Self-Reported Cognitive Function and Quality of Life in Patients With SCLC in the Hippocampal Avoidance Prophylactic Cranial Irradiation Versus Prophylactic Cranial Irradiation Randomized Phase 3 Trial (NCT01780675)

Elaine A C Albers; Haiyan Zeng; Dirk K M De Ruysscher; Marianne A Kuenen; Rob Kessels; Lizza E L Hendriks; Jose S A Belderbos; Sanne B Schagen

doi:10.1016/j.jtocrr.2023.100506

Self-Reported Cognitive Function and Quality of Life in Patients With SCLC in the Hippocampal Avoidance Prophylactic Cranial Irradiation Versus Prophylactic Cranial Irradiation Randomized Phase 3 Trial (NCT01780675)

JTO Clin Res Rep. 2023 Mar 24;4(5):100506. doi: 10.1016/j.jtocrr.2023.100506. eCollection 2023 May.

Authors

Elaine A C Albers¹, Haiyan Zeng², Dirk K M De Ruysscher², Marianne A Kuenen¹, Rob Kessels³, Lizza E L Hendriks², Jose S A Belderbos⁴, Sanne B Schagen^{1

5}

Affiliations

¹ Divison of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
² Department of Radiation Oncology (Maastro), GROW School for Oncology and Reproduction, Maastricht University Medical Centre+, Maastricht, The Netherlands.
³ Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
⁴ Department of radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
⁵ Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.

Abstract

Introduction: In the randomized controlled trial in patients with SCLC comparing standard prophylactic cranial irradiation (PCI) with hippocampal avoidance PCI (HA-PCI), we did not observe beneficial effects of HA-PCI on tested cognition. Here, we report findings on self-reported cognitive functioning (SRCF) and quality of life (QoL).

Methods: Patients with SCLC were randomized to receive PCI with or without HA (NCT01780675) and assessed at baseline (82 HA-PCI and 79 PCI patients) and at 4, 8, 12, 18, and 24 months of follow-up, using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and EORTC QLQ-brain cancer module (BN20). SRCF was assessed with the cognitive functioning scale of the EORTC QLQ-C30 and the Medical Outcomes Study questionnaire. A change of 10 points was used for minimal clinically important differences. Percentages of patients classified with having improved, stable, or deteriorated SRCF were compared between groups using chi-square tests. Changes in mean scores were analyzed using linear mixed models.

Results: There was no significant difference in the percentage of patients with deteriorated, stable, or improved SRCF between the treatment arms. Depending on the evaluated time point, 31% to 46% and 29% to 43% of patients in the HA-PCI and PCI arm, respectively, reported a deteriorated SRCF on the basis of the EORTC QLQ-C30 and Medical Outcomes Study. QoL outcomes were not significantly different between the study arms, except for physical functioning at 12 months (p = 0.019) and motor dysfunction at 24 months (p = 0.020).

Conclusions: Our trial did not find beneficial effects of HA-PCI over PCI on SRCF and QoL. The cognitive benefit of sparing the hippocampus in the context of PCI is still a subject of debate.

Keywords: Hippocampus; PCI; Prophylactic cranial irradiation; Quality of life; SCLC; Self-reported cognitive functioning.