Administration Method of Adjuvant Tegafur-Uracil and Leucovorin Calcium in Patients with Resected Colorectal Cancer: A Phase III Study.

LESSONS LEARNED: The 3-year disease-free survival rate of the twice-daily regimen was not inferior to that of the conventional three-times-daily regimen, and the twice-daily regimen did not lead to an increase in adverse events. The effectiveness of the twice-daily regimen highlights an increased number of treatment options for patients. This will facilitate personalized medicine, particularly for elderly or frail patients who may experience more severe side effects from the combination therapy. BACKGROUND: Tegafur-uracil (UFT)/leucovorin calcium (LV) is an adjuvant chemotherapy treatment for colorectal cancer. We conducted a multicenter randomized trial to assess the noninferiority of a twice-daily compared with a three-times-daily UFT/LV regimen for stage II/III colorectal cancer in an adjuvant setting. METHODS: Patients were randomly assigned to group A (three doses of UFT [300 mg/m2 per day]/LV [75 mg per day]) or B (two doses of UFT [300 mg/m2 per day]/LV [50 mg per day]). The primary endpoint was 3-year disease-free survival. RESULTS: In total, 386 patients were enrolled between July 28, 2011, and September 27, 2013. The 3-year disease-free survival rates of group A (n = 194) and B (n = 192) were 79.4% and 81.4% (95% confidence interval, 72.6-84.4-74.5-85.9), respectively. The most common grade 3/4 adverse events in group A and B were diarrhea (3.9% vs. 7.3%), neutropenia (2.9% vs. 1.6%), increase in aspartate aminotransferase (4.0% vs. 3.9%), increase in alanine aminotransferase (6.2% vs. 6.8%), nausea (1.7% vs. 3.4%), and fatigue (1.1% vs. 2.3%). CONCLUSION: Group B outcomes were not inferior to group A outcomes, and adverse events did not increase.

[Evaluation of prophylactic hepatic arterial infusion chemotherapy after curative hepatectomy for metastatic colorectal cancer].

We evaluated the effect of hepatic arterial infusion (HAI) chemotherapy after curative resection of liver metastases of colorectal cancer. A total of 161 patients underwent curative resection of liver metastases. Among them, 50 patients underwent HAI of 5-FU, and 111 patients had no HAI therapy. The 50% disease-free survival time (50% DFS) was 758 days and 342 days in the HAI group and the non-HAI group (logrank test, p<0.01), and the 50% overall survival time (50% OS) was 978 days versus 730 days (p<0.05), respectively. Among the 71 patients with multiple resectable metastases (H2 or H3), the HAI group had a significantly superior 50% DFS. HAI therapy seems to be an effective form of adjuvant chemotherapy after hepatic resection of metastatic colorectal cancer.

[Effectiveness of chemoradiotherapy for three cases of squamous cell anal carcinoma].

We report three patients with squamous cell anal carcinoma who were treated by chemoradiotherapy. Case 1: A 62-year-old female with squamous cell anal carcinoma invading the vagina underwent a posterior pelvic exenteration. She had paraaortic lymph node metastases. She was treated by chemoradiotherapy with 5-FU/CDDP and external irradiation (50 Gy) as an adjuvant therapy, and survived for 5 years. Case 2: A 74-year-old female with anal squamous cell carcinoma Stage II was treated by chemoradiotherapy with tegafur/uracil, external irradiation (30 Gy) and interstitial irradiation (24 Gy). She is currently living without any signs of recurrence for 3 years and 8 months. Case 3: A 53-year-old female with anal squamous cell carcinoma Stage IIIa was treated by chemoradiotherapy using 5'-DFUR and external irradiation (66 Gy). She is currently living without any signs of recurrence for 1 year and 9 months. The prognosis of anal squamous cell carcinoma that received Cur B or C resection was extremely poor with a median survival time (MST) of 7 or 6 months. Chemoradiotherapy seems to be effective as the first line treatment.