Surgical resection with or without pre-operative chemotherapy in oesophageal cancer

a randomised controlled trial

J Bancewicz, P I Clark, D B Smith, R J Donnelly, Peter Fayers, S Weeden, D J Girling, T. Hutchinson, A. Harvey, J. Lyddiard

Research output: Contribution to journalArticle

1104 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1727-1733
Number of pages7
JournalThe Lancet
Volume359
Issue number9319
DOIs
Publication statusPublished - 18 May 2002

Keywords

  • SQUAMOUS-CELL CARCINOMA
  • ESOPHAGEAL CANCER
  • ADENOCARCINOMA
  • RADIOTHERAPY
  • SURVIVAL
  • SURGERY
  • THERAPY

Cite this

Bancewicz, J., Clark, P. I., Smith, D. B., Donnelly, R. J., Fayers, P., Weeden, S., ... Lyddiard, J. (2002). Surgical resection with or without pre-operative chemotherapy in oesophageal cancer: a randomised controlled trial. The Lancet, 359(9319), 1727-1733. https://doi.org/10.1016/S0140-6736(02)08651-8

Surgical resection with or without pre-operative chemotherapy in oesophageal cancer : a randomised controlled trial. / Bancewicz, J ; Clark, P I; Smith, D B; Donnelly, R J; Fayers, Peter; Weeden, S ; Girling, D J; Hutchinson, T.; Harvey, A.; Lyddiard, J.

In: The Lancet, Vol. 359, No. 9319, 18.05.2002, p. 1727-1733.

Research output: Contribution to journalArticle

Bancewicz, J, Clark, PI, Smith, DB, Donnelly, RJ, Fayers, P, Weeden, S, Girling, DJ, Hutchinson, T, Harvey, A & Lyddiard, J 2002, 'Surgical resection with or without pre-operative chemotherapy in oesophageal cancer: a randomised controlled trial', The Lancet, vol. 359, no. 9319, pp. 1727-1733. https://doi.org/10.1016/S0140-6736(02)08651-8
Bancewicz, J ; Clark, P I ; Smith, D B ; Donnelly, R J ; Fayers, Peter ; Weeden, S ; Girling, D J ; Hutchinson, T. ; Harvey, A. ; Lyddiard, J. / Surgical resection with or without pre-operative chemotherapy in oesophageal cancer : a randomised controlled trial. In: The Lancet. 2002 ; Vol. 359, No. 9319. pp. 1727-1733.
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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.",
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TY - JOUR

T1 - Surgical resection with or without pre-operative chemotherapy in oesophageal cancer

T2 - a randomised controlled trial

AU - Bancewicz, J

AU - Clark, P I

AU - Smith, D B

AU - Donnelly, R J

AU - Fayers, Peter

AU - Weeden, S

AU - Girling, D J

AU - Hutchinson, T.

AU - Harvey, A.

AU - Lyddiard, J.

PY - 2002/5/18

Y1 - 2002/5/18

N2 - 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.

AB - 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.

KW - SQUAMOUS-CELL CARCINOMA

KW - ESOPHAGEAL CANCER

KW - ADENOCARCINOMA

KW - RADIOTHERAPY

KW - SURVIVAL

KW - SURGERY

KW - THERAPY

U2 - 10.1016/S0140-6736(02)08651-8

DO - 10.1016/S0140-6736(02)08651-8

M3 - Article

VL - 359

SP - 1727

EP - 1733

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9319

ER -