瑞戈非尼与TAS-102治疗化疗难治性转移性结直肠癌（mCRC）患者疗效及安全性的回顾性研究：一项多机构真实世界临床数据研究
Retrospective Study of Regorafenib Versus TAS-102 Efficacy and Safety in Chemorefractory Metastatic Colorectal Cancer (mCRC) Patients: A Multi-institution Real Life Clinical Data.
作者信息
Vitale Pasquale, Zanaletti Nicoletta, Famiglietti Vincenzo, De Falco Vincenzo, Cervantes Andres, Rosellò Susanna, Fenocchio Elisabetta, Milanesio Michela, Lombardi Pasquale, Ciardiello Davide, Martini Giulia, Martinelli Erika, Ciardiello Fortunato, Troiani Teresa, Napolitano Stefania
机构信息
Medical Oncology, Department of Precision Medicine, Università degli Studi della Campania "Luigi Vanvitelli", 80131, Naples, Italy.
Department of Medical Oncology, INCLIVA Biomedical Research institute, University of Valencia, Valencia, Comunitat Valenciana, Spain.
出版信息
Clin Colorectal Cancer. 2021 Sep;20(3):227-235. doi: 10.1016/j.clcc.2021.06.002. Epub 2021 Jun 10.
INTRODUCTION
There have been significant developments in colorectal cancer (CRC) research over the last few years, with the introduction of new agents that have been prolonged median overall survival of metastatic colorectal cancer (mCRC). These therapies have improved patient outcomes; however, despite significant progress in strategies for cancer treatment, their use is limited by development of resistant mechanism. Almost 30% of patients with refractory mCRC will remain good candidates for further treatment. Regorafenib and TAS-102 are novel antitumor agents for patients with refractory mCRC. However, it is unclear which patients may derive a survival benefit from these drugs in real-life clinical practice.
METHODS
We performed a retrospective analysis evaluating safety and efficacy of TAS-102 and regorafenib in a cohort of refractory mCRC patients, in 3 different centers between January 1 2018 and May 31 2020, with the aim of assessing the optimal sequence treatment for these 2 drugs.
RESULTS
One hundred and forty mCRC patients were included in the analysis. Of these patients, 64 received regorafenib and 76 received TAS-102 as first treatment. After progression, in the regorafenib 24 (37%) patients switched to secondary treatment with TAS-102, instead, in the TAS-102 group, among 76 patients, 29 (45%) patients switched to secondary treatment with regorafenib. Disease control was achieved in 8 (12.5%) of 64 patients in the regorafenib group and 17 (22.4%) of 76 patients in the TAS-102 group. In terms of efficacy, the PFS and OS were similar in both treatment groups for primary and secondary treatments. AEs reported in this analysis were mostly consistent with the known safety profiles of regorafenib and TAS-102 in previous clinical trials.
CONCLUSION
The present study is the first one to compare the activity of the two agents in a large cohort of chemo-refractory mCRC patients providing more details about the best sequence, to be incorporated in clinical practice.
引言
在过去几年中，结直肠癌（CRC）研究取得了重大进展，新型药物的引入延长了转移性结直肠癌（mCRC）患者的中位总生存期。这些疗法改善了患者的预后；然而，尽管癌症治疗策略取得了显著进展，但它们的应用受到耐药机制的限制。几乎30%的难治性mCRC患者仍有进一步治疗的良好指征。瑞戈非尼和TAS-102是用于难治性mCRC患者的新型抗肿瘤药物。然而，在实际临床实践中，尚不清楚哪些患者可能从这些药物中获得生存益处。
方法
我们进行了一项回顾性分析，评估2018年1月1日至2020年5月31日期间3个不同中心的一组难治性mCRC患者中TAS-102和瑞戈非尼的安全性和疗效，目的是评估这两种药物的最佳序贯治疗方案。
结果
140例mCRC患者纳入分析。其中，64例患者接受瑞戈非尼作为一线治疗，76例患者接受TAS-102作为一线治疗。疾病进展后，瑞戈非尼组24例（37%）患者改用TAS-102进行二线治疗，相反，在TAS-102组的76例患者中，29例（45%）患者改用瑞戈非尼进行二线治疗。瑞戈非尼组64例患者中有8例（12.5%）实现疾病控制，TAS-102组76例患者中有17例（22.4%）实现疾病控制。在疗效方面，一线和二线治疗的两个治疗组的无进展生存期（PFS）和总生存期（OS）相似。本分析中报告的不良事件大多与瑞戈非尼和TAS-102在既往临床试验中已知的安全性特征一致。
结论
本研究是首次在一大群化疗难治性mCRC患者中比较这两种药物的活性，为最佳序贯治疗提供了更多细节，可纳入临床实践。
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