Revista de Neurooncología y Neurociencia Acceso abierto

Abstracto

A Randomized Study of Radiation Therapy with or without Temozolomide in Elderly and/or Frail Patients and Newly Diagnosed Glioblastoma (GBM)

Subhash Thakur*

Addition of temozolamide to standard radiotherapy has shown survival benefit in patient with age 70 or younger. But there has been so far no robust randomized trial evaluating the efficacy of temozolamide with hypo-fractionated radiotherapy. So we in our centre studied the role of Temozolomide with short course (1 week) hypofractionated Radiotherapy in elderly/frail patients. Aims: To compare Overall Survival (OS) and Progression-Free Survival (PFS) between the two arms. Settings and design: The Study was Randomized trial of hypofractionated radiotherapy (25 Gy in 5 fractions) with temozolomide (arm A, N=35) or without temozolomide (arm B, N=35). This study was conducted at Department of Radiotherapy, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Methods and material: Total 70 patients with newly diagnosed Glioblastoma (post-operative) were enrolled and were randomized into two groups using computer generated randomization table. Statistical analysis used: The t test was used to compare the continuous variables of the two study arms, and chi square tests were used to compare the categorical variables. All tests were two-tailed and a P=0.05 was taken significant. Results: Median PFS was longer in arm A than in arm B (3.65 and 2.33 months, P=0.028) but median OS was similar (4.86 and 4.033 months, P=0.146). Conclusions: Addition of temozolomide to hypofractionated radiotherapy (25 Gy in 5 fractions) is a feasible and effective treatment option with limited morbidity for elderly and frail newly diagnosed GBM patients.