Efficacy and safety of HER2-targeted inhibitors for metastatic colorectal cancer with HER2-amplified: A meta-analysis

Sung, 2021, Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, J. CA Cancer J. Clin., 71, 209, 10.3322/caac.21660 Holch, 2017, Pattern and dynamics of distant metastases in metastatic colorectal cancer, J. Visc. Med., 33, 70, 10.1159/000454687 Martini, 2017, Present and future of metastatic colorectal cancer treatment: a review of new candidate targets, J. World J. Gastroenterol., 23, 4675, 10.3748/wjg.v23.i26.4675 Li, 2020, BRAF and KRAS mutations in metastatic colorectal cancer: future perspectives for personalized therapy, J. Gastroenterol. Rep., 8, 192, 10.1093/gastro/goaa022 Meric-Bernstam, 2019, Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study, J. Lancet Oncol., 20, 518, 10.1016/S1470-2045(18)30904-5 Sartore-Bianchi, 2016, Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial, J. Lancet Oncol., 17, 738, 10.1016/S1470-2045(16)00150-9 Siena, 2021, Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial, J. Lancet Oncol., 22, 779, 10.1016/S1470-2045(21)00086-3 Schechter, 1984, The neu oncogene: an erb-B-related gene encoding a 185,000-Mr tumour antigen, J. Nat., 312, 513, 10.1038/312513a0 Siena, 2018, Targeting the human epidermal growth factor receptor 2 (HER2) oncogene in colorectal cancer, J. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol., 29, 1108, 10.1093/annonc/mdy100 Hayes, 2019, HER2 and breast cancer - a phenomenal success story, J. New Engl. J. Med., 381, 1284, 10.1056/NEJMcibr1909386 Leto, 2015, Sustained inhibition of HER3 and EGFR is necessary to induce regression of HER2-amplified gastrointestinal carcinomas, J. Clin. Cancer Res. Off. J. Am. Assoc. Cancer Res., 21, 5519, 10.1158/1078-0432.CCR-14-3066 Ross, 2014, New routes to targeted therapy of intrahepatic cholangiocarcinomas revealed by next-generation sequencing, J. Oncol., 19, 235, 10.1634/theoncologist.2013-0352 Mazières, 2013, Lung cancer that harbors an HER2 mutation: epidemiologic characteristics and therapeutic perspectives, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 31, 1997, 10.1200/JCO.2012.45.6095 Sutton, 2000 Peto, 1973, Conservatism of the approximation sigma (O-E)2-E in the logrank test for survival data or tumor incidence data, J. Biom., 29, 579 Higgins, 2008 Filleron, 2017, Subgroup analysis and forest plots: Limitations and interests, J. Bull. Cancer, 104, 92, 10.1016/j.bulcan.2016.09.023 Hattori, 2018, Sensitivity analysis for publication bias in meta-analysis of diagnostic studies for a continuous biomarker, J. Stat. Med., 37, 327, 10.1002/sim.7510 Hayashino, 2005, Systematic evaluation and comparison of statistical tests for publication bias, J. J. Epidemiol., 15, 235, 10.2188/jea.15.235 Tosi, 2020, Long-term clinical outcome of trastuzumab and lapatinib for HER2-positive metastatic colorectal cancer, J. Clin. Colorectal Cancer, 19, 256, 10.1016/j.clcc.2020.06.009 Tsurutani, 2020, Targeting HER2 with trastuzumab deruxtecan: a dose-expansion, phase I study in multiple advanced solid tumors, J. Cancer Discov., 10, 688, 10.1158/2159-8290.CD-19-1014 Sartore-Bianchi, 2020, Pertuzumab and trastuzumab emtansine in patients with HER2-amplified metastatic colorectal cancer: the phase II HERACLES-B trial, J. ESMO Open, 5 Nakamura, 2021, Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial, J. Nat. Med., 27, 1899, 10.1038/s41591-021-01553-w Strickler, 2019, 527PD - Trastuzumab and tucatinib for the treatment of HER2 amplified metastatic colorectal cancer (mCRC): Initial results from the MOUNTAINEER trial, J. Ann. Oncol., 30, v200, 10.1093/annonc/mdz246.005 Zhong, 2021, Clinical observation of trastuzumab combined with pyrotinib in the treatment of human epidermal growth factor-2 positive advanced colorectal cancer, J. Tumor Basics Clin., 34, 114 Giantonio, 2007, Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 25, 1539, 10.1200/JCO.2006.09.6305 Van Cutsem, 2012, Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 30, 3499, 10.1200/JCO.2012.42.8201 Tabernero, 2015, J. Lancet Oncol., 16, 499, 10.1016/S1470-2045(15)70127-0 Cunningham, 2004, Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer, J. New Engl. J. Med., 351, 337, 10.1056/NEJMoa033025 Sobrero, 2008, EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer, J. Clin. Oncol.: Off. J. Am. Soc. Clin. Oncol., 26, 2311, 10.1200/JCO.2007.13.1193 Peeters, 2010, Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 28, 4706, 10.1200/JCO.2009.27.6055 Tabernero, 2021, Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: updated survival results and subgroup analyses from the BEACON study, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 39, 273, 10.1200/JCO.20.02088 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. Off. J. Am. Soc. Clin. Oncol., 38, 11, 10.1200/JCO.19.02107 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, J. Lancet Oncol., 18, 1182, 10.1016/S1470-2045(17)30422-9 Overman, 2018, Durable clinical benefit with nivolumab plus Ipilimumab in DNA mismatch repair-deficient/microsatellite instability-high metastatic colorectal cancer, J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol., 36, 773, 10.1200/JCO.2017.76.9901 Andre T., Berton D., Curigliano G., Ellard S., Pérez J.M. T., Arkenau H.-T., Abdeddaim C., Moreno V., Guo W., Im E., Starling N., Safety and efficacy of anti–PD-1 antibody dostarlimab in patients (pts) with mismatch repair-deficient (dMMR) solid cancers: Results from GARNET study, J. 2021, 39(3_suppl): 9–. https://dx.doi.org/10.1200/JCO.2021.39.3_suppl.9. Doebele, 2020, Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials, J. Lancet Oncol., 21, 271, 10.1016/S1470-2045(19)30691-6 Li, 2015, Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial, J. Lancet Oncol., 16, 619, 10.1016/S1470-2045(15)70156-7 Mayer, 2015, Randomized trial of TAS-102 for refractory metastatic colorectal cancer, J. New Engl. J. Med., 372, 1909, 10.1056/NEJMoa1414325 Slamon, 2001, Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2, J. New Engl. J. Med., 344, 783, 10.1056/NEJM200103153441101 Bang, 2010, Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial, J. Lancet, 376, 687, 10.1016/S0140-6736(10)61121-X Harbeck, 2017, Breast cancer, J. Lancet, 389, 1134, 10.1016/S0140-6736(16)31891-8 Richman, 2016, HER2 overexpression and amplification as a potential therapeutic target in colorectal cancer: analysis of 3256 patients enrolled in the QUASAR, FOCUS and PICCOLO colorectal cancer trials, J. J. Pathol., 238, 562, 10.1002/path.4679 Bertotti, 2011, A molecularly annotated platform of patient-derived xenografts (“xenopatients”) identifies HER2 as an effective therapeutic target in cetuximab-resistant colorectal cancer, J. Cancer Discov., 1, 508, 10.1158/2159-8290.CD-11-0109 Kavuri, 2015, HER2 activating mutations are targets for colorectal cancer treatment, J. Cancer Discov., 5, 832, 10.1158/2159-8290.CD-14-1211 Hecht, 2015, SPIRITT: a randomized, multicenter, phase II study of Panitumumab with FOLFIRI and Bevacizumab with FOLFIRI as second-line treatment in patients with unresectable wild type KRAS metastatic colorectal cancer, J. Clin. Colorectal Cancer, 14, 72, 10.1016/j.clcc.2014.12.009 Ciardiello, 2016, Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX, J. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol., 27, 1055, 10.1093/annonc/mdw136