Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer (mCRC): Preliminary results from the phase IIIb, international, open-label, early-access PRECONNECT study

Falcone, Alfredo; Thewis, André; Edeline, Julien; François, Ετιεννε; Taı̈eb, Julien; Phelip, J.; Portales, Fabienne; Price, Timothy; Becquart, M.; Vera, S. Moreno; Mounedji, Nadjat; Cutsem, Éric Van; Seitz, J.-F.

doi:10.1093/annonc/mdy149.012

Cited by 7 publications

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“…Preliminary results from the phase IIIb PRECONNECT early‐access study, which enrolled 462 patients from 10 countries, including 71 patients from Australia, support trifluridine/tipiracil as an efficacious treatment option in a real‐world setting 15 . Median PFS was 2.8 months in the whole population and 3.2 months in patients who received at least one dose of trifluridine/tipiracil and had at least one baseline and one post‐baseline tumor evaluation 15 …”

Section: Results From Clinical Trials and Observation Studiesmentioning

confidence: 96%

Trifluridine/tipiracil: A practical guide to its use in the management of refractory metastatic colorectal cancer in Australia

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Chantrill

et al. 2020

Asia-Pac J Clncl Oncology

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Trifluridine/tipiracil is available on the Australian Pharmaceutical Benefits Scheme for the treatment of patients with metastatic colorectal cancer (mCRC) previously treated with, or not considered candidates for, fluoropyrimidine-, oxaliplatin-and irinotecan-based chemotherapies, antivascular endothelial growth factor agents and anti-epidermal growth factor receptor agents. This article reviews trifluridine/tipiracil clinical data and presents practical information on its use in the management of refractory mCRC in Australia. Whereas the primary mechanism of action of fluoropyrimidines such as fluorouracil (5-FU) and capecitabine is enzyme inhibition of nucleotide synthesis, trifluridine/tipiracil primarily acts by incorporation into DNA, resulting in DNA dysfunction.Trifluridine/tipiracil has activity in patients with 5-FU-resistant tumors and can be considered in patients with prior intolerance or toxicity to 5-FU. In the pivotal phase III RECOURSE trial evaluating trifluridine/tipiracil in chemotherapy-refractory mCRC, efficacy benefits were observed across all a priori prognostic subgroups including those defined by age (≥65 and ≥75 years), geographical origin, primary tumor site or KRAS status. Trifluridine/tipiracil therapy benefits appropriately selected patients who have an ECOG performance status of 0 or 1, with no more than mild hepatic impairment or mild-to-moderate renal impairment, and who are capable of adhering to oral therapy safely. Appropriate dosing, monitoring for adverse events and effective management of side effects are essential.

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Section: Results From Clinical Trials and Observation Studiesmentioning

confidence: 96%

Trifluridine/tipiracil: A practical guide to its use in the management of refractory metastatic colorectal cancer in Australia

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Chantrill

et al. 2020

Asia-Pac J Clncl Oncology

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Section: Studies Favoring Ftd/tpi Treatment For Mcrc Patientsmentioning

confidence: 73%

“…A preliminary analysis of the data from the ongoing multicenter phase 3b study PRECONNECT, designed to evaluate the safety and efficacy of FTD/TPI in real-life conditions, confirms the advantages of FTD/TPI as a favorable treatment for refractory mCRC [10]. A preliminary analysis of data from 462 patients showed that patients on FTD/TPI had a median progression-free survival (PFS) of 2.8 months, disease control was achieved in 37% of the patients, and their performance status deteriorated to ECOG performance status ≥2 after a median of only 8.7 months [10]. The safety profile of the therapy was acceptable and consistent with that found in the RE-COURSE study -a pivotal phase 3 trial comparing the efficacy of FTD/TPI to that od placebo for the treatment of refractory CRC and mCRC in heavily pretreated patients (ECOG performance status 0-1) [11,12].…”

Section: Studies Favoring Ftd/tpi Treatment For Mcrc Patientsmentioning

confidence: 73%

“…Currently, there are only limited data available on the optimal therapy sequence involving FTD/TPI and regorafenib. The key question is whether FTD/TPI or regorafenib should be administered first, and this was investigated indirectly in PRECONNECT [10,30]. A post hoc subgroup analysis showed that the sequence of treatment with FTD/TPI and regorafenib did not affect the efficacy of the following treatment regimen [30].…”

Section: The Safety and Quality-of-life Profiles Of Ftd/tpi And Regormentioning

confidence: 99%

“…The PRECONNECT study shows that more than 20% of patients receiving FTD/TPI had improved EORTC Quality-Of-Life Core Questionnaire Core-30 (QCQ-C30) scores, and more than half of the patients (58.5%) showed no deterioration in their quality of life [34]. Furthermore, the ECOG performance status was maintained after treatment with FTD/TPI compared to placebo [2,[10][11][12]30]. With regorafenib, clinical studies have demonstrated that the quality of life did not deteriorate in patients treated with regorafenib compared to placebo [22,33].…”

Section: The Safety and Quality-of-life Profiles Of Ftd/tpi And Regormentioning

confidence: 99%

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Metastatic Colorectal Carcinoma after Second Progression and the Role of Trifluridine-Tipiracil (TAS-102) in Switzerland

et al. 2020

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Background: Metastatic colorectal carcinoma (mCRC) is one of the most prevalent types of cancer worldwide. After tumor progression with first-and second-line treatment, trifluridine (FTD) and tipiracil (TPI) has been shown to be a treatment option. Summary: Data from a pivotal phase 3 trial (RE-COURSE) and an ongoing phase 3b trial (PRECONNECT) have shown that, in mCRC patients who experienced disease progression after 2 lines of standard therapy, treatment with FTD/TPI is safe and efficacious. Other third-line options include regorafenib, rechallenge with previous treatment lines or personalized approaches based on comprehensive molecular profiling. Randomized trials or sequential studies aiming for the right treatment sequence or predefined subtypes for FTD/TPI or regorafenib as well for rechallenge are missing. However, FTD/TPI as well as regorafenib are recommended by the current ESMO, German S3, and National Comprehensive Cancer Network (NCCN) guidelines in the same situation, thus offering physicians a number of alternatives for the treatment of mCRC patients after the second progression. Key Message: This narrative review summariz-es published data and their impact for FTD/TPI as well for regorafenib and rechallenge chemotherapy in clinical practice settings of refractory situations of colorectal cancer.

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Immunomodulatory nanomedicine for colorectal cancer treatment: a landscape to be explored?

et al. 2021

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Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer (mCRC): Preliminary results from the phase IIIb, international, open-label, early-access PRECONNECT study

Cited by 7 publications

References 0 publications

Trifluridine/tipiracil: A practical guide to its use in the management of refractory metastatic colorectal cancer in Australia

Trifluridine/tipiracil: A practical guide to its use in the management of refractory metastatic colorectal cancer in Australia

Metastatic Colorectal Carcinoma after Second Progression and the Role of Trifluridine-Tipiracil (TAS-102) in Switzerland

Immunomodulatory nanomedicine for colorectal cancer treatment: a landscape to be explored?

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