Validity of studies suggesting preoperative chemotherapy for resectable thoracic esophageal cancer: A critical appraisal of randomized trials

Table 1 Summary of the three analysed studies

Study (year)	Boonstra et al[16]	MRC Allum et al[17]	Ychou et al[15]
Number of included patients (intervention vs control)	85 vs 84	400 vs 402	113 vs 111
Inclusion criteria	100% squamous-cell cancer of thoracic oesophagus (upper, middle and lower third), T1-3, any N, M0 (M1a eligible if distal oesophageal cancer and suspected celiac nodes) < 80 yr of age, Karnofsky > 70	Squamous-cell cancer, adenocarcinoma, undifferentiated, upper, middle and lower thirds of oesophagus, as well as the gastric cardia	Resectable adenocarcinoma of the lower third of the oesophagus or gastro-oesophageal junction or stomach 18-75 years of age, WHO performance status 0 or 1, adequate renal (Cr < 120 mol/L) and hematologic functions
Intervention group	Preop. CTxa: Cisplatin, Etoposid iv. po. + surgery	Preop.CTx: Cisplatin, 5-FU + preop.radiotherapy + surgery	Preop.CTx: 5-FU, Cisplatin + surgery
Control group	Surgery	Preop. radiotherapy + surgery	Surgery
Outcome (intervention vs control)	Median overall survival 16 mo vs 12 mo, P = 0.03, by the log-rank test, HRb: 0.71; (95%CIc: 0.51-0.98)	Overall survival is significantly greater in CS group (HR: 0.84, 95%CI: 0.72-0.98, P = 0.03)	Overall survival significantly higher in CS group (HR for death 0.69, 95%CI: 0.50-0.95, P = 0.02) 5-year survival: 38% (95%CI: 29%-47%) in the CS group vs 24% (95%CI: 26%-44%) in the S group
Weight assigned in the Cochrane review (%)	24.1	20.5	24.5

^aCTx: chemotherapy,

^bHR: hazard ratio,

^cCI: Confidence interval. HR: Hazard ratio; CS: Chemotherapy + surgery; WHO: World Health Organization.