Počet záznamů: 1
Dendritic Cell-based Immunotherapy (DCVAC/OvCa) Combined with Second-line Chemotherapy in Platinum-sensitive Ovarian Cancer (SOV02): A Randomized, Open-label, Phase 2 Trial
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SYSNO ASEP 0544091 Druh ASEP J - Článek v odborném periodiku Zařazení RIV J - Článek v odborném periodiku Poddruh J Článek ve WOS 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 Tvůrce(i) Cibula, D. (CZ)
Rob, L. (CZ)
Mallmann, P. (DE)
Knapp, P. (PL)
Klat, J. (CZ)
Chovanec, J. (CZ)
Minář, L. (CZ)
Melichar, B. (CZ)
Hein, A. (DE)
Kieszko, D. (PL)
Pluta, M. (CZ)
Špaček, J. (CZ)
Bartoš, P. (CZ)
Wimberger, P. (DE)
Madry, R. (PL)
Markowska, J. (PL)
Streb, J. (PL)
Valha, P. (CZ)
Bin Hassan, H. I. (CZ)
Pecen, Ladislav (UIVT-O) RID, SAI, ORCID
Galluzzi, L. (US)
Fučíková, J. (CZ)
Hrnčiarová, T. (CZ)
Hraška, M. (CZ)
Bartůňková, J. (CZ)
Spíšek, R. (CZ)Celkový počet autorů 26 Zdroj.dok. Gynecologic Oncology. - : Elsevier - ISSN 0090-8258
Roč. 162, č. 3 (2021), s. 652-660Poč.str. 9 s. Forma vydání Tištěná - P Jazyk dok. eng - angličtina Země vyd. US - Spojené státy americké Klíč. slova Ovarian cancer ; Dendritic-cell based immunotherapy ; Immunogenic cell death Obor OECD Oncology Způsob publikování Open access Institucionální podpora UIVT-O - RVO:67985807 UT WOS 000690807800020 EID SCOPUS 85110779404 DOI 10.1016/j.ygyno.2021.07.003 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. Pracoviště Ústav informatiky Kontakt Tereza Šírová, sirova@cs.cas.cz, Tel.: 266 053 800 Rok sběru 2022 Elektronická adresa http://dx.doi.org/10.1016/j.ygyno.2021.07.003
Počet záznamů: 1