0544091 - ÚI 2022 RIV US eng J - Journal Article
Cibula, D. - Rob, L. - Mallmann, P. - Knapp, P. - Klat, J. - Chovanec, J. - Minář, L. - Melichar, B. - Hein, A. - Kieszko, D. - Pluta, M. - Špaček, J. - Bartoš, P. - Wimberger, P. - Madry, R. - Markowska, J. - Streb, J. - Valha, P. - Bin Hassan, H. I. - Pecen, Ladislav - Galluzzi, L. - Fučíková, J. - Hrnčiarová, T. - Hraška, M. - Bartůňková, J. - Spíšek, R.
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. Roč. 162, č. 3 (2021), s. 652-660. ISSN 0090-8258. E-ISSN 1095-6859
Institutional support: RVO:67985807
Keywords : Ovarian cancer * Dendritic-cell based immunotherapy * Immunogenic cell death
OECD category: Oncology
Impact factor: 5.304, year: 2021 ; AIS: 1.432, rok: 2021
Method of publishing: Open access
Result website:
http://dx.doi.org/10.1016/j.ygyno.2021.07.003DOI: https://doi.org/10.1016/j.ygyno.2021.07.003

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.
Permanent Link: http://hdl.handle.net/11104/0321150