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多中心队列研究评估regorafenib 治疗后影像学变化与结局的相关性(KSCC1603)。

Multicenter Cohort Study to Assess the Association between Changes on Imaging and Outcome after Regorafenib Treatment (KSCC1603).

机构信息

Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan,

Shizuoka Cancer Center, Mishima, Japan.

出版信息

Oncology. 2020;98(10):719-726. doi: 10.1159/000507814. Epub 2020 Jul 8.

DOI:10.1159/000507814
PMID:32640458
Abstract

BACKGROUND

Molecular targeted drugs having angiogenesis-inhibiting properties allow the induction of necrosis inside tumors. We retrospectively investigated the relationship between changes on imaging associated with regorafenib (REGO) and treatment outcomes using real-world data.

PATIENTS AND METHODS

The eligibility criteria included an ECOG PS of 0-1, a starting dose of 120 or 160 mg/day of REGO, and a duration of treatment of at least 35 days. Regarding changes on imaging, cavitation in lung lesions (CLL), morphologic response of liver lesions (MRL), and change of liver metastasis density (CLD) were evaluated.

RESULTS

We finally screened 671 cases, and 226 cases were eligible. In total, 172 and 145 patients had lung and liver metastases, respectively. Among the patients with lung metastasis, CLL was found in 69 patients (40.0%). The median progression-free survival (PFS) of the patients with and those without CLL was 3.2 and 2.4 months, respectively (hazard ratio [HR] = 0.758; 95% confidence interval [CI]: 0.529-1.087), and the median overall survival (OS) of these groups was 10.5 and 8.9 months, respectively (HR = 0.862; 95% CI: 0.579-1.285). MRL and CLD of liver metastasis were analyzed in 145 and 90 patients, respectively. The median OS with and without MRL was 8.9 and 8.2 months, respectively, whereas the median OS with and without CLD was 11.6 and 7.7 months, respectively (HR = 0.523; 95% CI: 0.275-0.992).

CONCLUSION

CLL may predict PFS but not OS among patients with lung metastasis. CLD was predictive of favorable outcomes for REGO in patients with liver metastasis.

摘要

背景

具有抗血管生成作用的分子靶向药物可诱导肿瘤内部发生坏死。我们回顾性研究了使用真实世界数据的regorafenib(REGO)治疗与影像学变化之间的关系。

患者和方法

纳入标准为 ECOG PS 0-1,REGO 起始剂量为 120 或 160mg/天,治疗时间至少 35 天。关于影像学变化,评估肺病变空洞(CLL)、肝病变形态学反应(MRL)和肝转移密度变化(CLD)。

结果

我们最终筛选了 671 例患者,其中 226 例符合条件。共有 172 例和 145 例患者分别有肺和肝转移。在肺转移患者中,69 例(40.0%)存在 CLL。有和无 CLL 的患者中位无进展生存期(PFS)分别为 3.2 和 2.4 个月(HR=0.758;95%CI:0.529-1.087),中位总生存期(OS)分别为 10.5 和 8.9 个月(HR=0.862;95%CI:0.579-1.285)。分析了 145 例和 90 例患者的 MRL 和 CLD。有和无 MRL 的患者 OS 中位分别为 8.9 和 8.2 个月,而有和无 CLD 的患者 OS 中位分别为 11.6 和 7.7 个月(HR=0.523;95%CI:0.275-0.992)。

结论

在肺转移患者中,CLL 可能预测 PFS 而不是 OS。CLD 是 REGO 治疗肝转移患者预后良好的预测指标。

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