Real-world evidence of trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer using an administrative claims database in Japan.

BACKGROUND: Trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) are standard therapies for refractory metastatic colorectal cancer (mCRC). No results of large real-world data directly comparing FTD/TPI + bevacizumab (BEV) with FTD/TPI or REG monotherapy have been reported. We evaluated the efficacy and safety of FTD/TPI + BEV in a real-world setting. MATERIALS AND METHODS: This retrospective study used a Japanese claims database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). Eligible patients were aged 20 years and over with a diagnosis of mCRC, and received their first dose of FTD/TPI or REG from 2014 to 2021. The primary endpoint was overall survival (OS) in a propensity score matching (PSM) population in which PSM was carried out by matching using a 1 : 1 ratio for the FTD/TPI + BEV group and the control group (FTD/TPI or REG) by propensity score. To enhance robustness, sensitivity analyses of OS were carried out using the inverse probability treatment weighted (IPTW) approach and the analysis in the all eligible population. Secondary endpoints included time to treatment discontinuation (TTD), incidence of adverse events, and post-treatment. RESULTS: Eligible population was 2369 for the FTD/TPI + BEV group and 9318 for the control group. The PSM population was 1787 for each group. Median OS (mOS) was longer in the FTD/TPI + BEV group compared to the control group [17.0 versus 11.6 months, hazard ratio (HR) = 0.70, P < 0.001] in the PSM population. Similarly, mOS was longer for the FTD/TPI + BEV group compared to that for the control group in IPTW analyses and in the all eligible population (both HRs = 0.68). Median TTD was 3.3 months for the FTD/TPI + BEV group and 1.8 months for the control group in the PSM population (P < 0.001). CONCLUSIONS: Real-world data showed that FTD/TPI + BEV was significantly associated with OS and TTD compared to FTD/TPI or REG. In clinical practice, FTD/TPI + BEV can be a favorable regimen for refractory mCRC.

One-dimensional quantitative evaluation of peripheral lung adenocarcinoma with or without ground-glass opacity on thin-section CT images using profile curves.

The purpose of our investigation was to compare the usefulness of the subjective visual assessment of ground-glass opacity (GGO) with a quantitative method that used a profile curve to determine prognosis. 96 adenocarcinomas were studied. Three diameters ([D1]-[D3]) were defined for estimating the diameter of tumours on the monitor: the distance between two points was measured using software that displays a CT density profile across the tumour. One experienced and one less experienced radiologist independently evaluated the following six parameters: the three diameters [D1]-[D3]; the solid portion of total tumour in the two different ratios ([D2]/[D1], [D3]/[D1]); and the area ratio of GGO for total opacity to subjective visual evaluation. Interobserver agreement between the two radiologists of the diameters (mean bias+/- 1.96 standard deviations) was as follows: [D1], -0.7 +/- 6 mm; [D2], 0.4 +/- 4.4 mm; and [D3], -0.1 +/- 4.2 mm (Bland and Altman's method). Interobserver agreement was fair in evaluating the area ratio of GGO (kappa test, kappa = 0.309). Univariate logistic regression analysis revealed that two ratios ([D2]/[D1], [D3]/[D1]) might be significantly useful in estimating lymph node metastasis (p < 0.026), lymph duct invasion (p < 0.001) and recurrence (p < 0.015). Observation of the area ratio of GGO by an experienced radiologist would be necessary for estimating lymph node metastasis (p = 0.04) and lymph duct invasion (p < 0.001). We concluded that the ratio of solid component to total tumour, which is obtainable in a more objective and simple way using profile curves obtained by software, is a more useful method of estimating prognosis than is visual assessment.