Guideline Interpretation
Copyright ©The Author(s) 2021.
World J Gastroenterol. Jul 28, 2021; 27(28): 4493-4503
Published online Jul 28, 2021. doi: 10.3748/wjg.v27.i28.4493
Table 1 Overview of latest phase III trials in gastrointestinal cancers
StudiesPopulationInterventionControlPrimary endpointsResults
Gastroesophageal cancers
Neoadjuvant
NRG-RTOG 1010HER2-positive EC or GEJTrastuzumab + CXRT + surgeryCXRT + surgeryDFS19.6 mo vs 14.2 mo (HR = 0.97)
ARTDECOLocally advanced unresectable EC and GEJStandard CXRT + RT boostStandard CXRT3-yr LPFS73% vs 71% (NS)
Adjuvant
Checkmate-577EC and EGJ and residual pathologic diseaseNivolumabPlaceboDFS22.4 mo vs 11 mo (HR = 0.69)
Advanced/metastatic
Checkmate-649Untreated, unresectable advanced or metastatic GC/EGJNivolumab + CTCTOS; PFS14.4 mo vs 11.1 mo (HR = 0.71); 7.7 mo vs 6 mo (HR = 0.68)
ATTRACTION-4Untreated, unresectable advanced or metastatic GC/EGJNivolumab + CTCT + placeboOS; PFS17.45 mo vs 17.15 mo (HR = 0.90); 10.45 mo vs 8.34 mo (HR = 0.68)
Keynote-590Untreated, unresectable advanced or metastatic EC/EGJPembrolizumab + CTCT + placeboOS; PFS12.4 mo vs 9.8 mo (HR = 0.73); 6.3 mo vs 5.8 mo (HR = 0.65)
Hepatocellular carcinoma
Advanced/metastatic
Imbrave 150Untreated, unresectable HCCAtezolizumab + bevacizumabSorafenib12-mo OS; PFS67.2% vs 54.6% (HR = 0.58); 6.8 mo vs 4.3 mo (HR = 0.59)
Colon cancer
Adjuvant
IDEAResected stage III CRC3 mo adj. CAPOX 3 mo adj. FOLFOX6 mo adj. CAPOX ; 6 mo adj. FOLFOX5-yr DFS70% vs 69.3% (HR = 0.95); 68.4% vs 71.7% (HR = 1.16)
Follow-up
PRODIGE 13Resected stage II or III CRCLow intensity follow-upHigh intensity follow-up 5-yr OSNS
Metastatic
Keynote-177Untreated, unresectable metastatic MSI-H/dMMR CRCPembrolizumabCTPFS16.5 mo vs 8.2 mo (HR = 0.6)
iPACSAsymptomatic stage IV CRCTumor resection + CTCTOS25.9 mo vs 26.7 mo (HR = 1.10)
Rectal cancer
Neoadjuvant
RAPIDOLocally advanced rectal cancerRT + Neoadj. CT + surgeryCXRT + surgery +/-adj. CT3-yr DrTF23.7% vs 30.4% (HR = 0.76)
PRODIGE 23Locally advanced rectal cancerNeoadj. CT + CXRT + surgery + adj. CTCXRT + surgery +/-adj. CT3-yr DFS75.7% vs 68.5% (HR = 0.69)