This study is a retrospective study to compare the efficacy and safety between trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) with TAS-102 monotherapy in refractory metastatic colorectal cancer (mCRC) from November 2020 to October 2022 at the Hunan Cancer Hospital.
Our retrospective analysis was conducted to explore the efficacy and safety of patients treated with at least 1 cycle of TAS-102 with or without BEV in patients suffering refractory mCRC from November 2020 to October 2022 at the Hunan Cancer Hospital. Data from the electronic medical records were the sources. In TAS-102 monotherapy group, TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days were given to patients, while on days 1 and 15, every 28 days, patients received bevacizumab (5 mg /kg, intravenously) in TAS-102 plus BEV group. The median OS (mOS) was the primary end point.while mPFS, the ORR, the disease control rate(DCR) and the incidence of treatment-related adverse events (TRAEs) were the secondary end points.
Study Type
OBSERVATIONAL
Enrollment
90
TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days
Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days
Hunan Cancer hospital
Changsha, Hunan, China
Overall Survival (OS)
Overall survival defined as the observed time elapsed between the date of commencement of treatment and the date of death due to any cause
Time frame: Approximately 12 months
Progression-free survival (PFS)
Progression-free survival defined as the time elapsed between the date of commencement of treatment and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.
Time frame: Approximately 12 months
Overall response rate (ORR)
Overall response rate (ORR) was regarded as the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment
Time frame: Approximately 12 months
Disease control rate (DCR)
Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate
Time frame: Approximately 12 months
Treatment-Related Adverse Events (TRAE)
Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
Time frame: Approximately 12 months
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