Table 6.
Randomized trials of surgery and postoperative chemotherapy (CT) versus surgery alone.
| Study, year [Reference] | Participants | Number of patients | Interventions | Median Survival (Months) | Survival Rate (%) | Adverse Effects (Number of Patients) | ||||
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | ||||||
| Pouliquen et al. 1996 [39] | 120 patients total 62 had curative resections (no residual disease) France, 15 centres July 1987–Mar 1992 Excluded tracheal fistula, >30% liver metastases, brain metastases, node negative resections | 24 | esophagectomy + cisplatin 100 mg/m2 × 1 day × 6–8 cycles 5-fluorouracil 1000 mg/m2 × 5 days × 6–8 cycles | 20 | 83 | 34 | 32 | 18 | 17 | For 120 patients: tracheoesophageal fistulae, 9; sepsis, 5; infections, 11; pulmonary, 13; gastrointestinal, 26; neurologic, 9; neutropenia, 11; thrombocytopenia, 9; renal, 15; deaths, 4. |
| versus | versus | versus | versus | versus | ||||||
| 38 | esophagectomy | 20 | 70 | 44 | 32 | 20 | 12 | tracheoesophageal fistulae, 8; sepsis, 4; infections, 9; pulmonary, 12; gastrointestinal, 18; neurologic, 1; neutropenia, 3; thrombocytopenia, 5; renal, 1; no deaths. | ||
| This analysis based only on complete resections. No difference in survival (p-value not reported). | ||||||||||
| Ando et al. 1997 [40] | 205 patients Japan, multicenter Dec 1988–July 1991 Resectable T1b, < 75 years | 105 | esophagectomy + cisplatin 70 mg/m2 × 1 day × 2 cycles vindesine 3 mg/m2 × 2 days × 2 cycles | 57 | 90 | 67 | 58 | 58 | 48 | anemia, 2; neutropenia, 13; vomiting, 13; renal, 8; diarrhea, 2; infection, 1. |
| versus | versus | versus | versus | versus | ||||||
| 100 | esophagectomy (laparotomy and right thoracotomy with 3 field radical lymphadenectomy with gastric or colon interposition). | 47 | 90 | 67 | 54 | 48 | 45 | none reported | ||
| No difference in survival (p = 0.60). | Note: 36% unable to complete chemotherapy due to complications. | |||||||||
| Ando et al. 1999 [41] [abstract] | 242 patients | 120 | esophagectomy + cisplatin 80 mg/m2 × 2 cycles 5-fluorouracil (800 mg/m2 × 5 days × 2 cycles | NR | - | - | - | - | 51 | Grade 3 or 4 hematologic or non-hematologic toxicities were limited in the chemotherapy group. |
| Japan, multicenter Jul 1992–Jan 1997 | versus | versus | versus | versus | ||||||
| 122 | esophagectomy | NR | - | - | - | - | 61 | |||
| No difference in survival (p = 0.30) | ||||||||||