Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study

The Lancet Oncology - Tập 19 - Trang 521-536 - 2018
Marina Chiara Garassino1, Byoung-Chul Cho2, Joo-Hang Kim3, Julien Mazières4, Johan Vansteenkiste5, Hervé Lena6, Jesus Corral Jaime7, Jhanelle E Gray8, John Powderly9, Christos Chouaid10, Paolo Bidoli11, Paul Wheatley-Price12, Keunchil Park13, Ross A Soo14, Yifan Huang15, Catherine Wadsworth16, Phillip A Dennis15, Naiyer A Rizvi17
1Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
2Yonsei Cancer Center/Yonsei University College of Medicine, Seoul, South Korea
3CHA Bundang Medical Center, CHA University, Gyeonggi-do, South Korea
4Toulouse University Hospital, Université Paul Sabatier, Toulouse, France
5University Hospitals, KU Leuven, Leuven, Belgium
6CHU Rennes–Hôpital Pontchaillou, Rennes University, Rennes, France
7Hospital Universitario Virgen del Rocio, Seville, Spain
8H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA
9Carolina BioOncology Institute, Huntersville, NC, USA
10Centre Hospitalier Intercommunal de Créteil, Créteil, France
11Azienda Ospedaliera San Gerardo, Monza, Italy
12The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada
13Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
14National University Hospital and National University Cancer Institute, Singapore
15AstraZeneca, Gaithersburg, MD, USA
16AstraZeneca, Alderley Park, UK
17Columbia University Medical Center, New York, NY, USA

Tài liệu tham khảo

Novello, 2016, Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Ann Oncol, 27, v1, 10.1093/annonc/mdw326 Califano, 2016, Immune checkpoint blockade: a new era for non-small cell lung cancer, Curr Oncol Rep, 18, 59, 10.1007/s11912-016-0544-7 Marrone, 2016, Immune checkpoint therapy in non-small cell lung cancer, Cancer J, 22, 81, 10.1097/PPO.0000000000000178 Kawaguchi, 2014, Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non-small-cell lung cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA), J Clin Oncol, 32, 1902, 10.1200/JCO.2013.52.4694 Postow, 2015, Immune checkpoint blockade in cancer therapy, J Clin Oncol, 33, 1974, 10.1200/JCO.2014.59.4358 Pardoll, 2012, The blockade of immune checkpoints in cancer immunotherapy, Nat Rev Cancer, 12, 252, 10.1038/nrc3239 Abdel-Rahman, 2016, Correlation between PD-L1 expression and outcome of NSCLC patients treated with anti-PD-1/PD-L1 agents: a meta-analysis, Crit Rev Oncol Hematol, 101, 75, 10.1016/j.critrevonc.2016.03.007 Zhou, 2016, Anti-PD-1/PD-L1 antibody therapy for pretreated advanced nonsmall-cell lung cancer: a meta-analysis of randomized clinical trials, Medicine (Baltimore), 95, e4611, 10.1097/MD.0000000000004611 Bylicki, 2017, Targeting the PD-1/PD-L1 immune checkpoint in EGFR-mutated or ALK-translocated non-small-cell lung cancer, Target Oncol, 12, 563, 10.1007/s11523-017-0510-9 Gainor, 2016, EGFR mutations and ALK rearrangements are associated with low response rates to PD-1 pathway blockade in non-small cell lung cancer: a retrospective analysis, Clin Cancer Res, 22, 4585, 10.1158/1078-0432.CCR-15-3101 Oganesyan, 2008, Structural characterization of a human Fc fragment engineered for lack of effector functions, Acta Crystallogr D Biol Crystallogr, 64, 700, 10.1107/S0907444908007877 Stewart, 2015, Identification and characterization of MEDI4736, an antagonistic anti-PD-L1 monoclonal antibody, Cancer Immunol Res, 3, 1052, 10.1158/2326-6066.CIR-14-0191 Segal, 2014, A phase I multi-arm dose-expansion study of the anti-programmed cell death-ligand-1 (PD-L1) antibody MEDI4736: preliminary data, Ann Oncol, 25, 1058PD Antonia, 2016, Phase 1/2 study of the safety and clinical activity of durvalumab in patients with non-small cell lung cancer (NSCLC), Ann Oncol, 27, 1216PD Rebelatto, 2016, Development of a programmed cell death ligand-1 immunohistochemical assay validated for analysis of non-small cell lung cancer and head and neck squamous cell carcinoma, Diagn Pathol, 11, 95, 10.1186/s13000-016-0545-8 Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026 Brahmer, 2014, Clinical activity and biomarkers of MEDI4736, an anti-PD-L1 antibody, in patients with NSCLC, J Clin Oncol, 32, 8021, 10.1200/jco.2014.32.15_suppl.8021 Zhang, 2016, The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis, Oncotarget, 7, 78985, 10.18632/oncotarget.12587 Rizvi, 2015, Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial, Lancet Oncol, 16, 257, 10.1016/S1470-2045(15)70054-9 Garon, 2015, Pembrolizumab for the treatment of non-small-cell lung cancer, N Engl J Med, 372, 2018, 10.1056/NEJMoa1501824 Leighl, 2012, Treatment paradigms for patients with metastatic non-small-cell lung cancer: first-, second-, and third-line, Curr Oncol, 19, S52, 10.3747/co.19.1114 Borghaei, 2015, Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer, N Engl J Med, 373, 1627, 10.1056/NEJMoa1507643 Herbst, 2016, Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial, Lancet, 387, 1540, 10.1016/S0140-6736(15)01281-7 Rittmeyer, 2017, Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial, Lancet, 389, 255, 10.1016/S0140-6736(16)32517-X Fehrenbacher, 2016, Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial, Lancet, 387, 1837, 10.1016/S0140-6736(16)00587-0 Lee, 2017, Checkpoint inhibitors in metastatic EGFR-mutated non-small cell lung cancer—a meta-analysis, J Thorac Oncol, 12, 403, 10.1016/j.jtho.2016.10.007 Spigel, 2016, Total mutation burden (TMB) in lung cancer (LC) and relationship with response to PD-1/PD-L1 targeted therapies, Proc Am Soc Clin Oncol, 34, 9017, 10.1200/JCO.2016.34.15_suppl.9017