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
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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