Details

Autor(en) / Beteiligte

• Zemanova, Milada
• Cernovska, Marketa
• Havel, Libor
• Bartek, Tomas
• Lukesova, Sarka
• Jakesova, Jitka
• Vanasek, Jaroslav
• Reiterer, Pavel
• Kultan, Juraj
• Andrasina, Igor
• Siskova, Lenka
• Koubkova, Leona
• Skrickova, Jana
• Salajka, Frantisek
• Pesek, Milos
• Klepetko, Petr
• Beniak, Juraj
• Fricke, Harald
• Kadlecova, Pavla
• Korolkiewicz, Roman P.
• Hraska, Marek
• Bartunkova, Jirina
• Spisek, Radek

Titel

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

Ist Teil von

• Cancer treatment and research communications, 2021, Vol.28, p.100427-100427, Article 100427

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2021

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• •Dendritic cell-based immunotherapy (DCVAC/LuCa) plus a platinum doublet in NSCLC.•SLU01: a multicenter, open-label, parallel-group, randomized, phase I/II trial.•DCVAC/LuCa improved OS and PFS in patients with stage IV NSCLC.•DCVAC/LuCa in combination with carboplatin and paclitaxel was well tolerated. 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). 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. 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%). DCVAC/LuCa in combination with carboplatin and paclitaxel extended OS and was well tolerated.