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Titolo:
Phase I study of Gliadel (TM) wafers plus temozolomide in adults with recurrent supratentorial high-grade gliomas
Autore:
Gururangan, S; Cokgor, I; Rich, JN; Edwards, S; Affronti, ML; Quinn, JA; Herndon, JE; Provenzale, JM; McLendon, RE; Tourt-Uhlig, S; Sampson, JH; Stafford-Fox, V; Zaknoen, S; Early, M; Friedman, AH; Friedman, HS;
Indirizzi:
Duke Univ, Med Ctr, Dept Neurosurg, Durham, NC 27710 USA Duke Univ DurhamNC USA 27710 d Ctr, Dept Neurosurg, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA Duke Univ Durham NC USA 27710 iv, Med Ctr, Dept Med, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Community & Family Med, Durham, NC 27710 USA DukeUniv Durham NC USA 27710 ommunity & Family Med, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Neuroradiol, Durham, NC 27710 USA Duke Univ Durham NC USA 27710 Ctr, Dept Neuroradiol, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Pathol, Durham, NC 27710 USA Duke Univ Durham NCUSA 27710 Med Ctr, Dept Pathol, Durham, NC 27710 USA Schering Plough Corp, Kenilworth, NJ 07033 USA Schering Plough Corp Kenilworth NJ USA 07033 rp, Kenilworth, NJ 07033 USA Aventis, Collegeville, PA 19426 USA Aventis Collegeville PA USA 19426Aventis, Collegeville, PA 19426 USA
Titolo Testata:
NEURO-ONCOLOGY
fascicolo: 4, volume: 3, anno: 2001,
pagine: 246 - 250
SICI:
1522-8517(200110)3:4<246:PISOG(>2.0.ZU;2-#
Fonte:
ISI
Lingua:
ENG
Soggetto:
O-6-ALKYLGUANINE-DNA ALKYLTRANSFERASE ACTIVITY; DNA MISMATCH REPAIR; GLIOBLASTOMA-MULTIFORME; MALIGNANT GLIOMA; ANTITUMOR IMIDAZOTETRAZINES; BIODEGRADABLE POLYMERS; ONCOLOGY-GROUP; FIRST RELAPSE; TRIAL; CHEMOTHERAPY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
24
Recensione:
Indirizzi per estratti:
Indirizzo: Gururangan, S Duke Univ, Med Ctr, Dept Neurosurg, DUMC Box 3624, Durham, NC 27710 USA Duke Univ DUMC Box 3624 Durham NC USA 27710 am, NC 27710 USA
Citazione:
S. Gururangan et al., "Phase I study of Gliadel (TM) wafers plus temozolomide in adults with recurrent supratentorial high-grade gliomas", NEURO-ONCOL, 3(4), 2001, pp. 246-250

Abstract

Both Gliadel(TM) wafers [1,3-bis(2-chloroethyl)-1-nitrosourea] and temozolomide (TEMO) have been shown in independent studies to prolong survival of patients with recurrent malignant glioma following surgery and radiotherapy. On the basis of preclinical evidence of synergism between Gliadel wafers and TEMO, a phase I study was designed to evaluate the toxicity of combining these 2 agents in the treatment of patients with recurrent supratentorialmalignant glioma. All patients had surgical resection of the tumor at relapse, and up to 8 Gliadel (3.85%) wafers were placed in the surgical cavity following resection. Two weeks after surgery, TEMO was given orally daily for 5 days. Cohorts of 3 patients received TEMO at daily doses of 100 mg/m(2), 150 mg/m(2), and 200 mg/m2, respectively. Patients were assessed for toxicity 4 weeks after start of the first course of TEMO. Contrast-enhanced MRI of the brain was used to assess tumor response after the first cycle of TEMO. Patients with stable disease or response after the first cycle of TEMOwere allowed to continue treatment at the same dose every 4 weeks for 12 cycles or until disease progression or unacceptable toxicity. Ten patients with a median age of 47 years (range, 22-66 years) were enrolled in this study. There were 7 patients with glioblastoma multiforme and 3 patients with anaplastic astrocytoma. Three patients were treated with TEMO at the first dose level of 100 mg/m(2), 4 at the second dose level of 150 mg/m(2), and 3at the third dose level of 200 mg/m(2). The 10 patients received a median of 3 cycles (range, 1-12 cycles) of TEMO following placement of Gliadel wafers. The treatment was well tolerated, with only 1 patient suffering grade III thrombocytopenia at the highest dose level. Two patients at each dose level had no evidence of disease progression after treatment. Four patients suffered progressive disease on therapy. Our study demonstrates that TEMO can be given safely after placement of Gliadel (3.85%) wafers. The recommended dosage for TEMO for a phase II study of this combination is 200 mg/m(2) per day for 5 days.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 13/07/20 alle ore 07:38:56