Propensity Score Analysis of Regorafenib Versus Trifluridine/Tipiracil in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy (REGOTAS): A Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study.
Propensity Score Analysis of Regorafenib Versus Trifluridine/Tipiracil in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy (REGOTAS): A Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study.
复制标题
DOI：
10.1634/theoncologist.2017-0275
复制
发表时间：
2018-01
期刊：
影响因子：
--
通讯作者：
Shimada Y
中科院分区：
文献类型：
--
作者：
Moriwaki T;Fukuoka S;Taniguchi H;Takashima A;Kumekawa Y;Kajiwara T;Yamazaki K;Esaki T;Makiyama C;Denda T;Satake H;Suto T;Sugimoto N;Enomoto M;Ishikawa T;Kashiwada T;Sugiyama M;Komatsu Y;Okuyama H;Baba E;Sakai D;Watanabe T;Tamura T;Yamashita K;Gosho M;Shimada Y
本文比较了瑞非尼和曲氟定/替吡拉西对标准化疗难治的转移性结直肠癌患者的疗效，以确定是否需要进行进一步的前瞻性比较试验。本研究比较了瑞非尼（regorafenib）和trifluridine/tipiracil （TFTD）在标准化疗难治性转移性结直肠癌（mCRC）患者中的疗效，因为尽管这两种药物的临床批准，但仍不清楚这两种药物中的哪一种应该作为初始治疗。2014年6月至2015年9月，回顾性收集了日本24家机构中接受瑞非尼或TFTD治疗的mCRC患者和未用药患者的临床数据。采用基于基线特征倾向评分调整的Cox比例风险模型评估总生存期（OS）。共有550例患者（瑞非尼组223例，TFTD组327例）符合所有标准。瑞非尼组的中位OS为7.9个月（95%可信区间[CI]， 6.8-9.2）， TFTD组的中位OS为7.4个月（95% CI, 6.6-8.3）。倾向评分校正分析显示，两组间OS相似（校正风险比[HR]， 0.96; 95% CI, 0.78-1.18）。在亚组分析中，观察到与年龄的显著相互作用。Regorafenib在<65岁的患者中表现出良好的生存率（HR, 1.29; 95% CI, 0.98-1.69），而TFTD在≥65岁的患者中表现出良好的生存率（HR, 0.78; 95% CI, 0.59-1.03）。在mCRC患者中，瑞非尼和TFTD的OS无显著差异。尽管根据年龄选择药物可能会影响生存，但在进一步的研究中，应该确定一个明确的预测性生物标志物来区分这两种药物。先前对标准化疗难治的转移性结直肠癌患者的研究表明，与安慰剂相比，瑞非尼和曲氟定/替吡拉西都能提高总生存率，但没有头对头试验。这项大型、多中心、观察性研究回顾性比较了瑞非尼和trifluridine/tipiracil对550例标准化疗难治的转移性结直肠癌患者的疗效。虽然在倾向评分调整分析中，两种药物的总生存率没有差异，但在亚组分析中，瑞戈非尼在<65岁的患者中显示出较好的生存率，而trifluridine/tipiracil在≥65岁的患者中显示出较好的生存率。
This article compares the efficacy between regorafenib and trifluridine/tipiracil in patients with metastatic colorectal cancer refractory to standard chemotherapy, who had access to both drugs, to determine whether a further prospective comparative trial should be conducted. This study compared the efficacy of regorafenib and trifluridine/tipiracil (TFTD) in patients with metastatic colorectal cancer (mCRC) who are refractory to standard chemotherapy, because despite their clinical approval, it still remains unclear which of these two drugs should be used as initial treatment. The clinical data of patients with mCRC who were treated with regorafenib or TFTD and those of drug‐naive patients, between June 2014 and September 2015, were retrospectively collected from 24 institutions in Japan. Overall survival (OS) was evaluated using the Cox's proportional hazard models based on propensity score adjustment for baseline characteristics. A total of 550 patients (223 patients in the regorafenib group and 327 patients in the TFTD group) met all criteria. The median OS was 7.9 months (95% confidence interval [CI], 6.8–9.2) in the regorafenib group and 7.4 months (95% CI, 6.6–8.3) in the TFTD group. The propensity score adjusted analysis showed that OS was similar between the two groups (adjusted hazard ratio [HR], 0.96; 95% CI, 0.78–1.18). In the subgroup analysis, a significant interaction with age was observed. Regorafenib showed favorable survival in patients aged <65 years (HR, 1.29; 95% CI, 0.98–1.69), whereas TFTD was favored in patients aged ≥65 years (HR, 0.78; 95% CI, 0.59–1.03). No significant difference in OS between regorafenib and TFTD was observed in patients with mCRC. Although the choice of the drug by age might affect survival, a clearly predictive biomarker to distinguish the two drugs should be identified in further studies. Previous studies of patients with metastatic colorectal cancer refractory to standard chemotherapy had demonstrated that both regorafenib and trifluridine/tipiracil could result in increased overall survival compared with placebo, but there are no head‐to‐head trials. This large, multicenter, observational study retrospectively compared the efficacy of regorafenib and trifluridine/tipiracil in 550 patients with metastatic colorectal cancer refractory to standard chemotherapy who had access to both drugs. Although no difference in overall survival was found between the two drugs in adjusted analysis using propensity score, regorafenib showed favorable survival in patients aged <65 years, whereas trifluridine/tipiracil was favored in patients aged ≥65 years in the subgroup analysis.
登录
查看更多内容
影响因子：
3.8
作者：
Adenis A;de la Fouchardiere C;Paule B;Burtin P;Tougeron D;Wallet J;Dourthe LM;Etienne PL;Mineur L;Clisant S;Phelip JM;Kramar A;Andre T
通讯作者：
Andre T
影响因子：
3.4
作者：
Yoshino T;Komatsu Y;Yamada Y;Yamazaki K;Tsuji A;Ura T;Grothey A;Van Cutsem E;Wagner A;Cihon F;Hamada Y;Ohtsu A
通讯作者：
Ohtsu A
影响因子：
6.4
作者：
Wilhelm, Scott M.;Dumas, Jacques;Zopf, Dieter
通讯作者：
Zopf, Dieter
影响因子：
5.8
作者：
Fukushima, M;Suzuki, N;Asao, T
通讯作者：
Asao, T
影响因子：
50.5
作者：
Suenaga, M.;Schirripa, M.;Lenz, H. -J.
通讯作者：
Lenz, H. -J.