Adjuvant Chemotherapy With UFT/LV Versus UFT/LV Plus PSK in Stage II/III Colorectal Cancer

Authors: Hiroomi Ogawa, Takuya Shiraishi, Takuhisa Okada, Yohei Miyamae, Yoko Motegi, Ken Shirabe, Hiroshi Saeki

Journal: Anticancer Research

Study Design: Randomized phase II trial

Participants: 186 patients who underwent radical resection for stage II/III colorectal cancer

Trial Length: The trial was conducted between April 2011 and August 2016.

Intervention:

• Group A (n = 37): 6 months of UFT/LV (300 mg/m^2/day UFT and 75 mg/day LV, every 35 days for five cycles)
• Group B (n = 75): 6 months of UFT/LV + PSK (standard UFT/LV regimen and daily administration of 3 g/day of PSK)
• Group C (n = 74): 12 months of UFT/LV + PSK

Primary Outcomes: 3-year disease-free survivalSummary: The study compared the efficacy and safety of UFT/LV alone and in combination with PSK as adjuvant chemotherapy for stage II/III colorectal cancer. The addition of PSK did not significantly improve 3-year disease-free survival. However, the UFT/LV+PSK groups had lower rates of treatment discontinuation due to adverse events and a similar incidence of adverse events compared to UFT/LV alone. The preoperative lymphocyte ratio did not differ significantly between the groups. The study concludes that UFT/LV+PSK is a viable adjuvant chemotherapy option for high-risk stage II/III colorectal cancer, offering comparable efficacy to UFT/LV with potentially reduced adverse effects.