替氟尿苷/盐酸拓扑替康单药治疗在临床实践中的安全性概况：转移性结直肠癌患者德国同情用药项目的结果。
Safety profile of trifluridine/tipiracil monotherapy in clinical practice: results of the German compassionate-use program for patients with metastatic colorectal cancer.
机构信息
West German Cancer Center, Department of Medical Oncology, University Hospital Essen, Essen, Hufelandstrasse 55, 45147, Essen, Germany.
Community Praxis, Lübeck, Germany.
出版信息
BMC Cancer. 2018 Nov 16;18(1):1124. doi: 10.1186/s12885-018-5063-5.
BACKGROUND
Trifluridine/tipiracil (TAS-102, Lonsurf®), a novel oral anti-tumor agent combining an anti-neoplastic thymidine-based nucleoside analogue (trifluridine, FTD) with a thymidine phosphorylase inhibitor (tipiracil hydrochloride, TPI) presents a new treatment option for metastatic colorectal cancer (mCRC) patients refractory or intolerant to standard therapies. FTD/TPI was approved in the European Union (EU) in April 2016 and launched on the German market in August 15, 2016.
METHODS
We investigated the characteristics of patients (pts) with mCRC treated with FTD/TPI at 118 centers in Germany from January 12 to August 14, 2016 and analyzed the safety in a clinical real-world setting.
RESULTS
In Germany, a total of 226 mCRC patients were included into a compassionate-use-program (CUP) and received FTD/TPI. For 45.5% of patients (n = 101), 253 adverse events (AE) were documented, most of them drug-related (n = 135). From January 12 (2016) to March 2 (2017), 124 serious adverse events (SAE) were reported (74 drug related). The most common serious adverse drug reactions (SADR) were leukopenia (12 events), neutropenia (8 events), anemia (7 events), diarrhea and nausea (5 events each) (observation period January 12 2016 to October 7 2016). In total, 122 patients (54%) discontinued FTD/TPI treatment, mostly due to progression (n = 75) followed by AEs (n = 21), deaths (n = 16), and non-specified reasons (n = 16). Interestingly, 12 patients with ECOG PS ≥2 achieved up to 3 cycles of FTD/TPI and in this patient population only 3 treatment discontinuations due to AEs were documented and the safety profile was comparable to the entire population.
CONCLUSION
The patient characteristics as well as the safety profile of FTD/TPI documented in the German CUP were consistent with those reported in the pivotal trial RECOURSE without unexpected safety signals.
背景
替氟尿苷/盐酸拓扑替康（TAS-102，Lonsurf®）是一种新型口服抗肿瘤药物，由一种抗肿瘤嘧啶核苷类似物（替氟尿苷，FTD）与胸苷磷酸化酶抑制剂（盐酸拓扑替康，TPI）组成，为转移性结直肠癌（mCRC）患者提供了新的治疗选择，这些患者对标准治疗方案不耐受或无效。FTD/TPI 于 2016 年 4 月在欧盟（EU）获得批准，并于 2016 年 8 月 15 日在德国上市。
方法
我们调查了 2016 年 1 月 12 日至 8 月 14 日在德国 118 个中心接受 FTD/TPI 治疗的 mCRC 患者的特征，并在临床真实环境中分析了安全性。
结果
在德国，共有 226 例 mCRC 患者纳入同情用药计划（CUP）并接受 FTD/TPI 治疗。对于 45.5%的患者（n=101），记录了 253 次不良事件（AE），其中大多数与药物相关（n=135）。从 2016 年 1 月 12 日（2016 年）至 2017 年 3 月 2 日，报告了 124 例严重不良事件（SAE）（74 例与药物相关）。最常见的严重药物不良反应（SADR）是白细胞减少症（12 例）、中性粒细胞减少症（8 例）、贫血（7 例）、腹泻和恶心（各 5 例）（观察期为 2016 年 1 月 12 日至 2016 年 10 月 7 日）。共有 122 例患者（54%）停止了 FTD/TPI 治疗，主要原因是疾病进展（n=75），其次是 AE（n=21）、死亡（n=16）和不明原因（n=16）。有趣的是，12 名 ECOG PS≥2 的患者接受了多达 3 个周期的 FTD/TPI 治疗，在这一患者人群中，仅因 AE 而有 3 例治疗中断，安全性与整个人群相当。
结论
德国 CUP 中记录的 FTD/TPI 的患者特征和安全性与关键试验 RECURSE 中的报告一致，没有意外的安全性信号。
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