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A phase II study of chemoradiation followed by adjuvant temozolomide and poly-ICLC in patients with newly diagnosed glioblastoma: 12- and 18-month survival data (NABTT 0501).

Posted on: 05/14/2009

A phase II study of chemoradiation followed by adjuvant temozolomide and poly-ICLC in patients with newly diagnosed glioblastoma: 12- and 18-month survival data (NABTT 0501).

Time: Saturday May 30, 3:00 PM to 6:00 PM

Location: Level 3, W330A


Author(s): M. R. Rosenfeld, M. Chamberlain, S. A. Grossman, D. M. Peereboom, G. J. Lesser, T. T. Batchelor, S. Desideri, A. M. Salazar, X. Ye, New Approaches to Brain Tumor Therapy: A CNS Consortium; University of Pennsylvania, Philadelphia, PA; University of Washington, Seattle, WA; Johns Hopkins University School of Medicine, Baltimore, MD; Cleveland Clinic Foundation, Cleveland, OH; Wake Forest University School of Medicine, Winston-Salem, NC; Massachusetts General Hospital, Boston, MA; Oncovir, Inc., Washington, DC



Background: Polyinosinic-polycytidylic (poly-ICLC), is a double-stranded RNA that stimulates a variety of host defense mechanisms including T-cell and natural killer cell activation, cytokine release and specific anti-proliferative and anti-viral effects. The objective of this study was to determine the safety and efficacy of poly-ICLC when added to adjuvant treatment for newly diagnosed glioblastoma.

Methods: Newly diagnosed patients > 18 years with histologically proven glioblastoma received standard external beam radiation with concurrent low-dose temozolomide (TMZ) (75 mg/m2) followed by adjuvant cycles of TMZ for 5 days (150-200 mg/m2) (week 1) then intramuscular injections of poly-ICLC (20 mcg/kg) 3 times a week (weeks 2-8; total 21 injections) with week 9 off and no limit to the number of adjuvant cycles (TMZ + poly-ICLC). Imaging evaluations were performed before every cycle.

Results: There were 97 patients enrolled (60 men); median age 56 yrs (range 21-85); median KPS 90 (range 60-100). Fourteen patients did not start adjuvant treatment (5 patient request and 4 investigator withdrawal; 2 progressive disease; 1 death; 1 toxicity; 1 other). The most frequent CTC grade 3-4 toxicities occurring in > 5% of subjects at least possibly related to poly-ICLC were leukopenia (20%), thrombocytopenia (14%), anemia (13%), neutropenia (10%), and SGPT (9%) or alkaline phosphatase (7%) elevation. Two deaths during adjuvant treatment were considered unlikely related to poly-ICLC. To date 71 of 97 patients have survived at least 12 months from diagnosis. The estimated median survival for the entire cohort was 17.2 months (95% CI: 15.5-19.3 months). Overall survival for the cohort at 12 months was 73.2% (95% CI: 63%-82%) and at 18 months 47.4% (95% CI: 37-58%). For only those subjects 18-70 years, overall survival at 18 months was 51.8% (95% CI: 41-63%). This is contrasted with EORTC 26981/22981 that reported an 18 month overall survival of 39.4% (95% CI: 33.8-45.1).

Conclusions: The addition of poly-ICLC to a modified adjuvant treatment regimen for newly diagnosed GB is well-tolerated. Survival data at 12 and 18 months suggest increased efficacy compared to chemoradiation with adjuvant TMZ only.



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