Neo-adjuvant chemotherapy for operable gastric cancer: long term results of the Dutch randomised FAMTX trial.
OBJECTIVE
Gastric cancer in Western countries is often diagnosed in an advanced stage and prognosis is poor. We performed a randomised trial with pre-operative FAMTX vs. surgery alone in order to evaluate the effect of pre-operative chemotherapy on resectability and survival.


METHODS
Patients with proven adenocarcinoma of the stomach were randomised to receive four courses of chemotherapy using 5-Fluorouracil, doxorubicin and methotrexate (FAMTX) prior to surgery or to undergo surgery alone.


RESULTS
Fifty-nine patients were randomised; 29 patients were allocated to the FAMTX regimen prior to surgery and 30 patients had surgery alone. Resectability rates were equal for both groups. Complete or partial response was registered in 32% of the FAMTX group. With a median follow-up of 83 months the median survival since randomisation is 18 months in the FAMTX group vs. 30 months in the surgery alone group (p=0.17).


CONCLUSIONS
This trial could not show a beneficial effect of pre-operative FAMTX. Until large randomised studies prove otherwise, adequate surgery without delay is the best treatment for operable gastric cancer.
Hartgrink
H H
HH
Department of Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC Leiden, The Netherlands. h.h.hartgrink@lumc.nl
van de Velde
C J H
CJ
Putter
H
H
Songun
I
I
Tesselaar
M E T
ME
Kranenbarg
E Klein
EK
de Vries
J E
JE
Wils
J A
JA
van der Bijl
J
J
van Krieken
J H J M
JH
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D004317:Doxorubicin / Q000627:therapeutic use*; D005472:Fluorouracil / Q000627:therapeutic use*; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use*; D020360:Neoadjuvant Therapy / Q000379:methods; D009367:Neoplasm Staging; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome
D004317:Doxorubicin; D005472:Fluorouracil; D008727:Methotrexate