Universität zu Köln

Cibula, David, Rob, Lukas ORCID: 0000-0003-3770-651X, Mallmann, Peter, Knapp, Pawel, Klat, Jaroslav, Chovanec, Josef, Minar, Lubos, Melichar, Bohuslav, Hein, Alexander, Kieszko, Dariusz, Pluta, Marek, Spacek, Jiri, Bartos, Pavel, Wimberger, Pauline, Madry, Radoslaw, Markowska, Janina, Streb, Joanna, Valha, Petr, Bin Hassan, Hariz Iskandar, Pecen, Ladislav, Galluzzi, Lorenzo, Fucikova, Jitka, Hrnciarova, Tereza, Hraska, Marek, Bartunkova, Jirina and Spisek, Radek (2021). Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol. Oncol., 162 (3). S. 652 - 661. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE. ISSN 1095-6859

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Abstract

Objective. DCVAC/OvCa is an active cellular immunotherapy designed to stimulate an immune response against ovarian cancer. We explored the safety and efficacy of DCVAC/OvCa plus carboplatin and gemcitabine in platinum-sensitive ovarian cancer. Methods. In this open-label, parallel-group, phase 2 trial (ClinicalTrials.gov number NCT02107950), patients with platinum-sensitive ovarian cancer relapsing after first-line chemotherapy were randomized to DCVAC/OvCa and chemotherapy or chemotherapy alone. DCVAC/OvCa was administered every 3-6 weeks (10 doses). Endpoints included safety, progression-free survival (PFS; primary efficacy endpoint) and overall survival (OS; secondary efficacy endpoint). Results. Between November 2013 and May 2015, 71 patients were randomized to chemotherapy in combination with DCVAC/OvCa or to chemotherapy alone. Treatment-emergent adverse events related to DCVAC/OvCa, leukapheresis and chemotherapy occurred in six (16.2%), two (5.4%), and 35 (94.6%) patients in the DCVAC/OvCa group. Chemotherapy-related events occurred in all patients in the chemotherapy group. Seven patients in the DCVAC/OvCa group were excluded from primary efficacy analyses due to failure to receive >_1 dose of DCVAC/ OvCa. PFS was not improved (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.42-1.28, P = 0.274, data maturity 78.1%). Median OS was significantly prolonged (by 13.4 months) in the DCVAC/OvCa group (HR 0.38, 95% CI 0.20-0.74, P = 0.003; data maturity 56.3%). A signal for enhanced surrogate antigen-specific T-cell activity was seen with DCVAC/OvCa. Conclusions. DCVAC/OvCa combined with chemotherapy had a favorable safety profile in patients with platinum-sensitive ovarian cancer. DCVAC/OvCa did not improve PFS, but the exploratory analyses revealed OS prolongation and enhanced surrogate antigen-specific T-cell activity. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Cibula, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Rob, Lukas UNSPECIFIED orcid.org/0000-0003-3770-651X UNSPECIFIED Mallmann, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Knapp, Pawel UNSPECIFIED UNSPECIFIED UNSPECIFIED Klat, Jaroslav UNSPECIFIED UNSPECIFIED UNSPECIFIED Chovanec, Josef UNSPECIFIED UNSPECIFIED UNSPECIFIED Minar, Lubos UNSPECIFIED UNSPECIFIED UNSPECIFIED Melichar, Bohuslav UNSPECIFIED UNSPECIFIED UNSPECIFIED Hein, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Kieszko, Dariusz UNSPECIFIED UNSPECIFIED UNSPECIFIED Pluta, Marek UNSPECIFIED UNSPECIFIED UNSPECIFIED Spacek, Jiri UNSPECIFIED UNSPECIFIED UNSPECIFIED Bartos, Pavel UNSPECIFIED UNSPECIFIED UNSPECIFIED Wimberger, Pauline UNSPECIFIED UNSPECIFIED UNSPECIFIED Madry, Radoslaw UNSPECIFIED UNSPECIFIED UNSPECIFIED Markowska, Janina UNSPECIFIED UNSPECIFIED UNSPECIFIED Streb, Joanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Valha, Petr UNSPECIFIED UNSPECIFIED UNSPECIFIED Bin Hassan, Hariz Iskandar UNSPECIFIED UNSPECIFIED UNSPECIFIED Pecen, Ladislav UNSPECIFIED UNSPECIFIED UNSPECIFIED Galluzzi, Lorenzo UNSPECIFIED UNSPECIFIED UNSPECIFIED Fucikova, Jitka UNSPECIFIED UNSPECIFIED UNSPECIFIED Hrnciarova, Tereza UNSPECIFIED UNSPECIFIED UNSPECIFIED Hraska, Marek UNSPECIFIED UNSPECIFIED UNSPECIFIED Bartunkova, Jirina UNSPECIFIED UNSPECIFIED UNSPECIFIED Spisek, Radek UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-606355
DOI:	10.1016/j.ygyno.2021.07.003
Journal or Publication Title:	Gynecol. Oncol.
Volume:	162
Number:	3
Page Range:	S. 652 - 661
Date:	2021
Publisher:	ACADEMIC PRESS INC ELSEVIER SCIENCE
Place of Publication:	SAN DIEGO
ISSN:	1095-6859
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DCVAC/PCA; DEATH Multiple languages Oncology; Obstetrics & Gynecology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60635