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Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial
Author(s): Bancewicz J, Clark PI, Smith DB, Donnelly RJ, Fayers PM, Weeden S, Girling DJ, Hutchinson T, Harvey A, Lyddiard J, Al-Jilaihawi AN, Bown SG, Cottier B, Jeyasingham K, Lea RE, Matthews HR, Moghissi K, Morritt GN, Myskow MW, Pagliero KM, Rowland CR, Yosef HMA
Source: LANCET    Volume: 359    Issue: 9319    Pages: 1727-1733    Published: MAY 18 2002  
Times Cited: 399     References: 20     
Abstract: Background The outlook for patients with oesophageal cancer undergoing surgical resection with curative intent is poor. We aimed to assess the effects of preoperative chemotherapy on survival, dysphagia. and performance status in this group of patients.

Methods 802 previously untreated patients with resectable oesophageal cancer of any cell type were randomly allocated either two 4-day cycles, 3 weeks apart, of cisplatin 80 mg/m(2) by infusion over 4 h plus fluorouracil 1000 mg/m(2) daily by continuous infusion for 4 days followed by surgical resection (CS group, n=400), or resection alone (S group, 402). Clinicians could choose to give preoperative radiotherapy to all their patients irrespective of randomisation. Primary outcome measure was survival time, Analysis was by intention to treat,

Findings No patients dropped out of the study. Resection was microscopically complete in 233 (60%) of 390 assessable CS patients and 215 (54%) of 397 S patients (p<0.0001). Postoperative complications were reported in 146 (41%) CS and 161 (42%) S patients. Overall survival was better in the CS group (hazard ratio 0.79; 95% Cl 0.67-0.93: p=0.004). Median survival was 512 days (16.8 months) in the CS group compared with 405 days (13.3 months) in the S group (difference 107 days; 95% Cl 30-196), and 2-year survival rates were 43% and 34% (difference 9%: 3-14).

Interpretation Two cycles of preoperative cisplatin and fluorouracil improve survival without additional serious adverse events in the treatment of patients with resectable oesophageal cancer.

Document Type: Article
Language: English
Reprint Address: Girling, DJ (reprint author), MRC, Clin Trials Unit, Canc Div, 222 Euston Rd, London NW1 2DA, England
Addresses:
1. MRC, Clin Trials Unit, Canc Div, London NW1 2DA, England
2. Hope Hosp, Salford M6 8HD, Lancs England
3. Ctr Cardiothorac, Liverpool, Merseyside England
4. Clatterbridge Ctr Oncol, Liverpool, Merseyside England
Publisher: LANCET LTD, 84 THEOBALDS RD, LONDON WC1X 8RR, ENGLAND
Subject Category: Medicine, General & Internal
IDS Number: 554MV
ISSN: 0140-6736
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