Preoperative Tegafur Suppositories for Resectable Rectal Cancer: Phase II Trial

Abstract

Preoperative tegafur suppositories are associated with low toxicity and may lead to anal sphincter-sparing surgery with acceptable postoperative complications and favorable local and distal control.

Usefulness of the Preoperative Administration of Tegafur Suppositories as Alternative Adjuvant Chemotherapy for Patients with Resectable Stage II or III Colorectal Cancer: A KODK4 Multicenter Randomized Control Trial

“…the venous administration of 5-FU/leucovorin, consistent with the results of a similar study using tegafur suppositories [10,16]. In fact, tegafur suppositories can be used as an alternative adjuvant chemotherapy treatment, leading to a reduction in adverse effects.…”

“…Furthermore, our results support the importance of the preoperative administration of fluorouracil, which prevents postoperative recurrence regardless of the route of administration. A previous study reported that preoperative tegafur suppositories can lead to anal sphincter-sparing surgery with acceptable postoperative complications and a 4-year OS rate of 80.1% with favorable local and distal control among advanced rectal cancer patients [10]. Despite the use of this relatively old drug, our findings may provide new insights into standardized modern adjuvant cancer chemotherapy for advanced nonmetastatic colorectal cancer.…”

“…Similarly, the administration of 5-FU suppositories leads to a high intratumoral concentration of 5-FU [11]. A pathological response was found in 70% of patients who were treated preoperatively with tegafur suppositories for at least 14 days, with no severe adverse effects reported [10]. The subsequent 4-year DFS and OS rates were reportedly 67.6 and 80.1% [10].…”

“…Pharmacokinetic studies have demonstrated that, when administered per rectum, tegafur is absorbed rapidly through the rectal mucosa and enters the systemic and portal circulation, as well as the lymphatic circulation, ultimately reaching levels similar to those associated with intravenous tegafur administration [10]. Similarly, the administration of 5-FU suppositories leads to a high intratumoral concentration of 5-FU [11].…”

“…A pathological response was found in 70% of patients who were treated preoperatively with tegafur suppositories for at least 14 days, with no severe adverse effects reported [10]. The subsequent 4-year DFS and OS rates were reportedly 67.6 and 80.1% [10]. Another study demonstrated that the 5-year survival rate was 80.9% and the local recurrence rate was 6.7% in patients treated with preoperative chemoradiation therapy, which consisted of tegafur suppositories and radiation therapy [12].…”