Chemotherapy Rechallenge or Reintroduction Compared to Regorafenib or Trifluridine/Tipiracil for Pretreated Metastatic Colorectal Cancer Patients: A Propensity Score Analysis of Treatment Beyond Second Line (Proserpyna Study)

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer Pub Date : 2024-06-12 DOI:10.1016/j.clcc.2024.06.002

M.A. Calegari , I.V. Zurlo , E. Dell'Aquila , M. Basso , A. Orlandi , M. Bensi , F. Camarda , A. Anghelone , C. Pozzo , I. Sperduti , L. Salvatore , D. Santini , D.C. Corsi , E. Bria , G. Tortora

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引用次数: 0

Abstract

Background

The optimal treatment for metastatic colorectal cancer (mCRC) beyond second line is still questioned. Besides the standard of care agents (regorafenib, REG, or trifluridine/tipiracil, FTD/TPI), chemotherapy rechallenge or reintroduction (CTr/r) are commonly considered in clinical practice, despite weak supporting evidence. The prognostic performance of CTr/r, REG and FTD/TPI in this setting are herein evaluated.

Patients and methods

PROSERpYNa is a multicenter, observational, retrospective study, in which patients with refractory mCRC, progressing after at least 2 lines of CT, treated with CTr/r, REG or FTD/TPI, are considered eligible and were enrolled in 2 independent data sets (exploratory and validation). Primary endpoint was overall survival (OS); secondary endpoints were investigator-assessed progression-free survival (PFS), objective response rate (RR) and safety. A propensity score adjustment was accomplished for survival analyses.

Results

Data referring to patients treated between Jan-10 and Jan-19 from 3 Italian institutions were gathered (341 and 181 treatments for exploratory and validation data sets respectively). In the exploratory cohort, median OS (18.5 vs. 6.5 months), PFS (6.1 vs. 3.5 months) and RR (28.6% vs. 1.4%) were significantly longer for CTr/r compared to REG/FTD/TPI. Survival benefits were retained at the propensity score analysis, adjusted for independent prognostic factors identified at multivariate analysis. Moreover, these results were confirmed within the validation cohort analyses.

Conclusions

Although the retrospective fashion, CTr/r proved to be a valuable option in this setting in a real-world context, providing superior outcomes compared to standard of care agents at the price of a moderate toxicity.

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化疗再挑战或再引入与瑞戈非尼或曲氟尿苷/替吡拉西钠治疗预处理转移性结直肠癌患者的比较：二线治疗后疗效的密度扫描分析（PROSERpYNa 研究）

背景：对于二线以外的转移性结直肠癌（mCRC）的最佳治疗方法仍然存在疑问。除了标准治疗药物（瑞非尼，REG，或三氟定/替吡拉西，FTD/TPI），化疗再挑战或再引入（CTr/r）在临床实践中通常被考虑，尽管支持证据薄弱。在此评估CTr/r、REG和FTD/TPI的预后表现。患者和方法proserpyna是一项多中心、观察性、回顾性研究，在该研究中，接受CTr/r、REG或FTD/TPI治疗的难治性mCRC患者被认为符合条件，并被纳入2个独立数据集（探索性和验证性）。主要终点为总生存期（OS）；次要终点是研究者评估的无进展生存期（PFS）、客观缓解率（RR）和安全性。对生存分析进行倾向评分调整。结果收集意大利3家机构1月10日至1月19日治疗的患者数据（探索性数据集341例，验证性数据集181例）。在探索性队列中，CTr/r的中位OS（18.5个月vs. 6.5个月）、PFS（6.1个月vs. 3.5个月）和RR （28.6% vs. 1.4%）明显长于REG/FTD/TPI。在倾向评分分析中保留了生存获益，并根据多变量分析确定的独立预后因素进行了调整。此外，这些结果在验证队列分析中得到证实。结论：虽然采用回顾性方法，但CTr/r在现实环境中被证明是一个有价值的选择，与标准治疗药物相比，在中等毒性的代价下提供了更好的结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical colorectal cancer 医学-肿瘤学

CiteScore

5.50

自引率

2.90%

发文量

审稿时长

27 days

期刊介绍： Clinical Colorectal Cancer is a peer-reviewed, quarterly journal that publishes original articles describing various aspects of clinical and translational research of gastrointestinal cancers. Clinical Colorectal Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of colorectal, pancreatic, liver, and other gastrointestinal cancers. The main emphasis is on recent scientific developments in all areas related to gastrointestinal cancers. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.