TY - JOUR
T1 - Trifluridine/Tipiracil (TAS-102) in Refractory Metastatic Colorectal Cancer
T2 - A Multicenter Register in the Frame of the Italian Compassionate Use Program
AU - Cremolini, Chiara
AU - Rossini, Daniele
AU - Martinelli, Erika
AU - Pietrantonio, Filippo
AU - Lonardi, Sara
AU - Noventa, Silvia
AU - Tamburini, Emiliano
AU - Frassineti, Giovanni Luca
AU - Mosconi, Stefania
AU - Nichetti, Federico
AU - Murgioni, Sabina
AU - Troiani, Teresa
AU - Borelli, Beatrice
AU - Zucchelli, Gemma
AU - Dal Maso, Alessandro
AU - Sforza, Vincenzo
AU - Masi, Gianluca
AU - Antoniotti, Carlotta
AU - Di Bartolomeo, Maria
AU - Miceli, Rosalba
AU - Ciardiello, Fortunato
AU - Falcone, Alfredo
N1 - © AlphaMed Press 2018.
PY - 2018/10
Y1 - 2018/10
N2 - 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.
AB - 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.
U2 - 10.1634/theoncologist.2017-0573
DO - 10.1634/theoncologist.2017-0573
M3 - Article
C2 - 29739893
VL - 23
SP - 1178
EP - 1187
JO - Oncologist
JF - Oncologist
SN - 1083-7159
IS - 10
ER -