- Tytuł:
- Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02) : A randomized, open-label, phase 2 trial
- Autorzy:
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Pluta, Marek
Galluzzi, Lorenzo
Minar, Lubos
Hrnciarova, Tereza
Melichar, Bohuslav
Spacek, Jiri
Madry, Radoslaw
Rob, Lukas
Fucikova, Jitka
Streb, Joanna
Chovanec, Josef
Cibula, David
Hassan, Hariz Iskandar Bin
Pecen, Ladislav
Valha, Petr
Mallmann, Peter
Wimberger, Pauline
Kieszko, Dariusz
Spisek, Radek
Hein, Alexander
Markowska, Janina
Knapp, Pawel
Klat, Jaroslav
Hraska, Marek
Bartos, Pavel
Bartunkova, Jirina - Opis:
- 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.
- Dostawca treści:
- Repozytorium Uniwersytetu Jagiellońskiego
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