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Table 6 Randomized trials of surgery and postoperative chemotherapy (CT) versus surgery alone.

From: Neoadjuvant or adjuvant therapy for resectable esophageal cancer: a systematic review and meta-analysis

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)