Phase III Trial Comparing UFT + PSK to UFT + LV in Stage IIB, III Colorectal Cancer

Authors: Yasuhiro Miyake, Junichi Nishimura, Takeshi Kato, Masataka Ikeda, Masaki Tsujie, Taishi Hata, Ichiro Takemasa, Tsunekazu Mizushima, Hirofumi Yamamoto, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori, Multi-center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)

Journal: Surgery Today

Study Design: Randomized, non-inferiority study

Participants: 357 patients with stage IIB or III colorectal cancer who underwent D2/D3 lymph node dissection

Trial Length: The study enrollment period was from March 2006 to December 2010. The median follow-up of all eligible patients after randomization was 42.5 months.

Intervention:

• UFT/PSK group (n = 178): UFT (300 mg/m^2/day) + PSK (3.0 g/day) for 1 year
• UFT/LV group (n = 179): 5 courses of UFT (300 mg/m^2/day) + LV (75 mg/day) for 6 months (4 weeks on, 1 week off)

Primary Outcomes: 3-year disease-free survival (DFS)

Secondary Outcomes: Overall survival (OS), adverse events, compliance, and quality of life (QOL)

Summary: The study aimed to compare the efficacy and safety of UFT/PSK adjuvant immunochemotherapy to UFT/LV adjuvant chemotherapy in patients with resected stage IIB or III colorectal cancer. The results showed that UFT/PSK was not non-inferior to UFT/LV in terms of 3-year DFS. However, UFT/PSK had a lower incidence of Grade 3/4 adverse events and better QOL scores compared to UFT/LV. The study suggests that while UFT/PSK may not be as effective as UFT/LV in preventing disease recurrence, it may offer a better safety and QOL profile for patients with colorectal cancer.