Dana-Farber Cancer Institute, Boston, MA.
Analysis Group, Inc, Boston, MA.
Clin Colorectal Cancer. 2018 Sep;17(3):e531-e539. doi: 10.1016/j.clcc.2018.04.002. Epub 2018 Apr 21.
Trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) prolong survival in refractory metastatic colorectal cancer (mCRC) and have similar indications with different side-effect profiles. The present study compared real-world treatment patterns with FTD/TPI and REG for mCRC in a large, representative US claims database.
Retrospective data from the US Symphony Health Solutions' Integrated Dataverse database were analyzed for adult mCRC patients receiving FTD/TPI or REG from October 2014 to July 2016. The index date was the first FTD/TPI or REG prescription date. The observation period spanned from the index date to the end of data collection, end of continuous clinical activity, or treatment switch. Adherence was assessed using the medication possession ratio and proportion of days covered at 3 months. The time to discontinuation was assessed over the observation period with gaps of 45, 60, or 90 days. Outcomes were compared between the cohorts using logistic regression and Cox proportional hazards models adjusting for baseline characteristic differences.
A total of 1630 FTD/TPI patients and 1425 REG patients were identified. The FTD/TPI patients were 80% more likely to have a medication possession ratio of ≥ 0.80 compared with the REG patients (odds ratio, 1.80; P < .001) and more than twice as likely to have a proportion of days covered of ≥ 0.80 (odds ratio, 2.66; P < .001) at 3 months. The FTD/TPI patients were 37% less likely to discontinue their treatment compared with the REG patients when using the 60-day gap (hazard ratio, 0.63; P < .001). Similar results were found using the 45- and 90-day gaps.
mCRC patients taking FTD/TPI were significantly more likely to adhere to and comply with therapy compared with those taking REG.
替氟尿苷/盐酸替匹嘧啶（FTD/TPI）和瑞戈非尼（REG）延长了难治性转移性结直肠癌（mCRC）患者的生存期，且具有不同的副作用谱，适应证相似。本研究比较了大型代表性美国索赔数据库中 mCRC 患者使用 FTD/TPI 和 REG 的真实世界治疗模式。
回顾性分析了美国 Symphony Health Solutions 的 Integrated Dataverse 数据库中 2014 年 10 月至 2016 年 7 月接受 FTD/TPI 或 REG 治疗的成年 mCRC 患者的数据。索引日期为首次使用 FTD/TPI 或 REG 的日期。观察期从索引日期开始至数据收集结束、连续临床活动结束或治疗转换为止。使用药物占有率和 3 个月时的覆盖率来评估依从性。使用逻辑回归和 Cox 比例风险模型，在调整基线特征差异的情况下，评估观察期内的停药时间。使用 logistic 回归和 Cox 比例风险模型比较两个队列的结局，同时调整了基线特征差异。
共纳入 1630 例 FTD/TPI 患者和 1425 例 REG 患者。与 REG 患者相比，FTD/TPI 患者药物占有率≥0.80 的可能性高 80%（优势比，1.80；P＜0.001），3 个月时覆盖率≥0.80 的可能性高 2.66 倍（优势比，2.66；P＜0.001）。使用 60 天间隔时，FTD/TPI 患者停药的可能性比 REG 患者低 37%（风险比，0.63；P＜0.001）。使用 45 天和 90 天间隔时也得到了类似的结果。
与接受 REG 治疗的患者相比，接受 FTD/TPI 治疗的 mCRC 患者更有可能坚持和遵守治疗方案。
