Prophylactic Cranial Irradiation Versus Observation in Radically Treated Stage III Non-Small-Cell Lung Cancer: A Randomized Phase III NVALT-11/DLCRG-02 Study.

Autor:	De Ruysscher D; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Dingemans AC; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Praag J; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Belderbos J; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Tissing-Tan C; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Herder J; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Haitjema T; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Ubbels F; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Lagerwaard F; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., El Sharouni SY; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Stigt JA; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Smit E; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., van Tinteren H; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., van der Noort V; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium., Groen HJM; Dirk De Ruysscher and Anne-Marie C. Dingemans, Maastricht University Medical Center; GROW Research Institute, Maastricht; John Praag, Erasmus University Medical Center, Rotterdam; Jose Belderbos, Egbert Smit, Harm van Tinteren, and Vincent van der Noort, Netherlands Cancer Institute; Frank Lagerwaard, Free University Medical Center, Amsterdam; Caroline Tissing-Tan, Radiotherapy Institute Arnhem, Arnhem; Judith Herder, Antonius Hospital Nieuwegein, Nieuwegein; Tjeerd Haitjema, Medical Center Alkmaar, Alkmaar; Fred Ubbels and Harry J.M. Groen, University of Groningen; University Medical Center Groningen, Groningen; Sherif Y. El Sharouni, University Medical Center Utrecht, Utrecht; Jos A. Stigt, Isala Hospital, Zwolle, The Netherlands; and Dirk De Ruysscher, KU Leuven, Leuven, Belgium.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2018 Aug 10; Vol. 36 (23), pp. 2366-2377. Date of Electronic Publication: 2018 May 22.
DOI:	10.1200/JCO.2017.77.5817
Abstrakt:	Purpose The purpose of the current study was to investigate whether prophylactic cranial irradiation (PCI) reduces the incidence of symptomatic brain metastases in patients with stage III non-small-cell lung cancer (NSCLC) treated with curative intention. Patients and Methods Patients with stage III NSCLC-staged with a contrast-enhanced brain computed tomography or magnetic resonance imaging-were randomly assigned to either observation or PCI after concurrent/sequential chemoradiotherapy with or without surgery. The primary end point-development of symptomatic brain metastases at 24 months-was defined as one or a combination of key symptoms that suggest brain metastases-signs of increased intracranial pressure, headache, nausea and vomiting, cognitive or affective disturbances, seizures, and focal neurologic symptoms-and magnetic resonance imaging or computed tomography demonstrating the existence of brain metastasis. Adverse effects, survival, quality of life, quality-adjusted survival, and health care costs were secondary end points. Results Between 2009 and 2015, 175 patients were randomly assigned: 87 received PCI and 88 underwent observation only. Median follow-up was 48.5 months (95% CI, 39 to 54 months). Six (7.0%) of 86 patients in the PCI group and 24 (27.2%) of 88 patients in the control group had symptomatic brain metastases ( P = .001). PCI significantly increased the time to develop symptomatic brain metastases (hazard ratio, 0.23; [95% CI, 0.09 to 0.56]; P = .0012). Median time to develop brain metastases was not reached in either arm. Overall survival was not significantly different between both arms. Grade 1 and 2 memory impairment (26 of 86 v seven of 88 patients) and cognitive disturbance (16 of 86 v three of 88 patients) were significantly increased in the PCI arm. Quality of life was only decreased 3 months post-PCI and was similar to the observation arm thereafter. Conclusion PCI significantly decreased the proportion of patients who developed symptomatic brain metastases with an increase of low-grade toxicity.
Databáze:	MEDLINE
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