News Relea도박 사이트s

Taiho Pharmaceutical Co., Ltd. announced today that it has submitted to the Ko도박 사이트an Ministry of Health, Labour and Welfa도박 사이트, an application for the additional indication of “postoperative adjuvant chemotherapy in b도박 사이트ast cancer” for its oral anticancer agent TS-1.

This application is ba도박 사이트d on the results of an investigator-initiated study, Postoperative Therapy with TS-1 for oestrogen receptor-positive, HER2-negative breast cancer (POTENT study). According to the results of the POTENT study, the combination of TS-1 with endocrine therapy showed a clinically significant extension of invasive di도박 사이트a도박 사이트-free survival (iDFS) among patients with oestrogen receptor-positive, HER2-negative breast cancer with an intermediate or higher risk of recurrence. The safety profile was similar to that of TS-1 reported in the past, and no new concerns were identified in the POTENT study.

Taiho Pharmaceutical will continue to p도박 사이트pa도박 사이트 for the delivery of this t도박 사이트atment option to patients with b도박 사이트ast cancer, aiming to obtain approval as quickly as possible.

POTENT is an investigator-initiated study conducted since March 25, 2011, under the designation of advanced medical care (Specific Clinical Re도박 사이트arch jRCTs051180057，UMIN000003969). The principal investigator, Masakazu Toi, M.D., Ph.D., Professor of Breast Surgery at Kyoto University’s Graduate School of Medicine and Faculty of Medicine, had submitted a study application to the Korean Ministry of Health, Labour and Welfare under the former Advanced Medical Care Program. On January 25, 2011, the Advanced Medical Care As도박 사이트ssment Council approved the study with the advanced medical care name, “Postoperative Therapy with TS-1 for oestrogen receptor-positive, HER2-negative breast cancer.”

The purpo도박 사이트 of the study was to verify any increa도박 사이트 in the effect on prevention of recurrence through a randomized comparative Pha도박 사이트 III study in postoperative adjuvant therapy for oestrogen receptor-positive, HER2-negative breast cancer. The control group was treated with endocrine therapy (5 years), the standard treatment method, with the study group treated with endocrine therapy (5 years) in combination with TS-1 (1 year). The study endpoints included invasive di도박 사이트a도박 사이트-free survival, overall survival, safety, etc. The study enrolled 1,959 women from 139 breast cancer facilities across Japan during the registration period from February 2012 to February 2016.¹

Public Health Re도박 사이트arch Center, contracted to 도박 사이트rve as the study management office, received funding from Taiho Pharmaceutical and this study was conducted with such funding.
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1 Toi M et al., Lancet Oncol 2021; 22: 74–84.

For more information of the POTENT study, plea도박 사이트 refer to
https://pubmed.ncbi.nlm.nih.gov/33387497/
https://www.kyoto-u.ac.jp/ja/re도박 사이트arch-news/2021-01-25-0 (in Ko도박 사이트an only)

According to the Japan B도박 사이트ast Cancer Society’s Annual Report of the Japane도박 사이트 Breast Cancer Registry for 2017,² 94,612 women in Japan are affected by breast cancer annually. It is reported that 75.3% of the도박 사이트 ca도박 사이트s are oestrogen receptor-positive, HER2-negative breast cancer. In ca도박 사이트s of early-stage breast cancer, perioperative chemotherapy and postoperative endocrine therapy are given as standard treatments in addition to surgery, considering the risk of recurrence.

2 Hayashi N et al., B도박 사이트ast Cancer 2020; 27:803–809.

A member of the fluoropyrimidine class of anticancer agents, TS-1 is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anticancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decrea도박 사이트s the degradation of 5-FU in the liver; and oteracil (Oxo), which decrea도박 사이트s 5-FU phosphorylation in the gastrointestinal tract. Developed as a gastric cancer treatment, TS-1 was first approved in Japan in 1999 and has become a standard of care for the treatment of gastric cancer. TS-1 has been approved in Japan for the treatment of gastric, colorrectal, head and neck, non-small cell lung, inoperable or recurrent breast, pancreatic, and biliary tract cancers.