Pharmaceutical advances in the treatment of gastric adenocarcinoma

References

• National comprehensive cancer network. gastric cancer. Version 4.2021. www.nccn.org. Oct 5, 2021.
   Google Scholar
• Sung H, Ferlay J, Siegel R, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249.
   PubMed Web of Science ®Google Scholar
• Recio-Boiles A, and Babiker HM. Gastric cancer, in statpearls. Treasure Island (FL): StatPearls Publishing; 2021.
   Google Scholar
• Chandra R, Balachandar N, Wang S, et al. The changing face of gastric cancer: epidemiologic trends and advances in novel therapies. Cancer Gene Ther. 2021;28(5):390–399.
   PubMed Web of Science ®Google Scholar
• de Mello RA, Amaral GA, Neves NM, et al. Current and potential biomarkers in gastric cancer: a critical review of the literature. Future Oncol. 2021;17(25):3383–3396.
   PubMed Web of Science ®Google Scholar
• Cancer Genome Atlas Research, N., Comprehensive molecular characterization of gastric adenocarcinoma. Nature. 2014;513(7517):202–209.
   PubMed Web of Science ®Google Scholar
• Puliga E, Corso S, and Peitrantonio F, et al. Microsatellite instability in gastric cancer: between lights and shadows. In: Cancer treatment reviews. Elsevier Ltd;2021. p. 95.
   Google Scholar
• National Cancer Institute Surveillance, E., and End Results Program., Cancer Stat Facts Stomach Cancer.
   Google Scholar
• Shitara K, Bang YJ, Iwasa S, et al. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer. N Engl J Med. 2020;382(25):2419–2430. *Practice changing study
   PubMed Web of Science ®Google Scholar
• Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (checkmate 649): a randomised, open-label, phase 3 trial. Lancet. 2021;398(10294):27–40. *Practice changing study
   PubMed Web of Science ®Google Scholar
• Bang YJ, Van Cutsem E, Feyereislova A, et al. 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. Lancet. 2010;376(9742):687–697.
   PubMed Web of Science ®Google Scholar
• Grieb BC, Agarwal R. HER2-Directed therapy in advanced gastric and gastroesophageal adenocarcinoma: triumphs and troubles. Curr Treat Options Oncol. 2021;22(10):88.
   PubMed Web of Science ®Google Scholar
• Administration USFD. FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication.
   Google Scholar
• Network, N.C.C., Colon cancer version 3.2021
   Google Scholar
• Chao J, Fuchs CS, and Shitara K, et al. Pembrolizumab (pembro) in microsatellite instability-high (MSI-H) advanced gastric/gastroesophageal junction (G/GEJ) cancer by line of therapy. J Clin Oncol. 2020;38(4):430-430.
   Web of Science ®Google Scholar
• Chao JS, Fuchs CS, Shitara K, et al. Assessment of pembrolizumab therapy for the treatment of microsatellite instability-high gastric or gastroesophageal junction cancer among patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 clinical trials. JAMA Oncol. 2021;7(6):895–902.
   PubMed Web of Science ®Google Scholar
• Overman MJ, Lonardi S, Wong KYM, et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA mismatch repair-deficient/microsatellite instability-high metastatic colorectal cancer. J Clin Oncol. 2018;36(8):773–779.
   PubMed Web of Science ®Google Scholar
• Overman MJ, McDermott R, Leach JL, et al. 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. 2017;18(9):1182–1191.
   PubMed Web of Science ®Google Scholar
• Saito M, Kono K. Landscape of EBV-positive gastric cancer. Gastric Cancer. 2021;24(5):983–989.
   PubMed Web of Science ®Google Scholar
• Rodriquenz MG, Roviello G, and D’Angelo A, et al. MSI and EBV positive gastric cancer’s subgroups and their link with novel immunotherapy. J Clin Med. 2020;9(5):1427.
   PubMed Web of Science ®Google Scholar
• Xie T, Liu Y, Zhang Z, et al. Positive status of epstein-barr virus as a biomarker for gastric cancer immunotherapy: a prospective observational study. J Immunother. 2020;43(4):139–144.
   PubMed Web of Science ®Google Scholar
• Panda A, Mehnert JM, Hirshfield KM, et al. Immune activation and benefit from avelumab in EBV-positive gastric cancer. J Natl Cancer Inst. 2018;110(3):316–320.
   PubMedGoogle Scholar
• Wainberg ZA, Enzinger PC, and Kang YK, et al. Randomized double-blind placebo-controlled phase 2 study of bemarituzumab combined with modified FOLFOX6 (mFOLFOX6) in first-line (1L) treatment of advanced gastric/gastroesophageal junction adenocarcinoma (FIGHT). J Clin Oncol. 2021;39(3):160-160.
   Web of Science ®Google Scholar
• Post A. FDA pipeline: bemarituzumab granted breakthrough therapy designation for fgfr2b-overexpressing, her2-negative gastric cancer
   Google Scholar
• Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355(1):11–20.
   PubMed Web of Science ®Google Scholar
• Al-Batran SE, Homann N, Pauligk C, et al. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. Lancet. 2019;393(10184):1948–1957.
   PubMed Web of Science ®Google Scholar
• Cats A, Jansen EPM, NCT VG, et al. Chemotherapy versus chemoradiotherapy after surgery and preoperative chemotherapy for resectable gastric cancer (CRITICS): an international, open-label, randomised phase 3 trial. Lancet Oncol. 2018;19(5):616–628.
   PubMed Web of Science ®Google Scholar
• Smalley SR, Benedetti JK, Haller DG, et al. Updated analysis of SWOG-directed intergroup study 0116: a phase III trial of adjuvant radiochemotherapy versus observation after curative gastric cancer resection. J Clin Oncol. 2012;30(19):2327–2333.
   PubMed Web of Science ®Google Scholar
• Slagter AE, Jansen EPM, Hwm VL, et al. CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer. BMC Cancer. 2018;18(1):877.
   PubMedGoogle Scholar
• Leong T, Smithers BM, Haustermans K, et al. TOPGEAR: a RANDOMIZED, PHASE III trial of perioperative ECF Chemotherapy with or Without Preoperative Chemoradiation for Resectable Gastric Cancer: interim results from an international, intergroup trial of the AGITG, TROG, EORTC and CCTG. Ann Surg Oncol. 2017;24(8):2252–2258.
   PubMed Web of Science ®Google Scholar
• Noh SH, Park SR, Yang HK, et al. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(12):1389–1396.
   PubMed Web of Science ®Google Scholar
• Lee J, Lim DH, Kim S, et al. Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with d2 lymph node dissection: the ARTIST trial. J Clin Oncol. 2012;30(3):268–273.
   PubMed Web of Science ®Google Scholar
• Chung HC, Bang YJ, and Fuchs CS, et al. KEYNOTE-811 pembrolizumab plus trastuzumab and chemotherapy for HER2+metastatic gastric or gastroesophageal junction cancer (mG/GEJc): a double-blind, randomized, placebo-controlled phase III study. J Clin Oncol. 2020;38(4):4. *Practice changing study
   Web of Science ®Google Scholar
• Tabernero J, Hoff PM, Shen L, et al. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018;19(10):1372–1384.
   PubMed Web of Science ®Google Scholar
• Hecht JR, Bang YJ, Qin SK, et al. Lapatinib in combination with capecitabine plus oxaliplatin in human epidermal growth factor receptor 2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma: TRIO-013/LOGiC–A randomized phase III trial. J Clin Oncol. 2016;34(5):443–451.
   PubMed Web of Science ®Google Scholar
• Satoh T, Xu RH, Chung HC, et al. Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations: tyTAN–a randomized. Phase III Study. J Clin Oncol. 2014;32(19):2039–2049.
   PubMed Web of Science ®Google Scholar
• Thuss-Patience PC, Shah MA, Ohtsu A, et al. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017;18(5):640–653.
   PubMed Web of Science ®Google Scholar
• Ku G, Elimova E, and Denlinger CS, et al. Phase (ph) 2 study of zanidatamab + chemotherapy in first-line (1L) HER2-expressing Gastroesophageal Adenocarcinoma (GEA). abstract: 3678/ poster 1380P. European Society for Medical Oncology (ESMO21) September 16 – September 21; Zymeworks; 2021.
   Google Scholar
• Catenacci D, Park H, Shim BY, et al. Margetuximab with retifanlimab in HER2+, PD-L1+ first-line unresectable/metastatic gastroesophageal Adenocarcinoma (GEA): MAHOGANY cohort A. European Society for Medical Oncology (ESMO). 2021;16-21:2021.
   Google Scholar
• Wilke H, Muro K, Van Cutsem E, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224–1235.
   PubMed Web of Science ®Google Scholar
• Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31–39.
   PubMed Web of Science ®Google Scholar
• Shitara K, Dio T, Dvorkin M, et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19(11):1437–1448.
   PubMed Web of Science ®Google Scholar
• FDA.gov, Oncologic Drugs Advisory Committee (ODAC) Meeting. Pembrolizumab
   Google Scholar
• Administration, U.S.F.D. FDA approves pembrolizumab for adults and children with TMB-H solid tumors, U.S. Food & Drug Administration.
   Google Scholar
• Merck Sharp & Dohme Corp. Study of pembrolizumab (MK-3475) plus chemotherapy versus placebo plus chemotherapy in participants with Gastric or Gastroesophageal Junction (GEJ) adenocarcinoma (MK-3475-585/KEYNOTE-585). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT03221426. NLM Identifier: NCT03221426.
   Google Scholar
• Ono Pharmaceutical Co Ltd. Study of adjuvant ONO-4538 with resected gastric cancer. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from : https://clinicaltrials.gov/ct2/show/NCT03006705. NLM Identifier: NCT03006705.
   Google Scholar
• Shanghai Henlius Biotech. A clinical study of HLX10 combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT04139135. NLM Identifier: NCT04139135
   Google Scholar
• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest. Phase II study of atezolizumab + FLOT vs. FLOT alone in patients with gastric cancer and GEJ (DANTE). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT03421288. NLM Identifier: NCT03421288.
   Google Scholar
• The Netherlands Cancer Institute. Neoadjuvant capecitabine, oxaliplatin, docetaxel and atezolizumab in resectable gastric and ge-junction cancer (PANDA) (PANDA). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT03448835. NLM Identifier: NCT03448835
   Google Scholar
• Vall D’Hebron Institute of Oncology. Phase II study of avelumab plus chemotherapy in the peri-operative treatment for patients with resectable Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) (MONEO). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT03979131. NLM Identifier: NCT03979131.
   Google Scholar
• Centre Francois Baclesse. Perioperative treatment in resectable gastric cancer with spartalizumab (PDR001) in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) (GASPAR). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT04736485. NLM Identifier: NCT04736485
   Google Scholar
• Tianjin Medical University Cancer Institute and Hospital. Toripalimab combined with flot neoadjuvant chemotherapy in patients with resectable gastric cancer. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT04354662. NLM Identifier: NCT04354662.
   Google Scholar
• Roche H-L. A study of atezolizumab and trastuzumab in combination with capecitabine and oxaliplatin in patients with HER2 positive locally advanced resectable gastric cancer of adenocarcinoma of gastroesophageal junction. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from:https://clinicaltrials.gov/ct2/show/NCT04661150. NLM Identifier: NCT04661150
   Google Scholar
• U.T.M.D. Anderson Cancer Center. Nivolumab, Ipilimumab and chemoradiation in treating patients with resectable gastric cancer. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT03776487. NLM Identifier: NCT03776487.
   Google Scholar
• Raimondi A, Palermo F, Prisciandaro M, et al. TremelImumab and durvalumab combination for the Non-OperatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-high resectable gastric or gastroesophageal junction cancer: the multicentre, single-arm, multi-cohort, phase II INFINITY study. Cancers (Basel). 2021;13(11):2839.
   PubMed Web of Science ®Google Scholar
• U.T. M.D. Anderson Cancer Center. Pembrolizumab before surgery for the treatment of mismatch repair deficient locally advanced solid cancers. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT04082572. NLM Identifier: NCT04082572.
   Google Scholar
• Peking University. AK104 in locally advanced MSI-H/dMMR gastric carcinoma and colorectal cancer. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT04556253. NCT04556253
   Google Scholar
• RenJi Hospital. A a study to evaluate camrelizumab in combination with docetaxel +s-1 as adjuvant treatment therapy in stage iii gastric cancer. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from : https://clinicaltrials.gov/ct2/show/NCT04152889. NLM Identifier: NCT04152889.
   Google Scholar
• Leap Therapeutics. A study of DKN-01 in combination with tislelizumab ± chemotherapy in patients with gastric or gastroesophageal cancer (DisTinGuish). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from : https://clinicaltrials.gov/ct2/show/NCT04363801. NLM Identifier: NCT04363801
   Google Scholar
• Klempner SJ, Ajani JA, and Al-Batran SE, et al. Phase II study of zolbetuximab plus pembrolizumab in claudin 18.2: positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ)-ILUSTRO Cohort 3. J Clin Oncol. 2021;39(3):3.
   Web of Science ®Google Scholar
• Shah MA, Ajani JA, and Al-Batran SE, et al. Phase III study of first-line zolbetuximab plus CAPOX versus placebo plus CAPOX in Claudin 18.2(+)/HER2-advanced or metastatic gastric or gastroesophageal junction adenocarcinoma: GLOW. J Clin Oncol. 2020;38(15):15.
   Web of Science ®Google Scholar
• Feeney K, Kelly R, Lipton LR, et al. CA224-060: a randomized, open label, phase II trial of relatlimab (anti-LAG-3) and nivolumab with chemotherapy versus nivolumab with chemotherapy as first-line treatment in patients with gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol. 2019;37(15):4143–4143.
   Google Scholar
• Sunakawa Y, Matoba R, Inoue E, et al. Genomic pathway of gut microbiome to predict efficacy of nivolumab in advanced gastric cancer: DELIVER trial (JACCRO GC-08). J Clin Oncol. 2021;39(3_suppl):161.
   Web of Science ®Google Scholar
• Nasr R, Shamseddine A, Mukheriji D, et al. The crosstalk between microbiome and immune response in gastric cancer. Int J Mol Sci. 2020 Sep 9;21((18): 6586):6586.
   Web of Science ®Google Scholar
• Ogiono S, Nowak JA, Hamada T, et al. Insights into pathogenic interactions among environment, host, and tumor at the crossroads of molecular pathology and epidemiology.annu. Rev Pathol. 2019 Jan 24;14(1):83–103.
   PubMedGoogle Scholar
• National Comprehensive Cancer Network. Breast Cancer version 8.2021.
   Google Scholar
• Mitani S, and Kawakami H. emerging targeted therapies for her2 positive gastric cancer that can overcome trastuzumab resistance. Cancers (Basel). 2020;12(2):400.
   Web of Science ®Google Scholar
• Zymeworks, Inc. A dose finding study of ZW49 in patients with Her2-positive cancers. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT03821233. NLM Identifier: NCT03821233
   Google Scholar
• Ambrx, Inc. ARX788 in Selected HER2-mutated or HER2-amplified Solid Tumors. ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT05041972NLMIdentifier:NCT05041972
   Google Scholar
• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest. FLOT vs. FLOT/herceptin/pertuzumab for perioperative therapy of HER-2 Expressing Gastric or GEJ cancer (PETRARCA). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from : https://clinicaltrials.gov/ct2/show/NCT02581462NLMIdentifier:NCT02581462.
   Google Scholar
• European Organisation for Research and Treatment of Cancer. Neoadjuvant study using trastuzumab or trastuzumab with pertuzumab in gastric or gastroesophageal junction adenocarcinoma (INNOVATION). ClinicalTrials.gov. Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [[2022 Jan 18]. Available from: https://clinicaltrials.gov/ct2/show/NCT02205047. NLM Identifier: NCT02205047
   Google Scholar