Phase 3 Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampus Avoidance in SCLC (NCT01780675)

Abstract

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 *Corresponding author.

Trends and variations in the treatment of stage I-III small cell lung cancer from 2008 to 2019: A nationwide population-based study from the Netherlands

“…In patients in good clinical condition who have no progressive disease after CRT, prophylactic cranial irradiation (PCI) is recommended [12]. Nevertheless, PCI results in a significant neurocognitive decline [13] and did become controversial as in stage IV disease, when compared to only MRI follow-up of the brain, survival was not superior after PCI and MRI follow-up, despite a reduced incidence of brain metastases [14].…”

Recent developments in the treatment of small cell lung cancer

“…The accepted radiation dose is 25 Gy in 10 fractions of 2.5 Gy. There is no role for routine hippocampal sparing [24]. The results of the Japanese trial has led to the dismissal of PCI in many centres.…”

Management of complications from brain metastasis treatment: a narrative review

“…Another scenario where HA-IMRT may be ideal is for prophylactic cranial irradiation (PCI) in small cell lung cancer (SCLC). Two recent randomized trials of HA-IMRT for PCI in SCLC with a dose of 25 Gy in 10 fractions found divergent results with one study finding improved cognitive preservation based on delayed free recall (81), and the other finding no improvement in cognitive preservation based on verbal learning compared to standard WBRT (82). As there was no difference in brain failure, HA-IMRT should be considered for this group of favorable patients without clinically apparent brain metastases.…”