High Health-Related Quality of Life During Dendritic Cell Vaccination Therapy in Patients With Castration-Resistant Prostate Cancer

Harm Westdorp, Jeroen H A Creemers, Inge M van Oort, Niven Mehra, Simone M Hins-de Bree, Carl G Figdor, J Alfred Witjes, Gerty Schreibelt, I Jolanda M de Vries, Winald R Gerritsen, Petronella B Ottevanger, Harm Westdorp, Jeroen H A Creemers, Inge M van Oort, Niven Mehra, Simone M Hins-de Bree, Carl G Figdor, J Alfred Witjes, Gerty Schreibelt, I Jolanda M de Vries, Winald R Gerritsen, Petronella B Ottevanger

Abstract

Background: Maintaining health-related quality of life (HRQoL) is highly desirable during systemic therapies for patients with castration-resistant prostate cancer (CRPC). Patient-reported outcome measures (PROs) were studied in our phase IIa trial on cellular-based immunotherapy with dendritic cells (DC).

Methods: We treated 21 chemo-naive asymptomatic or minimally symptomatic patients with CRPC with maximally three cycles of DC vaccinations (ClinicalTrials.gov, NCT02692976). Here, we report the impact of DC vaccination on HRQoL. PROs were assessed using the EORTC-QLQ-C30, the EORTC-QLQ-PR25, Checklist Individual Strength (CIS20-R), and Beck Depression Inventory Primary Care questionnaires. Short-term and long-term vaccine-related effects on HRQoL were studied.

Results: Questionnaires were collected at baseline (n=20), week 6 (n=19), week 12 (n=18), week 24 (n=13), week 50 (n=8) and week 100 (n=2). No clinically relevant differences in symptom-related outcome, functioning-related outcome, and Global Health Status were observed directly after the first cycle of DC vaccinations (week 6) and at follow-up (week 12) compared to baseline. HRQoL remained high throughout the vaccination cycle and six weeks afterward. In radiographic non-progressive patients, who continued DC vaccination, high HRQoL scores were observed up to one and two years after study enrolment.

Conclusions: Patients with asymptomatic or minimally symptomatic CRPC show high HRQoL throughout DC-based immunotherapy. This is a clinically relevant finding in this older-aged patient population with advanced prostate cancer.

Keywords: castration-resistant prostate cancer; dendritic cell vaccination; health-related quality of life (HRQoL); immunotherapy; patient-reported outcomes (PROs).

Copyright © 2020 Westdorp, Creemers, van Oort, Mehra, Hins-de Bree, Figdor, Witjes, Schreibelt, de Vries, Gerritsen and Ottevanger.

Figures

Figure 1
Figure 1
Completed patient-reported outcome measurements during the study period.
Figure 2
Figure 2
Heat map of functional and symptom scales of the EORTC-QLQ-C30 at different timepoints in patients with CRPC. (A–F) represent the functioning-related domains, (G, H) show two of the symptom-related domains. Other symptom scales are shown in Supplementary Figure 2.
Figure 3
Figure 3
Heat map of symptom scales of the EORTC-QLQ-PR25 at different timepoints in patients with CRPC. (A) Urinary symptoms, (B) Bowel symptoms, (C) Hormonal treatment-related symptoms, (D) Incontinence aid. Functional scales are presented in Supplementary Figure 3.
Figure 4
Figure 4
Heat map of CIS1 (subjective fatigue severity) and BDI-PC scores at different timepoints in patients with CRPC. (A) represents the CIS1 scores, (B) represents the BDI-PC scores. CIS2-4 scores are presented in Supplementary Figure 4.

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