Table 1.
Pivotal phase 3 trials in advanced gastric cancer
| Trial | Arm | PFS (months) | OS (months) | RR (%) | Subsequent chemotherapy (%) |
|---|---|---|---|---|---|
| First-line chemotherapy | |||||
| JCOG9912 | 5-FU | 2.9 | 10.8 | 9 | 83 |
| S-1 | 4.2 | 11.4 | 28 | 74 | |
| SPIRITS | S-1 | 4.0 | 11.0 | 31 | 75 |
| SP | 6.0 | 13.0 | 54 | 74 | |
| ML17032 | FP | 5.0 | 9.3 | 32 | 24 |
| XP | 5.6 | 10.5 | 46 | 24 | |
| AVAGAST | XP | 5.3 | 10.1 | 37.4 | 45 |
| G-SOX | SP | 5.4 | 13.1 | 52.2 | 84.7 |
| SOX | 5.5 | 14.1 | 55.7 | 84.3 | |
| JCOG1013 | SP | 6.5 | 15.3 | 56 | 79 |
| DCS | 7.4 | 14.2 | 59 | 77 | |
| ToGA* | XP/FP | 5.5 | 11.1 | 35 | 43 |
| XP/FP + Tmab | 6.7 | 13.8 | 47 | 38 | |
| JACOB* | XP + Tmab | 7.0 | 14.2 | 48.3 | 42 |
| XP + Tmab + pertuzumab | 8.5 | 17.5 | 56.7 | 43 | |
| Second-line chemotherapy | |||||
| COUGAR-02 | ASC | – | 3.6 | – | 19 |
| DTX | – | 5.2 | 7 | 8.3 | |
| WJOG4007 | PTX | 3.6 | 9.5 | 20.9 | 89.8 |
| IRI | 2.3 | 8.4 | 13.6 | 72.1 | |
| REGARD | BSC | 1.3 | 3.8 | 3 | 39.3 |
| RAM | 2.1 | 5.2 | 3 | 31.5 | |
| RAINBOW | PTX | 2.9 | 7.4 | 16 | 46 |
| PTX + RAM | 4.4 | 9.6 | 28 | 48 | |
| ABSOLUTE | PTX | 3.8 | 10.9 | 24 | 77 |
| nab-PTX (q1w) | 5.3 | 11.1 | 33 | 70 | |
| nab-PTX (q3w) | 3.8 | 10.3 | 25 | 72 | |
| Third- or later-line chemotherapy | |||||
| ATTRACTION-2 | BSC | 1.45 | 4.14 | 0 | 44.2 |
| Nivolumab | 1.61 | 5.26 | 11.2 | 47.0 | |
| TAGS | BSC | 1.8 | 3.6 | 2 | 25 |
| FTD/TPI | 2.0 | 5.7 | 4 | 26 | |
PFS: progression-free survival; OS: overall survival; RR: response rate; 5-FU: fluorouracil; SP: S-1 plus cisplatin; FP: 5-FU plus cisplatin; XP: capecitabine plus cisplatin; SOX: S-1 plus oxaliplatin; DCS: docetaxel and cisplatin plus S-1; ASC: active symptom control; DTX: docetaxel; PTX: paclitaxel; IRI: irinotecan; BSC: best supportive care; RAM: ramucirumab; nab-PTX: nab-paclitaxel; Tmab: trastuzumab; FTD/TPI: trifluridine/tipiracil
*Patients with HER2-positive metastatic gastric or gastroesophageal junction cancers were included in these trials