Phase II study evaluating trifluridine/tipiracil + bevacizumab and capecitabine + bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are non-eligible for intensive therapy (TASCO1): Results of the primary analysis

Leśniewski-Kmak, Krzysztof; Моисеенко, В.; Saunders, Mark; Wasan, Harpreet; Argilés, Guillem; Borg, Christophe; Creemers, Geert-Jan; Fedyanin, M.; Glynne‐Jones, Rob; Pfeiffer, Per; Punt, Cornelis J.A.; Stroyakovskiy, Daniil; Tije, A ten; Wouw, A. van de; Kanehisa, Akira; Fougeray, Ronan; Busto, N. Lopez; Amellal, Nadia; Cutsem, Éric Van

doi:10.1093/annonc/mdy149.021

Cited by 14 publications

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“…Ongoing trials are assessing the combination of trifluridine/tipiracil with other standard mCRC therapies such as irinotecan, oxaliplatin, anti‐VEGF and anti‐EGFR, in the first‐line, second‐line, maintenance and refractory settings (Table 2). A phase III study of trifluridine/tipiracil in combination with bevacizumab, compared with capecitabine plus bevacizumab, in patients not suitable for intensive therapy in first‐line is ongoing, with phase II results showing promising activity 50 . The activity of trifluridine/tipiracil has also been explored in other tumor types.…”

Section: Future Developmentsmentioning

confidence: 99%

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: Future Developmentsmentioning

confidence: 99%

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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“…Furthermore, the non-comparative phase 2 TASCO1 study evaluated the efficacy and safety of trifluridine/tipiracil plus bevacizumab and capecitabine plus bevacizumab and provided evidence demonstrating the efficacy of trifluridine/tipiracil plus bevacizumab in patients with untreated mCRC who were not eligible for standard first-line intensive therapy. The primary endpoint of PFS was 9.2 months in the trifluridine/tipiracil plus bevacizumab group and 7.8 months in the capecitabine plus bevacizumab group [12].…”

Section: Introductionmentioning

confidence: 99%

Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer

et al. 2019

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BackgroundA previous phase I/II C-TASK FORCE study of trifluridine/tipiracil plus bevacizumab for patients with heavily pretreated metastatic colorectal cancer (mCRC) showed promising activity with an acceptable toxicity profile. This retrospective study aimed to investigate the safety and efficacy of trifluridine/tipiracil plus bevacizumab compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC in clinical settings.MethodsRecords of patients with mCRC refractory to standard therapies who initiated trifluridine/tipiracil plus bevacizumab from January 2016 to March 2018 or trifluridine/tipiracil monotherapy from June 2014 to December 2015 were retrospectively reviewed at our institution.ResultsTotally, 60 patients received trifluridine/tipiracil plus bevacizumab and 66 received trifluridine/tipiracil monotherapy. All patients had previously received standard chemotherapy. Median progression-free survival (PFS) was 3.7 months [95% confidence interval (CI), 2.3–5.1] in the trifluridine/tipiracil plus bevacizumab group and 2.2 months (95% CI, 1.8–2.6) in the trifluridine/tipiracil monotherapy group [hazards ratio (HR) 0.69; 95% CI 0.48–0.99]. PFS rate at 16 weeks was 46.6% for the trifluridine/tipiracil plus bevacizumab group and 33.9% for the trifluridine/tipiracil monotherapy group. Although a relatively higher incidence of grade ≥ 3 neutropenia was observed in the trifluridine/tipiracil plus bevacizumab group than that in the other group (50.0% vs. 40.9%, p = 0.371), the incidence of febrile neutropenia was not high (3.3% vs. 7.8%, p = 0.444).ConclusionsIn real-world settings, trifluridine/tipiracil plus bevacizumab prolonged PFS and helped achieve higher 16-week PFS rate compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC with manageable toxicities.Trial registrationRetrospectively registered.

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“…In general, TAS‐102 plus BEV combination therapy does not show tumor shrinkage in the late‐line setting. In contrast to late‐line use, however, TAS‐102 plus BEV combination is expected to induce tumor shrinkage when administered in the first‐line setting (objective response rate 33.8% in TASCO1 trial [14], 40.5% in KSCC1602 trial [15]). These findings suggest that TAS‐102 plus BEV may be introduced in first‐line treatment in patients for whom intensive chemotherapy is not indicated.…”

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confidence: 99%

Phase Ib/II Study of Biweekly TAS-102 in Combination with Bevacizumab for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies (BiTS Study)

et al. 2020

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• A biweekly TAS-102 plus BEV schedule in patients with heavily pretreated mCRC showed equivalent efficacy with less toxicity compared with the current schedule of TAS-102 plus BEV combination. • Biweekly TAS-102 plus BEV combination could reduce unnecessary dose reduction of TAS-102, maintain higher doses, and possibly be effective even in cases without chemotherapy-induced neutropenia (CIN). • The prespecified subgroup analysis of this study showed an obvious association between CIN within the first two cycles and prognosis of biweekly TAS-102 plus BEV.

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Phase II study evaluating trifluridine/tipiracil + bevacizumab and capecitabine + bevacizumab in first-line unresectable metastatic colorectal cancer (mCRC) patients who are non-eligible for intensive therapy (TASCO1): Results of the primary analysis

Cited by 14 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

Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer

Phase Ib/II Study of Biweekly TAS-102 in Combination with Bevacizumab for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies (BiTS Study)

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