Table 6

Randomized trials of surgery and postoperative chemotherapy (CT) 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


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)


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

Open Data