PMID- 31289984
OWN - NLM
STAT- MEDLINE
DCOM- 20201023
LR  - 20210201
IS  - 1573-0646 (Electronic)
IS  - 0167-6997 (Print)
IS  - 0167-6997 (Linking)
VI  - 38
IP  - 1
DP  - 2020 Feb
TI  - TS-1 add-on therapy in Japanese patients with triple-negative breast cancer after 
      neoadjuvant or adjuvant chemotherapy: a feasibility study.
PG  - 140-147
LID - 10.1007/s10637-019-00829-w [doi]
AB  - Purpose We examined the feasibility, efficacy, and safety of TS-1 add-on therapy 
      (TAT) in Japanese patients with triple-negative breast caner (TNBC). Methods TAT 
      (TS-1, 80 mg/m(2)/day, BID, PO), consisting of the 21-day cycles of 14-day 
      consecutive administration followed by 7-day drug holiday, was conducted for 
      365 days. The median follow-up was 75.2 months (range, 7.3-103.3 months). The 
      primary endpoint was the feasibility of TAT. The secondary endpoints included 
      relapse-free survival (RFS), overall survival (OS), and safety. Results 63 
      Japanese patients with TNBC (median age, 52.5 years; range, 23.7-68.6 years) were 
      examined. Among them, 34 (54.0%) were postmenopausal, 54 (93.7%) had TNBC of 
      common histological type, 51 (81.0%) had T1 to 3 tumors, 63 (100%) had undergone 
      standardized surgery, and 44 (69.8%) and 19 (30.2%) had undergone neoadjuvant 
      chemotherapy and adjuvant chemotherapy, respectively. The 365-day cumulative rate 
      of TS-1 administration was 68.3% (95% confidence interval, 55.3-79.4), being 
      comparable to 65.8% previously reported for gastric cancer. The 5-year RFS rates 
      were 52.3% and 84.2% in the neoadjuvant and adjuvant chemotherapy groups, 
      respectively, and the 5-year OS rates were 68.0% and 89.5%, respectively. The 
      most common adverse events (AEs) were leucocyte count decreased (50.8%), total 
      bilirubin decreased (44.4%), and pigmentation (42.9%). AEs were manageable 
      clinically, and any grade 4 AEs did not develop. Conclusions The 365-day 
      cumulative rate of TS-1 administration in TNBC patients was comparable to that in 
      gastric cancer patients despite previous chemotherapy with anthracyclines and/or 
      taxanes. TAT was feasible for TNBC patients after standard primary therapy.
FAU - Inoue, Kenichi
AU  - Inoue K
AUID- ORCID: 0000-0003-2686-8732
AD  - Division of Breast Oncology, Saitama Cancer Center, 780 Komuro, Ina-machi, 
      Kita-adachi-gun, Saitama, 362-0806, Japan. ino.bad.ken@gmail.com.
FAU - Nagai, Shigenori E
AU  - Nagai SE
AD  - Division of Breast Oncology, Saitama Cancer Center, 780 Komuro, Ina-machi, 
      Kita-adachi-gun, Saitama, 362-0806, Japan.
FAU - Saito, Tsuyoshi
AU  - Saito T
AD  - Department of Breast Surgery, Saitama Red Cross Hospital, Saitama, 330-8553, 
      Japan.
FAU - Sakurai, Takashi
AU  - Sakurai T
AD  - Division of Breast Surgery, JCHO Saitama Medical Center, Saitama, 330-0074, 
      Japan.
FAU - Kimizuka, Kei
AU  - Kimizuka K
AD  - Department of Breast Surgery, Kasukabe Medical Center, Saitama, 344-8588, Japan.
FAU - Yamada, Hirofumi
AU  - Yamada H
AD  - Department of Surgery, Sekishindo Hospital, Saitama, 350-1123, Japan.
FAU - Kuroda, Toru
AU  - Kuroda T
AD  - Department of Surgery, Sekishindo Hospital, Saitama, 350-1123, Japan.
FAU - Hata, Satoshi
AU  - Hata S
AD  - Breast Center, Mitsui Hospital, Saitama, 350-0066, Japan.
FAU - Yamazaki, Yasuo
AU  - Yamazaki Y
AD  - Division of Surgery, Ina Hospital, Saitama, 362-0806, Japan.
FAU - Kojima, Masato
AU  - Kojima M
AD  - Department of Breast, Dokkyo Medical University, Saitama Medical Center, Saitama, 
      343-8555, Japan.
FAU - Futsuhara, Kazushige
AU  - Futsuhara K
AD  - Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, 
      330-8503, Japan.
CN  - SBCCSG-14 investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190710
PL  - United States
TA  - Invest New Drugs
JT  - Investigational new drugs
JID - 8309330
RN  - 0 (Silicates)
RN  - 12067-57-1 (titanium silicide)
RN  - 15H5577CQD (Docetaxel)
RN  - 3Z8479ZZ5X (Epirubicin)
RN  - D1JT611TNE (Titanium)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Chemotherapy, Adjuvant/*mortality
MH  - Docetaxel/administration & dosage
MH  - Epirubicin/administration & dosage
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Middle Aged
MH  - Neoadjuvant Therapy/*mortality
MH  - Paclitaxel/administration & dosage
MH  - Prognosis
MH  - Silicates/administration & dosage
MH  - Survival Rate
MH  - Titanium/administration & dosage
MH  - Triple Negative Breast Neoplasms/*drug therapy/pathology
PMC - PMC6985043
OTO - NOTNLM
OT  - Add-on therapy
OT  - Adjuvant chemotherapy
OT  - Feasibility
OT  - Neoadjuvant chemotherapy
OT  - TS-1
OT  - Triple-negative breast cancer
COIS- Dr. Inoue received grant from Novartis, Pfizer, Chugai, Daiichi-Sankyo, 
      Parexel/Puma Biotechnology, MSD, Bayer, Lilly, and Eisai during the conduct of 
      the study. The other authors declare that they have no conflict of interest.
EDAT- 2019/07/11 06:00
MHDA- 2020/10/24 06:00
PMCR- 2019/07/10
CRDT- 2019/07/11 06:00
PHST- 2019/04/29 00:00 [received]
PHST- 2019/07/01 00:00 [accepted]
PHST- 2019/07/11 06:00 [pubmed]
PHST- 2020/10/24 06:00 [medline]
PHST- 2019/07/11 06:00 [entrez]
PHST- 2019/07/10 00:00 [pmc-release]
AID - 10.1007/s10637-019-00829-w [pii]
AID - 829 [pii]
AID - 10.1007/s10637-019-00829-w [doi]
PST - ppublish
SO  - Invest New Drugs. 2020 Feb;38(1):140-147. doi: 10.1007/s10637-019-00829-w. Epub 
      2019 Jul 10.