Efficacy, safety and quality-of-life data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: results of the TALLISUR trial

Abstract

Introduction: Trifluridine/tipiracil (FTD/TPI) improved both overall and progression-free survival (OS, PFS) of patients with pre-treated metastatic colorectal cancer (mCRC) in the pivotal phase III RECOURSE trial. However, healthrelated quality of life (HRQoL) was not assessed directly. To this end and to generate post-authorisation data, the TALLISUR trial was conducted. 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). A validated questionnaire, EORTC QLQ-C30, was employed to assess HRQoL. Secondary endpoints included OS, PFS and safety. Results: Of 194 eligible patients, 185 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. On the other hand, treatment with FTD/TPI was associated with maintained HRQoL. Median OS was 6.9 months [95% confidence interval (CI) 6.1-8.2 months] and median PFS was 2.5 months (95% CI 2.1-2.9 months). The most frequent treatment-emergent adverse events were neutropenia (27.6%) and anaemia (22.7%). 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 HRQoL.

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

“…The number of returned/evaluable questionnaires decreased over time, which may limit further conclusions that can be drawn. Nevertheless, the results of patient‐reported QoL in our study are in line with data reported in several clinical trials, indicating a preservation of QoL in patients with mCRC treated with FTD/TPI 28‐30 …”

“…Evaluation of effectiveness of treatment in subgroups of patients with different characteristics might provide valuable information in terms of prognostic value. In TACTIC, PFS was comparable between the prognostic subgroups (BPC/GPC vs PPC), while OS was markedly longer in the subgroups of patients with BPC (median 13.3 months) or GPC (median 8.9 months) as compared to the subgroup of patients with PPC (median 5.1 months), which is in line with the data reported in the explorative post hoc analysis of the results of the RECOURSE trial ( [28][29][30] To potentially achieve full benefit of therapy, maintaining a high relative dose intensity is of key importance. The median relative dose intensity of FTD/TPI in TACTIC was 91.3%, which is in line with the 89% reported in the RECOURSE trial.…”

Long-Term Progression-Free Survival of a Pre-Treated Patient with Metastatic Colorectal Cancer Receiving Trifluridine/Tipiracil

“…Nevertheless, treatment with trifluridine/tipiracil achieved disease control for an outstanding 31 months. This therapeutic effect is encouraging, since PFS of the described patient was considerably longer compared to median PFS and OS data from several clinical phase 3 studies and real-world settings (median PFS <5 months, median OS <9 months) [7,9,10,[16][17][18]. In earlier Michl/Vogt/Nouriani/Ladurner/Kremer/ Reisländer/Michl treatment lines, trifluridine/tipiracil is currently under investigation as a novel chemotherapy backbone for monoclonal antibodies (Table 1).…”

“…Although in the last 2 decades novel therapeutic regimens, optimized surgical interventions, and more sensitive diagnostic approaches have increased the median OS from 15 to 30 months [3][4][5], patients with refractory mCRC or intolerance to standard treatment have an unmet medical need [6]. For these patients, the novel oral anti-tumor agent trifluridine/tipiracil (sometimes known as TAS-102 or by its tradename Lonsurf ® ), which combines the antineoplastic thymidine-based nucleoside analog trifluridine with the thymidine phosphorylase inhibitor tipiracil hydrochloride, was shown to improve survival while maintaining a manageable toxicity profile [7][8][9][10].…”

Trifluridine/tipiracil (FTD/TPI) in metastatic colorectal cancer treatment

“…That study assessed the health--related quality of life (HRQoL) with the QLQ-C30 Version 3.0 questionnaire designed by the European Organization for Research and Treatment of Cancer (EORTC). Considering the extended time to complete the questionnaires, 67.0% (95% CI 57.3-75.7%) of patients reported a stabilized or improved HRQoL score [35].…”