Table 2.
Patient characteristics and survival in GEJ carcinoma trials
| 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)† |
+ Locations of esophageal carcinomas were further specified as follows: proximal third: 2%; middle third: 13%; distal third 58%.
‡ Control arm in ACCORD07 and CROSS was surgery only; Stahl 2009 had no surgery only arm, we considered CT without radiotherapy as control arm in this table.
§ FU: fluorouracil.
# PLF: cisplatin, fluorouracil, and leucovorin.
* TNM in ACCORD07 is pathologically (pTNM) staged; TNM in CROSS is clinically (cTNM) by means of endoscopic ultrasonography, computed tomography (CT), or 18F-fluorooxyglucose positron-emission tomography; TNM in Stahl 2009 is clinically for T-staging (uT), but pathological for N-staging.
† All mentioned p-values refer to comparison of the specified factor between CT/CRT arm, and control arm.
Patient characteristics and outcome of patients with GEJ- and esophageal carcinoma; in ACCORD07 and CROSS trial, surgery only arm was regarded as control arm; in Stahl 2009, neoadjuvant PLF without irradiation followed by surgery was considered control arm while neoadjuvant CRT was considered CT/CRT arm.