title: A pilot study of hypofractionated radiation therapy with temozolomide for adults with glioblastoma multiforme.
abstract: To evaluate the safety and efficacy of hypofractionated radiotherapy (RT) with a standard temozolomide (TMZ) regimen for adults with newly diagnosed glioblastoma multiforme (GBM), twenty-six consecutive adults (range 39-79 years) who met our enrollment criteria received short courses of hypofractionated RT (45 Gy in 15 fractions over three weeks) with concomitant TMZ at 75 mg/m(2)/d. After 28 days, TMZ was maintained at 150-200 mg/m(2)/d on five days for 12 cycles or until tumor progression or unacceptable toxicity. The primary end point was determined by overall survival (OS) and toxicity. Secondary assessed end points were: progression-free survival (PFS) at six months, health-related quality of life (HRQOL), and pseudo-progression. We assessed HRQOL by use of the Karnofsky performance status (KPS) and the Functional Assessment of Cancer Therapy-Brain (FACT-Br) Subscale. All 26 patients were evaluated for OS, PFS, and HRQOL. At a median follow-up of 20 months, the median OS was 15.6 months (95% confidence interval 9.0-22.2 months) with acceptable toxicity. PFS rate at six months was 65%. KPS and FACT-Br Subscale scores did not decline after this procedure. Pseudo-progression occurred in two (8%) patients. Adult patients with GBM benefitted from favorable OS and PFS rate as a result of the hypofractionated RT with TMZ. An additional advantage is that this procedure may reduce the course of treatment. Further studies using this procedure are warranted.
authors.affiliation: Department of Neurosurgery, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. jintara@med.kurume-u.ac.jp
authors.forename: Mizuhiko
authors.initials: M
authors.lastname: Terasaki
authors.forename: Tomoko
authors.initials: T
authors.lastname: Eto
authors.forename: Shinji
authors.initials: S
authors.lastname: Nakashima
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Okada
authors.forename: Etsuyo
authors.initials: E
authors.lastname: Ogo
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Sugita
authors.forename: Takashi
authors.initials: T
authors.lastname: Tokutomi
authors.forename: Minoru
authors.initials: M
authors.lastname: Shigemori
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D019583:Dose Fractionation, Radiation; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D015996:Survival Rate; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide