Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with
second-line chemotherapy in platinum-sensitive ovarian cancer
(SOV02): A randomized, open-label, phase 2 trial

J 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

CIBULA, David, Lukas ROB, P. MALLMANN, P. KNAPP, Jaroslav KLAT et. al.

Basic information

Original name

Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial

Authors

CIBULA, David (203 Czech Republic, guarantor), Lukas ROB (203 Czech Republic), P. MALLMANN, P. KNAPP, Jaroslav KLAT (203 Czech Republic), Josef CHOVANEC (203 Czech Republic), Luboš MINÁŘ (203 Czech Republic, belonging to the institution), Bohuslav MELICHAR (203 Czech Republic), A. HEIN, D. KIESZKO, Marek PLUTA (203 Czech Republic), Jiri SPACEK (203 Czech Republic), Pavel BARTOS (203 Czech Republic), P. WIMBERGER, R. MADRY, J. MARKOWSKA, J. STREB, Petr VALHA (203 Czech Republic), H. I. BIN HASSAN, Ladislav PECEN (203 Czech Republic), L. GALLUZZI, Jitka FUCIKOVA (203 Czech Republic), Tereza HRNCIAROVA (203 Czech Republic), Marek HRASKA (203 Czech Republic), Jirina BARTUNKOVA (203 Czech Republic) and Radek SPISEK (203 Czech Republic)

Edition

Gynecologic Oncology, SAN DIEGO, ACADEMIC PRESS INC ELSEVIER SCIENCE, 2021, 0090-8258

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30214 Obstetrics and gynaecology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.304

RIV identification code

RIV/00216224:14110/21:00122900

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.ygyno.2021.07.003

UT WoS

000690807800020

Keywords in English

Ovarian cancer; Dendritic-cell based immunotherapy; Immunogenic cell death

Abstract

V originále

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/).

Citovat

CIBULA, David, Lukas ROB, P. MALLMANN, P. KNAPP, Jaroslav KLAT, Josef CHOVANEC, Luboš MINÁŘ, Bohuslav MELICHAR, A. HEIN, D. KIESZKO, Marek PLUTA, Jiri SPACEK, Pavel BARTOS, P. WIMBERGER, R. MADRY, J. MARKOWSKA, J. STREB, Petr VALHA, H. I. BIN HASSAN, Ladislav PECEN, L. GALLUZZI, Jitka FUCIKOVA, Tereza HRNCIAROVA, Marek HRASKA, Jirina BARTUNKOVA and Radek SPISEK. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecologic Oncology. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE, 2021, vol. 162, No 3, p. 652-660. ISSN 0090-8258. Available from: https://dx.doi.org/10.1016/j.ygyno.2021.07.003.

@article{1804604,
   author = {Cibula, David and Rob, Lukas and Mallmann, P. and Knapp, P. and Klat, Jaroslav and Chovanec, Josef and Minář, Luboš and Melichar, Bohuslav and Hein, A. and Kieszko, D. and Pluta, Marek and Spacek, Jiri and Bartos, Pavel and Wimberger, P. and Madry, R. and Markowska, J. and Streb, J. and Valha, Petr and Bin Hassan, H. I. and Pecen, Ladislav and Galluzzi, L. and Fucikova, Jitka and Hrnciarova, Tereza and Hraska, Marek and Bartunkova, Jirina and Spisek, Radek},
   article_location = {SAN DIEGO},
   article_number = {3},
   doi = {http://dx.doi.org/10.1016/j.ygyno.2021.07.003},
   keywords = {Ovarian cancer; Dendritic-cell based immunotherapy; Immunogenic cell death},
   language = {eng},
   issn = {0090-8258},
   journal = {Gynecologic Oncology},
   title = {Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial},
   url = {https://www.sciencedirect.com/science/article/pii/S0090825821005333?via%3Dihub},
   volume = {162},
   year = {2021}
}

TY  - JOUR
ID  - 1804604
AU  - Cibula, David - Rob, Lukas - Mallmann, P. - Knapp, P. - Klat, Jaroslav - Chovanec, Josef - Minář, Luboš - Melichar, Bohuslav - Hein, A. - Kieszko, D. - Pluta, Marek - Spacek, Jiri - Bartos, Pavel - Wimberger, P. - Madry, R. - Markowska, J. - Streb, J. - Valha, Petr - Bin Hassan, H. I. - Pecen, Ladislav - Galluzzi, L. - Fucikova, Jitka - Hrnciarova, Tereza - Hraska, Marek - Bartunkova, Jirina - Spisek, Radek
PY  - 2021
TI  - Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial
JF  - Gynecologic Oncology
VL  - 162
IS  - 3
SP  - 652-660
EP  - 652-660
PB  - ACADEMIC PRESS INC ELSEVIER SCIENCE
SN  - 00908258
KW  - Ovarian cancer
KW  - Dendritic-cell based immunotherapy
KW  - Immunogenic cell death
UR  - https://www.sciencedirect.com/science/article/pii/S0090825821005333?via%3Dihub
N2  - 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/).
ER  -

CIBULA, David, Lukas ROB, P. MALLMANN, P. KNAPP, Jaroslav KLAT, Josef CHOVANEC, Luboš MINÁŘ, Bohuslav MELICHAR, A. HEIN, D. KIESZKO, Marek PLUTA, Jiri SPACEK, Pavel BARTOS, P. WIMBERGER, R. MADRY, J. MARKOWSKA, J. STREB, Petr VALHA, H. I. BIN HASSAN, Ladislav PECEN, L. GALLUZZI, Jitka FUCIKOVA, Tereza HRNCIAROVA, Marek HRASKA, Jirina BARTUNKOVA and Radek SPISEK. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. \textit{Gynecologic Oncology}. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE, 2021, vol.~162, No~3, p.~652-660. ISSN~0090-8258. Available from: https://dx.doi.org/10.1016/j.ygyno.2021.07.003.

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