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Early response evaluation and CEA response in patients treated in a Danish randomized study comparing trifluridine/tipiracil (TAS-102) with or without bevazicumab in patients with chemorefractory metastatic colorectal cancer (mCRC)

医学 贝伐单抗 伊立替康 奥沙利铂 结直肠癌 内科学 随机对照试验 耐火材料(行星科学) 肿瘤科 化疗 胃肠病学 癌症 物理 天体生物学
作者
Camilla Qvortrup,Melih Yilmaz,Sören Möller,Daniela Žitnjak,L. Maltha,Merete Krogh,Lone N. Petersen,Finn Hejlesen,Stine Brændegaard Winther,Karina Gravgaard Thomsen,Per Pfeiffer
出处
期刊:Annals of Oncology [Elsevier BV]
卷期号:30: v233-v233
标识
DOI:10.1093/annonc/mdz246.094
摘要

Abstract Background Trifluridine/tipiracil (FTD/TPI, also known as TAS-102) prolongs OS in patients with chemorefractory mCRC. Inspired by the results of C-TASK FORCE (Kuboki 2017), we designed an investigator-initiated randomized trial in the last setting in mCRC patients demonstrating improved PFS and OS in patients receiving bevazicumab combined with TAS-102 as compared to patients treated with TAS-102 alone (Pfeiffer WCGI 2019). In the last line setting half of patients will not benefit from therapy as they have PD at the first evaluation performed after 2 months of therapy. In the present study we included an early response evaluation after 1 month of therapy aiming to identify patients not having any effect of therapy. In addition, we evaluated plasma CEA as a marker of response. Methods The main inclusion criteria were: histologically confirmed and chemo-refractory mCRC; PD during or after therapy with FU, irinotecan, oxaliplatin, and EGFR-inhibitor (RASwt); prior treatment with bevacizumab was allowed; PS 0-1. In arm A: FTD/TPI 35 mg/m²/dose bid from days 1-5 and 8-12; in arm B the same dose of FTD/TPI with bevacizumab (5 mg/kg), days 1 and 15 of a 28-day cycle. Response evaluation performed during treatment at 4 weeks, 8 weeks, and every 8 weeks thereafter. CEA was tested at baseline and at every 2. cycle. Results 93 patients with chemo-refractory mCRC were randomized from Sep. 2017 to Oct. 2018. The median PFS was significantly improved from 2.6 months (arm A) to 4.6 months (arm B) with a HR 0.45 (95% CI, 0.29-0.72; P = 0.001). Median OS was significantly prolonged from 6.7 months (arm A) to 9.4 months (arm B) with HR 0.55 (95% CI, 0.32-0.94; P = 0.03) (Pfeiffer WCGI 2019). Sub-group analyses including predictive markers for early progression will presented. Conclusions FTD/TPI in combination with bevacizumab prolong PFS and OS and is a new option in patients with chemo-refractory mCRC. Predictive markers for early progression are ongoing and will be presented. Clinical trial identification 2016-005241-23. Legal entity responsible for the study Per Pfeiffer. Funding Servier. Disclosure C. Qvortrup: Research grant / Funding (institution): Servier. P. Pfeiffer: Research grant / Funding (institution): Servier; Research grant / Funding (institution): Merck. All other authors have declared no conflicts of interest.

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