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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

2663 - Safety and efficacy of trifluridine/tipiracil (FTD/TPI) in metastatic colorectal cancer (mCRC) patients according to previous treatment with regorafenib in the international phase 3b PRECONNECT study

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Julien Taieb

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

J. Taieb1, A. Falcone2, S. Lonardi3, T.J. Price4, J. Bachet5, L. Wyrwicz6, F. Ciardiello7, M. Becquart8, N. Mounedji8, E. van Cutsem9

Author affiliations

  • 1 Department Of Gastroenterology And Digestive Oncology, Hopital European George Pompidou, 75015 - Paris/FR
  • 2 Department Of Medical Oncology, University of Pisa, Pisa/IT
  • 3 Dip. Oncologia Clinica E Sperimentale, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 4 Haematology And Oncology Clinical Cancer Research, Queen Elizabeth Hospital, 5011 - Woodville/AU
  • 5 Service D’hepato-gastro-entérologie, Groupe Hospitalier Pitié Salpetriere, 75651 - Paris/FR
  • 6 Department Of Digestive System Oncology, Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warszawa/PL
  • 7 Dipartimento Di Medicina Di Precisione, Università degli Studi della Campania Luigi Vanvitelli, 80131 - Napoli/IT
  • 8 Global Medical Affairs Oncology, Servier, 92284 - Suresnes/FR
  • 9 Digestive Oncology, University Hospitals Gasthuisberg/Leuven and KULeuven, 3000 - Leuven/BE
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Resources

Abstract 2663

Background

The oral chemotherapy trifluridine/tipiracil (FTD/TPI or TAS-102) is approved for treatment of previously treated mCRC patients (pts) beyond the second line, in the same setting as regorafenib. Optimal treatment sequencing between the two at this stage is not established. Here, a descriptive post hoc sub-group analysis assessed safety and efficacy of FTD/TPI in mCRC pts according to previous treatment with regorafenib in a preliminary analysis of the phase 3b PRECONNECT study (NCT03306394).

Methods

PRECONNECT is enrolling pts with histologically confirmed mCRC previously treated with available therapies, with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0/1. Pts receive oral FTD/TPI (35 mg/m2 bid) on days 1–5 and 8–12 of each 28-day cycle. Of the 462 patients who received at least one dose at cutoff (1 Nov 2017), 166 (36%) were pretreated with regorafenib.

Results

Patient subgroups pretreated (n = 166) and non-pretreated (n = 296) with regorafenib were broadly similar, with a slight imbalance for RAS mutant status (61% vs 47%), left-sided tumour (58% vs 65%) and treatment line (12% vs 36% receiving FTD/TPI third line), respectively. There was no difference in rate of emergent or drug-related any grade adverse events (AEs), or drug-related grade ≥3 AEs in pts treated with FTD/TPI between the regorafenib pretreated and regorafenib non-pretreated subgroups (98% vs 96%; 77% vs 79%; and 54% vs 51%, respectively). The most common drug-related grade ≥3 AEs were neutropenia (43% vs 40%) and anemia (8% vs 7%). Median FTD/TPI treatment duration were 2.7 and 3.1 months, with a median PFS of 2.7 (95% CI 2.2-3.3) and 3.3 months (95% CI 2.8-3.7), disease control rate was 38% (95% CI 30–46) and 43% (95% CI 37-49) and median time to ECOG-PS ≥2 was 8.5 and 8.7 months in the regorafenib pretreated and regorafenib non-pretreated, respectively.

Conclusions

FTD/TPI may be used either before or after regorafenib with similar efficacy results making treatment safety profile and patient quality of life major points to determine treatment option in third-line for mCRC patients.

Clinical trial identification

EudraCT: 2016-002311-18.

Legal entity responsible for the study

Laboratoires Servier.

Funding

Laboratoires Servier.

Editorial Acknowledgement

Not applicable

Disclosure

J. Taieb: Honoraria speaker or advisory role: Servier, Roche, Lilly, Celgene, Shire, Amgen, Sanofi, Merck, Lilly, Sirtex. A. Falcone: Compensation for participation Advisory Boards, Research Grants to institution: Amgen, Bayer, Merck, MSD, Roche, Lilly, Servier, Bristol. S. Lonardi: Consulting or advisory role: Amgen, Bayer, Merck, Lilly; Speakers' bureau: Lilly; Roche, BMS; Research funding: Amgen. T.J. Price: Advisory board: Amgen (paid self), Merck, Roche, Takeda (paid self). J-B. Bachet: Honoraria: Amgen, Bayer, Celgene, Merck Serono, Roche, Shire, Servier. L. Wyrwicz: Funding or fees: Halozyme, Eisai, Merck. F. Ciardiello: Advisory board role: Servier, Merck, Roche, Amgen, Bayer, Symphogen. M. Becquart, N. Mounedji: Employee: Servier. E. Van Cutsem: Grants: Amgen, Bayer, BMS, Boehringer, Celgene, Ipsen, Lilly, Merck, MSD, Novartis, Roche, Servier; Honoraria: Bayer, BMS, Celgene, Lilly, Novartis, Servier.

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