Prophylactic Cranial Irradiation in high-risk metastatic non-small cell lung cancer patients: Quality of life and neurocognitive analysis of a randomized phase II study

• Published in: International journal of radiation oncology, biology, physics
• Main Authors: Maldonado, Federico, Gonzalez-Ling, Ana, Oñate-Ocaña, Luis F, Cabrera-Miranda, Luis Antonio, Zatarain-Barrón, Zyanya Lucia, Turcott, Jenny G, Flores-Estrada, Diana, Lozano-Ruiz, Francisco, Cacho-Díaz, Bernardo, Arrieta, Oscar
• Format: Journal Article
• Language: English
• Published: United States 26.04.2021
• Subjects: ALK; Carcinoembryonic antigen; prophylactic irradiation; EGFR; Neurocognitive function; Quality of life
• ISSN: 1879-355X

To this date, studies regarding the use of prophylactic cranial irradiation (PCI) vs. standard of care (SoC) for NSCLC patients have shown limited benefit in survival outcomes, in addition to the potential effects in quality of life (QoL) and neurocognitive function (NCF). This randomized, phase II study evaluated the role of PCI in QoL and NCF, in a population comprised of subjects at a high-risk for development of BM. Eligible patients had histologically confirmed NSCLC without baseline BM, harboring EGFRm, ALKr or elevated CEA at diagnosis. Participants were assigned to receive SoC or SoC plus PCI (25 Gy in 10 fractions). Primary endpoint was brain metastases at 24 months (BM-24), for which the study was powered. Secondary endpoints included QoL assessed using the EORTC QLQ-C30 and the LC13, and NCF assessed using the Mini Mental State Examination. Patients were followed every 3 months for a year for QoL and NCF. Clinicaltrials.gov XXXXXXX. From May 2012 to December 2017, 84 patients were enrolled in the study, 41 were allocated to PCI while 43 received SoC. Efficacy outcomes are discussed in a separate article. The Global health-QoL scores were similar at 3, 6, 9- and 12-months following randomization among both study arm, with no significant differences when comparing by groups. At one-year post-randomization, median global health QoL scores were 83 (p25-p75: 75-83) and 83 (p25-p75: 75-83) in the control and experimental arms, respectively. There were no significant changes in terms of the mean differences between subjects in either study arm when analyzing the change between baseline and 12-month scores (16.4 ± 19.9 vs. 12.9 ± 14.7; p=0.385). Seventeen patients were alive at database lockdown on February 2020, without significant differences in median MMSE (30 [p25-75: 29-30] vs. 30 [p25-75: 28-30]) or QLQ-C30 scores (75.0 [p25-75: 50-87.2] vs. 67.0 [p25-75: 50.0-100.0]), respectively. Among a selected high-risk population for developing BM, PCI did not significantly decrease QoL or neurocognitive function as assessed using the MMSE. Future studies are warranted in order to assess this observation, using more varied and sensitive tools available to date.