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Titolo:
A randomized phase II and pharmacokinetic study of dacarbazine in patientswith recurrent glioma
Autore:
Rajkumar, SV; Reid, JM; Novotny, PJ; Safgren, SL; Scheithauer, BW; Johnson, PS; Nair, S; Morton, RF; Hatfield, AK; Krook, JE; Ames, MM; Buckner, JC;
Indirizzi:
Mayo Clin & Mayo Fdn, Div Med Oncol, Rochester, MN 55905 USA Mayo Clin & Mayo Fdn Rochester MN USA 55905 ncol, Rochester, MN 55905 USA Rapid City Reg Oncol Grp, Rapid City, SD USA Rapid City Reg Oncol Grp Rapid City SD USA Oncol Grp, Rapid City, SD USA Geisinger Clin Oncol Program, Danville, PA USA Geisinger Clin Oncol Program Danville PA USA l Program, Danville, PA USA Iowa Oncol Res Assoc CCOP, Des Moines, IA USA Iowa Oncol Res Assoc CCOP Des Moines IA USA soc CCOP, Des Moines, IA USA Carle Canc Ctr CCOP, Urbana, IL USA Carle Canc Ctr CCOP Urbana IL USACarle Canc Ctr CCOP, Urbana, IL USA Duluth CCOP, Duluth, MN USA Duluth CCOP Duluth MN USADuluth CCOP, Duluth, MN USA
Titolo Testata:
JOURNAL OF NEURO-ONCOLOGY
fascicolo: 3, volume: 49, anno: 2000,
pagine: 255 - 261
SICI:
0167-594X(200009)49:3<255:ARPIAP>2.0.ZU;2-6
Fonte:
ISI
Lingua:
ENG
Soggetto:
MALIGNANT GLIOMAS; ANTITUMOR IMIDAZOTETRAZINES; RADIATION-THERAPY; ADVANCED CANCER; CLINICAL-TRIAL; TEMOZOLOMIDE; RADIOTHERAPY; CHEMOTHERAPY; ASTROCYTOMA; NSC-45388;
Keywords:
DTIC; dacarbazine; recurrent gliomas; brain tumors; chemotherapy; glioblastoma;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
30
Recensione:
Indirizzi per estratti:
Indirizzo: Buckner, JC Mayo Clin & Mayo Fdn, Div Med Oncol, E 12,200 1st St SW, Rochester, MN 55905 USA Mayo Clin & Mayo Fdn E 12,200 1st St SW Rochester MN USA55905
Citazione:
S.V. Rajkumar et al., "A randomized phase II and pharmacokinetic study of dacarbazine in patientswith recurrent glioma", J NEURO-ONC, 49(3), 2000, pp. 255-261

Abstract

We conducted a randomized phase II study to determine the efficacy of dacarbazine (DTIC) in recurrent gliomas. Patients were randomly assigned to receive either DTIC 750 mg/m(2) IV day 1 every 28 days (Arm A) or DTIC 200 mg/m(2) IV days 1-5 every 28 days (Arm B). Pharmacokinetics were studied in 6 patients on each arm using HPLC analysis. Thirty-nine patients (30 male, 9 female), ages 27-67 years (median 53) were entered on the study (20 on Arm A, 19 on Arm B). No objective responses were seen. Median time to progression was 3 months. Median survival was 8 months. Treatment was generally welltolerated. Major toxicities were grade 1-2 nausea (33%), lethargy (28%), diarrhea (15%), alopecia (15%), and grade 3 neutropenia (8%). Four patients on Arm A had mild self-limited episodes of intravascular hemolysis occurring immediately after drug infusion, the mechanism of which is unknown. Mean AUC for DTIC, HMMTIC (5-[3-hydroxymethyl-3-methyl-1-triazeno] imidazole-4-carboxamide), and MTIC (5-[3-methyl-1-triazeno] imidazole-4-carboxamide), inArm A were 14.8, 0.17, and 1.15 mM min, respectively. Corresponding valuesfor Arm B (on day 1 of 5) were 1.7, 0.06, and 0.29 mM min, respectively. The predicted HMMTIC and MTIC exposure over 5 days for Arm B, based on the day 1 data, is higher than with Arm A. We conclude that DTIC is well tolerated but does not have activity in patients with recurrent gliomas. The 5-dayschedule appears less toxic, and pharmacokinetic studies show that it provides greater exposure to MTIC and HMMTIC compared to the one-day schedule.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 05/07/20 alle ore 07:24:08