Efficacy and Safety of Lucitanib in Advanced Thymic Carcinoma: A Randomized Phase II Trial

Figures

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  FIGURE 1. Kaplan‒Meier analysis of progression‐free survival and overall survival. (A) Progression‐free survival assessed by the independent review committee (IRC). The median progression‐free survival was 5.8 months in the lucitanib group and 3.7 months in the placebo group. (B) Progression‐free survival assessed by investigators. The median progression‐free survival was 6.6 months in the lucitanib group and 1.9 months in the placebo group. (C) Overall survival. The median overall survival was 15.9 months in the lucitanib group and was not reached (NE) in the placebo group. Survival curves were compared between treatment groups using the log‐rank test, and hazard ratios (HRs) with corresponding 95% confidence intervals (CIs) were estimated with the Cox proportional hazards model.

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  FIGURE 2. Subgroup analyses of progression‐free survival assessed by the independent review committee (IRC) and investigators. Forest plots summarize subgroup analyses of progression‐free survival as assessed by the IRC (A) and investigators (B), comparing the lucitanib group with the placebo group. Across subgroups, the analyses consistently demonstrated a progression‐free survival benefit favoring lucitanib, with hazard ratios (HRs) of less than 1. The symbol ‘#’ indicates patients with a history of smoking, including current and former smokers. An asterisk ‘*’ indicates subgroups in which the HR and corresponding confidence interval could not be calculated because of an insufficient number of progression‐free survival events. EVT denotes event and N denotes number of patients.

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  FIGURE 3. Restricted mean survival time (RMST) analysis of progression‐free survival assessed by the independent review committee. RMST was used to estimate average progression‐free survival at prespecified time points. The RMST analyses showed a significantly longer progression‐free survival with lucitanib than with placebo at weeks 8, 16, 24, and 32 (p < 0.05). The blue shaded area represents the RMST, with larger areas indicating longer progression‐free survival in the lucitanib group. The red shaded area represents the restricted mean time lost (RMTL), with smaller areas indicating longer progression‐free survival. CI denotes confidence interval.

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  FIGURE 4. Tumor response assessed by the independent review committee (IRC) and investigators. Waterfall plots show the maximum percentage change from baseline in the sum of target lesion diameters, as assessed by the IRC (A) and investigators (B). According to IRC assessment, tumor shrinkage was observed in 82% of patients in the lucitanib group and 36% of patients in the placebo group. According to investigator assessment, tumor shrinkage was observed in 80% of patients in the lucitanib group and 27% of patients in the placebo group. Spider plots show the percentage change from baseline over time in the sum of target lesion diameters according to IRC (C) and investigator (D) assessments. Baseline tumor assessments were performed before initiation of study treatment, and subsequent tumor assessments were performed according to the study protocol until disease progression, treatment discontinuation, or the end of follow‐up. Each line represents an individual patient.