5-Fluorouracil, mitomycin-c, and polysaccharide-k versus uracil-ftorafur and polysaccharide-K as adjuvant chemoimmunotherapy for patients with locally advanced gastric cancer with curative resection.
BACKGROUND
Despite the small but significant survival benefit of adjuvant chemotherapy in locally advanced gastric cancer (LAGC), the optimal regimen remains to be determined. We conducted a randomized trial comparing oral (PO) chemoimmunotherapy (CITX) with intravenous (IV) CITX in LAGC patients (stages IB-IIIB) with curative resection (≥ D2 dissection).


METHODS
The patients were randomized to the IV (5-fluorouracil 500 mg/m(2) weekly for 24 weeks, mitomycin-C 8 mg/m(2) every 6 weeks × 4) or the PO (uracil-ftorafur (UFT) 400-600 mg/day for 12 months) group. Patients in both groups received PO polysaccharide-K (3 g/day for 4 months). The planned number of patients was 368 for proving the non-inferiority of PO CITX compared to IV CITX for overall survival.


RESULTS
The trial was closed prematurely after enrolling 82 patients (44 in the IV group, 38 in the PO group). With a median follow-up of 82 months, there were no significant differences in the 5-year disease-free survival (73% vs. 55%, p = 0.358) and overall survival (77% vs. 66%, p = 0.159) between the 2 groups. The IV group demonstrated a higher incidence of grade 2 or 3 neutropenia, thrombocytopenia, and vomiting.


CONCLUSIONS
PO CITX with UFT appeared to be at least non-inferior to 5-fluorouracil and mitomycin-C CITX, with lower toxicity in the adjuvant treatment for LAGC.
Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea (Rep.).
Mi-Sun
MS
Ahn
Seok-Yun
SY
Kang
Hyun-Woo
HW
Lee
Seong-Hyun
SH
Jeong
Joon-Seong
JS
Park
Kwang-Jae
KJ
Lee
Yong-Kwan
YK
Cho
Sang-Uk
SU
Han
Soon-Young
SY
Lee
Ho-Yeong
HY
Lim
Jin-Hyuk
JH
Choi
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007167:Immunotherapy / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D015995:Prevalence; D011509:Proteoglycans / Q000008:administration & dosage*; D056910:Republic of Korea / Q000453:epidemiology; D012307:Risk Factors; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000601:surgery; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
D011509:Proteoglycans; D005641:Tegafur; C010770:polysaccharide-K; D016685:Mitomycin; D014498:Uracil; D005472:Fluorouracil