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

Authors :
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.
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.
Source :
Department of Medical Oncology Faculty Papers
Publication Year :
2018

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 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.

Details

Database :
OAIster
Journal :
Department of Medical Oncology Faculty Papers
Notes :
application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1048927489
Document Type :
Electronic Resource