José S A Belderbos1, Dirk K M De Ruysscher2, Katrien De Jaeger3, Friederike Koppe4, Maarten L F Lambrecht5, Yolande N Lievens6, Edith M T Dieleman7, Jaap P M Jaspers8, Jan P Van Meerbeeck9, Fred Ubbels10, Margriet H Kwint11, Marianne A Kuenen12, Sabine Deprez13, Michiel B De Ruiter12, Willem Boogerd14, Karolina Sikorska15, Harm Van Tinteren15, Sanne B Schagen12. 1. Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: j.belderbos@nki.nl. 2. Radiation Oncology (MAASTRO), School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands. 3. Radiation Oncology, Catharina Hospital, Eindhoven, The Netherlands. 4. Radiation Oncology, Institute Verbeeten, Tilburg, The Netherlands. 5. Radiation Oncology, UZ Gasthuisberg, Leuven, Belgium. 6. Radiation Oncology, Ghent University Hospital and Ghent University, Gent, Belgium. 7. Radiation Oncology, Amsterdam UMC-Location AMC, Amsterdam, The Netherlands. 8. Radiation Oncology, Erasmus MC Cancer Institute, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 9. Pulmonology & Thoracic Oncology, Antwerp University and Antwerp University Hospital, Edegem, Belgium. 10. Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 11. Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. 12. Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. 13. Department of Imaging & Pathology, KU Leuven, Leuven, Belgium; Leuven Cancer Institute (LKI), Leuven, Belgium. 14. Neurology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. 15. Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Abstract
INTRODUCTION: To compare neurocognitive functioning in patients with SCLC who receivedprophylactic cranial irradiation (PCI) with or without hippocampus avoidance (HA). METHODS: In a multicenter, randomized phase 3 trial (NCT01780675), patients with SCLC were randomized to standard PCI or HA-PCI of 25 Gy in 10 fractions. Neuropsychological tests were performed at baseline and 4, 8, 12, 18, and 24 months after PCI. The primary end point was total recall on the Hopkins Verbal Learning Test-Revised at 4 months; a decline of at least five points from baseline was considered a failure. Secondary end points included other cognitive outcomes, evaluation of the incidence, location of brain metastases, and overall survival. RESULTS:From April 2013 to March 2018, a total of 168 patients were randomized. The median follow-up time was 26.6 months. In both treatment arms, 70% of the patients had limited disease and baseline characteristics were well balanced. Decline on the Hopkins Verbal Learning Test-Revised total recall score at 4 months was not significantly different between the arms: 29% of patients on PCI and 28% of patients on HA-PCI dropped greater than or equal to five points (p = 1.000). Performance on other cognitive tests measuring memory, executive function, attention, motor function, and processing speed did not change significantly different over time between the groups. The overall survival was not significantly different (p = 0.43). The cumulative incidence of brain metastases at 2 years was 20% (95% confidence interval: 12%-29%) for the PCI arm and 16% (95% confidence interval: 7%-24%) for the HA-PCI arm. CONCLUSIONS: This randomized phase 3 trial did not find a lower probability of cognitive decline in patients with SCLC receiving HA-PCI compared withconventional PCI. No increase in brain metastases at 2 years was observed in the HA-PCI arm.
RCT Entities:
INTRODUCTION: To compare neurocognitive functioning in patients with SCLC who received prophylactic cranial irradiation (PCI) with or without hippocampus avoidance (HA). METHODS: In a multicenter, randomized phase 3 trial (NCT01780675), patients with SCLC were randomized to standard PCI or HA-PCI of 25 Gy in 10 fractions. Neuropsychological tests were performed at baseline and 4, 8, 12, 18, and 24 months after PCI. The primary end point was total recall on the Hopkins Verbal Learning Test-Revised at 4 months; a decline of at least five points from baseline was considered a failure. Secondary end points included other cognitive outcomes, evaluation of the incidence, location of brain metastases, and overall survival. RESULTS: From April 2013 to March 2018, a total of 168 patients were randomized. The median follow-up time was 26.6 months. In both treatment arms, 70% of the patients had limited disease and baseline characteristics were well balanced. Decline on the Hopkins Verbal Learning Test-Revised total recall score at 4 months was not significantly different between the arms: 29% of patients on PCI and 28% of patients on HA-PCI dropped greater than or equal to five points (p = 1.000). Performance on other cognitive tests measuring memory, executive function, attention, motor function, and processing speed did not change significantly different over time between the groups. The overall survival was not significantly different (p = 0.43). The cumulative incidence of brain metastases at 2 years was 20% (95% confidence interval: 12%-29%) for the PCI arm and 16% (95% confidence interval: 7%-24%) for the HA-PCI arm. CONCLUSIONS: This randomized phase 3 trial did not find a lower probability of cognitive decline in patients with SCLC receiving HA-PCI compared with conventional PCI. No increase in brain metastases at 2 years was observed in the HA-PCI arm.
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