Okuno K, et al. - A randomized phase III trial was undertaken to compare tegafur/uracil (UFT) and Polysaccharide-K (PSK) to surgery alone in curatively resected stage II rectal cancer patients. Findings revealed slightly worse disease-free survival (DFS) in the UFT and PSK arm than in the surgery-alone arm, thereby suggesting that UFT and PSK are not attractive candidates to advance to the next phase III study.

Methods

• Random allocation of patients was performed to receive either UFT and PSK or surgery alone in a 1:1 ratio with a minimization method to balance the treatment allocation.
• The DFS was assessed as the primary end point.
• The OS was assessed as the secondary end point.

Results

• From 62 institutions, 111 patients were registered from October 2011 to February 2013 .
• Due to poor accrual after reaching 20% of its goal, the study was prematurely terminated.
• Between the UFT and PSK group and the surgery-alone group, the patients’ characteristics were similar.
• In the UFT and PSK arm, the DFS rate was 76.0% at 3 years and 65.1% at 5 years and in the surgery-alone arm, the analogous values were 84.0% and 77.2%.
• Compared to the surgery-alone arm, the UFT + PSK arm indicated slightly worse DFS, but the difference did not reach statistical significance (log rank p=0.102).
• The UFT + PSK arm indicated OS rate of 100% at 3 years and 97.9% at 5 years in comparison to 100% at 3 years and 93.4% at 5 years in the surgery-alone arm.
• The UFT + PSK arm and surgery-alone arm were similar in terms of the OS (p=0.533).