التفاصيل البيبلوغرافية
| العنوان: |
Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial |
| المؤلفون: |
Cibula, David, Rob, Lukas, Mallmann, Peter, Knapp, Pawel, Klat, Jaroslav, Chovanec, Josef, Minar, Lubos, Melichar, Bohuslav, Hein, Alexander, Kieszko, Dariusz, Pluta, Marek, Spacek, Jiri, Bartos, Pavel, Wimberger, Pauline, Madry, Radoslaw, Markowska, Janina, Streb, Joanna, Valha, Petr, Bin Hassan, Hariz Iskandar, Pecen, Ladislav, Galluzzi, Lorenzo, Fucikova, Jitka, Hrnciarova, Tereza, Hraska, Marek, Bartunkova, Jirina, Spisek, Radek |
| بيانات النشر: |
ACADEMIC PRESS INC ELSEVIER SCIENCE |
| سنة النشر: |
2021 |
| المجموعة: |
Cologne University: KUPS |
| مصطلحات موضوعية: |
ddc:no |
| الوصف: |
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/). |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| العلاقة: |
Cibula, David, Rob, Lukas orcid:0000-0003-3770-651X , Mallmann, Peter, Knapp, Pawel, Klat, Jaroslav, Chovanec, Josef, Minar, Lubos, Melichar, Bohuslav, Hein, Alexander, Kieszko, Dariusz, Pluta, Marek, Spacek, Jiri, Bartos, Pavel, Wimberger, Pauline, Madry, Radoslaw, Markowska, Janina, Streb, Joanna, Valha, Petr, Bin Hassan, Hariz Iskandar, Pecen, Ladislav, Galluzzi, Lorenzo, Fucikova, Jitka, Hrnciarova, Tereza, Hraska, Marek, Bartunkova, Jirina and Spisek, Radek (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. Gynecol. Oncol., 162 (3). S. 652 - 661. SAN DIEGO: ACADEMIC PRESS INC ELSEVIER SCIENCE. ISSN 1095-6859 |
| الإتاحة: |
https://kups.ub.uni-koeln.de/60635Test/ |
| رقم الانضمام: |
edsbas.CFB8463B |
| قاعدة البيانات: |
BASE |
