title: Low-dose fractionated radiotherapy and concomitant chemotherapy for recurrent or progressive glioblastoma: final report of a pilot study.
abstract: BACKGROUND
  Evaluated in this study were the feasibility and the efficacy of concurrent low dose fractionated radiotherapy (LD-FRT) and chemotherapy as palliative treatment for recurrent/progressive glioblastoma multiforme (GBM).
  
  
  METHODS
  Eligible patients had recurrent or progressive GBM, Karnofsky performance status ≥ 70, prior surgery, and standard radiochemotherapy treatment. Recurrence/progression disease during temozolomide (TMZ) received cisplatin (CDDP; 30 mg/m(2) on days 1, 8, 15), fotemustine (FTM; 40 mg/m(2) on days 2, 9, 16), and concurrent LD-FRT (0.3 Gy twice daily); recurrence/progression after 4 months from the end of adjuvant TMZ were treated by TMZ (150/200 mg/m(2) on days 1-5) concomitant with LD-FRT (0.4 Gy twice daily). Primary endpoints were safety and toxicity.
  
  
  RESULTS
  A total of 32 patients were enrolled. Hematologic toxicity G1-2 was observed in 18.7 % of patients and G3-4 in 9.4 %. One patient (3.1 %) had complete response, 3 (9.4 %) had partial response, 8 (25 %) had stable disease for at least 8 weeks, while 20 patients (62.5 %) experienced progressive disease. The clinical benefit was 37.5 %. Median progression-free survival (PFS) and overall survival (OS) were 5 and 8 months, respectively. Survival rate at 12 months was of 27.8 %.
  
  
  CONCLUSIONS
  LD-FRT and chemotherapy for recurrent/progressive GBM have a good toxicity profile and clinical outcomes, even though further investigation of this novel palliative treatment approach is warranted.
authors.affiliation: Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo Agostino Gemelli, 1, 00168, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Balducci
authors.forename: B
authors.initials: B
authors.lastname: Diletto
authors.forename: S
authors.initials: S
authors.lastname: Chiesa
authors.forename: G R
authors.initials: GR
authors.lastname: D'Agostino
authors.forename: M A
authors.initials: MA
authors.lastname: Gambacorta
authors.forename: M
authors.initials: M
authors.lastname: Ferro
authors.forename: C
authors.initials: C
authors.lastname: Colosimo
authors.forename: G
authors.initials: G
authors.lastname: Maira
authors.forename: C
authors.initials: C
authors.lastname: Anile
authors.forename: V
authors.initials: V
authors.lastname: Valentini
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001932:Brain Neoplasms / Q000175:diagnosis / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D019583:Dose Fractionation, Radiation; D005260:Female; D005909:Glioblastoma / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000628:therapy*; D010865:Pilot Projects; D020266:Radiotherapy, Conformal / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult