An effect of adjuvant immunochemotherapy using krestin and 5-FU on gastric cancer patients with radical surgery (first report)–a randomized controlled trial by the cooperative study group.

Authors: H Nakazato, A Koike, H Ichihashi, S Saji, M Danno, N Ogawa

Journal: Gan To Kagaku Ryoho

Study Design: Randomized controlled trial

• Participants: 262 patients who had undergone radical gastrectomy for gastric cancer
• Trial Length: 2 years
• Intervention:
  • All patients received Mitomycin C (MMC) post-surgery
  • Group P: 5-FU + PSK
  • Group C: 5-FU alone
• Primary Outcomes: Disease-free and overall survival rates

Summary: The study aimed to evaluate the efficacy of adjuvant immunochemotherapy with PSK (Krestin) and 5-FU in patients who had undergone radical gastrectomy for gastric cancer. The trial employed a randomized controlled design, comparing the combination of 5-FU and PSK to 5-FU alone, with all patients also receiving Mitomycin C post-surgery. The primary endpoints were disease-free survival and overall survival.

The results demonstrated a clear advantage for the group receiving both 5-FU and PSK. Both their disease-free survival and overall survival curves were statistically significantly better than those of the group receiving 5-FU alone (p = 0.018 and p = 0.045, respectively). This suggests that the addition of PSK to the standard 5-FU regimen significantly enhances the long-term outcomes for patients with gastric cancer who have undergone curative surgery.