Trifluridine/tipiracil in Real Clinical Practice – Current Data from Spain
Trifluridine/tipiracil is indicated for the treatment of patients with refractory metastatic colorectal cancer (mCRC), where clinical studies have shown it extends overall survival (OS) and progression-free survival (PFS). At this year's virtual World Congress on Gastrointestinal Cancer of the European Society for Clinical Oncology (ESMO), held from June 30, a Spanish study on the efficacy of trifluridine/tipiracil in real-world clinical practice was presented.
Assessed Patient Population
This was a multicenter retrospective analysis of data from mCRC patients who were treated with the combination of trifluridine and tipiracil in 4 Spanish hospitals from November 2015 to the present. The efficacy and safety profile of the treatment were assessed.
A total of 222 patients (62.6% male) with a median age of 62 years (range 31–83 years) were included in the evaluation. Most patients received trifluridine/tipiracil in the 3rd (54.5%) or 4th line of therapy (29.3%).
Results
Disease control (DCR) was achieved in 33.8% of patients after an average of 3 cycles of therapy. The median PFS was 3.9 months (95% confidence interval [CI] 3.5–4.2), and the median OS was 9.3 months (95% CI 7.9–10.7). No significant differences in treatment efficacy were observed based on the location of the primary tumor or mutations in the RAS/BRAF genes.
Efficacy Based on Metastatic Disease Extent
Patients with low-volume metastases (absence of massive liver metastases or without concurrent liver and lung metastases) achieved better disease control than patients with high-volume metastases (44.9% vs. 24.2%; p = 0.03). This subgroup also observed longer PFS (4.1 vs. 3.5 months; p = 0.024) and OS (11.7 vs. 7.8 months; p = 0.012).
Characteristics of the Subgroup with the Greatest Benefit from Treatment
In the group with the longest treatment duration (6 or more cycles; n = 51), almost all patients (92.2%) achieved disease stabilization. 43.1% of patients in this subgroup were younger than 65 years, 60.8% had low-volume metastatic disease, and 54.9% were treated with trifluridine/tipiracil in the 2nd or 3rd line of therapy. PFS in this subgroup was significantly higher (9.3 months; p < 0.001) with higher OS (15.9 months; p < 0.001).
Safety Profile
Trifluridine/tipiracil treatment was very well tolerated. Dose reduction was necessary in 34.7% of patients, and therapy had to be discontinued due to toxicity in only 4.1% of patients. Common adverse events included neutropenia (in 74.1% of patients; grade ≥ 3 in 20.2%). Other frequently observed adverse events were fatigue (57.8%), diarrhea (21.5%), and nausea (24.7%).
Conclusion
The efficacy of trifluridine/tipiracil observed in the cohort of mCRC patients treated in real-world clinical practice was in line with the results of the RECOURSE clinical trial. The safety profile was also consistent with previous evaluations. Patients with low-volume metastases who received early treatment (2nd and 3rd line) benefited the most from the therapy.
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Source:
- Martínez Pérez J., Espinosa Montaño M., Luque Caro N., Aviñó Tarazona V. P-116 What have we learned about trifluridine/tipiracil (TAS-102)? Real-world data from four GEODA hospitals (Spain). Ann Oncol 2021; 32 (Suppl. 3): S138, doi: 10.1016/j.annonc.2021.05.171.
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SPC - Souhrn údajů o přípravku Lonsurf [pdf]
SPC - Souhrn údajů o přípravku Lonsurf
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