Correction to: First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma
Autor: | Samuel Goldlust, Tom Mikkelsen, Reid C. Thompson, David Avigan, John E. Trusheim, Marnix L. Bosch, Kevin Petrecca, David S. Baskin, David Mathieu, Sarah A. Taylor, Timothy F. Cloughesy, Jian Campian, Raphael P. Davis, Christopher Duma, Lyndon Kim, Robert M. Prins, Kevin A. Walter, Keyoumars Ashkan, Scott Lindhorst, Tobias Walbert, Andrew E. Sloan, John L. Villano, Daniela A. Bota, Simon Khagi, Santosh Kesari, David Piccioni, Michael Salacz, Manfred Westphal, Steven A. Toms, Jose Lutzky, Dietmar Krex, Linda M. Liau, Timothy J. Pluard, Paul Duic, Richard M. Green, Rekha Chaudhary, Clement Pillainayagam, Andrew Brenner, Fabio M. Iwamoto, Steven Brem, Heinrich Elinzano, Edward J. Dropcho, Karen Fink, Hans Jorg Meisel, Michael Pearlman, Michel Lacroix, Jason Heth, Julian Wu, Lynne Taylor, Kevin O. Lillehei, Stacy D. D’Andre, Pamela Z. New, Gabriele Schackert, Arnold B. Etame, David Tran, Steven R. Abram, Jai Grewal, Paul Mulholland, William G. Loudon, Sven Axel May, Francois J. Geoffroy, Victor Tse, Robert Aiken, Matthew G. Ewend, Anthony E. Maida, Michael Schulder, Jana Portnow, Charles S. Cobbs, Yaron A. Moshel |
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Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
0301 basic medicine
Oncology medicine.medical_specialty Immunology lcsh:Medicine Phases of clinical research Newly diagnosed Medical and Health Sciences General Biochemistry Genetics and Molecular Biology 03 medical and health sciences 0302 clinical medicine Internal medicine medicine business.industry Research lcsh:R General Medicine medicine.disease 030104 developmental biology Dendritic cell vaccine 030220 oncology & carcinogenesis Immunotherapy Glioblastoma business Vaccine Dendritic cell |
Zdroj: | Liau, Linda M; Ashkan, Keyoumars; Tran, David D; Campian, Jian L; Trusheim, John E; Cobbs, Charles S; et al.(2018). Correction to: First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma.. Journal of translational medicine, 16(1), 179. doi: 10.1186/s12967-018-1552-1. UC Office of the President: Research Grants Program Office (RGPO). Retrieved from: http://www.escholarship.org/uc/item/1k3480p0 Journal of Translational Medicine Journal of Translational Medicine, Vol 16, Iss 1, Pp 1-2 (2018) |
Popis: | 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 |
Databáze: | OpenAIRE |
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