title: Health related quality of life and cognitive status in patients with glioblastoma multiforme receiving escalating doses of conformal three dimensional radiation on RTOG 98-03.
abstract: The Radiation Therapy Oncology Group (RTOG) embarked on a phase I/II study of patients suffering from glioblastoma multiforme (protocol 98-03) to assess the impact of dose escalation with 3-D conformal techniques. The primary endpoints were feasibility and survival. This report describes the outcome of secondary endpoints (quality of life and neurocognitive function). Patients with supratentorial GBM were treated with a combination of carmustine (BCNU) and conformal irradiation (dose levels: 66, 72, 78, 84 Gy, respectively). Quality of Life was assessed with the Spitzer Quality of Life Index. Neurocognitive function was determined by the Mini Mental Status Examination. The latter tests were administered at the start of irradiation, at the end of irradiation and then at 4 month intervals. Relatively high compliance was achieved with both of the tools (SQLI; MMSE). Overall rates of survival between baseline SQLI scores <7 and 7-10 were statistically significantly different [HR = 1.72, 95% CI (1.22, 2.4), P = 0.0015]. The significant impact of high SQLI score on survival was preserved in multivariate analysis. The component of this index which made the greatest contribution was the patient's independence. There was continual deterioration of neurocognitive function within the populations studied. No correlation was seen between dose escalation and the secondary endpoints studied. Radiation dose escalation and assessment of its impact on life quality and neurocognition can be carried out in a large international trial. Baseline SQLI is a statistically significant determinant of survival. Those who maintain independence have superior survival to those who are reliant on others.
authors.affiliation: Tel Aviv Medical Center, 6 Weizman Street, Tel Aviv, 64239, Israel. bencorn@tasmc.health.gov.il.
authors.forename: Benjamin W
authors.initials: BW
authors.lastname: Corn
authors.affiliation: Statistical Unit, RTOG, 1800 Market Street, Philadelphia, PA, USA.
authors.forename: Meihua
authors.initials: M
authors.lastname: Wang
authors.affiliation: Cullather Brain Tumor QOL Center Bonsecours Richmond, 4349 Collingswood Dr, Chesterfield, VA, 23832, USA.
authors.forename: Sherry
authors.initials: S
authors.lastname: Fox
authors.affiliation: Washington University Medical Center, 4921 Parkview Pl Campus Box 8224, St. Louis, MO, 63110, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Michalski
authors.affiliation: UC Davis Medical Center, 4501 X St Ste G140, Sacramento, CA, 95817, USA.
authors.forename: James
authors.initials: J
authors.lastname: Purdy
authors.affiliation: Washington University in St. Louis, 4921 Parkview Pl Campus Box 8224, St. Louis, MO, 63110-1001, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Simpson
authors.affiliation: Arizona Oncology Services, 350 W Thomas Rd, Phoenix, AZ, 85013, USA.
authors.forename: John
authors.initials: J
authors.lastname: Kresl
authors.affiliation: Emory University School of Medicine, 1365 Clifton Rd, NE Atlanta, GA, 30322, USA.
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Curran
authors.affiliation: Cancer Therapy and Research Center, 7703 Floyd Curl Dr MSC 7889, San Antonio, TX, 78229, USA.
authors.forename: Aidnag
authors.initials: A
authors.lastname: Diaz
authors.affiliation: University of Wisconsin School of Medicine and Public Health, 600 Highland Ave K4 312-3685, Madison, WI, 53792, USA.
authors.forename: Minesh
authors.initials: M
authors.lastname: Mehta
authors.affiliation: Henry Ford Hospital, 2799 W Grand Blvd, Detroit, MI, 48202, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Movsas
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D002330:Carmustine / Q000627:therapeutic use*; D003072:Cognition Disorders / Q000175:diagnosis / Q000209:etiology; D003131:Combined Modality Therapy; D016371:Cranial Irradiation; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005909:Glioblastoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D011379:Prognosis; D011788:Quality of Life; D011880:Radiotherapy Planning, Computer-Assisted; D020266:Radiotherapy, Conformal; D015996:Survival Rate; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D002330:Carmustine