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Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial
D. Cibula, L. Rob, P. Mallmann, P. Knapp, J. Klat, J. Chovanec, L. Minar, B. Melichar, A. Hein, D. Kieszko, M. Pluta, J. Spacek, P. Bartos, P. Wimberger, R. Madry, J. Markowska, J. Streb, P. Valha, HIB. Hassan, L. Pecen, L. Galluzzi, J. Fucikova,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- dendritické buňky imunologie transplantace MeSH
- deoxycytidin aplikace a dávkování analogy a deriváty MeSH
- dospělí MeSH
- epiteliální ovariální karcinom terapie MeSH
- imunoterapie adoptivní škodlivé účinky metody MeSH
- karboplatina aplikace a dávkování MeSH
- kombinovaná terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory vaječníků farmakoterapie imunologie patologie terapie MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- staging nádorů MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
Caryl and Israel Englander Institute for Precision Medicine 1300 York Avenue New York NY 10065 USA
Department of Dermatology Yale University School of Medicine 333 Cedar Street New Haven CT 06510 USA
Jagiellonian University Hospital Jakubowskiego 2 30 688 Krakow Poland
Masaryk Memorial Cancer Institute Zluty kopec 7 653 53 Brno Czech Republic
Medical University of Bialystok 24a M Sklodowskiej Curie Str 15 276 Bialystok Poland
Oncological Center of the Lublin Region ul dr K Jaczewskiego 720 090 Lublin Poland
Sandra and Edward Meyer Cancer Center 1300 York Avenue New York NY 10065 USA
SOTIO a s Jankovcova 1518 2 170 00 Prague 7 Czech Republic
Université de Paris 15 Rue de l'Ecole de Médecine 75006 Paris France
University Hospital of Cologne Kerpener Str 34 50931 Cologne Germany
Citace poskytuje Crossref.org
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- $a Cibula, David $u First Faculty of Medicine, Charles University and General University Hospital in Prague, Apolinarska 18, Prague 12801, Czech Republic. Electronic address: dc@davidcibula.cz
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- $a Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial / $c D. Cibula, L. Rob, P. Mallmann, P. Knapp, J. Klat, J. Chovanec, L. Minar, B. Melichar, A. Hein, D. Kieszko, M. Pluta, J. Spacek, P. Bartos, P. Wimberger, R. Madry, J. Markowska, J. Streb, P. Valha, HIB. Hassan, L. Pecen, L. Galluzzi, J. Fucikova, T. Hrnciarova, M. Hraska, J. Bartunkova, R. Spisek
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- $a 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.
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