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Published on: September 30, 2016
Prognostic factors in refractory metastatic colorectal cancer patients treated with Trifluridine/Tipiracil
Agnieszka Koper1,2, Sławomir Wileński3,4, Paulina Śledzińska5
1Department of Oncology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Collegium Medicum, 85-067, Bydgoszcz, Poland.
Purpose:
The systemic treatment options for metastatic colorectal cancer (mCRC) are unsatisfactory, and the disease recurs despite the use of numerous medications and their combinations. Trifluridine/Tipiracil is a relatively new drug used in refractory mCRC. Little is known about its real-world effectiveness and prognostic and predictive factors. Therefore, this study aimed to develop a prognostic model for refractory mCRC treated with Trifluridine/Tipiracil.
Methods:
We retrospectively evaluated the data from 163 patients who had received Trifluridine/Tipiracil as a third or fourth line of treatment for refractory mCRC.
Results:
After starting Trifluridine/Tipiracil, 21.5% of patients survived one year, and the median overall survival after Trifluridine/Tipiracil initiation was 251 days (SD: 17.855; 95%CI: 216-286). Median progression-free survival after Trifluridine/Tipiracil initiation was 56 days (SD: 4.826; 95%CI 47-65). Moreover, the median overall survival from diagnosis was 1333 days (SD: 82.84; 95%CI: 1170-1495). In forward stepwise multivariate Cox regression analysis, initial radical treatment (HR = 0.552, 95% CI 0.372-0.819, p < 0.003), the number of cycles of first-line chemotherapy (HR = 0.978, 95% CI 0.961-0.995, p < 0.011), the number of cycles of second-line chemotherapy (HR = 0.955, 95% CI 0.931-0.98, p < 0.011), BRAF mutation (HR = 3.016, 95% CI = 1.207-7.537, p = 0.018), and hypertension (HR = 0.64, 95% CI = 0.44-0.931, p = 0.02) were all associated with survival after Trifluridine/Tipiracil initiation. Our model and model-based nomogram displayed an AUC of 0.623 for one-year survival estimation in the testing cohort. The C-index for the prediction nomogram was 0.632.
Conclusion:
We have developed a prognostic model for refractory mCRC treated with Trifluridine/Tipiracil based on five variables. Moreover, we reported a nomogram which could be used by oncologists in clinic visits on a daily basis.
Insights
This study developed a prognostic model for metastatic colorectal cancer (mCRC) patients treated with Trifluridine/Tipiracil. The model identifies key factors to predict survival in refractory mCRC, aiding clinical decision-making.
Area of Science:
- Oncology
- Clinical Research
- Cancer Therapeutics
Background:
- Metastatic colorectal cancer (mCRC) presents limited systemic treatment options, with frequent recurrence despite combination therapies.
- Trifluridine/Tipiracil is a newer therapeutic agent for refractory mCRC, but its real-world efficacy and prognostic factors remain underexplored.
Purpose of the Study:
- To develop a predictive prognostic model for patients with refractory metastatic colorectal cancer (mCRC) undergoing treatment with Trifluridine/Tipiracil.
- To identify significant prognostic and predictive factors influencing survival in this patient cohort.
Main Methods:
- Retrospective analysis of data from 163 patients with refractory mCRC treated with Trifluridine/Tipiracil as third or fourth-line therapy.
- Multivariate Cox regression analysis was employed to identify variables associated with survival outcomes.
Main Results:
- The median overall survival post-Trifluridine/Tipiracil initiation was 251 days, with a one-year survival rate of 21.5%.
- Key prognostic factors identified include initial radical treatment, number of chemotherapy cycles in first and second lines, BRAF mutation status, and hypertension.
- The developed prognostic model and nomogram demonstrated predictive accuracy (AUC 0.623, C-index 0.632) for one-year survival.
Conclusions:
- A novel prognostic model incorporating five variables has been established for refractory mCRC patients treated with Trifluridine/Tipiracil.
- A clinical nomogram derived from this model is presented for practical application by oncologists in daily practice.

