Feasibility and effectiveness of trifluridine/tipiracil in metastatic colorectal cancer: real-life data from The Netherlands

Kwakman, Johannes J.M.; Vink, Geraldine R.; Vestjens, J.H.M.J.; Beerepoot, Laurens V.; Groot, Jan Willem de; Jansen, R. L. H.; Opdam, Frans; Boot, H.; Creemers, Geert-Jan; Rooijen, Johan M. van; Los, Maartje; Vulink, A. J. E.; Schut, H.; Meerten, Esther van; Baars, Arnold; Hamberg, Paul; Kapiteijn, Ellen; Sommeijer, Dirkje W.; Punt, Cornelis J.A.; Koopman, Miriam

doi:10.1007/s10147-017-1220-0

Cited by 39 publications

(69 citation statements)

References 16 publications

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“…The reasons for these differences are unclear but may reflect differing clinical practice in the evaluation and recording of ECOG-PS scores in different countries, or may suggest that patients included in the German and UK NPPs were at a more advanced stage of disease at enrolment. The number and type of previous treatments observed were similar to those reported in observational studies from the Netherlands [14], Japan [15], Latvia [16] and Germany [17]. However, a smaller proportion of the patients receiving trifluridine/tipiracil in this analysis had at least 4 prior treatment regimens (19%) than in the RE-COURSE trial [10] (60%).…”

Section: Discussionsupporting

confidence: 80%

“…The demographics and clinical characteristics of patients enrolled in the NPP who went on to receive at least one dose of trifluridine/ tipiracil were broadly similar to those not receiving trifluridine/tipiracil. Furthermore, patients enrolled had similar demographic characteristics (median age, sex) to those in the RECOURSE trial [10] and several real-world studies [13][14][15][16]. However, there was a higher proportion of patients in the RECOURSE trial [10] and the Italian single-centre compassionate use programme (CUP) [13] with ECOG-PS scores of 0 (56 and 63% respectively) than patients enrolled in the UK NPP (28% of patients receiving ≥1 dose of trifluridine/tipiracil, 14% of patients not receiving trifluridine/tipiracil).…”

Section: Discussionmentioning

confidence: 99%

“…Subsequent post-hoc analysis of RECOURSE trial data has demonstrated the clinical efficacy and tolerability of trifluridine/tipiracil in various subgroups [11] and clinically meaningful improvements in quality-adjusted survival [12]. There is further evidence supporting the clinical effectiveness and tolerability of trifluridine/tipiracil in various geographies [13][14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 97%

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Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Iveson

Carter²,

Shiu

et al. 2020

BMC Cancer

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Background: The standard first-and second-line chemotherapy backbone regimens for metastatic colorectal cancer (mCRC) are 5-fluorouracil (5-FU)/capecitabine-based with addition of irinotecan or oxaliplatin. Until recently, evidence for optimal sequencing post second-line was sparse. Trifluridine/tipiracil (indicated for mCRC and gastric cancer after standard chemotherapies) was made available to UK patients via a named patient programme (NPP) before receiving marketing authorisation in Europe in 2016, allowing characterisation of UK treatment pathways, and evaluation of trifluridine/tipiracil in a UK non-trial population.Methods: Data collected routinely for the NPP were analysed to describe the patient demographics, clinical characteristics and treatment pathways. Patients eligible for the programme were adults (≥18 years) with histologically or cytologically confirmed mCRC who had previously received chemotherapy treatment(s).Results: Of the 250 eligible patients enrolled in the NPP, 194 patients received ≥1 dose of trifluridine/tipiracil and 56 patients did not receive trifluridine/tipiracil. The following results are reported first for patients who received trifluridine/tipiracil and second for those who did not receive trifluridine/tipiracil: median (IQR) age was 63.0 (54.0-69.0) and 62.0 (54.8-69.0) years; Eastern Cooperative Oncology Group performance status score was 0 for 28 and 14%, 1 for 65 and 70%, 2 for 7 and 16%. In terms of previous systemic treatments 47 and 43% had 2 prior lines of therapy. FOLFOX-, FOLFIRI-and CAPOX-based therapies were the most common first-line regimens in patients receiving trifluridine/tipiracil (37, 35 and 21%, respectively), and in patients not receiving trifluridine/tipiracil (41, 30 and 20%, respectively). Second-line treatment regimens in patients receiving and not receiving trifluridine/tipiracil were most commonly FOLFIRI-based (48 and 41%, respectively) and respectively). Patients received a median of 2 cycles of trifluridine/tipiracil with a median treatment duration of 1.8 (95% CI: 1.8-2.4) months. In patients who discontinued treatment due to disease progression, the median progression-free duration was 2.8 (95% CI: 2.4-2.9) months. Conclusions:The results highlight the number of treatment pathways used to treat mCRC in routine UK clinical practice prior to the marketing authorisation and National Institute for Health and Care Excellence approval of trifluridine/tipiracil and highlight the lack of clinical guidelines for mCRC.

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Section: Discussionsupporting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

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Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Iveson

Carter²,

Shiu

et al. 2020

BMC Cancer

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“…In contrast in other European countries like the Netherland the treatment of patients with advanced cancers is more centralized. In line, in the Netherlands’ CUP 148 patients were enrolled in only 17 centers [21]. Taken together, the here reported patient population of the German CUP differs from those previously reported.…”

Section: Discussionmentioning

confidence: 51%

Safety profile of trifluridine/tipiracil monotherapy in clinical practice: results of the German compassionate-use program for patients with metastatic colorectal cancer

Kasper

Kisro²,

Fuchs

et al. 2018

BMC Cancer

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BackgroundTrifluridine/tipiracil (TAS-102, Lonsurf®), a novel oral anti-tumor agent combining an anti-neoplastic thymidine-based nucleoside analogue (trifluridine, FTD) with a thymidine phosphorylase inhibitor (tipiracil hydrochloride, TPI) presents a new treatment option for metastatic colorectal cancer (mCRC) patients refractory or intolerant to standard therapies. FTD/TPI was approved in the European Union (EU) in April 2016 and launched on the German market in August 15, 2016.MethodsWe investigated the characteristics of patients (pts) with mCRC treated with FTD/TPI at 118 centers in Germany from January 12 to August 14, 2016 and analyzed the safety in a clinical real-world setting.ResultsIn Germany, a total of 226 mCRC patients were included into a compassionate-use-program (CUP) and received FTD/TPI. For 45.5% of patients (n = 101), 253 adverse events (AE) were documented, most of them drug-related (n = 135). From January 12 (2016) to March 2 (2017), 124 serious adverse events (SAE) were reported (74 drug related). The most common serious adverse drug reactions (SADR) were leukopenia (12 events), neutropenia (8 events), anemia (7 events), diarrhea and nausea (5 events each) (observation period January 12 2016 to October 7 2016). In total, 122 patients (54%) discontinued FTD/TPI treatment, mostly due to progression (n = 75) followed by AEs (n = 21), deaths (n = 16), and non-specified reasons (n = 16). Interestingly, 12 patients with ECOG PS ≥2 achieved up to 3 cycles of FTD/TPI and in this patient population only 3 treatment discontinuations due to AEs were documented and the safety profile was comparable to the entire population.ConclusionThe patient characteristics as well as the safety profile of FTD/TPI documented in the German CUP were consistent with those reported in the pivotal trial RECOURSE without unexpected safety signals.

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“…Several compassionate use programs of FTD/TPI across Europe, the USA, and Asia have been conducted and in summary they underline the efficacy and safety of FTD/TPI in a real-world population with refractory mCRC [17][18][19][20][21].…”

Section: Studies Favoring Ftd/tpi Treatment For Mcrc Patientsmentioning

confidence: 99%

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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Feasibility and effectiveness of trifluridine/tipiracil in metastatic colorectal cancer: real-life data from The Netherlands

Cited by 39 publications

References 16 publications

Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Safety profile of trifluridine/tipiracil monotherapy in clinical practice: results of the German compassionate-use program for patients with metastatic colorectal cancer

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

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