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Larotrectinib versus historical standard of care in patients with infantile fibrosarcoma: protocol of EPI-VITRAKVI

The EPI VITRAKVI study is a retrospective study designed to place the results of the single-arm Phase I/II larotrectinib SCOUT trial into context by comparison with external historical controls. Its primary objective is to compare the time to medical treatment failure between larotrectinib and the historical standard of care (chemotherapy) in patients with infantile fibrosarcoma. External historical cohorts have been selected by using objective criteria. The Inverse Probability of Treatment Weighting method will be used to adjust for potential confounding. The current publication illustrates how an external control arm study can complement data from a single-arm trial and addresses uncertainties encountered in the assessment of therapies targeting rare abnormalities where randomized controlled trials are considered not feasible. 

 

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The EPI VITRAKVI study is a retrospective study conducted to provide context to the results of the single-arm Phase I/II larotrectinib SCOUT trial. Its primary objective is to compare the time to medical treatment failure between larotrectinib and the historical standard of care, which in this case is chemotherapy, in patients with infantile fibrosarcoma. The study aims to use external historical controls to make this comparison.

To ensure a fair and unbiased analysis, external historical cohorts have been selected based on objective criteria. This helps to establish a reference group against which the outcomes of larotrectinib can be evaluated. The study acknowledges the limitations of a single-arm trial and aims to address uncertainties encountered in assessing therapies that target rare abnormalities. In situations where conducting randomized controlled trials may not be feasible, incorporating an external control arm study can provide valuable insights.

The Inverse Probability of Treatment Weighting (IPTW) method will be employed in the analysis to account for potential confounding factors. IPTW adjusts the treatment effect estimates by assigning weights to each patient based on the probability of receiving the treatment they received. This helps to balance the characteristics of the treatment and control groups, reducing the impact of confounding variables.

Overall, the current publication demonstrates how an external control arm study can complement the findings of a single-arm trial. By comparing the outcomes of larotrectinib with historical controls, the study aims to provide a more comprehensive understanding of its efficacy in treating infantile fibrosarcoma.

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S7960 Larotrectinib sulfate Larotrectinib sulfate is an oral potent and selective ATP-competitive inhibitor of tropomyosin receptor kinases (TRK). Larotrectinib inhibition of TRKs induces cellular apoptosis and G1 cell-cycle arrest.

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Apoptosis related Trk receptor