PMID- 29176395
OWN - NLM
STAT- MEDLINE
DCOM- 20180510
LR  - 20201209
IS  - 1473-5741 (Electronic)
IS  - 0959-4973 (Linking)
VI  - 29
IP  - 1
DP  - 2018 Jan
TI  - Integrated safety summary for trifluridine/tipiracil (TAS-102).
PG  - 89-96
LID - 10.1097/CAD.0000000000000554 [doi]
AB  - Trifluridine/tipiracil, an oral treatment combining trifluridine (an 
      antineoplastic thymidine-based nucleoside analog) and tipiracil hydrochloride (a 
      thymidine phosphorylase inhibitor), led to significant improvement in overall 
      survival in metastatic colorectal cancer (mCRC) patients refractory to standard 
      therapy in the phase III RECOURSE trial. Here, we report an integrated summary of 
      the safety of trifluridine/tipiracil. The main safety analysis includes 
      integrated data from the RECOURSE and J003 studies (safety data group 2) of 
      patients with refractory mCRC receiving trifluridine/tipiracil at the recommended 
      starting dose: 35 mg/m twice daily for 5 days with 2 days' rest for 2 weeks, 
      followed by a 14-day rest (one cycle). Integrated data from a larger group of 
      mCRC patients receiving trifluridine/tipiracil at the recommended starting dose 
      (group 1) and nonintegrated data on serious adverse events (SAEs) representing 
      all clinical experience with trifluridine/tipiracil as of the data cutoff date 
      (group 3) are also summarized. In group 2, myelosuppressive and all-grade 
      gastrointestinal adverse events (AEs) were more frequent in 
      trifluridine/tipiracil patients than in placebo patients. The 
      trifluridine/tipiracil and placebo patients had similar frequencies of AEs 
      leading to discontinuation (9.0 vs. 11.5%) and SAEs (27.7 vs. 29.2%); fatal AEs 
      were more frequent in placebo patients than in trifluridine/tipiracil patients 
      (9.3 vs. 2.8%). AEs leading to interruptions/delays/reductions were more frequent 
      in trifluridine/tipiracil patients (56.3 vs. 12.7%). Trifluridine/tipiracil was 
      generally well tolerated, but over 50% of patients required 
      interruptions/delays/reductions. There was a low rate of discontinuations, SAEs, 
      and fatal AEs. This analysis confirms the safety profile observed in RECOURSE.
FAU - Falcone, Alfredo
AU  - Falcone A
AD  - Department of Oncology and the Specialization School, Pisana University Hospital, 
      University of Pisa, Pisa.
FAU - Ohtsu, Atsushi
AU  - Ohtsu A
AD  - Department of GI Oncology/Gastroenterology.
FAU - Van Cutsem, Eric
AU  - Van Cutsem E
AD  - Digestive Oncology Unit, University Hospitals Leuven, Leuven, Belgium.
FAU - Mayer, Robert J
AU  - Mayer RJ
AD  - Center for Gastrointestinal Oncology, Dana-Farber Cancer Institute, Boston, 
      Massachusetts.
FAU - Buscaglia, Michele
AU  - Buscaglia M
AD  - Radiodynamics Service, IRCCS AOU San Martino IST, Genoa, Italy.
FAU - Bendell, Johanna C
AU  - Bendell JC
AD  - GI Oncology Research, Development Unit, Sarah Cannon Research Institute, 
      Tennessee Oncology, Nashville, Tennessee.
FAU - Kopetz, Scott
AU  - Kopetz S
AD  - Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson 
      Cancer Center, Houston, Texas.
FAU - Bebeau, Paul
AU  - Bebeau P
AD  - Pharmacovigilance, Taiho Oncology, Inc., Princeton, New Jersey, USA.
FAU - Yoshino, Takayuki
AU  - Yoshino T
AD  - Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer 
      Center Hospital East, Kashiwa, Japan.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Anticancer Drugs
JT  - Anti-cancer drugs
JID - 9100823
RN  - 0 (Drug Combinations)
RN  - 0 (Pyrrolidines)
RN  - 0 (trifluridine tipiracil drug combination)
RN  - 56HH86ZVCT (Uracil)
RN  - QR26YLT7LT (Thymine)
RN  - RMW9V5RW38 (Trifluridine)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/*adverse 
      effects
MH  - Clinical Trials, Phase I as Topic
MH  - Colorectal Neoplasms/*drug therapy
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pyrrolidines
MH  - Randomized Controlled Trials as Topic
MH  - Thymine
MH  - Trifluridine/administration & dosage/*adverse effects
MH  - Uracil/administration & dosage/adverse effects/*analogs & derivatives
EDAT- 2017/11/28 06:00
MHDA- 2018/05/11 06:00
CRDT- 2017/11/28 06:00
PHST- 2017/11/28 06:00 [pubmed]
PHST- 2018/05/11 06:00 [medline]
PHST- 2017/11/28 06:00 [entrez]
AID - 10.1097/CAD.0000000000000554 [doi]
PST - ppublish
SO  - Anticancer Drugs. 2018 Jan;29(1):89-96. doi: 10.1097/CAD.0000000000000554.