TY - JOUR
T1 - Phase 3 Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampus Avoidance in SCLC (NCT01780675)
AU - Belderbos, José S.A.
AU - De Ruysscher, Dirk K.M.
AU - De Jaeger, Katrien
AU - Koppe, Friederike
AU - Lambrecht, Maarten L.F.
AU - Lievens, Yolande N.
AU - Dieleman, Edith M.T.
AU - Jaspers, Jaap P.M.
AU - Van Meerbeeck, Jan P.
AU - Ubbels, Fred
AU - Kwint, Margriet H.
AU - Kuenen, Marianne A.
AU - Deprez, Sabine
AU - De Ruiter, Michiel B.
AU - Boogerd, Willem
AU - Sikorska, Karolina
AU - Van Tinteren, Harm
AU - Schagen, Sanne B.
N1 - Publisher Copyright:
© 2021 International Association for the Study of Lung Cancer
PY - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
KW - Hippocampus
KW - Neurocognition
KW - PCI
KW - Prophylactic cranial irradiation
KW - SCLC
UR - http://www.scopus.com/inward/record.url?scp=85102383500&partnerID=8YFLogxK
U2 - 10.1016/j.jtho.2020.12.024
DO - 10.1016/j.jtho.2020.12.024
M3 - Article
C2 - 33545387
AN - SCOPUS:85102383500
SN - 1556-0864
VL - 16
SP - 840
EP - 849
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 5
ER -