Rationale and design of the POLEM trial: avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III mismatch repair deficient or POLE exonuclease domain mutant colon cancer: a phase III randomised study

ESMO Open - Tập 5 - Trang e000638 - 2020
David Lau1, Eleftheria Kalaitzaki1, David N. Church2, Hardev Pandha3, Ian Tomlinson4, Nicola Annels3, Marco Gerlinger5, Francesco Sclafani1, Gillian Smith1, Ruwaida Begum1, Richard Crux1, Angela Gillbanks1, Sarah Wordsworth6, Ian Chau1, Naureen Starling1, David Cunningham1, Tony Dhillon7,8
1Royal Marsden Hospital NHS Foundation Trust, London, UK
2Wellcome Centre for Human Genetics, University of Oxford, Oxford, Oxfordshire, UK
3University of Surrey, Guildford, Surrey, UK
4Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK
5Institute of Cancer Research, London, UK
6Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK
7Royal Surrey NHS Foundation Trust, Guildford, UK
8University of Surrey, Guildford, United Kingdom

Tài liệu tham khảo

Cunningham, 2010, Colorectal cancer, The Lancet, 375, 1030, 10.1016/S0140-6736(10)60353-4 Brenner, 2014, Colorectal cancer, The Lancet, 383, 1490, 10.1016/S0140-6736(13)61649-9 Sargent, 2009, Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient data from 20,898 patients on 18 randomized trials, J Clin Oncol, 27, 872, 10.1200/JCO.2008.19.5362 Imai, 2008, Carcinogenesis and microsatellite instability: the interrelationship between genetics and epigenetics, Carcinogenesis, 29, 673, 10.1093/carcin/bgm228 Peltomäki, 2003, Role of DNA mismatch repair defects in the pathogenesis of human cancer, J Clin Oncol, 21, 1174, 10.1200/JCO.2003.04.060 Timmermann, 2010, Somatic mutation profiles of MSI and MSS colorectal cancer identified by whole exome next generation sequencing and bioinformatics analysis, PLoS One, 5, 10.1371/journal.pone.0015661 Eshleman, 1995, Increased mutation rate at the HPRT locus accompanies microsatellite instability in colon cancer, Oncogene, 10, 33 Cancer Genome Atlas Network, 2012, Comprehensive molecular characterization of human colon and rectal cancer, Nature, 487, 330, 10.1038/nature11252 Roth, 2009, Stage-specific prognostic value of molecular markers in colon cancer: results of the translational study on the PETACC 3-EORTC 40993-SAKK 60–00 trial, J Clin Oncol, 27, 4002, 10.1200/jco.2009.27.15_suppl.4002 Koopman, 2009, Deficient mismatch repair system in patients with sporadic advanced colorectal cancer, Br J Cancer, 100, 266, 10.1038/sj.bjc.6604867 Greenson, 2003, Phenotype of microsatellite unstable colorectal carcinomas: well-differentiated and focally mucinous tumors and the absence of dirty necrosis correlate with microsatellite instability, Am J Surg Pathol, 27, 563, 10.1097/00000478-200305000-00001 Klingbiel, 2015, Prognosis of stage II and III colon cancer treated with adjuvant 5-fluorouracil or FOLFIRI in relation to microsatellite status: results of the PETACC-3 trial, Annals of Oncology, 26, 126, 10.1093/annonc/mdu499 Cho, 2019, The prognostic role of PD-L1 expression according to MSI status in stage III colon cancer after curative resection, J Clin Oncol, 37, 555, 10.1200/JCO.2019.37.4_suppl.555 Le, 2015, Pd-1 blockade in tumors with mismatch-repair deficiency, N Engl J Med, 372, 2509, 10.1056/NEJMoa1500596 Overman, 2017, Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study, Lancet Oncol, 18, 1182, 10.1016/S1470-2045(17)30422-9 Le, 2020, Phase II open-label study of pembrolizumab in treatment-refractory, microsatellite Instability-High/Mismatch repair-deficient metastatic colorectal cancer: KEYNOTE-164, J Clin Oncol, 38, 11, 10.1200/JCO.19.02107 NICE. Molecular testing strategies for Lynch syndrome in people with colorectal cancer. Available: https://www.nice.org.uk/guidance/dg27/chapter/1-Recommendations [Accessed Sep 2019]. Palles, 2013, Germline mutations affecting the proofreading domains of pole and POLD1 predispose to colorectal adenomas and carcinomas, Nat Genet, 45, 136, 10.1038/ng.2503 Donehower, 2013, MLH1 -silenced and non-silenced subgroups of hypermutated colorectal carcinomas have distinct mutational landscapes, J Pathol, 229, 99, 10.1002/path.4087 Domingo, 2016, Somatic pole proofreading domain mutation, immune response, and prognosis in colorectal cancer: a retrospective, pooled biomarker study, The Lancet Gastroenterology & Hepatology, 1, 207, 10.1016/S2468-1253(16)30014-0 Kothari, 2016, Increased incidence of FBXW7 and POLE proofreading domain mutations in young adult colorectal cancers, Cancer, 122, 2828, 10.1002/cncr.30082 Stenzinger, 2014, Mutations in POLE and survival of colorectal cancer patients - link to disease stage and treatment, Cancer Med, 3, 1527, 10.1002/cam4.305 Silberman, 2019, Complete and Prolonged Response to Immune Checkpoint Blockade in POLE -Mutated Colorectal Cancer, JCO Precis Oncol, 3, 1 André, 2004, Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer, N Engl J Med, 350, 2343, 10.1056/NEJMoa032709 Grothey, 2018, Duration of adjuvant chemotherapy for stage III colon cancer, N Engl J Med, 378, 1177, 10.1056/NEJMoa1713709