Clinical Trial | ACCORD07 | CROSS | Stahl 2009 |
---|---|---|---|
Number of patients randomized | 224 | 368 | 126 |
Histology | Adenocarcinoma: 100% | Adenocarcinoma: 75%; SCC: 23%; other: 2% | Adenocarcinoma: 100% |
Tumor location | Distal esophagus: 11%; GEJ: 64%; stomach: 25% | Esophagus+: 73%; GEJ: 24%; Unspecified: 3% | 100% GEJ Siewert I: 55%, Siewert II/III: 45% |
Treatment in CT/CRT arm | Cisplatin and FU§ in perioperative combination with surgery | Neoadjuvant carboplatin & paclitaxel with concurrent 41.8/1.8Gy, followed by surgery | Neoadjuvant PLF#, followed by cisplatin & etoposide with concurrent 30/2Gy, followed by surgery |
Treatment in control arm ‡ | Surgery only | Surgery only | PLF#, followed by surgery |
TNM in CT/CRT arm * | T0: 3%; T1-2: 39%; T3-4: 58%; N0: 33%; N+: 67%; M0: 99%; M1: 1% | T1-2: 16%; T3-4: 84%; unspecified T: 1%; N0: 33%; N+: 65%; unspecified N: 2% | T1-2: 0%; T3: 92%; T4: 8%; N0: 64%; N+: 36% |
TNM in control arm ‡ * | T1-2: 32%; T3-4: 68%; N0: 20%; N+ 80%; M0: 93%; M1: 7% | T1-2: 20%; T3-4: 79%; unspecified T: 2%; N0: 31%; N+: 64%; unspecified N: 5% | T1-2: 0%; T3: 92%; T4: 8%; N0: 37%; N+: 63% |
OS in CT/CRT arm | 5-year: 38% (p=0.02)† | 5-year: 47%; 3-year: 58%; median: 49.4 months (p=0.003)† | Median: 33.1months; 3-year: 47.4% (p=0.07)† |
OS in control arm ‡ | 5-year: 24% (p=0.02)† | 5-year: 34%; 3-year: 44%; median: 24 months (p=0.003)† | Median: 21.1months 3-year: 27.7% (p=0.07)† |
DFS in CT/CRT arm | 5-year: 34% (p=0.003)† | Median DFS not reached (p<0.001)† | 3-Y: 41.3% (P not significant, value not reported)† |
DFS in control arm ‡ | 5-year: 19% (p=0.003)† | Median DFS 24.2 months (p<0.001)† | 3-Y: 24.9% (P not significant, value not reported)† |
Postoperative mortality in CT/CRT arm | 4.6% (p=0.76)† | 4% (P not significant, value not reported)† | 10.2% (p=0.26)† |
Postoperative mortality in control arm ‡ | 4.5% (p=0.76)† | 4% (P not significant, value not reported)† | 3.8% (p=0.26)† |
R0 resection rate in CT/CRT arm | 84% (p=0.04)† | R0: 92% (p<0.001)† | 72% (P not significant, value not reported)† |
R0 resection rate in control arm | 74% (p=0.04)† | R0: 69% (p<0.001)† | 69% (P not significant, value not reported)† |
Complete response in CT/CRT arm | Unspecified | 29% (23% in adenocarcinoma patients, 49% in SCC patients) | 15.6% (p=0.03)† |
Complete response in control arm ‡ | - | - | 2% (p=0.03)† |
Tumor free LN at time of surgery in CT/CRT arm | 33% (p=0.054)† | 69% (p<0.001)† | 64% (p=0.01)† |
Tumor free LN at time of surgery in control arm ‡ | 20% (p=0.054)† | 25% (p<0.001)† | 37% (p=0.01)† |