Tegafur/Uracil

The purpose of this study is to examine the appropriateness of MRI navigation surgery following chemoradiotherapy (CRT), including lateral pelvic lymph node dissection (LLND) for middle to low rectal cancer.

Forty-three consecutive patients with cT2-4b rectal cancer within 10 cm from the anal verge who underwent laparoscopic radical surgery following CRT (45-50.4Gy + S1 80mg/m2) from January 2014 and February 2020 were analyzed. We decided on the operative procedure, including LLND, based on the restaging MRI. We examined the rates of 3-year postoperative local pelvic recurrence, permanent stoma, and recurrent risk factors (Group S). We also compared the results to that of the fourteen patients who enrolled in the previous phase II trial and underwent laparoscopic radical surgery following CRT (40Gy + S-1 (80mg/m2) or UFT (300 mg/m2)) for consecutive cT2-4b rectal cancer below the peritoneal reflection. The operative procedure was decided at the initial MRI diagnosis, and the LLND was not performed (Group P).

We had no local pelvic recurrence in Group S, and the three-year local pelvic recurrence-free survival was significantly better in Group S than P (100 % in S 85.1 % in P, p < 0.05). The permanent stoma rate was not different between the Groups, irrespective of the significantly high rate of cCRM(+) in Group S. The Cox proportional hazards model for significant factors of recurrence on the univariate analysis revealed that ycM and ycEMVI scores were independently significant (p < 0.001).

MRI navigation surgery, including LLND for rectal cancer following chemoradiotherapy, improves local control and functional preservation.

Uracil-tegafur+leucovorin (UFT/LV), an oral adjuvant therapy for stage II/III colorectal cancer, is non-inferior to standard weekly fluorouracil and folinate. Although polysaccharide K (PSK) has been evaluated as a postoperative adjuvant colorectal cancer drug, its efficacy remains unclear. This randomized phase II trial compared UFT/LV+PSK with UFT/LV as adjuvant chemotherapy.

Between April 2011 and August 2016, 186 patients who underwent radical resection randomly received 6 months of UFT/LV (Group A: 300 mg/m²/day UFT and 75 mg/day LV, every 35 days for five cycles), 6 months of UFT/LV+PSK (Group B: standard UFT/LV regimen and daily administration of 3 g/day of PSK), or 12 months of UFT/LV+PSK (Group C). The primary endpoint was the 3-year disease-free survival.

Groups A, B, and C consisted of 37, 75, and 74 patients, of which treatment was completed by 33 (89.2%), 63 (84.9%), and 53 (70.4%) patients, respectively (p=0.0279). Adverse event incidence for all grades were 59.5%, 52.1%, and 59.2%, and for grade ≥3 were 13.5%, 9.6%, and 9.9%, respectively. The 3-year disease-free survival rates were 72.5%, 82.2%, and 74.2%, respectively, with no significant differences. The preoperative lymphocyte ratio did not significantly differ between groups.

UFT/LV+PSK is comparable to UFT/LV therapy in terms of prognostic efficacy and reduced adverse effects. Thus, UFT/LV+PSK is a useful adjuvant chemotherapy option for patients with high-risk stage II/III colorectal cancer.