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Multicenter Study
. 2023 Sep 15;153(6):1227-1240.
doi: 10.1002/ijc.34603. Epub 2023 Jun 1.

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

Hendrik Kröning  1 , Thomas Göhler  2 , Thomas Decker  3 , Marc Grundeis  4 , Georgi Kojouharoff  5 , Jörg Lipke  6 , Dieter Semsek  7 , Enno Moorahrend  8 , Annette Sauer  9 , Harald-Robert Bruch  10 , Rüdiger Liersch  11 , Arnd Nusch  12 , Ursula Vehling-Kaiser  13 , Manfred Welslau  14 , Ralf Grunewald  15 , Hanns-Detlev Harich  16 , Marcel Stephany  17 , Jens Uhlig  18 , Rebecca de Buhr  19 , Melanie Frank  19 , Cathrin Hogrefe  19 , Norbert Marschner  19 , Karin Potthoff  19 , Frank Hartmann  20 , Timo Reisländer  20 , Ingo Schwaner  21
Affiliations
Multicenter Study

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

Hendrik Kröning et al. Int J Cancer. .

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 inclusion, ≥18 months from diagnosis of first metastasis to inclusion) or poor (remaining patients) prognostic characteristics (GPC/PPC). GPC without liver metastases was considered best prognostic characteristics (BPC). In total, 307 eligible patients (pretreated or not suitable for other available therapies) were treated with FTD/TPI. Overall, median [95%-CI] OS was 7.4 months [6.4-8.6], median PFS was 2.9 months [2.8-3.3]. In BPC (n = 65) and GPC (n = 176) compared to PPC (n = 124) subgroup, median OS (13.3 [9.1-17.6] vs 8.9 [7.6-9.8] vs 5.1 [4.4-7.0] months) and median PFS (4.0 [3.3-5.3] vs 3.4 [3.0-3.7] vs 2.6 [2.4-2.8] months) were longer. Patient-reported QoL, assessed by validated questionnaires (EQ-5D-5L, PRO-CTCAE), was stable throughout FTD/TPI treatment. Predominant FTD/TPI-related adverse events of grades 3 or 4 were neutropenia (13.0%), leukopenia (7.5%), and anemia (5.2%). Altogether, palliative FTD/TPI therapy in patients with pretreated mCRC was associated with prolonged survival, delayed progression, maintained health-related QoL, and manageable toxicity. Low metastatic burden and indolent disease were favorable prognostic factors for survival. TACTIC confirms the effectiveness and safety of FTD/TPI, highlighting its value in routine clinical practice.

Trial registration: ClinicalTrials.gov NCT03665506.

Keywords: metastatic colorectal cancer; real-world data; trifluridine/tipiracil.

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References

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