结直肠肝转移灶切除术与二线aflibercept加FOLFIRI疗法：法国前瞻性队列RESECTION的研究结果

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2024-10-22 DOI:10.1016/j.ejca.2024.115082

David Tougeron , Frederic Bibeau , Benoist Chibaudel , Stefano Kim , Thierry Nguyen , Jean-Marc Phelip , Dominique Mille , Mohamed Bouattour , David Tavan , Yves Rinaldi , Thierry Lecomte , Hervé Perrier , Dominique Spaeth , François-Xavier Caroli Bosc , Jean-Philippe Metges , Marc Ferec , Vincent Hautefeuille , Marion Deslandres-Cruchant , Jerome Danion , Pascal Hammel , René Adam

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引用次数: 0

摘要

方法这项法国多中心、前瞻性、观察性队列研究（NCT05178745）纳入了结直肠肝转移（CLM）患者（单独或主要；最多允许5个肺结节<2 cm），根据医生的选择，每2周开始一次aflibercept加FOLFIRI治疗。主要终点是R0/R1切除率。次要终点包括总生存期（OS）、无进展生存期（PFS）、放射学和病理学反应以及安全性。结果共有137名患者（中位年龄65岁，RAS/BRAF突变57%/9%）在22个法国研究机构接受了治疗。82%的CLM（中位数为4）为同步，71%为双叶，54%仅位于肝脏。总体而言，17%的患者进行了R0/R1切除术（21%的患者只切除了肝脏）。根据 Blazer 评分，55% 的切除患者有主要病理反应，与未切除患者相比，OS（中位 34.8 个月 vs 9.1 个月，p < 0.0001）和 PFS（中位 11.4 个月 vs 4.9 个月，p < 0.0001）显著延长。17%的患者出现术后并发症（均为丁多-克拉维恩 I-II 级），无术后死亡病例。总的来说，34%的患者出现了≥3级的不良反应，主要是全身健康状况恶化和腹泻。结论结果表明，在既往奥沙利铂方案治疗失败后，aflibercept加FOLFIRI可使近20%的CLM患者进行R0/R1切除，大多数病例可获得主要病理反应，与未切除患者相比，中位OS延长了3倍以上。

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Resection of colorectal liver metastases with second-line aflibercept plus FOLFIRI: Results from the RESECTION prospective French cohort

Aim

To evaluate R0/R1 resection rate in patients with colorectal liver metastases (CLM) treated with aflibercept plus FOLFIRI after failure of a prior oxaliplatin-based regimen in daily clinical practice.

Methods

This French, multicentre, prospective, observational cohort (NCT05178745) included patients with CLM (alone or predominant; up to 5 lung nodules <2 cm allowed) initiating aflibercept plus FOLFIRI every 2 weeks per physician choice. Primary endpoint was R0/R1 resection rate. Secondary endpoints included overall survival (OS), progression-free survival (PFS), radiological and pathological responses, and safety.

Results

A total of 137 patients (median age 65 years, RAS/BRAF mutant 57 %/9 %) were enrolled at 22 French sites. CLM (median 4) were synchronous in 82 %, bilobar in 71 % and located in liver only in 54 %. Overall, 17 % of patients had R0/R1 resection (21 % for patients with liver-only disease). A major pathological response per Blazer score was observed in 55 % of resected patients, along with significantly longer OS (median 34.8 vs 9.1 months, p < 0.0001) and PFS (median 11.4 vs 4.9 months, p < 0.0001) compared to non-resected patients. Post-operative complications occurred in 17 % of patients (all Dindo-Clavien grade I-II) and there was no post-operative deaths. Overall, 34 % had grade ≥ 3 adverse events, mainly general health deterioration and diarrhea.

Conclusions

Results suggest that aflibercept plus FOLFIRI, after failure of a prior oxaliplatin-based regimen, allows R0/R1 resection of CLM in almost 20 % of patients with a major pathological response in most cases and a median OS prolonged by more than 3-fold versus non-resected patients.

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.