Background

Combination therapy comprised of fluoropyrimidine plus irinotecan with an angiogenesis inhibitor is widely used as a second-line treatment for metastatic colorectal cancer (mCRC).

Patients and Methods

This retrospective study evaluated the efficacy and safety of fluorouracil and irinotecan (FOLFIRI) plus ramucirumab (RAM); FOLFIRI plus aflibercept (AFL); irinotecan and S-1 (IRIS) plus bevacizumab (BEV); and capecitabine and irinotecan (CAPIRI) plus BEV, with FOLFIRI plus BEV serving as the control among mCRC patients who failed treatment with fluoropyrimidine and oxaliplatin plus BEV. Data were collected from a medical claim database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). The primary outcome was time to treatment failure (TTF). Secondary outcomes were time to first subsequent therapy (TFST), overall survival (OS), and safety.

Results

Among 3,136 patients assessed, TTF was significantly shorter with FOLFIRI plus RAM (adjusted hazard ratio [HR], 1.40; 95% confidence interval [CI], 1.26-1.56; P < .001) and FOLFIRI plus AFL (HR, 1.34; 95% CI, 1.09-1.66; P = .002), and significantly longer with IRIS plus BEV (HR, 0.80; 95% CI, 0.70-0.92; P = .002). TFST was significantly shorter with FOLFIRI plus RAM (HR, 1.32; 95% CI, 1.17-1.49; P < .001); no significant difference in OS was observed. The incidences of neutropenia requiring granulocyte colony-stimulating factor were significantly lower with IRIS plus BEV and CAPIRI plus BEV.

Conclusion

Regarding TTF, BEV seemed to be a favorable option compared with RAM and AFL when combined with FOLFIRI, and IRIS might be preferable compared to FOLFIRI when combined with BEV for patients who failed to respond to fluoropyrimidine, oxaliplatin, and BEV.

中文翻译：

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使用氟嘧啶、伊立替康和血管生成抑制剂二线治疗转移性结直肠癌的真实世界证据

背景

氟嘧啶加伊立替康和血管生成抑制剂的联合治疗被广泛用作转移性结直肠癌 (mCRC) 的二线治疗。

患者和方法

这项回顾性研究评估了氟尿嘧啶和伊立替康 (FOLFIRI) 加雷莫芦单抗 (RAM) 的疗效和安全性；FOLFIRI 加阿柏西普 (AFL)；伊立替康和 S-1 (IRIS) 加贝伐单抗 (BEV)；和卡培他滨和伊立替康 (CAPIRI) 加 BEV，FOLFIRI 加 BEV 作为氟嘧啶和奥沙利铂加 BEV 治疗失败的 mCRC 患者的对照。数据来自 Medical Data Vision Co., Ltd.（日本东京）提供的医疗索赔数据库。主要结果是治疗失败时间（TTF）。次要结果是首次后续治疗的时间 (TFST)、总生存期 (OS) 和安全性。

结果

在评估的 3,136 名患者中，FOLFIRI 加 RAM（调整后的风险比 [HR]，1.40；95% 置信区间 [CI]，1.26-1.56；P < .001）和 FOLFIRI 加 AFL（HR，1.34；95）显着缩短 TTF % CI，1.09-1.66；P  = .002），IRIS 加 BEV 显着延长（HR，0.80；95% CI，0.70-0.92；P  = .002）。FOLFIRI 加 RAM 的 TFST 显着缩短（HR，1.32；95% CI，1.17-1.49；P < .001）；没有观察到 OS 的显着差异。IRIS加BEV和CAPIRI加BEV的中性粒细胞减少症需要粒细胞集落刺激因子的发生率显着降低。

结论

关于 TTF，与 RAM 和 AFL 相比，BEV 与 FOLFIRI 联合似乎是一个有利的选择，对于氟嘧啶、奥沙利铂和 BEV 治疗无效的患者，与 FOLFIRI 联合 BEV 相比，IRIS 可能更可取。