2,572
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Real-World Association of HER2/ERBB2 Concordance with Trastuzumab Clinical Benefit in Advanced Esophagogastric Cancer

ORCID Icon, ORCID Icon, , ORCID Icon, ORCID Icon, ORCID Icon, , ORCID Icon, ORCID Icon, & ORCID Icon show all
Pages 4101-4114 | Received 16 Feb 2021, Accepted 30 Jun 2021, Published online: 31 Aug 2021

References

  • Bray F , FerlayJ, SoerjomataramI, SiegelRL, TorreLA, JemalA. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin.68(6), 394–424 (2018).
  • Arnold M , LaversanneM, BrownLM, DevesaSS, BrayF. Predicting the future burden of esophageal cancer by histological subtype: international trends in incidence up to 2030. Am. J. Gastroenterol.112(8), 1247–1255 (2017).
  • Karimi P , IslamiF, AnandasabapathyS, FreedmanND, KamangarF. Gastric cancer: descriptive epidemiology, risk factors, screening, and prevention. Cancer Epidemiol. Biomarkers Prev.23(5), 700–713 (2014).
  • Howlader N , NooneAM, KrapchoMet al. SEER cancer statistics review (CSR) 1975–2017. https://seer.cancer.gov/csr/1975_2017/
  • Bartley AN , WashingtonMK, ColasaccoCet al. HER2 testing and clinical decision making in gastroesophageal adenocarcinoma: guideline from the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. J. Clin. Oncol.35(4), 446–464 (2017).
  • National Cancer Institute Surveillance, Epidemiology, and End Results Program . Cancer stat facts: stomach cancer. https://seer.cancer.gov/statfacts/html/stomach.html
  • National Cancer Institute Surveillance, Epidemiology, and End Results Program . Cancer stat facts: esophagus cancer. https://seer.cancer.gov/statfacts/html/esoph.html
  • Ross DS , ZehirA, ChengDTet al. Next-generation assessment of human epidermal growth factor receptor 2 (ERBB2) amplification status: clinical validation in the context of a hybrid capture-based, comprehensive solid tumor genomic profiling assay. J. Mol. Diagn.19(2), 244–254 (2017).
  • Battaglin F , NaseemM, PucciniA, LenzH. Molecular biomarkers in gastro-esophageal cancer: recent developments, current trends and future directions. Cancer Cell. Int.18, 99 (2018).
  • Van Cutsem E , BangY, Feng-YiFet al. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer18(3), 476–484 (2015).
  • Ieni A , BarresiV, GiuffrèGet al. HER2 status in advanced gastric carcinoma: a retrospective multicentric analysis from Sicily. Oncol. Lett.6(6), 1591–1594 (2013).
  • Bang Y , Van CutsemE, FeyereislovaAet 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. Lancet376(9742), 687–697 (2010).
  • Tafe LJ , JanjigianYY, ZaidinskiMet al. Human epidermal growth factor receptor 2 testing in gastroesophageal cancer: correlation between immunohistochemistry and fluorescence in situ hybridization. Arch. Pathol. Lab. Med.135(11), 1460–1465 (2011).
  • Tanner M , HollménM, JunttilaTTet al. Amplification of HER-2 in gastric carcinoma: association with topoisomerase IIα gene amplification, intestinal type, poor prognosis and sensitivity to trastuzumab. Ann. Oncol.16(2), 273–278 (2005).
  • HERCEPTIN® (trastuzumab) [package insert]. Genentech, Inc, CA, USA (2018).
  • National Comprehensive Cancer Network . Gastric cancer version 4.2020. www.nccn.org/professionals/physician_gls/pdf/gastric.pdf
  • National Comprehensive Cancer Network . Esophageal and esophagogastric junction cancers version 5.2020. www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf
  • Janjigian YY , Sanchez-VegaF, JonssonPet al. Genetic predictors of response to systemic therapy in esophagogastric cancer. Cancer Discov.8(1), 49–58 (2018).
  • Cancer Genome Atlas Research Network . Comprehensive molecular characterization of gastric adenocarcinoma. Nature513(7517), 202–209 (2014).
  • Kim J , BowlbyR, MungallAJet al. Integrated genomic characterization of oesophageal carcinoma. Nature541(7636), 169–175 (2017).
  • Klempner SJ , ChaoJ, BaileyMet al. Genomic alterations (GA) predicted to confer lack of benefit from trastuzumab in advanced esophagogastric cancers (EGC): analysis of 527 HER2-amplified (HER2amp) cases. J. Clin. Oncol.36(Suppl. 4), 44–44 (2018).
  • Ellegård S , VeenstraC, Pérez-TenorioGet al. ERBB2 and PTPN2 gene copy numbers as prognostic factors in HER2-positive metastatic breast cancer treated with trastuzumab. Oncol. Lett.17(3), 3371 (2019).
  • Gomez-Martin C , PlazaJC, Pazo-CidRet al. Level of HER2 gene amplification predicts response and overall survival in HER2-positive advanced gastric cancer treated with trastuzumab. J. Clin. Oncol.31(35), 4445–4452 (2013).
  • Frampton GM , FichtenholtzA, OttoGAet al. Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing. Nat. Biotechnol.31(11), 1023–1031 (2013).
  • Birnbaum B , NussbaumN, Seidl-RathkopfKet al. Model-assisted cohort selection with bias analysis for generating large-scale cohorts from the EHR for oncology research (2020). ( Epub ahead of print). https://arxiv.org/abs/2001.09765
  • Ma X , LongL, MoonS, AdamsonBJS, BaxiSS. Comparison of population characteristics in real-world clinical oncology databases in the US: Flatiron health, SEER, and NPCR (2020). ( Epub ahead of print). www.medrxiv.org/content/10.1101/2020.03.16.20037143v2
  • Singal G , MillerPG, AgarwalaVet al. Association of patient characteristics and tumor genomics with clinical outcomes among patients with non-small cell lung cancer using a clinicogenomic database. JAMA321(14), 1391–1399 (2019).
  • Curtis MD , GriffithSD, TuckerMet al. Development and validation of a high-quality composite real-world mortality endpoint. Health Serv. Res.53(6), 4460–4476 (2018).
  • Blumenthal GM , GongY, KehlKet al. Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer. Ann. Oncol.30(5), 830–838 (2019).
  • US Food and Drug Administration . Statistical guidance on reporting results from studies evaluating diagnostic tests - guidance for industry and FDA staff. www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-guidance-reporting-results-studies-evaluating-diagnostic-tests-guidance-industry-and-fda
  • Yip W , SkoletskyJ, MaPet al. Abstract 1607: an ERBB2 follow-on companion diagnostic for clinical care of patients with breast cancer. Cancer Res.78(Suppl. 13), 1607 (2018).
  • US Food and Drug Administration . PMA P170019/S006: FDA summary of safety and effectiveness data. www.accessdata.fda.gov/cdrh_docs/pdf17/P170019S006B.pdf
  • Yang J , LuoH, LiYet al. Intratumoral heterogeneity determines discordant results of diagnostic tests for human epidermal growth factor receptor (HER) 2 in gastric cancer specimens. Cell Biochem. Biophys.62(1), 221–228 (2012).
  • Kim MA , LeeH, YangH, BangY, KimWH. Heterogeneous amplification of ERBB2 in primary lesions is responsible for the discordant ERBB2 status of primary and metastatic lesions in gastric carcinoma. Histopathology59(5), 822–831 (2011).
  • Pectasides E , StachlerMD, DerksSet al. Genomic heterogeneity as a barrier to precision medicine in gastroesophageal adenocarcinoma. Cancer Discov.8(1), 37–48 (2018).
  • Maron SB , ChaseLM, LomnickiSet al. Circulating tumor DNA sequencing analysis of gastroesophageal adenocarcinoma. Clin. Cancer Res.25(23), 7098 (2019).
  • Catenacci DVT , MoyaS, LomnickiSet al. Personalized antibodies for gastroesophageal adenocarcinoma (PANGEA): a Phase II study evaluating an individualized treatment strategy for metastatic disease. Cancer Discov.11(2), 308–325 (2021).
  • Huang D , LuN, FanQet al. HER2 status in gastric and gastroesophageal junction cancer assessed by local and central laboratories: Chinese results of the HER-EAGLE study. PLoS ONE8(11), e80290 (2013).
  • Huemer F , WeissL, RegitnigPet al. Local and central evaluation of HER2 positivity and clinical outcome in advanced gastric and gastroesophageal cancer-results from the AGMT GASTRIC-5 registry. J. Clin. Med.9(4), 935 (2020).
  • Le DT , OttPA, KorytowskyBet al. Real-world treatment patterns and clinical outcomes across lines of therapy in patients with advanced/metastatic gastric or gastroesophageal junction cancer. Clin. Colorectal Cancer19(1), 32–38.e3 (2020).
  • Paulson AS , HessLM, LiepaAMet al. Ramucirumab for the treatment of patients with gastric or gastroesophageal junction cancer in community oncology practices. Gastric Cancer21(5), 831–844 (2018).
  • Al-Batran SE , MoorahrendE, MaintzCet al. Clinical practice observation of trastuzumab in patients with human epidermal growth receptor 2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. Oncologist25(8), e1181–e1187 (2020).
  • Dijksterhuis WPM , VerhoevenRHA, MeijerSLet al. Increased assessment of HER2 in metastatic gastroesophageal cancer patients: a nationwide population-based cohort study. Gastric Cancer23(4), 579–590 (2020).
  • Franchi M , TrittoR, TorroniL, RenoC, LaVecchia C, CorraoG. Effectiveness and healthcare cost of adding trastuzumab to standard chemotherapy for first-line treatment of metastatic gastric cancer: a population-based cohort study. Cancers12(6), 1691 (2020).
  • Merchant SJ , KongW, GyawaliBet al. Effectiveness of trastuzumab in routine clinical practice: a population-based study of patients with HER-2-positive oesophageal, gastroesophageal and gastric cancer. Clin. Oncol. (R. Coll. Radiol.)33(3), 202–207 (2021).
  • Phillips CM , ParmarA, GuoHet al. Assessing the efficacy–effectiveness gap for cancer therapies: a comparison of overall survival and toxicity between clinical trial and population-based, real-world data for contemporary parenteral cancer therapeutics. Cancer126(8), 1717–1726 (2020).
  • Nam SK , YunS, KohJet al. BRAF, PIK3CA, and HER2 oncogenic alterations according to KRAS mutation status in advanced colorectal cancers with distant metastasis. PLoS ONE11(3), e0151865 (2016).
  • Pietrantonio F , FucàG, MoranoFet al. Biomarkers of primary resistance to trastuzumab in HER2-positive metastatic gastric cancer patients: The AMNESIA case-control study. Clin. Cancer Res.24(5), 1082–1089 (2018).
  • McKenzie A , SchlauchD, SharmaYet al. Adoption and utilization of NGS-based molecular profiling in community-based oncology practices: insights from sarah cannon. J. Clin. Oncol.37(Suppl. 15), e18064 (2019).
  • Presley CJ , TangD, SoulosPRet al. Association of broad-based genomic sequencing with survival among patients with advanced non-small cell lung cancer in the community oncology setting. JAMA320(5), 469–477 (2018).
  • Fujii S , MaglioccoAM, KimJet al. International harmonization of provisional diagnostic criteria for ERBB2-amplified metastatic colorectal cancer allowing for screening by next-generation sequencing panel. JCO Precis. Oncol.4, 6–19 (2020).
  • Pennell NA , MutebiA, ZhouZet al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis. Oncol.3, 1–9 (2020).