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


Note: NR, not reported.

*Patients randomized to four groups; data shown are for surgery + radiotherapy versus surgery alone.

Malthaner et al. BMC Medicine 2004 2:35   doi:10.1186/1741-7015-2-35

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