Martin Faehling1, Christian Schumann2, Petros Christopoulos3, Petra Hoffknecht4, Jürgen Alt5, Marlitt Horn6, Stephan Eisenmann7, Anke Schlenska-Lange8, Philipp Schütt9, Felix Steger10, Wolfgang M Brückl11, Daniel C Christoph12. 1. Klinik für Kardiologie und Pneumologie, Klinikum Esslingen, 73730 Esslingen, Germany. 2. Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin, Klinikum Kempten, 87439 Kempten, Germany. 3. Thoraxklinik-Heidelberg, 69126 Heidelberg, Germany. 4. Klinik für Thoraxonkologie und Palliativstation, Franziskus-Hospital Harderberg, 49124 Georgsmarienhütte, Germany. 5. III. Medizinische Klinik und Poliklinik, Johannes Gutenberg-Universität, 55131 Mainz, Germany. 6. LungenClinic Grosshansdorf, Großhansdorf, Germany. 7. Universitätsklinik und Poliklinik für Innere Medizin I (Gastroenterologie & Pneumologie), Universitätsklinikum Halle (Saale), 06120 Halle, Germany. 8. Klinik für Onkologie und Hämatologie, Krankenhaus Barmherzige Brüder Regensburg, 93049 Regensburg, Germany. 9. Onkologische Gemeinschaftspraxis, Gütersloh, Germany. 10. Klinik und Poliklinik für Strahlentherapie, Universitätsklinikum Regensburg, 93053 Regensburg, Germany. 11. Klinik für Innere Medizin 3, Klinikum Nürnberg Nord, 90419 Nürnberg, Germany. 12. Klinik für Internistische Onkologie und Hämatologie mit integrierter Palliativmedizin, Evang. Kliniken Essen-Mitte, 45136 Essen, Germany.
Abstract
BACKGROUND: Following the PACIFIC trial, durvalumab has been approved by the European Medicines Agency (EMA) for consolidation of locally advanced PD-L1-positive NSCLC after chemoradiotherapy (CRT). Patients were treated with durvalumab in the EAP from 22.11.2017 to 15.10.2018 allowing analysis of its efficacy and safety. METHODS: Data from 56 centres were analysed for adverse events (AE), progression-free survival (PFS), overall survival (OS). RESULTS: 126 patients actually received at least 1 cycle durvalumab. Compared to the PACIFIC trial, the EAP population had more advanced stage and included "oligometastatic" stage IV patients and patients with autoimmune disease. PFS (20.1 months) and OS (not reached) were similar in the EAP and the PACIFIC trial. 42.9 % completed 12 months of durvalumab without deaths during FU. Stage IV patients (n = 7) had encouraging OS (not reached at 27 months). Autoimmune disease did not affect survival. PFS and OS were similar in PD-L1-negative patients (n = 32) and PD-L1-positive patients (n = 79). CONCLUSIONS: Survival in the EAP was comparable to the PACIFIC trial. Selected stage IV patients and patients with autoimmune disease may benefit from durvalumab consolidation and should be included in future immuno-oncological trials. PD-L1 did not predict survival challenging the exclusion of PD-L1-negative patients from durvalumab consolidation. In summary, durvalumab consolidation is safe and effective in a European real-world setting.
BACKGROUND: Following the PACIFIC trial, durvalumab has been approved by the European Medicines Agency (EMA) for consolidation of locally advanced PD-L1-positive NSCLC after chemoradiotherapy (CRT). Patients were treated with durvalumab in the EAP from 22.11.2017 to 15.10.2018 allowing analysis of its efficacy and safety. METHODS: Data from 56 centres were analysed for adverse events (AE), progression-free survival (PFS), overall survival (OS). RESULTS: 126 patients actually received at least 1 cycle durvalumab. Compared to the PACIFIC trial, the EAP population had more advanced stage and included "oligometastatic" stage IV patients and patients with autoimmune disease. PFS (20.1 months) and OS (not reached) were similar in the EAP and the PACIFIC trial. 42.9 % completed 12 months of durvalumab without deaths during FU. Stage IV patients (n = 7) had encouraging OS (not reached at 27 months). Autoimmune disease did not affect survival. PFS and OS were similar in PD-L1-negative patients (n = 32) and PD-L1-positive patients (n = 79). CONCLUSIONS: Survival in the EAP was comparable to the PACIFIC trial. Selected stage IV patients and patients with autoimmune disease may benefit from durvalumab consolidation and should be included in future immuno-oncological trials. PD-L1 did not predict survival challenging the exclusion of PD-L1-negative patients from durvalumab consolidation. In summary, durvalumab consolidation is safe and effective in a European real-world setting.
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Authors: David R Spigel; Corinne Faivre-Finn; Jhanelle E Gray; David Vicente; David Planchard; Luis Paz-Ares; Johan F Vansteenkiste; Marina C Garassino; Rina Hui; Xavier Quantin; Andreas Rimner; Yi-Long Wu; Mustafa Özgüroğlu; Ki H Lee; Terufumi Kato; Maike de Wit; Takayasu Kurata; Martin Reck; Byoung C Cho; Suresh Senan; Jarushka Naidoo; Helen Mann; Michael Newton; Piruntha Thiyagarajah; Scott J Antonia Journal: J Clin Oncol Date: 2022-02-02 Impact factor: 50.717