Table 3 Randomized trials of surgery and postoperative radiotherapy (RT) 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 | ||||||
Fok et al. 1993 [27] | 130 patients July 1986-Dec 1989 Hong Kong, single centre squamous cell adenocarcinoma excluded leaks, respiratory failure, poor performance, metastases | 65 | esophagectomy + 49–52.5 Gy postop RT | 8.7 | 34 | 18 | 16 | 16 | - | gastritis, 6; ulcer, 17; tracheo-esophageal fistulae, 1; strictures, 6 |
versus | versus | versus | versus | versus | ||||||
65 | esophagectomy (Lewis-Tanner or transhiatal or sternal split) | 15.2 | 65 | 25 | 21 | 16 | - | gastritis, 3; ulcer, 1; tracheo-esophageal fistulae, 0; strictures, 6 | ||
Shorter survival with RT (p = 0.02). Better local control with RT (p = 0.06) but with more complications. | ||||||||||
Teniere et al. 1991 [28] | 221 patients Dec 1979-Dec 1985 France, multi centre squamous cell distal 2/3 esophagus | 102 | esophagectomy + 45–55 Gy postop RT | 18 | 68 | 50 | 27 | 24 | 21 | minor, 18; major, 4; death, 1 |
versus | versus | versus | versus | versus | ||||||
119 | esophagectomy (transhiatal or right thoracotomy with stomach or colon interposition) | 18 | 73 | 51 | 29 | 22 | 19 | none reported | ||
No difference in survival (p-value not reported). Local or regional recurrence was lower with RT (70% versus 85%, p-value not reported). | ||||||||||
Fok* 1994 [5] | 79 patients 1968–1981 Hong Kong, single centre Squamous cell middle 1/3 esophagus | 42 | esophagectomy (one or two stage) + 45–53 Gy postop RT | 11 | 48 | 17 | 17 | 12 | 10 | respiratory 25; postoperative deaths 3; leaks 11 |
versus | versus | versus | versus | versus | ||||||
39 | esophagectomy (right thoracotomy, left neck, and abdomen) | 22 | 58 | 36 | 24 | 16 | 16 | respiratory 15; postoperative deaths 3; leaks 7 | ||
No difference in survival. | ||||||||||
Zieren et al. 1995 [29] | 68 patients (did not accrue entire sample size 68/160) June 1988-Dec 1991 Germany, single centre squamous cell excluded cervical location, metastases, other cancers, previous treatment | 33 | esophagectomy + 55.8 Gy postop RT | 14 | 57 | 29 | 22 | - | - | tracheo-esophageal fistulae, 1; skin, 18; strictures, 2 |
versus | versus | versus | versus | versus | ||||||
35 | esophagectomy (transhiatal or right thoracotomy with stomach interposition) | 13 | 53 | 31 | 20 | - | - | strictures, 1 | ||
No difference in survival (p-value not reported). | ||||||||||
Xiao et al. 2003 [47] | 495 patients | 220 | Midplane dose of 50–60 Gy in 25–30 fractions over 5–6 weeks | NR | - | - | - | - | 41 | NR |
versus | versus | versus | versus | |||||||
275 | Surgery alone | NR | - | - | - | - | 32 | |||
p = 0.4474 | ||||||||||