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- Title
Trifluridine/Tipiracil (TAS‐102) in Refractory Metastatic Colorectal Cancer: A Multicenter Register in the Frame of the Italian Compassionate Use Program.
- Authors
Cremolini, Chiara; Rossini, Daniele; Martinelli, Erika; Pietrantonio, Filippo; Lonardi, Sara; Noventa, Silvia; Tamburini, Emiliano; Frassineti, Giovanni Luca; Mosconi, Stefania; Nichetti, Federico; Murgioni, Sabina; Troiani, Teresa; Borelli, Beatrice; Zucchelli, Gemma; Dal Maso, Alessandro; Sforza, Vincenzo; Masi, Gianluca; Antoniotti, Carlotta; Di Bartolomeo, Maria; Miceli, Rosalba
- Abstract
Background: TAS‐102 is indicated for patients with metastatic colorectal cancer (mCRC) previously treated with, or not considered candidates for, available therapies. Given the complete inefficacy in half of patients, the lack of predictive factors, the palliative setting, and the financial and clinical toxicity, optimizing the cost‐benefit ratio is crucial. The "ColonLife" nomogram allows an estimate of the 12‐week life expectancy of patients with refractory mCRC. Materials and Methods: We collected data from patients treated at eight Italian centers in the compassionate use program. Baseline characteristics of patients who were or were not progression free at 6 months were compared. The discriminative ability of the ColonLife nomogram was assessed. Among patients who received both TAS‐102 and regorafenib, clinical outcomes of the two sequences were compared. Results: This study included 341 patients. Six (2%) and 93 (27%) patients achieved response and disease stabilization, respectively. The median progression‐free survival (PFS) was 2.4 months with an estimated 6‐month PFS rate of 19%; the median overall survival (OS) was 6.2 months. An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, normal lactate dehydrogenase (LDH), and a time from the diagnosis of metastatic disease of >18 months were independently associated with higher chances of a patient being progression free at 6 months. The discriminative ability of ColonLife was confirmed. Among 121 patients who received both regorafenib and TAS‐102, no differences in first or second PFS or OS were reported between the two sequences. Conclusion: One out of five patients achieves clinical benefit with TAS‐102. ECOG PS, LDH, and time from diagnosis of metastatic disease may help to identify these patients. Excluding patients with very short life expectancy appears a reasonable approach. Implications for Practice: Improving the cost‐efficacy ratio of TAS‐102 in metastatic colorectal cancer is needed to spare useless toxicities in a definitely palliative setting. Eastern Cooperative Oncology Group performance status, lactate dehydrogenase levels, and time from the diagnosis of metastatic disease may help to identify patients more likely to achieve benefit. Properly designed prognostic tools (i.e., the "ColonLife" nomogram) may enable excluding from further treatments patients with very limited life expectancy. A new fluoropyrimidine recently entered the scene of metastatic colorectal cancer (mCRC): trifluridine/tipiracil, also known as TAS‐102. Improving the cost/efficacy ratio of TAS‐102 in mCRC is needed to avoid toxicities in a definitely palliative setting. ECOG performance score, LDH levels, and time from diagnosis of metastatic disease may help identify patients most likely to benefit. Properly designed prognostic tools, such as the "ColonLife" nomogram, may allow for better treatment decisions for patients with limited life expectancy.
- Subjects
ITALY; ENZYME inhibitors; DEOXYRIBONUCLEOSIDES; RESEARCH; CANCER patients; COLON tumors; LACTATE dehydrogenase; LIFE expectancy; LIFE skills; MEDICAL cooperation; METASTASIS; SURVIVAL; RECTUM tumors; TREATMENT effectiveness; DISEASE progression; STATISTICAL models; DIAGNOSIS; PROGNOSIS; THERAPEUTICS
- Publication
Oncologist, 2018, Vol 23, Issue 10, p1178
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2017-0573