Systematic review and non-inferiority meta-analysis of randomised phase II/III trials on S-1-based therapy versus 5-fluorouracil- or capecitabine-based therapy in the treatment of patients with metastatic colorectal cancer

Derksen, Jeroen W.G.; Smit, K; May, Anne M.; Punt, Cornelis J.A.

doi:10.1016/j.ejca.2022.02.004

Cited by 10 publications

(6 citation statements)

References 35 publications

(47 reference statements)

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“… 7 A systematic review and noninferiority meta-analysis of randomized phase II/III trials of patients with metastatic CRC found S-1 to be noninferior to 5-FU-/capecitabine-based therapy in the treatment of metastatic CRC with regard to progression-free survival (PFS), and at least as efficacious as 5-FU-/capecitabine-based therapy in terms of overall response rate (ORR) and overall survival (OS). 8 These data support the use of S-1 in patients with metastatic CRC who are intolerant to 5-FU-/capecitabine-based treatment. Subsequently, S-1 was approved by the European Medicines Agency as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic CRC for whom it is not possible to continue treatment with another FP due to HFS or CVT that developed in the adjuvant or metastatic setting.…”

Section: Introductionsupporting

confidence: 58%

Fluoropyrimidine-induced hand-foot syndrome and cardiotoxicity: recommendations for the use of the oral fluoropyrimidine S-1 in metastatic colorectal cancer

Punt¹,

Maughan²,

Cremolini³

et al. 2023

ESMO Open

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Section: Introductionsupporting

confidence: 58%

Fluoropyrimidine-induced hand-foot syndrome and cardiotoxicity: recommendations for the use of the oral fluoropyrimidine S-1 in metastatic colorectal cancer

Punt¹,

Maughan²,

Cremolini³

et al. 2023

ESMO Open

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“…Currently, S1 has been reported to be non-inferior to other fluoropyrimidines in colorectal cancer and is recognized as an alternative to 5-FU or capecitabine in case of intolerance to these latter agents. [31] Our results warrant further study whether carriers of CES1 1165-33 C>A experience better treatment effects if they are directly treated with S1, rather than after onset of toxicity during treatment with 5-FU or capecitabine.…”

Section: Discussionmentioning

confidence: 69%

Capecitabine-induced hand-foot syndrome: A pharmacogenetic study beyond DPYD

With

Doorn

Maasland

et al. 2023

Biomedicine & Pharmacotherapy

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“…Both studies found QoL to be maintained during treatment, thus supporting trifluridine/tipiracil use in clinical practice. More recently, following trial evidence of efficacy and safety of the oral fluoropyrimidine S-1 in Western patients [ 49 – 51 ], additional descriptive RWE on long-term safety and cardiotoxicity recurrence supported EMA approval [ 52 – 54 ]. The ESMO guideline now recommends switching to S-1 in patients with mCRC who experience hand-foot syndrome or cardiovascular toxicity while being treated with capecitabine or 5-FU [ 39 , 55 ].…”

Section: Using Rwd For Treatment Effect Evaluationmentioning

confidence: 99%

Harnessing the Potential of Real-World Evidence in the Treatment of Colorectal Cancer: Where Do We Stand?

van Nassau,

Bol,

van der Baan

et al. 2024

Curr. Treat. Options in Oncol.

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Opinion statementTreatment guidelines for colorectal cancer (CRC) are primarily based on the results of randomized clinical trials (RCTs), the gold standard methodology to evaluate safety and efficacy of oncological treatments. However, generalizability of trial results is often limited due to stringent eligibility criteria, underrepresentation of specific populations, and more heterogeneity in clinical practice. This may result in an efficacy-effectiveness gap and uncertainty regarding meaningful benefit versus treatment harm. Meanwhile, conduct of traditional RCTs has become increasingly challenging due to identification of a growing number of (small) molecular subtypes. These challenges—combined with the digitalization of health records—have led to growing interest in use of real-world data (RWD) to complement evidence from RCTs. RWD is used to evaluate epidemiological trends, quality of care, treatment effectiveness, long-term (rare) safety, and quality of life (QoL) measures. In addition, RWD is increasingly considered in decision-making by clinicians, regulators, and payers. In this narrative review, we elaborate on these applications in CRC, and provide illustrative examples. As long as the quality of RWD is safeguarded, ongoing developments, such as common data models, federated learning, and predictive modelling, will further unfold its potential. First, whenever possible, we recommend conducting pragmatic trials, such as registry-based RCTs, to optimize generalizability and answer clinical questions that are not addressed in registrational trials. Second, we argue that marketing approval should be conditional for patients who would have been ineligible for the registrational trial, awaiting planned (non) randomized evaluation of outcomes in the real world. Third, high-quality effectiveness results should be incorporated in treatment guidelines to aid in patient counseling. We believe that a coordinated effort from all stakeholders is essential to improve the quality of RWD, create a learning healthcare system with optimal use of trials and real-world evidence (RWE), and ultimately ensure personalized care for every CRC patient.

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Systematic review and non-inferiority meta-analysis of randomised phase II/III trials on S-1-based therapy versus 5-fluorouracil- or capecitabine-based therapy in the treatment of patients with metastatic colorectal cancer

Cited by 10 publications

References 35 publications

Fluoropyrimidine-induced hand-foot syndrome and cardiotoxicity: recommendations for the use of the oral fluoropyrimidine S-1 in metastatic colorectal cancer

Fluoropyrimidine-induced hand-foot syndrome and cardiotoxicity: recommendations for the use of the oral fluoropyrimidine S-1 in metastatic colorectal cancer

Capecitabine-induced hand-foot syndrome: A pharmacogenetic study beyond DPYD

Harnessing the Potential of Real-World Evidence in the Treatment of Colorectal Cancer: Where Do We Stand?

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