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Cited by 537

The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.

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

Open access
Liau, Linda M., Ashkan, Keyoumars, Tran, David D., Campian, Jian L., Trusheim, John E., Cobbs, Charles S., Heth, Jason A., Salacz, Michael, Taylor, Sarah, D’Andre, Stacy D., Iwamoto, Fabio M., Dropcho, Edward J., Moshel, Yaron A., Walter, Kevin A., Pillainayagam, Clement P., Aiken, Robert, Chaudhary, Rekha, Goldlust, Samuel A., Bota, Daniela A., Duic, Paul, Grewal, Jai, Elinzano, Heinrich, Toms, Steven A., Lillehei, Kevin O., Mikkelsen, Tom, Walbert, Tobias, Abram, Steven R., Brenner, Andrew J., Brem, Steven, Ewend, Matthew G., Khagi, Simon, Portnow, Jana, Kim, Lyndon J., Loudon, William G., Thompson, Reid C., Avigan, David E., Fink, Karen L., Geoffroy, Francois J., Lindhorst, Scott, Lutzky, Jose, Sloan, Andrew E., Schackert, Gabriele, Krex, Dietmar, Meisel, Hans-Jorg, Wu, Julian, Davis, Raphael P., Duma, Christopher, Etame, Arnold B., Mathieu, David, Kesari, Santosh, Piccioni, David, Westphal, Manfred, Baskin, David S., New, Pamela Z., Lacroix, Michel, May, Sven-Axel, Pluard, Timothy J., Tse, Victor, Green, Richard M., Villano, John L., Pearlman, Michael, Petrecca, Kevin, Schulder, Michael, Taylor, Lynne P., Maida, Anthony E., Prins, Robert M., Cloughesy, Timothy F., Mulholland, Paul, Bosch, Marnix L.·2018·Journal of Translational Medicine
DOI 10.1186/s12967-018-1507-6
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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

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Authors
Liau, L. M., Ashkan, K., Tran, D. D., Campian, J. L., Trusheim, J. E., Cobbs, C. S., Heth, J. A., Salacz, M., Taylor, S., D’Andre, S. D., Iwamoto, F. M., Dropcho, E. J., Moshel, Y. A., Walter, K. A., Pillainayagam, C. P., Aiken, R., Chaudhary, R., Goldlust, S. A., Bota, D. A., Duic, P., Grewal, J., Elinzano, H., Toms, S. A., Lillehei, K. O., Mikkelsen, T., Walbert, T., Abram, S. R., Brenner, A. J., Brem, S., Ewend, M. G., Khagi, S., Portnow, J., Kim, L. J., Loudon, W. G., Thompson, R. C., Avigan, D. E., Fink, K. L., Geoffroy, F. J., Lindhorst, S., Lutzky, J., Sloan, A. E., Schackert, G., Krex, D., Meisel, H.-J., Wu, J., Davis, R. P., Duma, C., Etame, A. B., Mathieu, D., Kesari, S., Piccioni, D., Westphal, M., Baskin, D. S., New, P. Z., Lacroix, M., May, S.-A., Pluard, T. J., Tse, V., Green, R. M., Villano, J. L., Pearlman, M., Petrecca, K., Schulder, M., Taylor, L. P., Maida, A. E., Prins, R. M., Cloughesy, T. F., Mulholland, P., & Bosch, M. L.
Venue
Journal of Translational Medicine
Publisher
Springer Science and Business Media LLC
Published
2018-05-29
Volume
16
Issue
1
Pages
142-142
ISSN
1479-5876 (ISSN-L)
DOI
10.1186/s12967-018-1507-6
OpenAlex
W2805359783
Cited by
537
References
29
FWCI
26.87
Type
journal article
Language
en
Open access
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Liau, L. M., Ashkan, K., Tran, D. D., Campian, J. L., Trusheim, J. E., Cobbs, C. S., Heth, J. A., Salacz, M., Taylor, S., D’Andre, S. D., Iwamoto, F. M., Dropcho, E. J., Moshel, Y. A., Walter, K. A., Pillainayagam, C. P., Aiken, R., Chaudhary, R., Goldlust, S. A., Bota, D. A., . . . Bosch, M. L. (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. https://doi.org/10.1186/s12967-018-1507-6

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.