Not all immune-checkpoint inhibitors are created equal: Meta-analysis and systematic review of immune-related adverse events in cancer trials
Tài liệu tham khảo
Altomonte, 2013, Clinical experience with ipilimumab 10mg/kg in patients with melanoma treated at Italian centres as part of a European expanded access programme, J. Exp. Clin. Cancer Res., 32, 82, 10.1186/1756-9966-32-82
Ansell, 2009, Phase I study of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with relapsed and refractory B-cell non-Hodgkin lymphoma, Clin. Cancer Res., 15, 6446, 10.1158/1078-0432.CCR-09-1339
Ansell, 2015, PD-1 blockade with nivolumab in relapsed or refractory Hodgkin’s lymphoma, N. Engl. J. Med., 372, 311, 10.1056/NEJMoa1411087
Antonia, 2016, Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study, Lancet Oncol., 17, 299, 10.1016/S1470-2045(15)00544-6
Armand, 2013, Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial, J. Clin. Oncol., 31, 4199, 10.1200/JCO.2012.48.3685
Balar, 2017, Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial, Lancet, 389, 67, 10.1016/S0140-6736(16)32455-2
Bashey, 2009, CTLA4 blockade with ipilimumab to treat relapse of malignancy after allogeneic hematopoietic cell transplantation, Blood, 113, 1581, 10.1182/blood-2008-07-168468
Berger, 2008, Phase I safety and pharmacokinetic study of CT-011, a humanized antibody interacting with PD-1, in patients with advanced hematologic malignancies, Clin. Cancer Res., 14, 3044, 10.1158/1078-0432.CCR-07-4079
Bertrand, 2015, Immune related adverse events associated with anti-CTLA-4 antibodies: systematic review and meta-analysis, BMC Med., 13, 211, 10.1186/s12916-015-0455-8
Borghaei, 2015, Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer, N. Engl. J. Med., 373, 1627, 10.1056/NEJMoa1507643
Brahmer, 2010, Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates, J. Clin. Oncol., 28, 3167, 10.1200/JCO.2009.26.7609
Brahmer, 2012, Safety and activity of anti-PD-L1 antibody in patients with advanced cancer, N. Engl. J. Med., 366, 2455, 10.1056/NEJMoa1200694
Calabro, 2013, Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial, Lancet Oncol., 14, 1104, 10.1016/S1470-2045(13)70381-4
Camacho, 2009, Phase I/II trial of tremelimumab in patients with metastatic melanoma, J. Clin. Oncol., 27, 1075, 10.1200/JCO.2008.19.2435
Carthon, 2010, Preoperative CTLA-4 blockade: tolerability and immune monitoring in the setting of a presurgical clinical trial, Clin. Cancer Res., 16, 2861, 10.1158/1078-0432.CCR-10-0569
Chen, 2015, A systematic review of immune-related adverse event reporting in clinical trials of immune checkpoint inhibitors, Ann. Oncol., 26, 1824, 10.1093/annonc/mdv182
Chiarion Sileni, 2014, Efficacy and safety of ipilimumab in elderly patients with pretreated advanced melanoma treated at Italian centres through the expanded access programme, J. Exp. Clin. Cancer Res., 33, 30, 10.1186/1756-9966-33-30
Chung, 2010, Phase II study of the anti-cytotoxic T-lymphocyte-associated antigen 4 monoclonal antibody, tremelimumab, in patients with refractory metastatic colorectal cancer, J. Clin. Oncol., 28, 3485, 10.1200/JCO.2010.28.3994
Danielli, 2012, Ipilimumab in pretreated patients with metastatic uveal melanoma: safety and clinical efficacy, Cancer Immunol. Immunother., 61, 41, 10.1007/s00262-011-1089-0
Davids, 2016, Ipilimumab for patients with relapse after allogeneic transplantation, N. Engl. J. Med., 375, 143, 10.1056/NEJMoa1601202
Di Giacomo, 2011, Ipilimumab experience in heavily pretreated patients with melanoma in an expanded access program at the University Hospital of Siena (Italy), Cancer Immunol. Immunother., 60, 467, 10.1007/s00262-010-0958-2
Downey, 2007, Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade, Clin. Cancer Res., 13, 6681, 10.1158/1078-0432.CCR-07-0187
Eggermont, 2015, Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial, Lancet Oncol., 16, 522, 10.1016/S1470-2045(15)70122-1
Eggermont, 2016, Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy, N. Engl. J. Med., 375, 1845, 10.1056/NEJMoa1611299
Eigentler, 2014, Effectiveness and tolerability of ipilimumab: experiences from 198 patients included in a named-patient program in various daily-practice settings and multiple institutions, J. Immunother., 37, 374, 10.1097/CJI.0000000000000046
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
Ferris, 2016, Nivolumab for recurrent squamous-cell carcinoma of the head and neck, N. Engl. J. Med., 10.1056/NEJMoa1602252
Floyd, 2016, First report of parkinsonism associated with Indoximod, an immune-modulating agent, J. Global Oncol., 10.1200/JGO.2016.007492
Garon, 2015, Pembrolizumab for the treatment of non-small-cell lung cancer, N. Engl. J. Med., 372, 2018, 10.1056/NEJMoa1501824
Gettinger, 2015, Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer, J. Clin. Oncol., 33, 2004, 10.1200/JCO.2014.58.3708
Hamid, 2013, Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma, N. Engl. J. Med., 369, 134, 10.1056/NEJMoa1305133
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
Hersh, 2011, A phase II multicenter study of ipilimumab with or without dacarbazine in chemotherapy-naive patients with advanced melanoma, Invest. New Drugs, 29, 489, 10.1007/s10637-009-9376-8
Hodi, 2010, Improved survival with ipilimumab in patients with metastatic melanoma, N. Engl. J. Med., 363, 711, 10.1056/NEJMoa1003466
Hodi, 2014, Ipilimumab plus sargramostim vs ipilimumab alone for treatment of metastatic melanoma: a randomized clinical trial, JAMA, 312, 1744, 10.1001/jama.2014.13943
Kaufman, 2016, Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial, Lancet Oncol., 17, 1374, 10.1016/S1470-2045(16)30364-3
Keir, 2008, PD-1 and its ligands in tolerance and immunity, Annu. Rev. Immunol., 26, 677, 10.1146/annurev.immunol.26.021607.090331
Kirkwood, 2008, Next generation of immunotherapy for melanoma, J. Clin. Oncol., 26, 3445, 10.1200/JCO.2007.14.6423
Kirkwood, 2010, Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma, Clin. Cancer Res., 16, 1042, 10.1158/1078-0432.CCR-09-2033
Kwon, 2014, Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial, Lancet Oncol., 15, 700, 10.1016/S1470-2045(14)70189-5
Larkin, 2015, Combined nivolumab and ipilimumab or monotherapy in untreated melanoma, N. Engl. J. Med., 373, 23, 10.1056/NEJMoa1504030
Le, 2013, Evaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previously treated pancreatic cancer, J. Immunother., 36, 382, 10.1097/CJI.0b013e31829fb7a2
Le, 2015, PD-1 blockade in tumors with mismatch-repair deficiency, N. Engl. J. Med., 372, 2509, 10.1056/NEJMoa1500596
Luke, 2013, Clinical activity of ipilimumab for metastatic uveal melanoma: a retrospective review of the Dana-Farber Cancer Institute, Massachusetts General Hospital, Memorial Sloan-Kettering Cancer Center, and University Hospital of Lausanne experience, Cancer, 119, 3687, 10.1002/cncr.28282
Margolin, 2012, Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial, Lancet Oncol., 13, 459, 10.1016/S1470-2045(12)70090-6
Massard, 2016, Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer, J. Clin. Oncol., 34, 3119, 10.1200/JCO.2016.67.9761
McDermott, 2015, Survival, durable response, and long-term safety in patients with previously treated advanced renal cell carcinoma receiving nivolumab, J. Clin. Oncol., 33, 2013, 10.1200/JCO.2014.58.1041
McDermott, 2016, Atezolizumab, an anti-programmed death-ligand 1 antibody, in metastatic renal cell carcinoma: long-term safety, clinical activity, and immune correlates from a phase ia study, J. Clin. Oncol., 34, 833, 10.1200/JCO.2015.63.7421
Motzer, 2015, Nivolumab versus everolimus in advanced renal-cell carcinoma, N. Engl. J. Med., 373, 1803, 10.1056/NEJMoa1510665
Nghiem, 2016, PD-1 blockade with pembrolizumab in advanced merkel-cell carcinoma, N. Engl. J. Med., 374, 2542, 10.1056/NEJMoa1603702
O'Day, 2010, Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study, Ann. Oncol., 21, 1712, 10.1093/annonc/mdq013
Pardoll, 2012, The blockade of immune checkpoints in cancer immunotherapy, Nat. Rev. Cancer, 12, 252, 10.1038/nrc3239
Postow, 2013, Ipilimumab for patients with advanced mucosal melanoma, Oncologist, 18, 726, 10.1634/theoncologist.2012-0464
Postow, 2015, Immune checkpoint blockade in cancer therapy, J. Clin. Oncol., 33, 1974, 10.1200/JCO.2014.59.4358
Postow, 2015, Nivolumab and ipilimumab versus ipilimumab in untreated melanoma, N. Engl. J. Med., 372, 2006, 10.1056/NEJMoa1414428
Ralph, 2010, Modulation of lymphocyte regulation for cancer therapy: a phase II trial of tremelimumab in advanced gastric and esophageal adenocarcinoma, Clin. Cancer Res., 16, 1662, 10.1158/1078-0432.CCR-09-2870
Reck, 2016, Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer, N. Engl. J. Med., 375, 1823, 10.1056/NEJMoa1606774
Ribas, 2012, Safety profile and pharmacokinetic analyses of the anti-CTLA4 antibody tremelimumab administered as a one hour infusion, J. Transl. Med., 10, 236, 10.1186/1479-5876-10-236
Ribas, 2013, Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma, J. Clin. Oncol., 31, 616, 10.1200/JCO.2012.44.6112
Ribas, 2015, Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial, Lancet Oncol., 16, 908, 10.1016/S1470-2045(15)00083-2
Ribas, 2012, Tumor immunotherapy directed at PD-1, N. Engl. J. Med., 366, 2517, 10.1056/NEJMe1205943
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
Robert, 2013, Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control, Clin. Cancer Res., 19, 2232, 10.1158/1078-0432.CCR-12-3080
Robert, 2014, Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial, Lancet, 384, 1109, 10.1016/S0140-6736(14)60958-2
Robert, 2015, Pembrolizumab versus ipilimumab in advanced melanoma, N. Engl. J. Med., 372, 2521, 10.1056/NEJMoa1503093
Robert, 2015, Nivolumab in previously untreated melanoma without BRAF mutation, N. Engl. J. Med., 372, 320, 10.1056/NEJMoa1412082
Rosenberg, 2016, Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial, Lancet, 387, 1909, 10.1016/S0140-6736(16)00561-4
Royal, 2010, Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma, J. Immunother., 33, 828, 10.1097/CJI.0b013e3181eec14c
Sangro, 2013, A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C, J. Hepatol., 59, 81, 10.1016/j.jhep.2013.02.022
Seiwert, 2016, Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial, Lancet Oncol., 17, 956, 10.1016/S1470-2045(16)30066-3
Slovin, 2013, Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study, Ann. Oncol., 24, 1813, 10.1093/annonc/mdt107
Small, 2007, A pilot trial of CTLA-4 blockade with human anti-CTLA-4 in patients with hormone-refractory prostate cancer, Clin. Cancer Res., 13, 1810, 10.1158/1078-0432.CCR-06-2318
Spellman, 2016, Immunotherapy for breast cancer: past, present, and future, Cancer Metastasis Rev., 10.1007/s10555-016-9654-9
Weber, 2008, Phase I/II study of ipilimumab for patients with metastatic melanoma, J. Clin. Oncol., 26, 5950, 10.1200/JCO.2008.16.1927
Weber, 2009, A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma, Clin. Cancer Res., 15, 5591, 10.1158/1078-0432.CCR-09-1024
Weber, 2013, Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma, Cancer, 119, 1675, 10.1002/cncr.27969
Weber, 2013, Safety, efficacy, and biomarkers of nivolumab with vaccine in ipilimumab-refractory or -naive melanoma, J. Clin. Oncol., 31, 4311, 10.1200/JCO.2013.51.4802
Weber, 2015, Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial, Lancet Oncol., 16, 375, 10.1016/S1470-2045(15)70076-8
Wolchok, 2008, The mechanism of anti-CTLA-4 activity and the negative regulation of T-cell activation, Oncologist, 13, 2, 10.1634/theoncologist.13-S4-2
Wolchok, 2010, Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study, Lancet Oncol., 11, 155, 10.1016/S1470-2045(09)70334-1
Yang, 2007, Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis, J. Immunother., 30, 825, 10.1097/CJI.0b013e318156e47e