An Observational Study of Trifluridine/Tipiracil-Containing Regimen Versus Regorafenib-Containing Regimen in Patients With Metastatic Colorectal Cancer
Abstract:BackgroundThere are no randomized control trials comparing the efficacy of trifluridine/tipiracil and regorafenib in patients with metastatic colorectal cancer (mCRC). Herein, we conducted an observational study to compare the oncologic outcomes of trifluridine/tipiracil-containing regimen (TAS-102) and regorafenib-containing regimen (REG) in patients with mCRC.Material and methodPatients who were diagnosed to have mCRC in 2015 to 2021 and treated with TAS-102-containing regimen or REG-containing regimen were … Show more
“…Of these, 19 articles were selected for full text assessment. In addition to the seven studies originally included in the review by Walter et al [ 11 ], eight new publications met the eligibility criteria and were included [ 4 , 25 – 31 ] (Fig. 1 ), resulting in a total of 15 studies.…”
Section: Resultsmentioning
confidence: 99%
“…1 ), resulting in a total of 15 studies. Of the eight new studies, three were RCTs [ 4 , 30 , 31 ] and five were observational studies [ 25 – 29 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…The key characteristics of the included studies are summarized in Table 2 [ 4 , 25 – 38 ]. Of the new studies, none assessed SIRT; five studies compared TFD/TPI with REG [ 25 – 29 ], one compared TFD/TPI with a placebo group [ 30 ], and two compared REG with a placebo group [ 4 , 31 ].…”
Section: Resultsmentioning
confidence: 99%
“…Considering all 15 studies, ECOG performance status was not reported in three studies [ 25 , 27 , 32 ]. EHD was an exclusion criterion in one study [ 33 ].…”
Section: Resultsmentioning
confidence: 99%
“…The proportion of patients exposed to previous chemotherapy is summarized in Supplementary Materials Table S11 . Among the 15 studies, three did not provide information on the number of prior chemotherapy regimens [ 4 , 27 , 33 ], and five did not report the chemotherapeutic agent used [ 25 , 26 , 28 ]. Of the studies providing this information, most reported two or three prior chemotherapy regimens.…”
Introduction
This literature review and exploratory network meta-analysis (NMA) aimed to compare the clinical effectiveness and tolerability of selective internal radiation therapy (SIRT) using yttrium-90 (Y-90) resin microspheres, regorafenib (REG), trifluridine–tipiracil (TFD/TPI), and best supportive care (BSC) in adult patients with chemotherapy-refractory or chemotherapy-intolerant metastatic colorectal cancer (mCRC).
Methods
In light of recently published data, the literature was searched to complement and update a review published in 2018. Studies up to December 2022 comparing two or more of the treatments and reporting overall survival (OS), progression-free survival (PFS), or incidence of adverse events (AE) were included. The NMA compared hazard ratios (HRs) for OS and PFS using Markov chain Monte Carlo techniques.
Results
Fifteen studies were included, with eight studies added (none addressing SIRT). All active treatments improved OS in relation to BSC. SIRT had the longest OS among all treatments, although without statistically significant differences (HR [95% credible interval] for SIRT, 0.48 [0.27, 0.87]; TFD/TPI, 0.62 [0.46, 0.83]; REG, 0.78 [0.57, 1.05]) in a fixed effects model. Information regarding SIRT was insufficient for PFS analysis, and TFD/TPI was the best intervention (HR 2.26 [1.6, 3.18]). One SIRT study reported radioembolization-induced liver disease in > 10% of the sample; this was symptomatically managed. Non-haematological AEs (hand-foot skin reaction, fatigue, diarrhoea, hypertension, rash or desquamation) were more common with REG, while haematological events (neutropoenia, leukopenia, and anaemia) were more common with TFD/TPI.
Conclusion
Current evidence supports SIRT treatment in patients with chemotherapy-refractory or chemotherapy-intolerant mCRC compared to newer oral agents, with comparable OS and low incidence of AEs.
Supplementary Information
The online version contains supplementary material available at 10.1007/s12325-024-02800-5.
“…Of these, 19 articles were selected for full text assessment. In addition to the seven studies originally included in the review by Walter et al [ 11 ], eight new publications met the eligibility criteria and were included [ 4 , 25 – 31 ] (Fig. 1 ), resulting in a total of 15 studies.…”
Section: Resultsmentioning
confidence: 99%
“…1 ), resulting in a total of 15 studies. Of the eight new studies, three were RCTs [ 4 , 30 , 31 ] and five were observational studies [ 25 – 29 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…The key characteristics of the included studies are summarized in Table 2 [ 4 , 25 – 38 ]. Of the new studies, none assessed SIRT; five studies compared TFD/TPI with REG [ 25 – 29 ], one compared TFD/TPI with a placebo group [ 30 ], and two compared REG with a placebo group [ 4 , 31 ].…”
Section: Resultsmentioning
confidence: 99%
“…Considering all 15 studies, ECOG performance status was not reported in three studies [ 25 , 27 , 32 ]. EHD was an exclusion criterion in one study [ 33 ].…”
Section: Resultsmentioning
confidence: 99%
“…The proportion of patients exposed to previous chemotherapy is summarized in Supplementary Materials Table S11 . Among the 15 studies, three did not provide information on the number of prior chemotherapy regimens [ 4 , 27 , 33 ], and five did not report the chemotherapeutic agent used [ 25 , 26 , 28 ]. Of the studies providing this information, most reported two or three prior chemotherapy regimens.…”
Introduction
This literature review and exploratory network meta-analysis (NMA) aimed to compare the clinical effectiveness and tolerability of selective internal radiation therapy (SIRT) using yttrium-90 (Y-90) resin microspheres, regorafenib (REG), trifluridine–tipiracil (TFD/TPI), and best supportive care (BSC) in adult patients with chemotherapy-refractory or chemotherapy-intolerant metastatic colorectal cancer (mCRC).
Methods
In light of recently published data, the literature was searched to complement and update a review published in 2018. Studies up to December 2022 comparing two or more of the treatments and reporting overall survival (OS), progression-free survival (PFS), or incidence of adverse events (AE) were included. The NMA compared hazard ratios (HRs) for OS and PFS using Markov chain Monte Carlo techniques.
Results
Fifteen studies were included, with eight studies added (none addressing SIRT). All active treatments improved OS in relation to BSC. SIRT had the longest OS among all treatments, although without statistically significant differences (HR [95% credible interval] for SIRT, 0.48 [0.27, 0.87]; TFD/TPI, 0.62 [0.46, 0.83]; REG, 0.78 [0.57, 1.05]) in a fixed effects model. Information regarding SIRT was insufficient for PFS analysis, and TFD/TPI was the best intervention (HR 2.26 [1.6, 3.18]). One SIRT study reported radioembolization-induced liver disease in > 10% of the sample; this was symptomatically managed. Non-haematological AEs (hand-foot skin reaction, fatigue, diarrhoea, hypertension, rash or desquamation) were more common with REG, while haematological events (neutropoenia, leukopenia, and anaemia) were more common with TFD/TPI.
Conclusion
Current evidence supports SIRT treatment in patients with chemotherapy-refractory or chemotherapy-intolerant mCRC compared to newer oral agents, with comparable OS and low incidence of AEs.
Supplementary Information
The online version contains supplementary material available at 10.1007/s12325-024-02800-5.
2 Oddělení buněčné a vývojové biologie, Ústav molekulární genetiky AV ČR, v. v. i., Praha Systémová onkologická léčba metastazujícího kolorektálního karcinomu je v současnosti založena na chemoterapii kombinované s cílenou léčbou indikovanou podle přítomnosti aktivačních mutací v signální dráze EGFR-RAS-RAF, a to bez ohledu na histologickou podskupinu nádoru. V kazuistice popisujeme pacienta s mucinózní variantou kolorektálního karcinomu, který ve třetí linii léčby velmi dobře zareagoval na trifluridin/tipiracil. Ve stručném přehledu uvádíme základní charakteristiky tohoto histologického subtypu, který představuje 5-15 % všech případů, je charakterizován vysokou produkcí extracelulárního mucinu a je v souvislosti s nižší léčebnou odpovědí na chemoterapii spojován s horší prognózou. Dále poukazujeme na časný výskyt neutropenie jako potenciálního prediktivního ukazatele při léčbě trifluridinem/tipiracilem.
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