Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma.
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Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma. / PRECISE Study Group.
in: NEURO-ONCOLOGY, Jahrgang 12, Nr. 8, 8, 2010, S. 871-881.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma.
AU - Kunwar, Sandeep
AU - Chang, Susan
AU - Westphal, Manfred
AU - Vogelbaum, Michael
AU - Sampson, John
AU - Barnett, Gene
AU - Shaffrey, Mark
AU - Ram, Zvi
AU - Piepmeier, Joseph
AU - Prados, Michael
AU - Croteau, David
AU - Pedain, Christoph
AU - Leland, Pamela
AU - Husain Syed, R
AU - Joshi Bharat, H
AU - Puri Raj, K
AU - PRECISE Study Group
PY - 2010
Y1 - 2010
N2 - Convection-enhanced delivery (CED) of cintredekin besudotox (CB) was compared with Gliadel wafers (GW) in adult patients with glioblastoma multiforme (GBM) at first recurrence. Patients were randomized 2:1 to receive CB or GW. CB (0.5 microg/mL; total flow rate 0.75 mL/h) was administered over 96 hours via 2-4 intraparenchymal catheters placed after tumor resection. GW (3.85%/7.7 mg carmustine per wafer; maximum 8 wafers) were placed immediately after tumor resection. The primary endpoint was overall survival from the time of randomization. Prestated interim analyses were built into the study design. Secondary and tertiary endpoints were safety and health-related quality-of-life assessments. From March 2004 to December 2005, 296 patients were enrolled at 52 centers. Demographic and baseline characteristics were balanced between the 2 treatment arms. Median survival was 36.4 weeks (9.1 months) for CB and 35.3 weeks (8.8 months) for GW (P = .476). For the efficacy evaluable population, the median survival was 45.3 weeks (11.3 months) for CB and 39.8 weeks (10 months) for GW (P = .310). The adverse-events profile was similar in both arms, except that pulmonary embolism was higher in the CB arm (8% vs 1%, P = .014). This is the first randomized phase III evaluation of an agent administered via CED and the first with an active comparator in GBM patients. There was no survival difference between CB administered via CED and GW. Drug distribution was not assessed and may be crucial for evaluating future CED-based therapeutics.
AB - Convection-enhanced delivery (CED) of cintredekin besudotox (CB) was compared with Gliadel wafers (GW) in adult patients with glioblastoma multiforme (GBM) at first recurrence. Patients were randomized 2:1 to receive CB or GW. CB (0.5 microg/mL; total flow rate 0.75 mL/h) was administered over 96 hours via 2-4 intraparenchymal catheters placed after tumor resection. GW (3.85%/7.7 mg carmustine per wafer; maximum 8 wafers) were placed immediately after tumor resection. The primary endpoint was overall survival from the time of randomization. Prestated interim analyses were built into the study design. Secondary and tertiary endpoints were safety and health-related quality-of-life assessments. From March 2004 to December 2005, 296 patients were enrolled at 52 centers. Demographic and baseline characteristics were balanced between the 2 treatment arms. Median survival was 36.4 weeks (9.1 months) for CB and 35.3 weeks (8.8 months) for GW (P = .476). For the efficacy evaluable population, the median survival was 45.3 weeks (11.3 months) for CB and 39.8 weeks (10 months) for GW (P = .310). The adverse-events profile was similar in both arms, except that pulmonary embolism was higher in the CB arm (8% vs 1%, P = .014). This is the first randomized phase III evaluation of an agent administered via CED and the first with an active comparator in GBM patients. There was no survival difference between CB administered via CED and GW. Drug distribution was not assessed and may be crucial for evaluating future CED-based therapeutics.
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Adolescent
KW - Young Adult
KW - dosage
KW - Magnetic Resonance Imaging
KW - Antineoplastic Agents administration
KW - Kaplan-Meier Estimate
KW - Drug Administration Routes
KW - Brain Neoplasms drug therapy
KW - Neoplasm Recurrence, Local drug therapy
KW - Catheters, Indwelling
KW - Convection
KW - Decanoic Acids administration
KW - Exotoxins administration
KW - Glioblastoma drug therapy
KW - Interleukin-13 administration
KW - Polyesters administration
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Adolescent
KW - Young Adult
KW - dosage
KW - Magnetic Resonance Imaging
KW - Antineoplastic Agents administration
KW - Kaplan-Meier Estimate
KW - Drug Administration Routes
KW - Brain Neoplasms drug therapy
KW - Neoplasm Recurrence, Local drug therapy
KW - Catheters, Indwelling
KW - Convection
KW - Decanoic Acids administration
KW - Exotoxins administration
KW - Glioblastoma drug therapy
KW - Interleukin-13 administration
KW - Polyesters administration
M3 - SCORING: Zeitschriftenaufsatz
VL - 12
SP - 871
EP - 881
JO - NEURO-ONCOLOGY
JF - NEURO-ONCOLOGY
SN - 1522-8517
IS - 8
M1 - 8
ER -
