Randomized Phase III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small-Cell Lung Cancer (PREMER): A GICOR-GOECP-SEOR Study

  • Núria Rodríguez de Dios
    Radiation Oncology, Hospital del Mar, Barcelona, Spain
  • Felipe Couñago
    Department of Radiation Oncology, Hospital Universitario Quirónsalud, Madrid, Spain
  • Mauricio Murcia-Mejía
    Department of Radiation Oncology, Hospital Universitario Sant Joan de Reus, Reus, Tarragona, Spain
  • Mikel Rico-Oses
    Department of Radiation Oncology, Complejo Hospitalario Navarra, Pamplona, Spain
  • Patricia Calvo-Crespo
    Department of Radiation Oncology, Hospital Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
  • Pilar Samper
    Department of Radiation Oncology, Hospital Universitario Rey Juan Carlos, Móstoles, Madrid, Spain
  • Carmen Vallejo
    Department of Radiation Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain
  • Javier Luna
    Department of Radiation Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
  • Itziar Trueba
    Department of Radiation Oncology, Hospital Universitario de Álava-sede Txagorritxu.Vitoria-Gasteiz, Spain
  • Amalia Sotoca
    Department of Radiation Oncology, Hospital Ruber Internacional, Madrid, Spain
  • Cristina Cigarral
    Department of Radiation Oncology, Hospital Clínico de Salamanca, Salamanca, Spain
  • Núria Farré
    Department of Radiation Oncology, Hospital Universitario Santa Creu i Sant Pau, Barcelona, Spain
  • Rosa M. Manero
    Department of Neurology, Hospital del Mar, Barcelona, Spain
  • Xavier Durán
    IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
  • Juan Domigo Gispert
    IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
  • Gonzalo Sánchez-Benavides
    IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
  • Teresa Rognoni
    Department of Neurology, Clínica Universidad de Navarrra, Madrid, Spain
  • Margarita Torrente
    Department of Psychology, School of Educational Sciences and Psychology, Rovira i Virgili University, Tarragona, Spain
  • Jaume Capellades
    Department of Radiology, Hospital del Mar, Barcelona, Spain
  • Mar Jiménez
    Department of Radiology, Hospital Universitario Quirónsalud, Madrid, Spain
  • Teresa Cabada
    Department of Radiology, Complejo Hospitalario Navarra, Pamplona, Spain
  • Miguel Blanco
    Department of Radiology, Hospital Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
  • Ana Alonso
    Department of Radiology, Hospital Universitario Rey Juan Carlos, Móstoles, Madrid, Spain
  • Juan Martínez-San Millán
    Department of Radiology, Hospital Universitario Ramón y Cajal, Madrid, Spain
  • José Escribano
    Department of Radiology, Hospital Ruber Internacional, Madrid, Spain
  • Beatriz González
    Department of Radiation Oncology, Hospital Clínico de Salamanca, Salamanca, Spain
  • José Luis López-Guerra
    Department of Radiation Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain

抄録

<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Radiation dose received by the neural stem cells of the hippocampus during whole-brain radiotherapy has been associated with neurocognitive decline. The key concern using hippocampal avoidance-prophylactic cranial irradiation (HA-PCI) in patients with small-cell lung cancer (SCLC) is the incidence of brain metastasis within the hippocampal avoidance zone. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> This phase III trial enrolled 150 patients with SCLC (71.3% with limited disease) to standard prophylactic cranial irradiation (PCI; 25 Gy in 10 fractions) or HA-PCI. The primary objective was the delayed free recall (DFR) on the Free and Cued Selective Reminding Test (FCSRT) at 3 months; a decrease of 3 points or greater from baseline was considered a decline. Secondary end points included other FCSRT scores, quality of life (QoL), evaluation of the incidence and location of brain metastases, and overall survival (OS). Data were recorded at baseline, and 3, 6, 12, and 24 months after PCI. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Participants' baseline characteristics were well balanced between the two groups. The median follow-up time for living patients was 40.4 months. Decline on DFR from baseline to 3 months was lower in the HA-PCI arm (5.8%) compared with the PCI arm (23.5%; odds ratio, 5; 95% CI, 1.57 to 15.86; P = .003). Analysis of all FCSRT scores showed a decline on the total recall (TR; 8.7% v 20.6%) at 3 months; DFR (11.1% v 33.3%), TR (20.3% v 38.9%), and total free recall (14.8% v 31.5%) at 6 months, and TR (14.2% v 47.6%) at 24 months. The incidence of brain metastases, OS, and QoL were not significantly different. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Sparing the hippocampus during PCI better preserves cognitive function in patients with SCLC. No differences were observed with regard to brain failure, OS, and QoL compared with standard PCI. </jats:p></jats:sec>

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