Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

The Lancet - Tập 387 - Trang 1540-1550 - 2016
Roy S Herbst1, Paul Baas2, Dong-Wan Kim3, Enriqueta Felip4, José L Pérez-Gracia5, Ji-Youn Han6, Julian Molina7, Joo-Hang Kim8, Catherine Dubos Arvis9, Myung-Ju Ahn10, Margarita Majem11, Mary J Fidler12, Gilberto de Castro13, Marcelo Garrido14, Gregory M Lubiniecki15, Yue Shentu15, Ellie Im15, Marisa Dolled-Filhart15, Edward B Garon16
1Yale School of Medicine, Yale Cancer Center, and Smilow Cancer Hospital, New Haven, CT, USA
2The Netherlands Cancer Institute and The Academic Medical Hospital Amsterdam, Amsterdam, Netherlands
3Seoul National University Hospital, Seoul, South Korea
4Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain
5Clinica Universidad de Navarra, Pamplona, Spain
6National Cancer Center, Goyang, South Korea
7Mayo Clinic, Rochester, MN, USA
8CHA Bundang Medical Center, CHA University, Gyeonggi-do, South Korea
9Centre François Baclesse Caen, France
10Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
11Hospital de la Santa Creu I Sant Pau, Barcelona, Spain
12Rush University Medical Center, Chicago, IL, USA
13Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil
14Pontificia Universidad Católica de Chile, Santiago, Chile
15Merck & Co, Kenilworth, NJ, USA
16David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, CA, USA

Tài liệu tham khảo

Mok, 2009, Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma, N Engl J Med, 361, 947, 10.1056/NEJMoa0810699 Shaw, 2013, Crizotinib versus chemotherapy in advanced ALK-positive lung cancer, N Engl J Med, 368, 2385, 10.1056/NEJMoa1214886 Shaw, 2014, Ceritinib in ALK-rearranged non-small-cell lung cancer, N Engl J Med, 370, 1189, 10.1056/NEJMoa1311107 Jänne, 2015, AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer, N Engl J Med, 372, 1689, 10.1056/NEJMoa1411817 Sequist, 2015, Rociletinib in EGFR-mutated non-small-cell lung cancer, N Engl J Med, 372, 1700, 10.1056/NEJMoa1413654 Camidge, 2014, Acquired resistance to TKIs in solid tumours: learning from lung cancer, Nat Rev Clin Oncol, 11, 473, 10.1038/nrclinonc.2014.104 Brahmer, 2015, Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer, N Engl J Med, 373, 123, 10.1056/NEJMoa1504627 Borghaei, 2015, Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer, N Engl J Med, 373, 1627, 10.1056/NEJMoa1507643 Garon, 2015, Pembrolizumab for the treatment of non-small-cell lung cancer, N Engl J Med, 372, 2018, 10.1056/NEJMoa1501824 Herbst, 2014, Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients, Nature, 515, 563, 10.1038/nature14011 Spira, 2015, Efficacy, safety and predictive biomarker results from a randomized phase II study comparing MPDL3280A vs docetaxel in 2L/3L NSCLC (POPLAR) [abstract], J Clin Oncol, 33, 8010, 10.1200/jco.2015.33.15_suppl.8010 Francisco, 2010, The PD-1 pathway in tolerance and autoimmunity, Immunol Rev, 236, 219, 10.1111/j.1600-065X.2010.00923.x Pardoll, 2012, The blockade of immune checkpoints in cancer immunotherapy, Nat Rev Cancer, 12, 252, 10.1038/nrc3239 Dong, 2002, Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion, Nat Med, 8, 793, 10.1038/nm730 Iwai, 2002, Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade, Proc Natl Acad Sci USA, 99, 12293, 10.1073/pnas.192461099 Greenwald, 2005, The B7 family revisited, Annu Rev Immunol, 23, 515, 10.1146/annurev.immunol.23.021704.115611 Freeman, 2000, Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation, J Exp Med, 192, 1027, 10.1084/jem.192.7.1027 Garon, 2015, Pembrolizumab 2 mg/kg Q3W for previously treated, PD-L1-positive advanced NSCLC [abstract], J Thorac Oncol, 10, 3024 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 Wolchok, 2009, Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria, Clin Cancer Res, 15, 7412, 10.1158/1078-0432.CCR-09-1624 Efron, 1977, The efficiency of Cox's likelihood function for censored data, J Am Stat Assoc, 72, 557, 10.1080/01621459.1977.10480613 Miettinen, 1985, Comparative analysis of two rates, Stat Med, 4, 213, 10.1002/sim.4780040211 Garon, 2014, Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial, Lancet, 384, 665, 10.1016/S0140-6736(14)60845-X Brahmer, 2014, Clinical activity and biomarkers of MEDI4736, an anti-PD-L1 antibody, in patients with NSCLC [abstract], J Clin Oncol, 32, 8021, 10.1200/jco.2014.32.15_suppl.8021 Papadimitrakopoulou, 2015, Pembrolizumab (pembro; MK-3475) plus platinum doublet chemotherapy (PDC) as front-line therapy for advanced non-small cell lung cancer (NSCLC): KEYNOTE-021 cohorts A and C [abstract], J Clin Oncol, 33, 8031, 10.1200/jco.2015.33.15_suppl.8031 Patnaik, 2015, Phase 1 study of pembrolizumab (pembro; MK-3475) plus ipilimumab (IPI) as second-line therapy for advanced non-small cell lung cancer (NSCLC): KEYNOTE-021 cohort D [abstract], J Clin Oncol, 33, 8011, 10.1200/jco.2015.33.15_suppl.8011 Gettinger, 2014, B7-H1/PD-1 blockade therapy in non-small cell lung cancer: current status and future direction, Cancer J, 20, 281, 10.1097/PPO.0000000000000063 McLaughlin, 2015, Quantitative assessment of the heterogeneity of PD-L1 expression in non-small-cell lung cancer, JAMA Oncol Dong, 1999, B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion, Nat Med, 12, 1365, 10.1038/70932 Schalper, 2014, In situ tumor PD-L1 mRNA expression is associated with increased TILs and better outcome in breast carcinomas, Clin Cancer Res, 20, 2773, 10.1158/1078-0432.CCR-13-2702 Rizvi, 2015, Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer, Science, 348, 124, 10.1126/science.aaa1348 Ascierto, 2013, The additional facet of immunoscore: immunoprofiling as a possible predictive tool for cancer treatment, J Transl Med, 11, 54, 10.1186/1479-5876-11-54 Messina, 2012, 12-Chemokine gene signature identifies lymph node-like structures in melanoma: potential for patient selection for immunotherapy?, Sci Rep, 2, 765, 10.1038/srep00765