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Real-world Study of Patients with Metastatic Colorectal Cancer Receiving Investigational Bevacizumab in Combination with TAS-102 in the Third or Posterior Line

ABSTRACT: Interventions: Group 1:Bevacizumab combined with TAS-102 Primary outcome(s): overall survival;disease progress free survival Study Design: Single arm

DISEASE(S): Colorectal Cancer

PROVIDER: 81138 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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TAS-102, Irinotecan, and Bevacizumab in Pre-treated Metastatic Colorectal Cancer (TABAsCO), A Phase II Clinical Trial. ClinicalTrials.gov NCT04109924

Project description:Background: The efficacy of FOLFIRI plus an antiangiogenesis biologic agent as 2nd line therapy for metastatic colorectal adenocarcinoma is limited. TAS-102 is a novel oral antimetabolite with a distinct mechanism of action from fluoropyrimidines. We evaluated the antitumor efficacy of TAS-102, irinotecan and bevacizumab in patients with pre-treated, advanced colorectal adenocarcinoma in a multicenter, phase II, single-arm study. Methods: Patients with advanced colorectal adenocarcinoma who had progressed after oxaliplatin and fluoropyrimidine and were eligible for treatment with bevacizumab were treated with irinotecan, bevacizumab, and TAS-102 in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: We enrolled 35 evaluable patients. The study was positive. The median PFS was 7.9 (90% CI 6.2-11.8) months (vs. 6 months in historical control, p=0.018). The median overall survival was 16.5 (90% CI 9.8-17.5) months. Sixty-seven percent of patients experienced grade 3 or higher treatment-related adverse events. The most common toxicities were hematological (neutropenia) and gastrointestinal (diarrhea, nausea, and vomiting). Conclusions: Irinotecan, TAS-102 and bevacizumab is an active 2nd line therapy for patients with metastatic colorectal adenocarcinoma. Neutropenia is common and can affect dose density/intensity mandating use of G-CSF. A randomized study versus standard of care therapy is warranted.

2024-08-26 | GSE275628 | GEO

A phase II study of guadecitabien combined with irinotecan vs regorafenib or TAS-102 in previously treated metastatic colorectal cancer patients

Project description:A phase II study of guadecitabien combined with irinotecan vs regorafenib or TAS-102 in previously treated metastatic colorectal cancer patients

2023-03-31 | GSE226221 | GEO

Multicenter, prospective real-world study of the efficacy and safety of a comprehensive treatment regimen based on TAS-102 for metastatic colorectal cancer

Project description:Interventions: Case series:TAS-102 Primary outcome(s): Median progression free survival Study Design: Single arm

| 37888 | ecrin-mdr-crc

A Comparison of Bevacizumab Plus TAS-102 and TAS-102 Monotherapy for Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis.

Project description:BackgroundsAs a new oral chemotherapy drug, TAS-102 is currently recommended as the third-line treatment for metastatic colorectal cancer (mCRC). Recently, studies have reported the efficacy of TAS-102 combined with bevacizumab in colon cancer patients after standard treatment fails. Here, we evaluated the efficacy and safety of TAS-102 combined with bevacizumab versus TAS-102 as a single agent by a systematic review and a meta-analysis.MethodsPubMed, Web of Science and Cochrane libraries were searched. Studies involving bevacizumab combined with TAS-102 in mCRC were included. Study characteristics (author, year of publication, country et al.), efficacy (disease control rate(DCR), progression-free survival(PFS), overall survival(OS)) and adverse effects were extract from studies. Forest plots were created based on Cox model analysis.ResultsAfter screening 550 studies, a total of 3 studies were included, which compared the safety and effectiveness of TAS-102 with or without bevacizumab. Analysis based on Cox regression showed that the combined treatment group had advantages in 6-month (OR= 2.93, 95% CI: 1.72 to 5.00, P<0.0001), 12-month(OR= 2.18, 95% CI: 1.24 to 3.81, P=0.006), and 18-month (OR=3.08, 95% CI: 1.34 to 7.12, P=0.008) OS. The combined treatment group demonstrated superiority in 6-month PFS rates (OR= 2.50, 95% CI: 1.18 to 5.31, P=0.02). The incidence of thrombocytopenia in the dual-drug treatment group was higher (OR= 1.96, 95% CI: 1.14 to 3.36 P=0.01). The proportion of serious adverse events were similar in tow groups (OR= 1.01, 95% CI: 0.76 to 1.34 P=0.93).ConclusionBevacizumab combined with TAS-102 could improve the prognosis of patients with mCRC who have failed standard treatment. In terms of side effects, the addition of bevacizumab did not increase serious adverse reactions, but the occurrence of thrombocytopenia was worth noting.

| S-EPMC8637322 | biostudies-literature

TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial

Project description:Interventions: TAS-102: 35mg/m2 given orally twice daily on days 1-5 and 15-19 in a 28-day cycle. Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): progression free survival Study Design: Single arm Non-randomized

| 2645202 | ecrin-mdr-crc

TAS-102 and Bevacizumab as third line chemotherapy for colorectal cancer. Phase 2 trial

Project description:Interventions: TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): progression free survival Study Design: Single arm Non-randomized

| 2637698 | ecrin-mdr-crc

Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC

Project description:The purpose of this study is to evaluate the clinical benefit of regorafenib combined with TAS-102 compared with regorafenib monotherapy in patients with metastatic colorectal cancer who have failed at least two lines of treatment, to explore the rationality of this combination therapy strategy and to obtain relevant survival and safety data.

| 68234 | ecrin-mdr-crc

Tas-102 for Refractory Metastatic Colorectal Cancer: A Multicenter Retrospective Cohort Study.

Project description:Trifluridine/tipiracil (TAS-102) is an oral chemotherapy approved for the treatment of metastatic colorectal cancer. The efficacy and tolerability of TAS-102 were shown in phase II-III clinical trials and in several real-life studies. The elderly and other special subgroups are underrepresented in published literature. We conducted a retrospective multicenter study to assess the effectiveness and safety of TAS-102 in consecutive patients with pretreated mCRC. In particular, we estimated the effectiveness and safety of TAS-102 in elderly patients (aged ≥70, ≥75 and ≥80 years) and in special subgroups, e.g., patients with concomitant heart disease. One hundred and sixty patients were enrolled. In particular, 71 patients (44%) were 70 years of age or older, 50 (31%) were 75 years of age or older, and 23 (14%) were 80 years of age or older. 19 patients (12%) had a concomitant chronic heart disease, three (2%) patients were HIV positive, and one (<1%) patient had a DPYD gene polymorphism. In 115 (72%) cases TAS-102 was administered as a third-line treatment. The median overall survival (OS) in the overall population was 8 months (95% confidence interval [CI], 6-9), while the median progression-free survival (PFS) was 3 months (95% CI, 3-4). No significant age-related reduction in effectiveness was observed in the subpopulations of elderly patients included. The toxicity profile was acceptable in both the whole and subgroups' population. Our study confirms the effectiveness and safety of TAS-102 in patients with pretreated mCRC, suggesting a similar risk-benefit profile in the elderly.

| S-EPMC10340604 | biostudies-literature

Expression analysis of colorectal carcinoma cells with defunct TP53 using TAS

Project description:Whole transcriptome expression analysis of colorectal carcinoma cells with defunct TP53 on Affymetrix Human Tiling 1.0 array set. Expression data were processed with TAS.

2016-01-31 | GSE29839 | GEO

The application and exploration of Fruquintnib combined with TAS-102 and Stereotactic Body Radiotherapy(SBRT)for Third-line and Beyond Treatment of Metastatic Colorectal Cancer

Project description:Interventions: Cohort 1:Fruquintnib combined with TAS-102 and SBRT;Cohort 2:Fruquintnib combined with TAS-102 Primary outcome(s): Progression-free survival assessed by the investigator Study Design: Factorial

| 87000 | ecrin-mdr-crc

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