Phase II study of trifluridine/tipiracil (TAS-102) therapy in elderly patients with colorectal cancer (T-CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers.
Phase II study of trifluridine/tipiracil (TAS-102) therapy in elderly patients with colorectal cancer (T-CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers.
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DOI：
10.1007/s00280-021-04277-3
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发表时间：
2021-09
影响因子：
3
通讯作者：
Ishioka C
中科院分区：
文献类型：
--
作者：
Takahashi M;Sakamoto Y;Ohori H;Tsuji Y;Kuroki M;Kato S;Otsuka K;Komine K;Takahashi M;Takahashi S;Shirota H;Ouchi K;Takahashi Y;Imai H;Shibata H;Yoshioka T;Tanaka M;Yamaguchi H;Yamaguchi T;Shimodaira H;Ishioka C
本研究旨在确定曲氟尿苷/替吡嘧啶治疗老年晚期结直肠癌患者的疗效。这项单臂、开放标签、多中心、II期研究纳入了年龄≥ 65岁的氟尿嘧啶难治性晚期结直肠癌老年患者，这些患者接受曲氟尿苷/替吡嘧啶（70 mg/m2，第1-5天和第8-12天，每4周一次）治疗。主要终点为无进展生存期（PFS），次要终点包括总生存期（OS）、总缓解率（ORR）、毒性、疗效与老年评估评分之间的相关性以及毒性与血浆药物浓度之间的相关性。共入组了30例患者，平均年龄为73岁。中位PFS为2.3个月（95%置信区间，1.9-4.3个月），而中位OS为5.7个月（95%置信区间，3.7-8.9个月）。患者的ORR为0%，57%的患者病情稳定。在13%的患者中观察到4级中性粒细胞减少。G8评分较高（≥ 15）的患者的PFS长于G8评分较低的患者（中位4.6 vs. 2.0个月; p = 0.047）。此外，3级或4级中性粒细胞减少患者的曲氟尿苷最大浓度高于1级或2级中性粒细胞减少患者（平均值2945 vs. 2107 ng/mL; p = 0. 036）。目前的II期试验表明，曲氟尿苷/替吡嘧啶是老年晚期结直肠癌患者的有效和耐受性良好的选择。此外，老年评估工具和/或血浆药物浓度监测可能有助于预测接受该药物的老年患者的疗效和毒性。UMIN 000017589，2015年5月15日（大学医院医学信息网络）在线版本包含补充材料，可通过10.1007/s 00280 -021-04277-3获得。
The current study aimed to determine the efficacy of trifluridine/tipiracil for elderly patients with advanced colorectal cancer. This single-arm, open-label, multicenter, phase II study included elderly patients aged 65 years or more who had fluoropyrimidine-refractory advanced colorectal cancer and received trifluridine/tipiracil (70 mg/m2, days 1–5 and 8–12, every 4 weeks). The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), overall response rate (ORR), toxicities, association between efficacy and geriatric assessment scores, and association between toxicity and plasma drug concentrations. A total of 30 patients with a mean age of 73 years were enrolled. Median PFS was 2.3 months (95% confidence interval, 1.9–4.3 months), while median OS was 5.7 months (95% confidence interval, 3.7–8.9 months). Patients had an ORR of 0%, with 57% having stable disease. Grade 4 neutropenia was observed in 13% of the patients. Patients with a higher G8 score (15 or more) showed longer PFS than those with a lower G8 score (median 4.6 vs. 2.0 months; p = 0.047). Moreover, patients with grade 3 or 4 neutropenia showed higher maximum trifluridine concentrations than those with grade 1 or 2 neutropenia (mean 2945 vs. 2107 ng/mL; p = 0.036). The current phase II trial demonstrated that trifluridine/tipiracil was an effective and well-tolerated option for elderly patients with advanced colorectal cancer. Moreover, geriatric assessment tools and/or plasma drug concentration monitoring might be helpful in predicting the efficacy and toxicities in elderly patients receiving this drug. UMIN000017589, 15/May/2015 (The University Hospital Medical Information Network) The online version contains supplementary material available at 10.1007/s00280-021-04277-3.
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影响因子：
3.4
作者：
Hamauchi, Satoshi;Yamazaki, Kentaro;Taniguchi, Hiroya
通讯作者：
Taniguchi, Hiroya
在肿瘤学环境中对老年人的老年评估使用：系统评价。
DOI：
10.1093/jnci/djs285
发表时间：
2012-08-08
期刊：
Journal of the National Cancer Institute
影响因子：
--
作者：
Puts MT;Hardt J;Monette J;Girre V;Springall E;Alibhai SM
通讯作者：
Alibhai SM
影响因子：
5.8
作者：
Sattar, Schroder;Alibhai, Shabbirm. H.;Puts, Martine T. E.
通讯作者：
Puts, Martine T. E.
影响因子：
50.5
作者：
Yoshino, T.;Cleary, J. M.;Lenz, H-J
通讯作者：
Lenz, H-J
影响因子：
45.3
作者：
Kenis, Cindy;Decoster, Lore;Wildiers, Hans
通讯作者：
Wildiers, Hans