding was confirmed by ACSA (t(9)=2.388, p=.021). ACSA also indicates worse SWB in cohort 2 than cohort 1 at week 9 (W=13.5, p=.016).

Conclusions
At week 9, cohort 2 reported worse SWB than cohort 1. This is probably due to tapering corticosteroids to be able to start up avelumab in week 8, and which may result in edema related symptoms. Cohort 1 reported increased SWB even though they reported an increased (but not alarming) number of depressive symptoms. QOL of patients in cohort 2 remained stable even though they were less pleased with their daily activities at week 9. Overall, it seems that single item self report of SWB, when compared to the multi-dimensional EORTC QLQ-C30, is more sensitive to changes.