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

Central South University

Status: Completed

Conditions: Metastatic Colorectal Adenocarcinoma

Treatments: Drug: Bevacizumab; Drug: Trifluridine/Tipiracil

Study type: Observational

Funder types: Other

Identifiers

NCT05869097

TDTB-colorectal cancer

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

90 participants in 2 patient groups

TAS-102 plus BEV group

Description:

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.

Treatment:

Drug: Trifluridine/Tipiracil

Drug: Bevacizumab

TAS-102 monotherapy group

Description:

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.

Treatment:

Drug: Trifluridine/Tipiracil