W J A Witlox1, B L T Ramaekers2, M A Joore3, A-M C Dingemans4, J Praag5, J Belderbos6, C Tissing-Tan7, G Herder8, T Haitjema9, J F Ubbels10, J Lagerwaard11, S Y El Sharouni12, J A Stigt13, E F Smit14, H van Tinteren15, V van der Noort15, H J M Groen16, D K M De Ruysscher17. 1. Maastricht University Medical Centre(+), Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands. Electronic address: willem.witlox@mumc.nl. 2. Maastricht University Medical Centre(+), Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands. 3. Maastricht University Medical Centre(+), Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands; Care and Public Health Research Institute (CAPHRI), Maastricht University, The Netherlands. 4. Maastricht University Medical Center(+), Department of Pulmonology, GROW Research Institute, The Netherlands. 5. Erasmus University Medical Center, Department of Radiation Oncology, Rotterdam, The Netherlands. 6. Netherlands Cancer Institute (NKI), Department of Radiation Oncology, Amsterdam, The Netherlands. 7. Radiotherapy Institute Arnhem, Arnhem, The Netherlands. 8. Antonius Hospital Nieuwegein, Department of Pulmonology, The Netherlands. 9. Medical Center Alkmaar, Department of Pulmonology, The Netherlands. 10. University of Groningen, University Medical Center Groningen, Department of Radiation Oncology, The Netherlands. 11. Free University Medical Center, Department of Radiation Oncology, Amsterdam, The Netherlands. 12. University Medical Center Utrecht, Department of Radiation Oncology, The Netherlands. 13. Isala Hospital, Department of Pulmonology, Zwolle, The Netherlands. 14. Netherlands Cancer Institute (NKI), Department of Pulmonology, Amsterdam, The Netherlands. 15. Netherlands Cancer Institute (NKI), Department of Biometrics, Amsterdam, The Netherlands. 16. University of Groningen and University Medical Center Groningen, Department of Pulmonary Diseases, The Netherlands. 17. Maastricht University Medical Centre(+), Department of Radiation Oncology (Maastro Clinic), GROW School of Oncology and Developmental Biology, The Netherlands; KU Leuven, Radiation Oncology, Belgium.
Abstract
BACKGROUND AND PURPOSE: The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL. MATERIALS AND METHODS: Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter. Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores. RESULTS: In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914). CONCLUSION: No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed.
RCT Entities:
BACKGROUND AND PURPOSE: The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL. MATERIALS AND METHODS: Stage III NSCLCpatients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter. Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores. RESULTS: In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914). CONCLUSION: No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed.