Table 1 Landmark clinical trials of HER2-positive gastric cancer
From: Progress and challenges in HER2-positive gastroesophageal adenocarcinoma
Trials | Patients | Line of therapy | Region | Phase | Study arms | Results |
|---|---|---|---|---|---|---|
ToGA [17] | HER2-positive, locally advanced, recurrent or metastatic gastric and GEJ adenocarcinoma | 1st | Global | 3 | Trastuzumab plus chemotherapy (fluorouracil or capecitabine and cisplatin) vs chemotherapy alone | Improvement of median OS with trastuzumab plus chemotherapy (13.8 vs 11 months, P = 0.0046) |
HELOISE [18] | HER2-positive metastatic gastric cancer and GEJ cancer | 1st | Global | 3 | Trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg VS 10 mg/kg every 3 weeks) plus cisplatin (80 mg/m2 on day 1) and capecitabine (800 mg/m2twice daily on days 1–14) | No difference in median OS 12.5 vs 10.6 months (stratified HR, 1.24; 95% CI 0.86–1.78; P = 0.2401) |
TyTAN [32] | HER2 FISH-positive IHC 3+ advanced gastric cancer | 2nd | Asia | 3 | Lapatinib plus weekly paclitaxel vs paclitaxel alone | No difference in median OS (11.0 vs 8.9 months, P = 0.1044) nor median PFS (5.4 vs 4.4 months) |
LOGIC [19] | HER2-positive advanced or metastatic esophageal, gastric or GEJ adenocarcinoma | 1st | Asia | 3 | Lapatinib with capecitabine plus oxaliplatin vs capecitabine plus oxaliplatin | No difference in median OS (12.2 vs 10.5 months, HR, 0.91; 95% CI 0.73–1.12, P = 0.3492) and median PFS (6.0 vs 5.4 months, P = 0.0381). |
JACOB [23] | HER2-positive metastatic gastric cancer or GEJ cancer | 1st | Global | 3 | Pertuzumab, trastuzumab, and chemotherapy vs trastuzumab and chemotherapy | No difference in median OS (17.5 vs 14.2 months, P = 0.057) |
GATSBY [30] | HER2-positive gastric cancer | 2nd | Global | 2/3 | IV TD-M1(2.4 mg/kg weekly) vs taxane (docetaxel 75 mg/m2every 3 weeks or paclitaxel 80 mg/m2 weekly) | No difference in median OS (7.9 vs 8.6 months, P = 0.86). |
T-ACT [33] | HER2-positive advanced gastric or GEJ adenocarcinoma | 2nd | Japan | 2 | Paclitaxel 80 mg/m2 on days 1, 8, and 15 every 4 weeks vs paclitaxel plus trastuzumab | No difference in median PFS (3.19 vs 3.68 months, P = 0.334) and median OS (9.95 vs 10.20 months, P = 0.199). |