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二线 FOLFIRI 方案联合雷莫芦单抗,加或不加贝伐珠单抗,用于转移性结直肠癌患者。

Second-line FOLFIRI plus ramucirumab with or without prior bevacizumab for patients with metastatic colorectal cancer.

机构信息

Department of Gastroenterology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.

出版信息

Cancer Chemother Pharmacol. 2019 Aug;84(2):307-313. doi: 10.1007/s00280-019-03855-w. Epub 2019 May 7.

Abstract

PURPOSE

Few data of folinic acid, fluorouracil, and irinotecan (FOLFIRI) plus ramucirumab (RAM) obtained in bevacizumab-naïve patients in clinical trials or routine clinical practice are available. The purpose of this retrospective study was to report the results of FOLFIRI plus RAM treatment as second-line chemotherapy for metastatic colorectal cancer (mCRC).

METHODS

Seventy-four patients with mCRC who received second-line FOLFIRI + RAM mCRC therapy were stratified by previous first-line therapy to groups that had (PB) or had not (NPB) been given bevacizumab. The overall survival (OS), progression-free survival (PFS), and objective response were evaluated.

RESULTS

The overall median PFS was 6.2 months (95% CI 4.6-9.3) and median OS was 17.0 months (95% CI 11.6-NA). Median PFS was 8.0 months (95% CI 4.9-11.2) in NPB patients and 5.0 months (95% CI 3.1-7.3) in PB patients (hazard ratio = 0.72, 95% CI 0.40-1.30, p = 0.28). The response rates were 23% and 3% in NPB and PB patients, respectively. The disease control rates were 85% and 69% in NPB and PB patients, respectively.

CONCLUSIONS

The effectiveness of FOLFIRI + RAM as a second-line chemotherapy in patients with mCRC was in line with that reported in the previous RAISE phase III trial. The response was better in bevacizumab-naïve patients than those with first-line treatment that had included bevacizumab.

摘要

目的

在临床试验或常规临床实践中,几乎没有贝伐珠单抗治疗前患者接受亚叶酸钙、氟尿嘧啶、伊立替康(FOLFIRI)联合雷莫芦单抗(RAM)治疗的数据。本回顾性研究的目的是报告二线化疗转移性结直肠癌(mCRC)患者接受 FOLFIRI 联合 RAM 治疗的结果。

方法

对接受二线 FOLFIRI+RAM mCRC 治疗的 74 例 mCRC 患者,根据一线治疗分为接受(PB)或未接受(NPB)贝伐珠单抗治疗的两组。评估总生存期(OS)、无进展生存期(PFS)和客观缓解。

结果

总中位 PFS 为 6.2 个月(95%CI 4.6-9.3),中位 OS 为 17.0 个月(95%CI 11.6-NR)。NPB 患者中位 PFS 为 8.0 个月(95%CI 4.9-11.2),PB 患者为 5.0 个月(95%CI 3.1-7.3)(风险比=0.72,95%CI 0.40-1.30,p=0.28)。NPB 和 PB 患者的缓解率分别为 23%和 3%。NPB 和 PB 患者的疾病控制率分别为 85%和 69%。

结论

FOLFIRI+RAM 作为二线化疗在 mCRC 患者中的疗效与之前的 RAISE III 期试验报道的结果一致。在一线治疗中未包含贝伐珠单抗的患者中,其反应优于包含贝伐珠单抗的患者。

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