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©The Author(s) 2016.
World J Gastroenterol. Jan 14, 2016; 22(2): 471-489
Published online Jan 14, 2016. doi: 10.3748/wjg.v22.i2.471
Published online Jan 14, 2016. doi: 10.3748/wjg.v22.i2.471
Table 1 Completed randomized Phase II and Phase III trials
Target | Agents | Name of trial and setting | Phase | Number of patients | PFS (mo) | P value | OS (mo) | P value | Results |
HER-2 | Fluoropyrimide/cisplain + Trastuzumab vs Fluoropyrimide/cisplain | ToGA, First line | III | 594 | 6.7 vs 5·5 | < 0.001 | 13.8 vs 11.1 | 0.004 | PFS and OS was improved |
HER-2 | Lapatinib plus once-per-week paclitaxel vs paclitaxel | TYTAN, Second line | III | 261 | 5.4 vs 4.4 | 0.850 | 11.0 vs 8.9 | 0.104 | No effect on PFS and OS |
HER-2 | Cap/Ox plus lapatinib or Cap/Ox plus placebo | LOGiC, First line | III | 545 | 6.0 vs 5.4 | 0.100 | 12.2 vs 10.5 | 0.350 | No effect on PFS and OS |
EGFR | Cisplatin and capecitabine + cetuximab vs cisplatin and capecitabine | EXPAND, First line | III | 904 | 4.4 vs 5.6 | 0.320 | 9·4 vs 10.7 | 0.950 | No effect on PFS and OS |
EGFR | mEOC plus panitumumab vs EOC | REAL, First line | III | 553 | 6.0 vs 7.4 | 0.068 | 8·8 vs 11.3 | 0.013 | No effect on PFS and OS |
VEGF | Bevacizumab plus cisp/cape/fluorouracil vs plc plus cisplatin/capecitabine/fluorouracil | AVAGAST, First line | III | 774 | 6.7 vs 5.3 | 0.003 | 12.1 vs 10.1 | 0.100 | PFS was improved, No effect on OS |
VEGF | Ramucirumab vs placebo | REGARD, Second line | III | 355 | 2.1 vs 1.3 | < 0.001 | 5.2 vs 3.8 | 0.047 | PFS and OS was improved |
VEGF | Ramucirumab plus paclitaxel vs placebo plus paclitaxel | RAINBOW, Second line | III | 665 | 4.4 vs 2.9 | < 0.001 | 9.6 vs 7·4 | 0.017 | PFS and OS was improved |
VEGF | Apatinib 850 mg vs apatinib 425 vs placebo | NN, Third line | II | 144 | 3.67 vs 3.20 vs 1.40 | < 0.001 | 4.83 vs 4.27 vs 2.50 | < 0.001 | PFS and OS was improved |
MET | Rilotumumab 15 mg/kg per rilotumumab 7.5 mg/kg, or placebo plus ECX | NN, First line | II | 121 | 5.1 vs 6.8 vs 4.2 | 0.016 | 9.7 vs 11.1 vs 8.9 | 0.100 | PFS and OS was improved |
m-TOR | Everolimus 10 mg vs placebo | GRANITE, ≥ Second line | III | 656 | 1.7 vs 1.4 | 0.780 | 5.4 vs 4.3 | 0.124 | No effect on PFS and OS |
Table 2 Finished Phase II studies
Target | Agents | Name of Trial and Setting | Phase | Number of patients | PFS (mo) | OS (mo) | Results |
HER-2 | Lapatinib | S0413, First line | II | 47 | 1.9 | 4.8 | Positive |
HER-2 | Lapatinib plus ECF or ECX vs placebo plus ECF or ECX | EORTC 40071, First line | II | 28 | 7.1 vs 5.9 | 13.8 vs 10.1 | Negative1 |
HER-2 | MK-2206 (AKT inhibitor) | S1005, Second line | II | 70 | 1.8 | 5.1 | Negative |
Pan-HER | Saracatinib (Src inhibitor) | NN, ≥ Second line | II | 21 | 1.8 | 7.8 | Negative |
Pan-HER | Dacomitinib | NN, ≥ Second line | II | 27 | 2.1 | 7.1 | Positive |
EGFR | Cetuximab plus mFOLFOX6 | NN, First line | II | 40 | 5.5 | 9.9 | Positive |
EGFR | Cetuximab plus FOLFIRI | NN, First line | II | 49 | 9.0 | 16.5 | Positive |
EGFR | Panitumumab with dose dense DCF | NN, First line | II | 52 | 4.8 | 9.4 | Positive |
VEGF | Bevacizumab plus irinotecan and cisplatin | NN, First line | II | 47 | 8.3 | 12.3 | Positive |
VEGF | Bevacizumab plus docetaxel/oxaliplatin | NN, First line | II | 38 | 6.6 | 11.1 | Positive |
m-TOR | Everolimus 10 mg | NN, ≥ Second line | II | 53 | 2.7 | 10.1 | Positive |
Table 3 Ongoing Phase II and III studies
Target | Agents | Trial number | Setting | Phase | Primary end point | Status |
HER-2 | Arm A: pertuzumab + trastuzumab + cisplatin + fluoropyrimidine vs Arm B: placebo + trastuzumab + cisplatin + fluoropyrimidine | NCT01774786 | First line | III | OS | Recruiting |
HER-2 | Arm A: Docetaxel or paclitaxel | NCT01641939 | First line | II/III | Phase II: Dose of TDM-1 | Recruiting |
Arm B: T-DM1 3.6 mg/kg every 3 wk | ||||||
Arm C: T-DM1 2.4 mg/kg once a week | Phase III: OS | |||||
HER-3 | Arm A: MM-111 + Paclitaxel + Trastuzumab | NCT01774851 | ≥ Second line | II | PFS | Active, not recruiting |
Arm B: Paclitaxel + Trastuzumab | ||||||
MET | Arm A: Rilotumumab 15 mg/kg plus ECX | NCT01697072 | First line | III | OS | Active, not recruiting |
Arm B: Placebo plus ECX | ||||||
MET | Arm A: onartuzumab plus mFOLFOX6 | NCT01662869 | First line | III | OS | Active, not recruiting |
Aram B: placebo plus mFOLFOX6 | ||||||
CTLA4 | Arm A: Ipilimumab | NCT01585987 | Maintanence | II | PFS | Active, not recruiting |
Arm B: Best Supportive Care | ||||||
PD-1 | Arm A: Nivolumab (ONO-4538) | NCT02267343 | ≥ Second line | III | OS | Recruiting |
Arm B: Placebo |
- Citation: Yazici O, Sendur MAN, Ozdemir N, Aksoy S. Targeted therapies in gastric cancer and future perspectives. World J Gastroenterol 2016; 22(2): 471-489
- URL: https://www.wjgnet.com/1007-9327/full/v22/i2/471.htm
- DOI: https://dx.doi.org/10.3748/wjg.v22.i2.471