Clinical Trial | INT-0116 | MAGIC | ACTS-GC | CLASSIC | ARTIST | Zhu 2012 |
---|---|---|---|---|---|---|
Number of patients | 556 | 503 | 1059 | 1035 | 458 | 380 |
Tumor location | Stomach: 80% GEJ: 20% | Stomach: 74%; esophagus: 14.5%; GEJ: 11.5% | 100% stomach | 97.7% stomach; 2.3% GEJ | 100% stomach | 80.5% stomach; 19.5% GEJ |
Treatment in CT/CRT arm | Resection (D2: 10%), adjuvant FU/FA with 45/1.8Gy* | Perioperative 6 cycles of FU/epirubicin/cisplatin; D2 resection in 42.5%† | D2 (94.7%) or D3 (5.3%) surgery; adjuvant S-1 | D2 surgery; Adjuvant capecitabine and oxaliplatin | D2 resection, adjuvant XP, 45/1.8Gy/capecitabine; 2 cycles XP§ | D2 resection; 1 cycle adjuvant FU/FA; 45/1.8Gy IMRT/FU/FA; followed by 2 cycles FU/FA |
Treatment in control arm ‡ | Resection alone (D2: 10%)* | D2 resection in 40.4% of cases† | D2 (93.8%) or D3 (6%) resection (D1 in 0.2%) | D2 surgery | D2 surgery; adjuvant XP | D2 resection; adjuvant FU/FA only |
AJCC/UICC stage (or TNM) in CT/CRT arm | T1-2: 31%; T3-4: 69%; N0: 16%; N+: 84%‡‡ | T1-2: 51.7%; T3-4: 48.3%; N0: 31.1%; N+: 68.9%‡‡ | II: 44.6%; IIIA: 38.2%; IIIB: 17.0%; IV: 0.2% | IB: <1%; II: 49%; IIIA: 37%; IIIB: 14%; IV: 0% | IB: 21.3%; II: 36.5%; IIIA: 23%; IIIB: 7.8% IV: 11.3% | IB: 10.8%; II: 19.4%; III: 55.4%; IV: 14.5% |
AJCC/UICC stage (or TNM) in control ‡ arm | T1-2: 31%; T3-4: 68%; N0: 14%; N+: 85%‡‡ | T1-2: 36.8%; T3-4: 63.2%; N0: 26.9%; N+: 73.1%‡‡ | II: 44.9%; IIIA: 39.1%; IIIB: 16.0%; IV: 0% | I: 0%; II: 51%; IIIA 36%; IIIB 13%; IV: <1% | IB: 21.9%; II: 37.7%; IIIA: 21.1%; IIIB: 7.5%; IV: 11.8% | IB: 9.1%; II: 18.2%; III: 58.2%; IV: 14.5% |
OS in CT/CRT arm # | 3-yr: 50% (p=0.005) 5-yr: ~42% | 3-yr: ~42% 5-yr: 36.3% (p=0.008) | 3-yr: 80.1% (p=0.003) 5-yr: 71.7% | 3-yr: 83% (p=0.0493) | Unspecified | 5-yr: 48.4% (p=0.122) 3-yr: ~62% |
OS in control ‡ arm # | 3-yr: 41% (p=0.005) | 3-yr: ~31% 5-yr: 23.0% (p=0.008) | 3-year: 70.1% (p=0.003) 5-yr: 61.1% | 3-yr: 78% (p=0.0493) | Unspecified | 5-yr: 41.8% (p=0.122) 3-yr: ~53% |
DFS in CT/CRT arm # | 3-yr: 48% (p<0.001) 5-yr: ~40% | 3-yr: ~40% (p<0.001) | 3-yr: 72.2% (p<0.001) 5-yr: 65.4% | 3-yr: 74% (p<0.0001) | 3-year: 78.2% (p=0.0862)§§ | 3-yr: ~59% 5-yr: 45.2% (p=0.029) |
DFS in control ‡ arm # | 3-yr: 31% (p<0.001) | 3-yr: ~24% (p<0.001) | 3-yr: 59.6% (p<0.001) 5-year: 53.1% | 3-yr: 59% (p<0.0001) | 3-year: 74.2% (p=0.0862)§§ | 3-yr: ~47% 5-yr: 35.8% (p=0.029) |
Grade 3–4 hematologic events in CRT/CT arm | Hematologic events: 54%; most common: leukopenia; no further details specified | Leukopenia: 11.5% Neutropenia: 27.8% Lymphopenia: 19.9% Thrombopenia: 3% | Leukopenia: 1.2% Neutropenia and Lymphopenia unspecified Thrombopenia: 0.2% | Leukopenia: unspecified Neutropenia: 22% Lymphopenia: unspecified Thrombopenia: 8% | Leukopenia: unspecified Neutropenia: 48.5% Lymphopenia: unspecified Thrombopenia: 0.9% | Leukopenia: 7.5% Neutropenia and Lymphopenia unspecified Thrombopenia: 0% |
Grade 3–4 hematologic events in control ‡ arm | Unspecified | Unspecified | Leukopenia: 0.4% Thrombopenia: 0.4% | Leukopenia: unspecified Neutropenia: <1% Thrombopenia: 0% | Leukopenia: unspecified Neutropenia: 40.7% Thrombopenia: 0% | Leukopenia: 7.3% Neutropenia: unspecified Thrombopenia: 0% |
Most common grade 3–4 non-hematologic events in CRT/CT arm | Gastrointestinal: 33% Influenza-like: 9% Infection: 6% | Nausea: 12.3% Vomiting: 10.1% Stomatitis: 4.3% | Anorexia: 6% Nausea: 3.7% Diarrhea: 3.1% | Nausea: 8% Vomiting: 7% Decreased appetite: 5% | Nausea: 12.3% Vomiting: 3.1% Hand-foot syndrome: 3.1% | Nausea: 2.7% Vomiting: 1.6% Diarrhea: 1.6% |
Most common grade 3–4 non-hematologic events in control ‡ arm | Unspecified | Unspecified | Anorexia: 2.1% Vomiting: 1.9% Nausea: 1.1% | Each single event <1% | Nausea: 12.4% Vomiting: 3.5% Hand-foot syndrome: 2.2% | No grade 3–4 non-hematologic toxicities in CT group |