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J Clin Oncol. 2015 Dec 10;33(35):4145-50. doi: 10.1200/JCO.2015.62.6606. Epub 2015 Sep 21.

International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme.

Author information

1
Wilson Roa, Suzanne Drodge, and Sunita Ghosh, University of Alberta, Alberta Health Services-Cancer Control, Edmonton, Alberta, Canada; Lucyna Kepka, Warmia and Mazury Oncology Center, Olsztyn; Katarzyna Dyttus-Cebulok, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Narendra Kumar, Postgraduate Institute of Medical Education and Research, Chandigarh, India; Valery Sinaika, N.N. Alexandrov National Cancer Centre of Belarus, Minsk, Belarus; Juliana Matiello, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre; Douglas Guedes de Castro, Castro DG, AC Camargo Cancer Center, São Paulo, Brazil; Darejan Lomidze, High Technology Medical Center, University Clinic, Tbilisi, Georgia; Dalenda Hentati, Institut National de Cancer Salah Azaiz, Ministère de la Santé Publique, Bab Saadoum, Tunisia; Branislav Jeremić, Institute of Lung Diseases, Institutski put 4, Sremska Kamenica, Serbia; and Eduardo Rosenblatt and Elena Fidarova, International Atomic Energy Agency, Vienna, Austria. wilson.roa@albertahealthservices.ca.
2
Wilson Roa, Suzanne Drodge, and Sunita Ghosh, University of Alberta, Alberta Health Services-Cancer Control, Edmonton, Alberta, Canada; Lucyna Kepka, Warmia and Mazury Oncology Center, Olsztyn; Katarzyna Dyttus-Cebulok, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland; Narendra Kumar, Postgraduate Institute of Medical Education and Research, Chandigarh, India; Valery Sinaika, N.N. Alexandrov National Cancer Centre of Belarus, Minsk, Belarus; Juliana Matiello, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre; Douglas Guedes de Castro, Castro DG, AC Camargo Cancer Center, São Paulo, Brazil; Darejan Lomidze, High Technology Medical Center, University Clinic, Tbilisi, Georgia; Dalenda Hentati, Institut National de Cancer Salah Azaiz, Ministère de la Santé Publique, Bab Saadoum, Tunisia; Branislav Jeremić, Institute of Lung Diseases, Institutski put 4, Sremska Kamenica, Serbia; and Eduardo Rosenblatt and Elena Fidarova, International Atomic Energy Agency, Vienna, Austria.

Abstract

PURPOSE:

The optimal radiotherapy regimen for elderly and/or frail patients with newly diagnosed glioblastoma remains to be established. This study compared two radiotherapy regimens on the outcome of these patients.

PATIENTS AND METHODS:

Between 2010 and 2013, 98 patients (frail = age ≥ 50 years and Karnofsky performance status [KPS] of 50% to 70%; elderly and frail = age ≥ 65 years and KPS of 50% to 70%; elderly = age ≥ 65 years and KPS of 80% to 100%) were prospectively randomly assigned to two arms in a 1:1 ratio, stratified by age (< and ≥ 65 years old), KPS, and extent of surgical resection. Arm 1 received short-course radiotherapy (25 Gy in five daily fractions over 1 week), and arm 2 received commonly used radiotherapy (40 Gy in 15 daily fractions over 3 weeks).

RESULTS:

The short-course radiotherapy was noninferior to commonly used radiotherapy. The median overall survival time was 7.9 months (95% CI, 6.3 to 9.6 months) in arm 1 and 6.4 months (95% CI, 5.1 to 7.6 months) in arm 2 (P = .988). Median progression-free survival time was 4.2 months (95% CI, 2.5 to 5.9) in arm 1 and 4.2 months (95% CI, 2.6 to 5.7) in arm B (P = .716). With a median follow-up time of 6.3 months, the quality of life between both arms at 4 weeks after treatment and 8 weeks after treatment was not different.

CONCLUSION:

There were no differences in overall survival time, progression-free survival time, and quality of life between patients receiving the two radiotherapy regimens. In view of the reduced treatment time, the short 1-week radiotherapy regimen may be recommended as a treatment option for elderly and/or frail patients with newly diagnosed glioblastoma.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01450449.

PMID:
26392096
DOI:
10.1200/JCO.2015.62.6606
[Indexed for MEDLINE]

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