title: Phase II trial of hypofractionated IMRT with temozolomide for patients with newly diagnosed glioblastoma multiforme.
abstract: OBJECTIVE
  To report toxicity and overall survival (OS) in patients with newly diagnosed glioblastoma multiforme (GBM) treated with hypofractionated intensity-modulated radiotherapy (hypo-IMRT) with concurrent and adjuvant temozolomide (TMZ).
  
  
  METHODS
  Patients with newly diagnosed GBM after biopsy or resection and with adequate performance status and organ or bone marrow function were eligible for this study. Patients received postoperative hypo-IMRT to the surgical cavity and residual tumor seen on T1-weighted brain MRI with a 5-mm margin to a total dose of 60 Gy in 10 fractions (6 Gy/fraction) and to the T2 abnormality on T2-weighted MRI with 5-mm margin to 30 Gy in 10 fractions (3 Gy/fraction). Concurrent TMZ was given at 75 mg/m(2)/day for 28 consecutive days. Adjuvant TMZ was given at 150 to 200 mg/m(2)/day for 5 days every 28 days. Toxicities were defined using Common Terminology Criteria for Adverse Events version 3.0.
  
  
  RESULTS
  Twenty-four patients were treated, consisting of 14 men, 10 women; a median age of 60.5 years old (range, 27-77 years); and a median Karnofsky performance score of 80 (range, 60-90). All patients received hypo-IMRT and concurrent TMZ according to protocol, except for 2 patients who received only 14 days of concurrent TMZ. The median number of adjuvant TMZ cycles was 6.5 (range, 0-14).With a median follow-up of 14.8 months (range, 2.7-34.2 months) for all patients and a minimum follow-up of 20.6 months for living patients, no instances of grade 3 or higher nonhematologic toxicity were observed. The median OS was 16.6 months (range, 4.1-35.9 months). Six patients underwent repeated surgery for suspected tumor recurrence; necrosis was found in 50% to 100% of the resected specimens.
  
  
  CONCLUSIONS
  In selected GBM patients, 60 Gy hypo-IMRT delivered in 6-Gy fractions over 2 weeks with concurrent and adjuvant TMZ is safe. OS in this small cohort of patients was comparable to that treated with current standard of care therapy.
authors.affiliation: Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, CO 80045-0508, USA.
authors.forename: Krishna
authors.initials: K
authors.lastname: Reddy
authors.forename: Denise
authors.initials: D
authors.lastname: Damek
authors.forename: Laurie E
authors.initials: LE
authors.lastname: Gaspar
authors.forename: Douglas
authors.initials: D
authors.lastname: Ney
authors.forename: Allen
authors.initials: A
authors.lastname: Waziri
authors.forename: Kevin
authors.initials: K
authors.lastname: Lillehei
authors.forename: Kelly
authors.initials: K
authors.lastname: Stuhr
authors.forename: Brian D
authors.initials: BD
authors.lastname: Kavanagh
authors.forename: Changhu
authors.initials: C
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use; D019583:Dose Fractionation, Radiation; D005260:Female; D005909:Glioblastoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000601:surgery; D011446:Prospective Studies; D012086:Reoperation; D000077204:Temozolomide; D047368:Tumor Burden
chemical_list: D000893:Anti-Inflammatory Agents; D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D003907:Dexamethasone; D000077204:Temozolomide