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Background There is no community standard for the treatment of glioblastoma in patients 70 years of age or older. We conducted a randomized trial that compared radiotherapy and supportive care with supportive care alone in such patients.
Methods Patients 70 years of age or older with a newly diagnosed anaplastic astrocytoma or glioblastoma and a Karnofsky performance score of 70 or higher were randomly assigned to receive supportive care only or supportive care plus radiotherapy (focal radiation in daily fractions of 1.8 Gy given 5 days per week, for a total dose of 50 Gy). The primary end point was overall survival; secondary end points were progression-free survival, tolerance of radiotherapy, health-related quality of life, and cognition.
Results We randomly assigned 85 patients from 10 centers to receive either radiotherapy and supportive care or supportive care alone. The trial was discontinued at the first interim analysis, which showed that with a preset boundary of efficacy, radiotherapy and supportive care were superior to supportive care alone. A final analysis was carried out for the 81 patients with glioblastoma (median age, 73 years; range, 70 to 85). At a median follow-up of 21 weeks, the median survival for the 39 patients who received radiotherapy plus supportive care was 29.1 weeks, as compared with 16.9 weeks for the 42 patients who received supportive care alone. The hazard ratio for death in the radiotherapy group was 0.47 (95% confidence interval, 0.29 to 0.76; P=0.002). There were no severe adverse events related to radiotherapy. The results of quality-of-life and cognitive evaluations over time did not differ significantly between the treatment groups.
Conclusions Radiotherapy results in a modest improvement in survival, without reducing the quality of life or cognition, in elderly patients with glioblastoma. (ClinicalTrials.gov number, NCT00430911
[ClinicalTrials.gov]
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Source Information
From Groupe Hospitalier Pitié–Salpêtrière, Assistance Publique–Hôpitaux de Paris; INSERM Unité 711; and Université Pierre et Marie Curie, Paris (F.K.-G., K.M., J.-J.M., A.B., J.-Y.D.); Hôpital de la Timone, Marseille, France (O.C., M.B.); Hôpital Saint-Julien, Nancy, France (L.T., V.B.); Université Claude Bernard Lyon 1, INSERM Unité 842, and Hospices Civils de Lyon, Lyon, France (S.C.-C., J.H.); Centre Antoine Lacassagne, Nice, France (M.F., P.-Y.B.); Institut Bergonie, Bordeaux, France (G.K.); Centre Hospitalo-Universitaire Côte de Nacre, Caen, France (J.-S.G.); Centre Paul Papin, Angers, France (E.J.); Polyclinique de Courlancy, Reims, France (P.C.); Centre Hospitalo-Universitaire, Angers, France (P.M.); and Centre Hospitalo-Universitaire, Bordeaux, France (H.L.).
Address reprint requests to Dr. Delattre at Service de Neurologie Mazarin, Hôpital de la Salpêtrière, 47 Blvd. de l'Hôpital, 75013, Paris, France, or at jean-yves.delattre{at}psl.aphp.fr.
Related Letters:
Prophylactic Radiotherapy for Glioblastoma in the Elderly
Hanna S., Vordermark D., Tartarone A., Ardito R., Romano C., Delattre J.-Y.
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N Engl J Med 2007;
357:195-196, Jul 12, 2007.
Correspondence
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