Comparative impact of treatment on clinical benefit in patients with glioblastoma (GBM) enrolled in the phase II trial of ICT-107.

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Journal: J Clin Oncol 33, 2015 (suppl; abstr 2036)

Authors:
Terri S. Armstrong, Patrick Y. Wen, David A. Reardon, Surasak Phuphanich, Robert Aiken, Joseph C. Landolfi, William T. Curry, Jay-Jiguang Zhu, Michael J. Glantz, David M. Peereboom, James Markert, Renato V. LaRocca, Donald O’Rourke, Karen L. Fink, Lyndon J. Kim, Michael L. Gruber, Glenn Jay Lesser, Edward Pan, Santosh Kesari, John Yu; The University of Texas Health Science Center School of Nursing, Houston, TX; Dana-Farber Cancer Institute, Boston, MA; Dana-Farber Cancer Center Institute and Harvard School of Medicine, Boston, MA; Cedars-Sinai Med Ctr, Los Angeles, CA; Rush University Medical Center, Chicago, IL; NJ Neurosci Inst At JFK Medcl Ctr, Edison, NJ; Massachusetts General Hospital, Boston, MA; The University of Texas Medical School at Houston, Houston, TX; Penn State – Milton S Hershey Medcl Ctr, Hinsdale, MA; Cleveland Clinic Fndtn Desk, Cleveland, OH; The University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; Norton Cancer Inst, Louisville, KY; University of Pennsylvania, Philadelphia, PA; Baylor Research Institute, Dallas, TX; Thomas Jefferson University, Philadelphia, PA; NYU Clinical Cancer Ctr, Englewood, NJ; Wake Forest University, Winston Salem, NC; The University of Texas Southwestern Medical Center, Dallas, TX; UC San Diego, La Jolla, CA

ABSTRACT

Background: This study was a randomized double blind placebo-controlled phase 2 trial of dendritic cell(DC) Vaccine ICT-107 following standard treatment in newly diagnosed patients with GBM. Although OS was not different, PFS was longer in those receiving the vaccine. To evaluate the clinical benefit of this prolonged PFS, Karnofsky Performance Status (KPS) and steroid dosing, as well as patient reported QOL using the Functional Assessment of Cancer Therapy –Brain (FACT-BR) were evaluated during the progression free period.

Methods: The FACT-BR was completed by patients at baseline, and longitudinally during the maintenance phase after four induction vaccinations and at the end of study visit. Corticosteroid dosing and KPS were evaluated throughout the progression free period at monthly timepoints for 12 months and every 6 months thereafter. Between arm differences were evaluated using Fisher test or ANOVA statistics. A p-value of 0.05 was considered significant when comparing the two treatment groups for all analyses.

Results: Participants (81 patients in the ICT-107 arm and 43 patients in the control arm) completed baseline FACT-BR assessment (97% compliance), with 84% and 68% completing end of cycle 1 and end of study assessments respectively. Quality of life, as measured by the FACT-BR, was maintained equally until progression for ICT-107 and control patients. Performance level, as measured by KPS, was significantly higher during the treatment period in those receiving ICT-107 (p,0.05, Cycles 1-4 or maintenance phase). There was a trend for less steroid usage over time in the ICT-107 arm (30%) versus the control (44%) (p = 0.1, log rank).

Conclusions: Based on these initial analyses of clinical benefit, increased PFS time with ICT-107 is not associated with a detrimental impact on self-report of QOL, and is associated with retention of performance capacity as measured by KPS, and may be associated with a longer corticosteroid free period than those receiving standard treatment. Clinical trial information: NCT01280552.

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