Trifluridine/tipiracil in metastatic colorectal cancer: An updated multicentre real-world analysis on efficacy, safety and predictive factors
| Autor: | V. Aggelis, M. Hill, C.E. Holden, M. Chauhan, Timothy Iveson, Alicja Synowiec, Athanasios Pouptsis, Chara Stavraka, T. Mills-Baldock, Maria Martinou, Anne Thomas, S. Young, K K Shiu, Christina Karampera, Paul Ross, L. Satterthwaite, Mark Baxter, B.K. Eccles, Sherif Abdel-Raouf, S. Khan |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty education.field_of_study business.industry Population Hematology Disease control 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Survival benefit Oncology Tipiracil hydrochloride 030220 oncology & carcinogenesis Family medicine Neutropaenic fever medicine Dose reduction business education Toxicity profile Third line treatment |
| Zdroj: | Annals of Oncology. 30:v226 |
| ISSN: | 0923-7534 |
| Popis: | Background The orally administered combination trifluridine and tipiracil hydrochloride (TAS-102) has been approved as third line treatment in metastatic colorectal cancer, demonstrating survival benefit and acceptable toxicity profile in the phase III RECOURSE study. Methods We performed an updated multicentre retrospective observational study of patients with metastatic colorectal cancer, receiving TAS-102 as third line treatment between 2016 and 2019 in 8 cancer centers across the UK. Medical records were reviewed for clinicopathological characteristics, treatment, survival and toxicity outcomes. Prognostic and predictive factors were identified with uni-and multivariate regression analyses. Results A total of 236 patients were included. Median age was 69 years (31-89). All patients had received at least 2 lines of fluoropyrimidine-based chemotherapy doublet with oxaliplatin or irinotecan. About 10% of patients had ECOG > 2. Median duration of TAS-102 treatment was 3 months (0.2-25.9), with an ORR of 2.1% and disease control rate of 21.6%. Median OS was 7.6 months (95%CI 6.5-8.6) and median PFS 3.3 months (95%CI 3.01-3.57). A dose reduction was required in 27% of patients, while 7.6% discontinued treatment due to toxicity. Neutropenia was present in 53%, (>G3 34%) with 4.6% cases of neutropaenic fever. Thrombocytopenia was less frequent 11% (>G3 1.6%). Fatigue was reported in 67.3% (G3 9%), nausea 30% (G3 3.3%) and diarrhoea 24.5% (G3 2%). Baseline Neutrophil to Lymphocyte ratio (NLR) Conclusions These results are consistent with the efficacy and toxicity outcomes from RECOURSE study. However, lower disease control rates and higher rates of dose reductions are seen in the real-world population. Pre-treatment NLR and CEA could serve as potential markers for patient selection. Prospective validation is needed. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure C. Stavraka: Travel / Accommodation / Expenses: Servier; Travel / Accommodation / Expenses: Amgen. V. Aggelis: Travel / Accommodation / Expenses: Amgen. T.J. Iveson: Advisory / Consultancy: Servier; Advisory / Consultancy: Roche; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Bristol-Myers Squibb. K. Shiu: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Guardant Health; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck KGaA; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sirtex; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Servier. M.E. Hill: Honoraria (self), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Travel / Accommodation / Expenses: Servier; Honoraria (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Travel / Accommodation / Expenses: Roche. P.J. Ross: Research grant / Funding (self): Sanofi; Honoraria (self), Travel / Accommodation / Expenses: Servier; Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: Bayer; Honoraria (self): Sirtex; Honoraria (self): Celgene; Honoraria (self): Pierre Fabre. All other authors have declared no conflicts of interest. |
| Databáze: | OpenAIRE |
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