Effectiveness, safety and <scp>quality of life</scp> of trifluridine/tipiracil in pretreated patients with metastatic colorectal cancer: Real‐world data from the noninterventional <scp>TACTIC</scp> study in Germany

Kröning, H.; Göhler, Thomas; Decker, Thomas; Grundeis, Marc; Kojouharoff, G.; Lipke, Jörg; Semsek, Dieter; Moorahrend, Enno; Sauer, Annette; Bruch, Harald-Robert; Liersch, Rüdiger; Nusch, Arnd; Vehling-Kaiser, Ursula; Welslau, Manfred; Grunewald, Ralf; Harich, Hanns-Detlev; Stephany, Matthew P.; Uhlig, Jens; Buhr, R. de; Meyer, Frank; Hogrefe, Cathrin; Marschner, Norbert; Potthoff, Karin; Hartmann, Frank; Reisländer, Timo; Schwaner, Ingo

doi:10.1002/ijc.34603

Intl Journal of Cancer

2023

DOI: 10.1002/ijc.34603

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Effectiveness, safety and quality of life of trifluridine/tipiracil in pretreated patients with metastatic colorectal cancer: Real‐world data from the noninterventional TACTIC study in Germany

H. Kröning

Thomas Göhler

Thomas Decker

et al.

Abstract: The prospective, multicenter, noninterventional TACTIC study assessed effectiveness and safety of trifluridine/tipiracil (FTD/TPI) in patients with metastatic colorectal cancer (mCRC) in a real-world setting in Germany, thus evaluating the external validity of the findings from the pivotal RECOURSE trial. Primary endpoint was overall survival (OS). Secondary objectives included progression-free survival (PFS), safety, and quality of life (QoL). Subgroups comprised patients with good (<3 metastatic sites at inc… Show more

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Cited by 3 publications

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Incidence and survival of adenocarcinoma with mixed subtypes in patients with colorectal cancer

Zhang

Yao

et al. 2023

Int J Colorectal Dis

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Background Limited attention was paid to adenocarcinoma with mixed subtypes (AM) of the colon and rectum due to its low incidence. This study aims to assess the frequency and survival rates of tumors in the population. Methods The data were extracted from the Surveillance, Epidemiology, and End Results (SEER) database between 2000 and 2019. The incidence of tumors was evaluated based on patient gender, age, race, and location. Univariate and multivariate Cox analyses were performed to identify risk factors associated with tumor survival. Additionally, a nomogram was constructed using these risk factors to predict cancer-specific survival (CSS) at 1, 2, and 3 years. Receiver operating characteristic (ROC) and calibration curves were applied to examine the model’s accuracy. Results The overall incidence of colorectal AM reached its highest level in 2016 (2.350 (95% CI: 2.241–2.462)). AM is more frequent in elderly patients and predominantly located in the rectum. By forest plot for multivariable Cox regression analysis, patient age, the number of regional positive lymph nodes and lymph nodes removed, tumor N/M stage, and postoperative chemotherapy were identified as independent risk indicators for CSS. Nomogram was constructed and validated as a feasible prediction model of CSS in patients with colorectal AM. Conclusion The presence of colorectal AM in elderly patients, particularly in the rectum, is frequent and often associated with poor prognosis. Our nomograms can offer a relatively accurate prediction of CSS of patients with AM after tumor resection.

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Incidence and survival of adenocarcinoma with mixed subtypes in patients with colorectal cancer

Zhang

Yao

et al. 2023

Int J Colorectal Dis

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Subgroup analyses from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: results of the TALLISUR trial

Karthaus,

Heinemann,

Riera-Knorrenschild

et al. 2024

BMC Cancer

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Background In the pivotal phase III RECOURSE trial, trifluridine/tipiracil (FTD/TPI) improved progression-free and overall survival (PFS, OS) of patients with pre-treated metastatic colorectal cancer (mCRC). Subsequently, the TALLISUR trial provided post-authorisation efficacy and safety data and patient-reported outcomes on quality of life (QoL) in a German patient cohort. The present analysis reports the final data on efficacy, safety and QoL and investigates the impact of baseline characteristics and associated prognostic subgroups on outcome. Methods In this prospective, multi-centre, Germany-wide, phase IV study, patients with pre-treated mCRC were given the choice to receive either FTD/TPI or best supportive care (BSC). To assess the primary endpoint, QoL, EORTC QLQ-C30 questionnaires were employed. Secondary endpoints included QoL assessed through EQ-5D-5L questionnaires, OS, PFS and safety. Additionally, 3 subgroups were defined according to a post-hoc analysis of the RECOURSE trial: best, good and poor prognostic characteristics (BPC, GPC, PPC). Patients with < 3 metastatic sites at inclusion and/or ≥ 18 months from diagnosis to inclusion were considered to have GPC. GPC patients without liver metastasis at inclusion were considered to have BPC. All remaining patients were considered to have PPC. Results Of 195 patients, 186 decided to receive FTD/TPI and 9 to receive BSC. The low number of patients in the BSC-arm did not allow statistically meaningful analyses. Treatment with FTD/TPI was associated with maintained QoL. For all patients, median OS was 6.9 months (95% CI 6.1 – 8.3) and for the defined subgroups (BPC n = 20 vs GPC n = 65 vs PPC n = 121) 12.2, 7.9 and 6.8 months (95% CI 6.0 – 18.2, 6.2 – 13.3, 5.4 – 8.1). The most frequent TEAEs were neutropenia (29.6%), anaemia (24.7%) and nausea (23.7%). Febrile neutropenia occurred in 1.1%. Conclusions Treatment of patients suffering from pre-treated mCRC with FTD/TPI was associated not only with prolonged survival and delayed progression, but also with maintained QoL. Independent of other baseline characteristics such as ECOG performance status and age, low metastatic burden and indolent disease were factors associated with favourable outcome. Clinical trial registration EudraCT-Number 2017–000292-83, first registration 19/06/2017.

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Signal mining and analysis of trifluridine/tipiracil adverse events based on real-world data from the FAERS database

Hu,

Du,

Qiu

et al. 2024

Front. Pharmacol.

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ObjectiveThe objective of this research is to scrutinize adverse events (AEs) linked to Trifluridine/Tipiracil (TFTD/TPI), using data from the FDA Adverse Event Reporting System (FAERS) database.MethodsThe AEs data related to TFTD/TPI were collected from the fourth quarter of 2015 through the fourth quarter of 2023. After normalizing the data, multiple signal quantification techniques including Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian approaches such as Bayesian Confidence Propagation Neural Network (BCPNN) and the Multi-item Gamma Poisson Shrinker (MGPS) were used for overall and subgroup analysis and visualization analyses were performed.ResultsFrom the FAERS database, we analyzed 13,520,073 reports, identifying 8,331 as primary suspect (PS) AEs for TFTD/TPI, occurring across 27 organ systems. The study retained 99 significant disproportionality Preferred Terms (PTs) across four algorithms and unveiled unexpected serious AEs such as iron deficiency and intestinal perforation, hepatic failure, cholangitis and so on. The median onset of TFTD/TPI-associated AEs was 44 days (IQR 20-97 days), with most occurring within the first 30 days of treatment.ConclusionThis research uncovers critical new safety signals for TFTD/TPI, supporting its clinical monitoring and risk identification.

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Effectiveness, safety and quality of life of trifluridine/tipiracil in pretreated patients with metastatic colorectal cancer: Real‐world data from the noninterventional TACTIC study in Germany

Cited by 3 publications

References 26 publications

Incidence and survival of adenocarcinoma with mixed subtypes in patients with colorectal cancer

Incidence and survival of adenocarcinoma with mixed subtypes in patients with colorectal cancer

Subgroup analyses from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: results of the TALLISUR trial

Signal mining and analysis of trifluridine/tipiracil adverse events based on real-world data from the FAERS database

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