Παρασκευή 31 Μαρτίου 2017

Survival Outcomes with Short-Course Radiotherapy in Elderly Patients with Glioblastoma: Data from a Randomized Phase III Trial

Publication date: Available online 30 March 2017
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Douglas Guedes de Castro, Juliana Matiello, Wilson Roa, Sunita Ghosh, Lucyna Kepka, Narendra Kumar, Valery Sinaika, Darejan Lomidze, Dalenda Hentati, Eduardo Rosenblatt, Elena Fidarova
PurposeTo perform a subset analysis of survival outcomes in elderly patients with glioblastoma (GBM) from a randomized phase III trial comparing two short-course radiotherapy (RT) regimens in elderly and/or frail patients.Methods and MaterialsThe original trial population included elderly and/or frail patients diagnosed with GBM. Patients joined the phase III, randomized, multicenter, prospective, non-inferiority trial and were assigned to one of two groups in a 1:1 ratio to either short-course RT (25 Gy in 5 fractions, arm 1) or commonly used RT (40 Gy in 15 fractions, arm 2) and stratified by age (< and ≥ 65 years), Karnofsky performance status, and extent of surgery. For the subset analysis in this study, only patients ≥ 65 years were evaluated (elderly and frail patients were defined as age ≥ 65 years and KPS 50-70%; elderly and not frail patients were defined as age ≥ 65 years and KPS 80-100%), resulting in 61 out of 98 initial patients, with 26 patients randomized to arm 1 and 35 to arm 2.ResultsIn this unplanned analysis, the short-course RT results were not statistically significant different to commonly used RT in elderly patients. The median overall survival time was 6.8 months (95% CI, 4.5 to 9.1 months) in arm 1 and 6.2 months (95% CI, 4.7 to 7.7 months) in arm 2 (P = 0.936). Median progression-free survival time was 4.3 months (95% CI, 2.6 to 5.9 months) in arm 1 and 3.2 months (95% CI, .1 to 6.3 months) in arm 2 (P = 0.706).ConclusionsA short-course RT regimen of 25 Gy in 5 fractions is an acceptable treatment option for patients over 65 years old, mainly for those with poor performance or contraindication to chemotherapy, which would be indicated in cases of methylated MGMT promoted tumors.

Teaser

In this post-hoc, subset analysis of an International Atomic Energy Agency randomized phase III trial restricted to elderly patients ≥ 65 years, the short-course radiotherapy regimen of 25 Gy in 5 fractions was not inferior to commonly used regimen of 40 Gy in 15 fractions in terms of overall and progression-free survival.


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