Study TACTIC – Efficacy and Safety of Trifluridine/Tipiracil in Pre-treated mCRC Patients in Real-world Practice
In the pivotal phase III RECOURSE randomized placebo-controlled study, therapy with trifluridine/tipiracil (FTD/TPI) was associated with improved overall survival and progression-free survival in pre-treated metastatic colorectal cancer (mCRC) patients. The below-presented TACTIC study provides prospective data from German real-world practice.
Methodology and Study Progress, Monitored Population
In the German prospective multicenter open non-interventional TACTIC study, 307 patients (58% men, average age of 67.7 years) with pre-treated mCRC were included. They took FTD/TPI between June 2018 and August 2021 (on average for 3.4 cycles) at a dose of 35 mg/m2 orally twice daily on days 1-5 and 8-12 of each 28-day cycle. The primary monitored parameter was overall survival (OS). Secondary monitored parameters were progression-free survival (PFS) and treatment safety.
Based on post hoc analysis results of the RECOURSE study, patients were divided into 3 subgroups according to prognostic factors: "best prognostic group" (BPC; patients with GPC without liver metastases), "good prognostic group" (GPC; < 3 distant metastases and ≥ 18 months from diagnosis), and "poor prognostic group" (PPC; remaining patients).
Findings
A total of 17.0% of patients had an ECOG performance status (PS) of 2-3 at study inclusion. For patients with an ECOG PS of ≤ 1 (n = 243), a median OS of 8.6 months was achieved. OS was significantly longer in the BPC subgroup (n = 54; median OS = 16.2 months) and GPC subgroup (n = 147; median OS = 9.8 months) than in the PPC subgroup (n = 96; median OS = 6.3 months). These data correspond to the RECOURSE study findings.
Similar results were observed in patients with an ECOG PS of ≤ 3 (n = 300). The median OS for them was 7.4 months, with 13.3 months in the BPC subgroup (n = 65), 8.9 months in the GPC subgroup (n = 176), and 5.1 months in the PPC subgroup (n = 124).
The median PFS for the entire evaluated population was 2.9 months. For patients with BPC (4.0 months) and GPC (3.4 months), it was longer than for patients with PPC (2.6 months).
Regarding safety, the most common adverse events recorded during treatment were anemia (20.5%), leukopenia (18.6%), and neutropenia (16.9%).
Conclusion
Data from German real-world practice confirm the results of the placebo-controlled RECOURSE study, i.e., that FTD/TPI administration in pre-treated mCRC patients is associated with prolonged OS and PFS with manageable toxicity. Regardless of the patient performance status, favorable prognostic factors were low metastatic burden and longer time from disease diagnosis.
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Source: Semsek D., Kröning H., Göhler T. et al. P-55 Efficacy and safety data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: real-world data from the non-interventional TACTIC study. Ann Oncol 2022; 33 (4): 2666–2667, doi: 10.1016/j.annonc.2022.04.145.
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