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Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial

Lookup NU author(s): Dr Deborah Stocken

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Abstract

Background: The role of adjuvant treatment in pancreatic cancer remains uncertain. The European Study Group for Pancreatic Cancer (ESPAC) assessed the roles of chemoradiotherapy and chemotherapy in a randomised study. Methods: After resection, patients were randomly assigned to adjuvant chemoradiotherapy (20 Gy in ten daily fractions over 2 weeks with 500 mg/m2 fluorouracil intravenously on days 1—3, repeated after 2 weeks) or chemotherapy (intravenous fluorouracil 425 mg/m2 and folinic acid 20 mg/m2 daily for 5 days, monthly for 6 months). Clinicians could randomise patients into a two-by-two factorial design (observation, chemoradiotherapy alone, chemotherapy alone, or both) or into one of the main treatment comparisons (chemoradiotherapy versus no chemoradiotherapy or chemotherapy versus no chemotherapy). The primary endpoint was death, and all analyses were by intention to treat. Findings: 541 eligible patients with pancreatic ductal adenocarcinoma were randomised: 285 in the two-by-two factorial design (70 chemoradiotherapy, 74 chemotherapy, 72 both, 69 observation); a further 68 patients were randomly assigned chemoradiotherapy or no chemoradiotherapy and 188 chemotherapy or no chemotherapy. Median follow-up of the 227 (42%) patients still alive was 10 months (range 0—62). Overall results showed no benefit for adjuvant chemoradiotherapy (median survival 15·5 months in 175 patients with chemoradiotherapy vs 16·1 months in 178 patients without; hazard ratio 1·18 [95% Cl 0·90—1·55], p=0·24). There was evidence of a survival benefit for adjuvant chemotherapy (median survival 19·7 months in 238 patients with chemotherapy vs 14·0 months in 235 patients without; hazard ratio 0·66 [0·52—0·83], p=0·0005). Interpretation: This study showed no survival benefit for adjuvant chemoradiotherapy but revealed a potential benefit for adjuvant chemotherapy, justifying further randomised controlled trials of adjuvant chemotherapy in pancreatic cancer.


Publication metadata

Author(s): Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW, for the members of the European Study Group for Pancreatic Cancer

Publication type: Article

Publication status: Published

Journal: The Lancet

Year: 2001

Volume: 358

Issue: 9293

Pages: 1576-1585

ISSN (print): 0140-6736

ISSN (electronic): 1474-547X

Publisher: The Lancet Publishing Group

URL: http://dx.doi.org/10.1016/S0140-6736(01)06651-X

DOI: 10.1016/S0140-6736(01)06651-X


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