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 a 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, roč. 162, č. 3, s. 652-660. ISSN 0090-8258. doi:10.1016/j.ygyno.2021.07.003. 2021.
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Základní údaje
Originální název Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial
Autoři CIBULA, David (203 Česká republika, garant), Lukas ROB (203 Česká republika), P. MALLMANN, P. KNAPP, Jaroslav KLAT (203 Česká republika), Josef CHOVANEC (203 Česká republika), Luboš MINÁŘ (203 Česká republika, domácí), Bohuslav MELICHAR (203 Česká republika), A. HEIN, D. KIESZKO, Marek PLUTA (203 Česká republika), Jiri SPACEK (203 Česká republika), Pavel BARTOS (203 Česká republika), P. WIMBERGER, R. MADRY, J. MARKOWSKA, J. STREB, Petr VALHA (203 Česká republika), H. I. BIN HASSAN, Ladislav PECEN (203 Česká republika), L. GALLUZZI, Jitka FUCIKOVA (203 Česká republika), Tereza HRNCIAROVA (203 Česká republika), Marek HRASKA (203 Česká republika), Jirina BARTUNKOVA (203 Česká republika) a Radek SPISEK (203 Česká republika).
Vydání Gynecologic Oncology, SAN DIEGO, ACADEMIC PRESS INC ELSEVIER SCIENCE, 2021, 0090-8258.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30214 Obstetrics and gynaecology
Stát vydavatele Spojené státy
Utajení není předmětem státního či obchodního tajemství
WWW URL
Impakt faktor Impact factor: 5.304
Kód RIV RIV/00216224:14110/21:00122900
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.1016/j.ygyno.2021.07.003
UT WoS 000690807800020
Klíčová slova anglicky Ovarian cancer; Dendritic-cell based immunotherapy; Immunogenic cell death
Štítky 14110411, rivok
Příznaky Mezinárodní význam, Recenzováno
Změnil Změnila: Mgr. Tereza Miškechová, učo 341652. Změněno: 22. 11. 2021 13:26.
Anotace
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/).
VytisknoutZobrazeno: 29. 3. 2024 00:45