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
Autor: | P. Reiterer, Miloš Pešek, Radek Spisek, Milada Zemanova, Pavla Kadlecova, Tomas Bartek, Leona Koubková, M. Černovská, Jirina Bartunkova, Juraj Beniak, Juraj Kultan, Harald Fricke, Jitka Jakesova, Lenka Šišková, Igor Andrasina, Sarka Lukesova, Jana Skrickova, Libor Havel, Roman Pawel Korolkiewicz, Marek Hraska, Petr Klepetko, František Salajka, Jaroslav Vanasek |
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Rok vydání: | 2021 |
Předmět: |
Adult
Male 0301 basic medicine Cancer Research medicine.medical_specialty Lung Neoplasms Paclitaxel medicine.medical_treatment Population Neutropenia Gastroenterology Dendritic cells and a platinum doublet Metastatic non-small cell lung cancer Group B Carboplatin Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Lung cancer education RC254-282 Aged Chemotherapy education.field_of_study Cellular immunotherapy business.industry Immunotherapy combined with platinum-based chemotherapy Neoplasms. Tumors. Oncology. Including cancer and carcinogens Hydroxychloroquine Immuno-oncology Dendritic Cells Middle Aged medicine.disease 030104 developmental biology Oncology chemistry 030220 oncology & carcinogenesis Female Immunotherapy business medicine.drug |
Zdroj: | Cancer Treatment and Research Communications, Vol 28, Iss, Pp 100427-(2021) |
ISSN: | 2468-2942 |
Popis: | 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. |
Databáze: | OpenAIRE |
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