Adjuvant therapy with edrecolomab versus observation in stage II colon cancer: a multicenter randomized phase III study.
BACKGROUND
In a phase III study recruiting patients with stage II colon cancer the effect of adjuvant therapy with edrecolomab, a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, was compared to observation alone.


METHODS
From January 1997 until July 2000 a total of 377 patients were postoperatively stratified according to tumor stage (T3 vs. T4) and center, and randomly allocated to either treatment with edrecolomab (cohort A, n = 183) or observation (cohort B, n = 194). Patients in cohort A received a total of 900 mg edrecolomab. The study was terminated prematurely because of discontinuation of drug supply in Germany.


RESULTS
305 patients were eligible for the primary endpoint of overall survival and 282 patients for disease-free survival. After a median follow-up of 42 months overall survival and disease-free survival were not significantly different. Toxicity was mild.


CONCLUSIONS
In the present study, postoperative adjuvant treatment with edrecolomab in patients with resected stage II colon cancer did not improve overall or disease-free survival.
Hartung
G
G
Abteilung Hämatologie und Onkologie, Universität Rostock, Germany. Gernot.Hartung@med.uni-rostock.de
Hofheinz
R-D
RD
Dencausse
Y
Y
Sturm
J
J
Kopp-Schneider
A
A
Dietrich
G
G
Fackler-Schwalbe
I
I
Bornbusch
D
D
Gonnermann
M
M
Wojatschek
C
C
Lindemann
W
W
Eschenburg
H
H
Jost
K
K
Edler
L
L
Hochhaus
A
A
Queisser
W
W
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D015331:Cohort Studies; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D012720:Severity of Illness Index; D016019:Survival Analysis; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; C400149:Edrecolomab