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Table 4 Randomized trials of preoperative chemotherapy (CT) and surgery 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  
Nygaard* et al. 1992 [24] 106 patients Jan 1983–Jan 1988 Scandinavia, multi centre squamous cell < 75 years of age Karnofsky score > 50 T1, T2, Nx, M0 > 21 cm from incisors 56 cisplatin 20 mg/m2 × 5 days × 2 cycles bleomycin 10 mg/m2 × 5 days × 2 cycles + esophagectomy 7 31 6 3 - - respiratory, 3; leaks, 3; postoperative deaths, 6; hematologic, 1; alopecia, 1
   versus versus versus versus versus
   50 esophagectomy (laparotomy and right thoracotomy) 7 34 13 9 - - respiratory, 5; leaks, 2; postoperative deaths, 5
      No difference in survival (p-value not reported).  
Schlag 1992 [32] 46 patients dates not reported Germany, single centre squamous cell < 68 years of age Karnofsky > 70 Stage I, II, III 22 cisplatin 20 mg/m2 × 5 days × 3 cycles 5-fluorouracil 1 g/m2 × 5 days × 3 cycles + esophagectomy 7.5 20 - - - - vomiting, 11; alopecia, 10; fever, 2; bone marrow suppression, 5; renal, 2;
   versus versus versus versus versus
   24 esophagectomy (abdominothoracic or thoracoabdominocervical with gastric or colon interposition) 5 32 - - - - not reported
      No difference in survival (p = 0.91).  
Maipang et al. 1994 [33] 46 patients Aug 1988–Dec 1990 Thailand, single centre squamous cell < 75 years of age ECOG 1, 2. Stage I, II, III distal 2/3 esophagus 24 cisplatin 100 mg/m2 × 1 day × 2 cycles vinblastine 3 mg/m2 × 4 days × 2 cycles bleomycin 10 mg/m2 × 5 days × 2 cycles + esophagectomy 17 58 31 31 - - hematologic, 15; vomiting, 15; alopecia, 14; hepatic, 3; lung, 1; urologic, 8; perioperative deaths, 4
   versus versus versus versus versus
   22 esophagectomy (laparotomy, right thoracotomy with gastric or colon interposition) 17 85 40 36 - - none reported
      p = 0.186 Early survival better in surgery alone group.  
Law et al. 1997 [34] 147 patients Dec 1989–Jan 1995 Hong Kong, single centre squamous cell exclude non regional nodes, tracheal involvement, metastases 74 cisplatin 100 mg/m2 × 1 day × 2 cycles 5-fluorouracil 500 mg/m2 × 5 days × 2 cycles + esophagectomy 16.8 60 44 38 28 28 Anemia, 47; neutropenia, 43; thrombocytopenia, 12; renal, 24; vomiting, 34; electrolytes, 21; leaks, 3; pulmonary, 10; respiratory failure, 14; perioperative deaths, 5
   versus versus versus versus versus
   73 esophagectomy (transhiatal or Lewis-Tanner) 13 50 31 14 14 - pulmonary, 11; respiratory failure, 22; perioperative deaths, 6
      p = 0.17 Responders to CT lived longer but non-responders had lower median survival than controls (p = 0.03). Lower local recurrence with CT.  
Kok et al. 1997 [35] [abstract] 160 patients 1990–1996 Netherlands, multi-centered Squamous cell 74 cisplatin 80 mg/m2 × 1 day × 2 cycles, etoposide 100 mg IV × 2 days + 200 mg/m2 PO × 2 days × 2 cycles + esophagectomy Note: CT responders received an additional 2 cycles of CT prior to surgery while non-responders received only 2 cycles 18.5       toxic deaths, 1; alopecia, 67; renal, 10
   versus versus versus       versus
   74 esophagectomy (transhiatal). 11       none reported
      Not reported but median survival favoured CT (p = 0.002).  
MRC OE02 2002 [37] 802 patients Mar 1992 to June 1998 United Kingdom, multi-centered Resectable esophageal cancer 67% adenocarcinoma, 33% squamous or undifferentiated. 400 cisplatin 80 mg/m2 × 1 day × 2 cycles 5-fluorouracil 1 g/m2 × 4 days × 2 cycles + esophagectomy 16.8 59 43 35 28 26 postoperative complications, 41%; postoperative deaths, 10%
   versus versus versus versus versus
   402 esophagectomy 13.3 54 34 27 20 15 postoperative complications, 42%; postoperative deaths, 10%
      Significant improvement in survival with chemotherapy HR = 0.79 (95% CI 0.67 to 0.93; p = 0.004)  
Ancona et al. 2001 [48] 94 47 5-FU 1000 mg/m2 CI d1-5 + Cisplatin 100 mg/m2 d1 25 75 55 44 42 34 Gr. 3–4 neutropenia; 10 pts.
   versus versus versus versus versus
   47 Surgery alone 24 75 55 41 38 22 NR
  1. Note: NR, not reported.
  2. * Patients randomized to four groups; data shown are for chemotherapy + surgery versus surgery alone.