title: Hypofractionated radiotherapy followed by adjuvant chemotherapy with temozolomide in elderly patients with glioblastoma.
abstract: OBJECTIVE
  The optimal treatment for elderly patients (age >70 years) with glioblastoma (GBM) remains controversial. We conducted a prospective trial in 43 consecutive elderly patients with GBM treated with hypofractionated radiotherapy (RT) followed by adjuvant temozolomide.
  
  
  METHODS
  Forty-three patients 70 years of age or older with a newly diagnosed GBM and a Karnofsky performance status (KPS) > or = 60 were treated with hypofractionated RT (6 fractions of 5 Gy each for a total of 30 Gy over 2 weeks) followed by up to 12 cycles of adjuvant temozolomide (150-200 mg/m(2) for 5 days during each 28 day cycle). The HRQOL was assessed with the EORTC Quality of Life Questionnaire C30. The primary endpoint was overall survival (OS). Secondary endpoints included progression free survival (PFS), toxicity and quality of life.
  
  
  RESULTS
  The median OS was 9.3 months and the median PFS was 6.3 months. The 6 and 12 month survival rates were 86% and 35%, respectively. The 6 and 12 month PFS rates were 55% and 12%, respectively. In multivariate analysis KPS was the only significant independent predictive factor of survival (P = 0.008). Neurological deterioration occurred during or after RT in 16% of patients and was resolved in most cases with the use of steroids. Grade 3-4 hematologic toxicity occurred in 28% of patients during the adjuvant chemotherapy treatment with temozolomide. The treatment had no negative effect on HRQOL, however, fatigue (P = 0.02) and constipation (P = 0.01) scales worsened over time.
  
  
  CONCLUSIONS
  Hypofractionated RT followed by temozolomide may provide survival benefit maintaining a good quality of life in elderly patients with GBM. It may represent a reasonable therapeutic approach especially in patients with less favourably prognostic factors.
authors.affiliation: Department of Radiotherapy Oncology, Sant' Andrea Hospital, University "La Sapienza", Via di Grottarossa 1035, 00189, Rome, Italy. Giuseppe.Minniti@ospedalesantandrea.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Minniti
authors.forename: V
authors.initials: V
authors.lastname: De Sanctis
authors.forename: R
authors.initials: R
authors.lastname: Muni
authors.forename: D
authors.initials: D
authors.lastname: Rasio
authors.forename: G
authors.initials: G
authors.lastname: Lanzetta
authors.forename: A
authors.initials: A
authors.lastname: Bozzao
authors.forename: M F
authors.initials: MF
authors.lastname: Osti
authors.forename: M
authors.initials: M
authors.lastname: Salvati
authors.forename: M
authors.initials: M
authors.lastname: Valeriani
authors.forename: G P
authors.initials: GP
authors.lastname: Cantore
authors.forename: R
authors.initials: R
authors.lastname: Maurizi Enrici