First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma
| العنوان: | First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma |
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| المؤلفون: | Manfred Westphal, Dietmar Krex, Rekha Chaudhary, Christopher Duma, Jana Portnow, Tom Mikkelsen, Reid C. Thompson, Edward J. Dropcho, Charles S. Cobbs, Sven-Axel May, Santosh Kesari, Michel Lacroix, Raphael P. Davis, David Avigan, Robert M. Prins, Jian Campian, Keyoumars Ashkan, John L. Villano, Yaron A. Moshel, John E. Trusheim, David Piccioni, Timothy J. Pluard, Paul Duic, Timothy F. Cloughesy, Michael Salacz, Andrew Brenner, Daniela A. Bota, Stacy D. D’Andre, Jai Grewal, Victor Tse, Steven A. Toms, Jason Heth, Lyndon Kim, Clement Pillainayagam, David S. Baskin, David Tran, Kevin A. Walter, Steven R. Abram, Andrew E. Sloan, Richard M. Green, Julian Wu, Scott Lindhorst, Simon Khagi, Heinrich Elinzano, Matthew G. Ewend, Paul Mulholland, Fabio M. Iwamoto, Anthony E. Maida, Michael Schulder, Kevin O. Lillehei, Karen Fink, Robert Aiken, Lynne Taylor, Hans-Jorg Meisel, William G. Loudon, Arnold B. Etame, Francois J. Geoffroy, Sarah A. Taylor, Pamela Z. New, Steven Brem, Gabriele Schackert, David Mathieu, Marnix L. Bosch, Tobias Walbert, Linda M. Liau, Michael Pearlman, Kevin Petrecca, Samuel Goldlust, Jose Lutzky |
| المصدر: | Journal of Translational Medicine, Vol 16, Iss 1, Pp 1-9 (2018) Liau, Linda M; Ashkan, Keyoumars; Tran, David D; Campian, Jian L; Trusheim, John E; Cobbs, Charles S; et al.(2018). 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), 142. doi: 10.1186/s12967-018-1507-6. UC Office of the President: Research Grants Program Office (RGPO). Retrieved from: http://www.escholarship.org/uc/item/4zs134n7Test Journal of Translational Medicine |
| بيانات النشر: | BioMed Central, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Adult, Male, 0301 basic medicine, medicine.medical_specialty, Endpoint Determination, Immunology, Section (typography), lcsh:Medicine, Newly diagnosed, Cancer Vaccines, Medical and Health Sciences, General Biochemistry, Genetics and Molecular Biology, Young Adult, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Medical physics, Aged, Brain Neoplasms, business.industry, Published Erratum, lcsh:R, Correction, Dendritic Cells, General Medicine, Middle Aged, Prognosis, medicine.disease, Survival Analysis, Spelling, Treatment Outcome, 030104 developmental biology, Dendritic cell vaccine, 030220 oncology & carcinogenesis, Female, Immunotherapy, Glioblastoma, business, Vaccine, Author name, Dendritic cell, Sentence |
| الوصف: | 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=1Test; initially registered 19 September 2002 |
| وصف الملف: | application/pdf |
| اللغة: | English |
| DOI: | 10.17615/ez4x-3771 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7eee1a79d20bdb89286ba57579f8eecfTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....7eee1a79d20bdb89286ba57579f8eecf |
| قاعدة البيانات: | OpenAIRE |
| DOI: | 10.17615/ez4x-3771 |
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