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dc.contributor.authorBrada, Men_US
dc.contributor.authorHoang-Xuan, Ken_US
dc.contributor.authorRampling, Ren_US
dc.contributor.authorDietrich, PYen_US
dc.contributor.authorDirix, LYen_US
dc.contributor.authorMacdonald, Den_US
dc.contributor.authorHeimans, JJen_US
dc.contributor.authorZonnenberg, BAen_US
dc.contributor.authorBravo-Marques, JMen_US
dc.contributor.authorHenriksson, Ren_US
dc.contributor.authorStupp, Ren_US
dc.contributor.authorYue, Nen_US
dc.contributor.authorBruner, Jen_US
dc.contributor.authorDugan, Men_US
dc.contributor.authorRao, Sen_US
dc.contributor.authorZaknoen, Sen_US
dc.identifier.citationANNALS OF ONCOLOGY, 2001, 12 pp. 259 - 266en_US
dc.description.abstractBackground: Recurrent glioblastoma multiforme (GBM) is resistant to most therapeutic endeavors, with low response rates and survival rarely exceeding six months. There are no clearly established chemotherapeutic regimens and the aim of treatment is palliation with improvement in the quality of life. Patients and methods: We report an open-label, uncontrolled, multicenter phase II trial of temozolomide in 138 patients (intent-to-treat [ITT] population) with glioblastoma multiforme at first relapse and a Karnofsky performance status (KPS) greater than or equal to 70. One hundred twenty-eight patients were histologically confirmed with GBM or gliosarcoma (GS) by independent central review. Chemotherapy-naive patients were treated with temozolomide 200 mg/m(2)/day orally for the first five days of a 28-day cycle. Patients previously treated with nitrosourea-containing adjuvant chemotherapy received 150 mg/m(2)/day for the first five days of a 28-day cycle. In the absence of grade 3 or 4 toxicity, patients on the 150 mg/m(2) dose schedule were eligible for a 200 mg/m(2) dose on the next cycle. Results: The primary endpoint was six-month progression-free survival assessed with strict radiological and clinical criteria. Secondary endpoints included radiological response and Health-related Quality of Life (HQL). Progression-free survival at six months was 18% (95% confidence interval (CI): 11%-26%) for the eligible-histology population. Median progression-free survival and median overall survival were 2.1 months and 5.4 months, respectively. The six-month survival rate was 46%. The objective response rate (complete response and partial response) determined by independent central review of gadolinium-enhanced magnetic resonance imaging (MRI) scans was 8% for both the ITT and eligible-histology populations, with an additional 43% and 45% of patients, respectively, having stable disease (SD). Objectively assessed response and maintenance of a progression-free status were both associated with HQL benefits (characterized by improvements over baseline in HQL domains). Temozolomide had an acceptable safety profile, with only 9% of therapy cycles requiring a dose reduction due to thrombocytopenia. There was no evidence of cumulative hematologic toxicity. Conclusions: Temozolomide demonstrated modest clinical efficacy, with an acceptable safety profile and measurable improvement in quality of life in patients with recurrent GBM. The use of this drug should be explored further in an adjuvant setting and in combination with other agents.en_US
dc.format.extent259 - 266en_US
dc.titleMulticenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapseen_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfANNALS OF ONCOLOGYen_US
pubs.notesaffiliation: Brada, M (Reprint Author), Inst Canc Res, Downs Rd, Sutton SM2 5PT, Surrey, England. Royal Marsden Hosp, Surrey, England. Hop La Pitie Salpetriere, Paris, France. Univ Glasgow, Western Infirm, Beatson Oncol Ctr, Glasgow G11 6NT, Lanark, Scotland. Univ Hosp Geneva, Div Oncol, Geneva, Switzerland. Catholic Univ Louvain, Canc Res Lab, Louvain, Belgium. London Reg Canc Ctr, London, ON N6A 4L6, Canada. Free Univ Amsterdam Hosp, Amsterdam, Netherlands. Univ Utrecht Hosp, Utrecht, Netherlands. Inst Portugues Oncol, Ctr Lisboa, Lisbon, Portugal. Norrland Univ Hosp, Umea, Sweden. Ctr Pluralist Oncol, Lausanne, Switzerland. Johns Hopkins Univ, Baltimore, MD USA. Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA. Schering Plough Pharmaceut, Kenilworth, NJ USA. keywords: chemotherapy; glioblastoma multiforme; gliosarcoma; quality of life; temozolomide; tumor response keywords-plus: QUALITY-OF-LIFE; RECURRENT MALIGNANT GLIOMAS; HIGH-DOSE TAMOXIFEN; HIGH-GRADE GLIOMAS; ANAPLASTIC ASTROCYTOMA; PROCARBAZINE; SUPRATENTORIAL; CHEMOTHERAPY; CYTOTOXICITY; CARBOPLATIN research-areas: Oncology web-of-science-categories: Oncology number-of-cited-references: 33 times-cited: 270 usage-count-last-180-days: 1 usage-count-since-2013: 4 journal-iso: Ann. Oncol. doc-delivery-number: 402LH unique-id: ISI:000166988200027 oa: gold_or_bronze da: 2018-09-26en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams/Clinical Academic Radiotherapy (Brada)
pubs.embargo.termsNot knownen_US
icr.researchteamClinical Academic Radiotherapy (Brada)en_US
dc.contributor.icrauthorBrada, Michaelen_US

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