First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma Article Swipe
Linda M. Liau
,
Keyoumars Ashkan
,
David D. Tran
,
Jian Campian
,
John Trusheim
,
Charles Cobbs
,
Jason Heth
,
Michael Salacz
,
Sarah Taylor
,
Stacy D. D’Andre
,
Fábio M. Iwamoto
,
Edward J. Dropcho
,
Yaron A. Moshel
,
Kevin A. Walter
,
Clement Pillainayagam
,
Robert Aiken
,
Rekha Chaudhary
,
Samuel Goldlust
,
Daniela A. Bota
,
Paul Duic
,
Jai Grewal
,
Heinrich Elinzano
,
Steven A. Toms
,
Kevin O. Lillehei
,
Tom Mikkelsen
,
Tobias Walbert
,
Steven R. Abram
,
Andrew Brenner
,
Steven Brem
,
Matthew G. Ewend
,
Simon Khagi
,
Jana Portnow
,
Lyndon J. Kim
,
William G. Loudon
,
Reid C. Thompson
,
David Avigan
,
Karen Fink
,
Francois J. Geoffroy
,
Scott Lindhorst
,
Jose Lutzky
,
Andrew E. Sloan
,
Gabriele Schackert
,
Dietmar Krex
,
Hans-Joerg Meisel
,
Julian K. Wu
,
Raphael P. Davis
,
Christopher Duma
,
Arnold B. Etame
,
David Mathieu
,
Santosh Kesari
,
David Piccioni
,
Manfred Westphal
,
David S. Baskin
,
Pamela New
,
Michel Lacroix
,
Sven-Axel May
,
Timothy 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
·
YOU?
·
· 2018
· Open Access
·
· DOI: https://doi.org/10.1186/s12967-018-1507-6
YOU?
·
· 2018
· Open Access
·
· DOI: https://doi.org/10.1186/s12967-018-1507-6
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
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Metadata
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- en
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- https://doi.org/10.1186/s12967-018-1507-6
- https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-018-1507-6
- OA Status
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- Cited By
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- References
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- Related Works
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- OpenAlex ID
- https://openalex.org/W2805359783
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2805359783Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1186/s12967-018-1507-6Digital Object Identifier
- Title
-
First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastomaWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2018Year of publication
- Publication date
-
2018-05-25Full publication date if available
- Authors
-
Linda M. Liau, Keyoumars Ashkan, David D. Tran, Jian Campian, John Trusheim, Charles Cobbs, Jason Heth, Michael Salacz, Sarah Taylor, Stacy D. D’Andre, Fábio M. Iwamoto, Edward J. Dropcho, Yaron A. Moshel, Kevin A. Walter, Clement Pillainayagam, Robert Aiken, Rekha Chaudhary, Samuel Goldlust, Daniela A. Bota, Paul Duic, Jai Grewal, Heinrich Elinzano, Steven A. Toms, Kevin O. Lillehei, Tom Mikkelsen, Tobias Walbert, Steven R. Abram, Andrew Brenner, Steven Brem, Matthew G. Ewend, Simon Khagi, Jana Portnow, Lyndon J. Kim, William G. Loudon, Reid C. Thompson, David Avigan, Karen Fink, Francois J. Geoffroy, Scott Lindhorst, Jose Lutzky, Andrew E. Sloan, Gabriele Schackert, Dietmar Krex, Hans-Joerg Meisel, Julian K. Wu, Raphael P. Davis, Christopher Duma, Arnold B. Etame, David Mathieu, Santosh Kesari, David Piccioni, Manfred Westphal, David S. Baskin, Pamela New, Michel Lacroix, Sven-Axel May, Timothy 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. BoschList of authors in order
- Landing page
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https://doi.org/10.1186/s12967-018-1507-6Publisher landing page
- PDF URL
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https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-018-1507-6Direct link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-018-1507-6Direct OA link when available
- Concepts
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Temozolomide, Medicine, Clinical endpoint, Adverse effect, Population, Placebo, Internal medicine, Phases of clinical research, Surgery, Radiation therapy, Clinical trial, Chemoradiotherapy, Oncology, Pathology, Environmental health, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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517Total citation count in OpenAlex
- Citations by year (recent)
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2025: 36, 2024: 59, 2023: 99, 2022: 98, 2021: 91Per-year citation counts (last 5 years)
- References (count)
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33Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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