Members of the Medical Research Council Esophageal Cancer Working Party assessed the effects of preoperative chemotherapy on survival, dysphagia, and performance status in patients with esophageal cancer undergoing surgical resection.
A total of 802 previously untreated patients with resectable esophageal cancer of any cell type were included in the study.
Each was randomly allocated to one of two groups.
The first comprised of chemotherapy followed by surgical resection (CS Group, n = 400). The chemotherapy course consisted of two 4-day cycles, 3 weeks apart, of cisplatin 80 mg/m2 by infusion over 4 hours, plus fluorouracil 1000 mg/m2 daily by continuous infusion for 4 days.
The second group was resection alone (S Group, n = 402).
Clinicians could choose to give preoperative radiotherapy to all their patients irrespective of randomization.
All patients remained in the trial.
Resection was microscopically complete in 60% of 390 assessable CS patients and 54% of 397 S patients.
|2-year survival rates:|
Preoperative chemotherapy: 43%
Resection alone: 34%
Postoperative complications were reported in 41% of CS and 42% of S patients.
The authors found that overall survival was better in the CS group (hazard ratio 0·79).
Median survival was 512 days in the CS group compared with 405 days in the S group.
Furthermore, the 2-year survival rates were 43% and 34%, respectively.
Dr D. J. Girling, of the MRC Clinical Trials Unit, Cancer Division, London, England, concluded on behalf of the group, "Two cycles of preoperative cisplatin and fluorouracil improve survival without additional serious adverse events in the treatment of patients with resectable esophageal cancer."