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 |
||||||||||
