A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer.
BACKGROUND
The effect of adjuvant treatment on survival in pancreatic cancer is unclear. We report the final results of the European Study Group for Pancreatic Cancer 1 Trial and update the interim results.


METHODS
In a multicenter trial using a two-by-two factorial design, we randomly assigned 73 patients with resected pancreatic ductal adenocarcinoma to treatment with chemoradiotherapy alone (20 Gy over a two-week period plus fluorouracil), 75 patients to chemotherapy alone (fluorouracil), 72 patients to both chemoradiotherapy and chemotherapy, and 69 patients to observation.


RESULTS
The analysis was based on 237 deaths among the 289 patients (82 percent) and a median follow-up of 47 months (interquartile range, 33 to 62). The estimated five-year survival rate was 10 percent among patients assigned to receive chemoradiotherapy and 20 percent among patients who did not receive chemoradiotherapy (P=0.05). The five-year survival rate was 21 percent among patients who received chemotherapy and 8 percent among patients who did not receive chemotherapy (P=0.009). The benefit of chemotherapy persisted after adjustment for major prognostic factors.


CONCLUSIONS
Adjuvant chemotherapy has a significant survival benefit in patients with resected pancreatic cancer, whereas adjuvant chemoradiotherapy has a deleterious effect on survival.
Neoptolemos
John P
JP
Department of Surgery, Liverpool University, Liverpool, United Kingdom.
Stocken
Deborah D
DD
Friess
Helmut
H
Bassi
Claudio
C
Dunn
Janet A
JA
Hickey
Helen
H
Beger
Hans
H
Fernandez-Cruz
Laureano
L
Dervenis
Christos
C
Lacaine
François
F
Falconi
Massimo
M
Pederzoli
Paolo
P
Pap
Akos
A
Spooner
David
D
Kerr
David J
DJ
Büchler
Markus W
MW
D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D011379:Prognosis; D016016:Proportional Hazards Models; D011788:Quality of Life; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D016019:Survival Analysis
D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil