Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG.
BACKGROUND
In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil+adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm.


METHODS
This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan-Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial.


RESULTS
In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P=0.87) or OS (hazards ratio: 0.98, P=0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively.


CONCLUSIONS
Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.
Nitti
D
D
Università di Padova, Clinica Chirurgica II, Padova, Italy, and Laurentius Hospital, Roermond, The Netherlands. donato.nitti@unipd.it
Wils
J
J
Dos Santos
J Guimaraes
JG
Fountzilas
G
G
Conte
P F
PF
Sava
C
C
Tres
A
A
Coombes
R C
RC
Crivellari
D
D
Marchet
A
A
Sanchez
E
E
Bliss
J M
JM
Homewood
J
J
Couvreur
M L
ML
Hall
E
E
Baron
B
B
Woods
E
E
Emson
M
M
Van Cutsem
E
E
Lise
M
M
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery; D016019:Survival Analysis
D000970:Antineoplastic Agents; D015251:Epirubicin; D004317:Doxorubicin; D005472:Fluorouracil; D008727:Methotrexate