Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy for Refractory Metastatic Colorectal Cancer: a Retrospective Study

Conditions
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Metastatic Colorectal Adenocarcinoma

Intervention / Treatment
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* Drug: Trifluridine/Tipiracil
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded). 2. Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type). Fruquintinib or regorafenib was permitted but not required for inclusion. 3.Has measurable or non-measurable disease as defined by RECIST version 1.1 4.Is able to swallow oral tablets. 5.Estimated life expectancy ≥12 weeks. 6.Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 7. Has adequate organ function. Exclusion Criteria: 1.Pregnancy, lactating female or possibility of becoming pregnant during the study. 2.Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation). 3.Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. 4.Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAS-102 plus BEV group<br>In TAS-102 plus BEV group, Patients received TAS-102 (35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days) and bevacizumab (5 mg /kg, intravenously, on days 1 and 15, every 28 days). Bevacizumab was approved to be a 30-minute intravenous infusion before TAS-102. | Drug: Trifluridine/Tipiracil<br>* TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days<br>* Other names: S 95005;Drug: Bevacizumab<br>* Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days<br>* Other names: Avastin;|
| TAS-102 monotherapy group<br>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. | Drug: Trifluridine/Tipiracil<br>* TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days<br>* Other names: S 95005;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | Approximately 12 months | 
| Treatment-Related Adverse Events (TRAE) | Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs) | Approximately 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer; trifluridine/tipiracil ; bevacizumab