1. 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
- Author
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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, and Jaroslav Vanasek
- Subjects
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 - Abstract
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.
- Published
- 2021