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Autologous dendritic cell-based immunotherapy (DCVAC/LuCa) and carboplatin/paclitaxel in advanced non-small cell lung cancer: A randomized, open-label, phase I/II trial

M. Zemanova, M. Cernovska, L. Havel, T. Bartek, S. Lukesova, J. Jakesova, J. Vanasek, P. Reiterer, J. Kultan, I. Andrasina, L. Siskova, L. Koubkova, J. Skrickova, F. Salajka, M. Pesek, P. Klepetko, J. Beniak, H. Fricke, P. Kadlecova, RP....

. 2021 ; 28 (-) : 100427. [pub] 20210626

Language English Country Great Britain

Document type Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc22012542

PURPOSE: To investigate the efficacy and safety of an active cellular immunotherapy (DCVAC/LuCa) and chemotherapy in patients with stage IV non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: SLU01 was a multicenter, open-label, parallel-group, randomized, phase I/II trial. NSCLC patients were randomized in a ratio of 1:1:1 to receive: DCVAC/LuCa and chemotherapy (carboplatin and paclitaxel; Group A); DCVAC/LuCa, chemotherapy, pegylated interferon-α2b, and hydroxychloroquine (Group B); or chemotherapy alone (Group C). DCVAC/LuCa was administered subcutaneously every 3-6 weeks (up to 15 doses). The primary endpoint was overall survival (OS). During the study, enrollment into Group B was discontinued for strategic reasons. RESULTS: Forty-five patients were randomized to Group A, 29 patients to Group B, and 38 patients to Group C. The median OS in the modified intention-to-treat (mITT) population was 3.7 months longer in Group A than in Group C (15.5 vs. 11.8 months; p = 0.0179; hazard ratio = 0.54; 95% confidence interval: 0.32-0.91). This OS effect was consistent across subgroups of the mITT population (females, males, current smokers, former smokers, and patients with non-squamous and squamous cell histology). The most common treatment-emergent adverse events of any grade reported in Groups A, B, and C, respectively, were neutropenia (50.0%, 29.6%, and 20.6%), fatigue (40.0%, 18.5%, and 20.6%), anemia (35.0%, 44.4%, and 32.4%), paresthesia (27.5%, 25.9%, and 17.6%), and alopecia (25.0%, 29.6%, and 41.2%). CONCLUSION: DCVAC/LuCa in combination with carboplatin and paclitaxel extended OS and was well tolerated.

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$a Zemanova, Milada $u Department of Oncology, General Teaching Hospital, Prague, Czech Republic; First Faculty of Medicine, Charles University, Prague, Czech Republic
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$a Autologous dendritic cell-based immunotherapy (DCVAC/LuCa) and carboplatin/paclitaxel in advanced non-small cell lung cancer: A randomized, open-label, phase I/II trial / $c M. Zemanova, M. Cernovska, L. Havel, T. Bartek, S. Lukesova, J. Jakesova, J. Vanasek, P. Reiterer, J. Kultan, I. Andrasina, L. Siskova, L. Koubkova, J. Skrickova, F. Salajka, M. Pesek, P. Klepetko, J. Beniak, H. Fricke, P. Kadlecova, RP. Korolkiewicz, M. Hraska, J. Bartunkova, R. Spisek
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$a PURPOSE: To investigate the efficacy and safety of an active cellular immunotherapy (DCVAC/LuCa) and chemotherapy in patients with stage IV non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: SLU01 was a multicenter, open-label, parallel-group, randomized, phase I/II trial. NSCLC patients were randomized in a ratio of 1:1:1 to receive: DCVAC/LuCa and chemotherapy (carboplatin and paclitaxel; Group A); DCVAC/LuCa, chemotherapy, pegylated interferon-α2b, and hydroxychloroquine (Group B); or chemotherapy alone (Group C). DCVAC/LuCa was administered subcutaneously every 3-6 weeks (up to 15 doses). The primary endpoint was overall survival (OS). During the study, enrollment into Group B was discontinued for strategic reasons. RESULTS: Forty-five patients were randomized to Group A, 29 patients to Group B, and 38 patients to Group C. The median OS in the modified intention-to-treat (mITT) population was 3.7 months longer in Group A than in Group C (15.5 vs. 11.8 months; p = 0.0179; hazard ratio = 0.54; 95% confidence interval: 0.32-0.91). This OS effect was consistent across subgroups of the mITT population (females, males, current smokers, former smokers, and patients with non-squamous and squamous cell histology). The most common treatment-emergent adverse events of any grade reported in Groups A, B, and C, respectively, were neutropenia (50.0%, 29.6%, and 20.6%), fatigue (40.0%, 18.5%, and 20.6%), anemia (35.0%, 44.4%, and 32.4%), paresthesia (27.5%, 25.9%, and 17.6%), and alopecia (25.0%, 29.6%, and 41.2%). CONCLUSION: DCVAC/LuCa in combination with carboplatin and paclitaxel extended OS and was well tolerated.
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$a Cernovska, Marketa $u First Faculty of Medicine, Charles University, Prague, Czech Republic; Department of Respiratory Medicine, Thomayer Hospital, Prague, Czech Republic
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$a Havel, Libor $u First Faculty of Medicine, Charles University, Prague, Czech Republic; Department of Respiratory Medicine, Thomayer Hospital, Prague, Czech Republic
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$a Bartek, Tomas $u Department of Respiratory Medicine and Tuberculosis, University Hospital Ostrava, Ostrava, Czech Republic
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$a Lukesova, Sarka $u Department of Oncology, Hospital Nachod, Nachod, Czech Republic
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$a Jakesova, Jitka $u Department of Oncology, Hospital Pribram, Pribram, Czech Republic
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$a Vanasek, Jaroslav $u Oncology Centre Multiscan, Pardubice, Czech Republic
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$a Reiterer, Pavel $u Department of Pneumology, Masaryk Hospital Usti and Labem, Usti and Labem, Czech Republic
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$a Kultan, Juraj $u Department of Respiratory Medicine, University Hospital Olomouc, Olomouc, Czech Republic
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$a Andrasina, Igor $u Department of Oncology, Vychodoslovensky onkologicky ustav, a.s., Kosice, Slovak Republic
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$a Siskova, Lenka $u Department of Oncology, Hospital of Tomas Bata in Zlin, Zlin, Czech Republic
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$a Koubkova, Leona $u Department of Pneumology, 2nd Faculty of Medicine, University Hospital Motol, Charles University, Prague, Prague, Czech Republic
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$a Skrickova, Jana $u Department of Respiratory Medicine and Tuberculosis, University Hospital Brno, Brno, Czech Republic
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$a Salajka, Frantisek $u Department of Pneumology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic
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$a Pesek, Milos $u Department of Pneumology, University Hospital Pilsen, Charles University in Prague, Prague, Czech Republic
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$a Klepetko, Petr $u Avicennus Oncology, Kutna Hora, Czech Republic
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$a Beniak, Juraj $u POKO Poprad, Poprad, Slovak Republic
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$a Fricke, Harald $u SOTIO a.s., Prague, Czech Republic
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$a Kadlecova, Pavla $u SOTIO a.s., Prague, Czech Republic
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$a Korolkiewicz, Roman P $u SOTIO a.s., Prague, Czech Republic. Electronic address: korolkiewicz@sotio.com
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$a Hraska, Marek $u SOTIO a.s., Prague, Czech Republic
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$a Bartunkova, Jirina $u SOTIO a.s., Prague, Czech Republic
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