A randomized phase III trial of postoperative adjuvant therapy with S-1 alone versus S-1 plus PSK for stage II/IIIA gastric cancer: Hokuriku-Kinki Immunochemo-Therapy Study Group-Gastric Cancer (HKIT-GC).
In this randomized multicenter Phase III study, patients with curatively resected Stage II/IIIA gastric cancer were assigned to postoperative adjuvant therapy with an oral fluoropyrimidine S-1 alone (2 weeks of treatment and 1 week of rest for 6 months, followed by 2 weeks of treatment and 2 weeks of rest for 6 months) or S-1 combined with an oral biological response modifier PSK (the same regimen of S-1 plus daily PSK for 12 months). The main objective was to evaluate the survival benefit and quality of life (QOL) of combined therapy. The primary end points were the time to relapse and the duration of survival after surgery, i.e. the rates of disease-free survival and overall survival at 3 and 5 years. The secondary end points were the relations of survival rates to drug compliance, QOL, adverse events, postoperative complications, relapse status, and the preoperative expression of immune or tumor markers. The sample size was 140 per treatment arm.
Ueda
Yuji
Y
Department of Surgery and Oncology of Digestive System, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan. yueda@koto.kpu-m.ac.jp
Fujimura
Takashi
T
Kinami
Shinichi
S
Hirono
Yasuo
Y
Yamaguchi
Akio
A
Naitoh
Hiroyuki
H
Tani
Tohru
T
Kaji
Masahide
M
Yamagishi
Hisakazu
H
Miwa
Koichi
K
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005743:Gastrectomy; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage*; D007167:Immunotherapy; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage*; D011509:Proteoglycans / Q000008:administration & dosage*; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage*
D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D007155:Immunologic Factors; D011509:Proteoglycans; C079198:S 1 (combination); D005641:Tegafur; C010770:polysaccharide-K; D010094:Oxonic Acid