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. 2015 Jan 16;3(1):42–51. doi: 10.12998/wjcc.v3.i1.42

Table 1.

Clinical trials of HER2-targeted therapy in gastric cancer (after ToGA study)

Trial Study design No. of patients HER2 status Regimen duration of treatment Response rate Prognosis
LOGiC Phase III/1st Randomized Double Blind 545 HER2 amplification Lapatinib + XELOX XELOX No description of duration non-significant prolongation
TyTAN Phase III/2nd Parallel group Randomized 1923 HER2 amplification Lapatinib +Paclitaxel Paclitaxel 24 mo 27% vs 9% OS: 11.0 mo vs 8.9 mo PFS: 5.4 mo vs 4.4 mo
HERBIS-1 Phase II/1st Non-Randomized 56 IHC 3+ IHC 2+ FISH + S-1/cisplatin + trastuzumab No description of duration 68% OS: 16.0 mo PFS: 7.8 mo
PF299804 Phase II/2nd Non-Randomized 28 (estimated) IHC 3+ IHC 2+ FISH + PF299804 Cycles of 28 d 7.40% Ongoing
HIROISE (NCT01450646) Phase III/1st Randomized 400 (estimated)  Trastuzumab + cisplatin  + capecitabine 33 wk Ongoing
NCT01472029 Phase II/1st Non-Randomized 53 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab No description of duration Ongoing
NCT01130337 Phase II/preoperative Non-Randomized 36 Trastuzumab + XELOX 12 mo Ongoing
NCT01522768 Phase II/advanced Non-Randomized 40 IHC 3+ IHC 2+ FISH + Afatinib + trastuzumab 24 mo Ongoing
NCT01402401 Phase II/2nd Non-Randomized 21 IHC 3+ IHC 2+ FISH + AUY922 + trastuzumab Every 6 wk Ongoing
NCT01641939 Phase II/III/1st Randomized 412 (estimated) IHC 3+ IHC 2+ FISH + Trastuzumab emtansine Taxane 12 wk Ongoing

HER2: Human epidermal growth factor receptor; OS: Overall survival; PFS: Progression-free survival; IHC: Immunohistochemistry; FISH: Fluorescence in situ hybridization.