• Je něco špatně v tomto záznamu ?

Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial

NJ. Vogelzang, TM. Beer, W. Gerritsen, S. Oudard, P. Wiechno, B. Kukielka-Budny, V. Samal, J. Hajek, S. Feyerabend, V. Khoo, A. Stenzl, T. Csöszi, Z. Filipovic, F. Goncalves, A. Prokhorov, E. Cheung, A. Hussain, N. Sousa, A. Bahl, S. Hussain, H....

. 2022 ; 8 (4) : 546-552. [pub] 20220401

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22019017

IMPORTANCE: DCVAC/PCa is an active cellular immunotherapy designed to initiate an immune response against prostate cancer. OBJECTIVE: To evaluate the efficacy and safety of DCVAC/PCa plus chemotherapy followed by DCVAC/PCa maintenance treatment in patients with metastatic castration-resistant prostate cancer (mCRPC). DESIGN, SETTING, AND PARTICIPANTS: The VIABLE double-blind, parallel-group, placebo-controlled, phase 3 randomized clinical trial enrolled patients with mCRPC among 177 hospital clinics in the US and Europe between June 2014 and November 2017. Data analyses were performed from December 2019 to July 2020. INTERVENTIONS: Eligible patients were randomized (2:1) to receive DCVAC/PCa (add-on and maintenance) or placebo, both in combination with chemotherapy (docetaxel plus prednisone). The stratification was applied according to geographical region (US or non-US), prior therapy (abiraterone, enzalutamide, or neither), and Eastern Cooperative Oncology Group performance status (0-1 or 2). DCVAC/PCa or placebo was administered subcutaneously every 3 to 4 weeks (up to 15 doses). MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival (OS), defined as the time from randomization until death due to any cause, in all randomized patients. Survival was compared using 2-sided log-rank test stratified by geographical region, prior therapy with abiraterone and/or enzalutamide, and Eastern Cooperative Oncology Group performance status. RESULTS: A total of 1182 men with mCRPC (median [range] age, 68 [46-89] years) were randomized to receive DCVAC/PCa (n = 787) or placebo (n = 395). Of these, 610 (81.8%) started DCVAC/PCa, and 376 (98.4%) started placebo. There was no difference in OS between the DCVAC/PCa and placebo groups in all randomized patients (median OS, 23.9 months [95% CI, 21.6-25.3] vs 24.3 months [95% CI, 22.6-26.0]; hazard ratio, 1.04; 95% CI, 0.90-1.21; P = .60). No differences in the secondary efficacy end points (radiological progression-free survival, time to prostate-specific antigen progression, or skeletal-related events) were observed. Treatment-emergent adverse events related to DCVAC/PCa or placebo occurred in 69 of 749 (9.2%) and 48 of 379 (12.7%) patients, respectively. The most common treatment-emergent adverse events (DCVAC/PCa [n = 749] vs placebo [n = 379]) were fatigue (271 [36.2%] vs 152 [40.1%]), alopecia (222 [29.6%] vs 130 [34.3%]), and diarrhea (206 [27.5%] vs 117 [30.9%]). CONCLUSIONS AND RELEVANCE: In this phase 3 randomized clinical trial, DCVAC/PCa combined with docetaxel plus prednisone and continued as maintenance treatment did not extend OS in patients with mCRPC and was well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02111577.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22019017
003      
CZ-PrNML
005      
20220804135253.0
007      
ta
008      
220720s2022 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1001/jamaoncol.2021.7298 $2 doi
035    __
$a (PubMed)35142815
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Vogelzang, Nicholas J $u Comprehensive Cancer Centers of Nevada, Las Vegas $u US Oncology Research, The Woodlands, Texas
245    10
$a Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial / $c NJ. Vogelzang, TM. Beer, W. Gerritsen, S. Oudard, P. Wiechno, B. Kukielka-Budny, V. Samal, J. Hajek, S. Feyerabend, V. Khoo, A. Stenzl, T. Csöszi, Z. Filipovic, F. Goncalves, A. Prokhorov, E. Cheung, A. Hussain, N. Sousa, A. Bahl, S. Hussain, H. Fricke, P. Kadlecova, T. Scheiner, RP. Korolkiewicz, J. Bartunkova, R. Spisek, VIABLE Investigators
520    9_
$a IMPORTANCE: DCVAC/PCa is an active cellular immunotherapy designed to initiate an immune response against prostate cancer. OBJECTIVE: To evaluate the efficacy and safety of DCVAC/PCa plus chemotherapy followed by DCVAC/PCa maintenance treatment in patients with metastatic castration-resistant prostate cancer (mCRPC). DESIGN, SETTING, AND PARTICIPANTS: The VIABLE double-blind, parallel-group, placebo-controlled, phase 3 randomized clinical trial enrolled patients with mCRPC among 177 hospital clinics in the US and Europe between June 2014 and November 2017. Data analyses were performed from December 2019 to July 2020. INTERVENTIONS: Eligible patients were randomized (2:1) to receive DCVAC/PCa (add-on and maintenance) or placebo, both in combination with chemotherapy (docetaxel plus prednisone). The stratification was applied according to geographical region (US or non-US), prior therapy (abiraterone, enzalutamide, or neither), and Eastern Cooperative Oncology Group performance status (0-1 or 2). DCVAC/PCa or placebo was administered subcutaneously every 3 to 4 weeks (up to 15 doses). MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival (OS), defined as the time from randomization until death due to any cause, in all randomized patients. Survival was compared using 2-sided log-rank test stratified by geographical region, prior therapy with abiraterone and/or enzalutamide, and Eastern Cooperative Oncology Group performance status. RESULTS: A total of 1182 men with mCRPC (median [range] age, 68 [46-89] years) were randomized to receive DCVAC/PCa (n = 787) or placebo (n = 395). Of these, 610 (81.8%) started DCVAC/PCa, and 376 (98.4%) started placebo. There was no difference in OS between the DCVAC/PCa and placebo groups in all randomized patients (median OS, 23.9 months [95% CI, 21.6-25.3] vs 24.3 months [95% CI, 22.6-26.0]; hazard ratio, 1.04; 95% CI, 0.90-1.21; P = .60). No differences in the secondary efficacy end points (radiological progression-free survival, time to prostate-specific antigen progression, or skeletal-related events) were observed. Treatment-emergent adverse events related to DCVAC/PCa or placebo occurred in 69 of 749 (9.2%) and 48 of 379 (12.7%) patients, respectively. The most common treatment-emergent adverse events (DCVAC/PCa [n = 749] vs placebo [n = 379]) were fatigue (271 [36.2%] vs 152 [40.1%]), alopecia (222 [29.6%] vs 130 [34.3%]), and diarrhea (206 [27.5%] vs 117 [30.9%]). CONCLUSIONS AND RELEVANCE: In this phase 3 randomized clinical trial, DCVAC/PCa combined with docetaxel plus prednisone and continued as maintenance treatment did not extend OS in patients with mCRPC and was well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02111577.
650    _2
$a senioři $7 D000368
650    _2
$a protokoly antitumorózní kombinované chemoterapie $x škodlivé účinky $7 D000971
650    _2
$a dendritické buňky $x patologie $7 D003713
650    _2
$a docetaxel $x škodlivé účinky $7 D000077143
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a imunoterapie $x škodlivé účinky $7 D007167
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a prednison $7 D011241
650    12
$a nádory prostaty rezistentní na kastraci $x farmakoterapie $7 D064129
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Beer, Tomasz M $u Oregon Health & Science University, Portland
700    1_
$a Gerritsen, Winald $u Radboud UMC, Nijmegen, the Netherlands
700    1_
$a Oudard, Stéphane $u Georges Pompidou European Hospital, University of Paris, Paris, France
700    1_
$a Wiechno, Pawel $u Oncology Center-Institute Marii Sklodowskiej-Curie, Warszawa, Poland
700    1_
$a Kukielka-Budny, Bozena $u Center of Oncology of the Lublin Region St Jana z Dukli, Lublin, Poland
700    1_
$a Samal, Vladimir $u Regional Hospital Liberec, Liberec, Czechia $u Faculty of Medicine in Hradec Kralove, Charles University, Czechia
700    1_
$a Hajek, Jaroslav $u University Hospital Ostrava, Ostrava, Czechia
700    1_
$a Feyerabend, Susan $u Studienpraxis Urologie, Nuertingen, Germany
700    1_
$a Khoo, Vincent $u Royal Marsden NHS Foundation Trust, Sutton, United Kingdom
700    1_
$a Stenzl, Arnulf $u University Clinic of Urology, Tuebingen, Germany
700    1_
$a Csöszi, Tibor $u Geza Hetenyi Hospital in Szolnok, Szolnok, Hungary
700    1_
$a Filipovic, Zoran $u University Hospital Medical Center Bezanijska Kosa, Belgrade, Serbia
700    1_
$a Goncalves, Frederico $u CUIMED, Bratislava, Slovakia
700    1_
$a Prokhorov, Alexander $u Minsk City Oncological Dispensary, Minsk, Belarus
700    1_
$a Cheung, Eric $u Oncology Institute of Hope and Innovation, Long Beach, California
700    1_
$a Hussain, Arif $u University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland
700    1_
$a Sousa, Nuno $u Instituto Português de Oncologia do Porto Francisco Gentil, Porto, Portugal
700    1_
$a Bahl, Amit $u Bristol Haematology and Oncology Centre, Bristol, United Kingdom
700    1_
$a Hussain, Syed $u University of Sheffield, Sheffield, United Kingdom
700    1_
$a Fricke, Harald $u SOTIO a.s., Prague, Czechia
700    1_
$a Kadlecova, Pavla $u SOTIO a.s., Prague, Czechia
700    1_
$a Scheiner, Tomas $u SOTIO a.s., Prague, Czechia
700    1_
$a Korolkiewicz, Roman P $u SOTIO a.s., Prague, Czechia
700    1_
$a Bartunkova, Jirina $u SOTIO a.s., Prague, Czechia
700    1_
$a Spisek, Radek $u SOTIO a.s., Prague, Czechia
710    2_
$a VIABLE Investigators
773    0_
$w MED00186178 $t JAMA oncology $x 2374-2445 $g Roč. 8, č. 4 (2022), s. 546-552
856    41
$u https://pubmed.ncbi.nlm.nih.gov/35142815 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220720 $b ABA008
991    __
$a 20220804135246 $b ABA008
999    __
$a ok $b bmc $g 1822567 $s 1170260
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2022 $b 8 $c 4 $d 546-552 $e 20220401 $i 2374-2445 $m JAMA oncology $n JAMA Oncol $x MED00186178
LZP    __
$a Pubmed-20220720

Najít záznam

Citační ukazatele

    Možnosti archivace