Abstract 3136
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) <5 and CEA <200 had favourable prognostic (HR: 0.52 and 0.39, p < 0.001) and predictive value (OR: 4.1 and 6.7, p < 0.05). Development of G3 neutropenia predicted treatment response (OR: 0.32, p < 0.001). Following TAS-102 treatment 41% were referred for Phase I trial or rechallenged with chemotherapy.
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.
Clinical trial identification
Editorial acknowledgement
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.
Resources from the same session
2107 - Role of Individualized Intervention(s) on Quality of Life (QOL) and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women with Early-Stage Breast Cancer (BC): MyChoice Study
Presenter: Shahid Ahmed
Session: Poster Display session 2
Resources:
Abstract
5812 - Correlation between the density of tumor-infiltrating lymphocytes, immune cell subsets in tumor stroma and response to systemic therapy in breast cancer
Presenter: Cvetka Grasic Kuhar
Session: Poster Display session 2
Resources:
Abstract
4734 - BRCA1/2 Testing in HER2- Advanced Breast Cancer (ABC): Results from the European Component of a Multi-Country Real World Study
Presenter: Michael Patrick Lux
Session: Poster Display session 2
Resources:
Abstract
1686 - In vitro and in vivo rescue of resistance to BET inhibitors by targeting PLK1 in triple negative breast cancer.
Presenter: Cristina Nieto-jiménez
Session: Poster Display session 2
Resources:
Abstract
5020 - Neoadjuvant endocrine therapy in combination with melatonin and metformin in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
5082 - Melatonin and metformin in neoadjuvant chemotherapy in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
2642 - Patient-tailored tamoxifen dosing based on an increased quantitative understanding of its complex pharmacokinetics: A novel integrative modelling approach
Presenter: Anna Mueller-Schoell
Session: Poster Display session 2
Resources:
Abstract
2461 - Lack of benefit of neoadjuvant pertuzumab in high risk HER2 positive breast cancer. A retrospective case-control study of 355 cases with biomarker analysis.
Presenter: Manuela Tiako Meyo
Session: Poster Display session 2
Resources:
Abstract
4776 - Targeting CDCA3 to improve chemotherapy response in triple-negative breast cancer patients
Presenter: Kenneth O'Byrne
Session: Poster Display session 2
Resources:
Abstract
1674 - Activity of BET-proteolysis targeting chimeric (PROTAC) compounds in triple negative breast cancer
Presenter: María Del Mar Noblejas López
Session: Poster Display session 2
Resources:
Abstract