Table 5

Randomized trials of preoperative chemotherapy (CT) 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


Roth et al. 1988 [31]

39 patients

19

cisplatin 120 mg/m2 × 1 day × 1 cycle vindesine 3 mg/m2 × 4 days × 2 cycles bleomycin 10 U/m2 × 4 days × 2 cycles + esophagectomy + cisplatin 120 mg/m2 q 6 wks × 6 months + vindesine 3 mg/m2 q 12 wks × 6 months

9

50

28

28

-

-

alopecia, 17; vomiting, 2; pneumonia, 1; sepsis, 1; neurological, 1; respiratory failure, 1; renal, 1; leaks, 1; chylothorax, 3; pulmonary embolus, 1; wound infection, 1

Nov 1982–May 1986 NCI, single centre squamous cell Stage I, II, III

versus

versus

versus

versus

versus

20

esophagectomy (transthoracic with cervical or thoracic anastomosis)

9

35

15

8

-

-

leaks, 3; chylothorax, 1; pulmonary embolus, 1; pneumonia, 1; strictures, 1; empyema, 1; subphrenic abscess, 1

No difference in survival (p = 0.34). Survival advantage in responders and if less than 10% weight loss.

Kelsen et al. 1998 [36]

467 patients Aug 1990 to Dec 1995 North America, multi-centered Resectable esophageal cancer 55% adenocarcinoma 45% squamous cell

233

cisplatin 100 mg/m2 × 1 day × 3 cycles 5-fluorouracil 1 g/m2 × 5 days × 3 cycles + esophagectomy + cisplatin 75 mg/m2 × 1 day × 2 cycles if responded

14.9

59

35

23

19

18

minor, 49; major, 53; toxic deaths, 9; neutropenia, 68; mucositis, 58; postoperative deaths, 10

versus

versus

versus

versus

versus

234

esophagectomy

16.1

60

37

26

21

20

minor, 67; major, 57; postoperative deaths, 13

No survival difference.


Note: NCI, National Cancer Institute

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

Open Data