First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-12

AUTHORS

Linda M. Liau, Keyoumars Ashkan, David D. Tran, Jian L. Campian, John E. Trusheim, Charles S. Cobbs, Jason A. Heth, Michael Salacz, Sarah Taylor, Stacy D. D’Andre, Fabio M. Iwamoto, Edward J. Dropcho, Yaron A. Moshel, Kevin A. Walter, Clement P. Pillainayagam, Robert Aiken, Rekha Chaudhary, Samuel A. Goldlust, Daniela A. Bota, Paul Duic, Jai Grewal, Heinrich Elinzano, Steven A. Toms, Kevin O. Lillehei, Tom Mikkelsen, Tobias Walbert, Steven R. Abram, Andrew J. Brenner, Steven Brem, Matthew G. Ewend, Simon Khagi, Jana Portnow, Lyndon J. Kim, William G. Loudon, Reid C. Thompson, David E. Avigan, Karen L. Fink, Francois J. Geoffroy, Scott Lindhorst, Jose Lutzky, Andrew E. Sloan, Gabriele Schackert, Dietmar Krex, Hans-Jorg Meisel, Julian Wu, Raphael P. Davis, Christopher Duma, Arnold B. Etame, David Mathieu, Santosh Kesari, David Piccioni, Manfred Westphal, David S. Baskin, Pamela Z. New, Michel Lacroix, Sven-Axel May, Timothy J. Pluard, Victor Tse, Richard M. Green, John L. Villano, Michael Pearlman, Kevin Petrecca, Michael Schulder, Lynne P. Taylor, Anthony E. Maida, Robert M. Prins, Timothy F. Cloughesy, Paul Mulholland, Marnix L. Bosch

ABSTRACT

BACKGROUND: Standard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax®-L) to standard therapy for newly diagnosed glioblastoma. METHODS: After surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS). RESULTS: For the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are ≥ 30 months past their surgery date; 67 of these (30.0%) have lived ≥ 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are ≥ 36 months past surgery; 44 of these (24.2%) have lived ≥ 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone. CONCLUSIONS: Addition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival. Trial registration Funded by Northwest Biotherapeutics; Clinicaltrials.gov number: NCT00045968; https://clinicaltrials.gov/ct2/show/NCT00045968?term=NCT00045968&rank=1 ; initially registered 19 September 2002. More... »

PAGES

142

Journal

TITLE

Journal of Translational Medicine

ISSUE

1

VOLUME

16

Author Affiliations

  • University of California Los Angeles
  • King's College London
  • University of Florida
  • Washington University in St. Louis
  • Abbott Northwestern Hospital
  • Swedish Medical Center
  • University of Michigan–Ann Arbor
  • University of Kansas Cancer Center
  • Sutter Institute for Medical Research
  • Columbia University Medical Center
  • Indiana University – Purdue University Indianapolis
  • Overlook Medical Center
  • University of Rochester Medical Center
  • Rush University Medical Center
  • Rutgers University
  • University of Cincinnati Medical Center
  • Hackensack University Medical Center
  • University of California, Irvine Medical Center
  • Winthrop-University Hospital
  • New York University
  • Rhode Island Hospital
  • University of Colorado Hospital
  • Henry Ford Health System
  • The University of Texas Health Science Center at San Antonio
  • University of Pennsylvania
  • University of North Carolina System
  • City Of Hope National Medical Center
  • Thomas Jefferson University
  • St. Joseph Hospital
  • Vanderbilt University
  • Beth Israel Deaconess Medical Center
  • Baylor University Medical Center
  • Illinois CancerCare
  • Medical University of South Carolina
  • Mount Sinai Medical Center
  • University Hospitals Case Medical Center
  • University Hospital Carl Gustav Carus
  • Tufts Medical Center
  • Stony Brook University
  • Hoag Memorial Hospital Presbyterian
  • Moffitt Cancer Center
  • Université de Sherbrooke
  • University of California, San Diego
  • University Medical Center Hamburg-Eppendorf
  • Houston Methodist
  • Geisinger Health System
  • Klinikum Chemnitz
  • Saint Luke's Health System
  • Kaiser Permanente
  • University of Kentucky
  • Colorado Neurological Institute
  • McGill University
  • University of Washington
  • Northwest Biotherapeutics (United States)
  • University College London
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s12967-018-1507-6

    DOI

    http://dx.doi.org/10.1186/s12967-018-1507-6

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1104245321

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29843811


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