帕唑帕尼治疗转移性肾细胞癌患者：一项单中心、真实世界、回顾性的中国研究。

Pazopanib in patients with metastatic renal cell carcinoma: a single-center, real-world, retrospective Chinese study.

作者信息

Chen Jianhui, Ye Wen, Jiang Wei, Li Xiaofan, Liu Rong, Lin Bijuan, Xiang Jingnan, Tian Wei, Bai Junjie, Zuo Teng, Lin Bingxin, Guo Yinan, Zheng Song

机构信息

Department of Urology, Fujian Medical University Union Hospital, Fuzhou, China.

Department of Hematology, Fujian Institute of Hematology, Union Hospital, Fujian Medical University, Fuzhou, China.

出版信息

Transl Androl Urol. 2021 Mar;10(3):1321-1331. doi: 10.21037/tau-21-111.

DOI:10.21037/tau-21-111

PMID:33850766

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8039632/

Abstract

BACKGROUND

The efficacy and safety of pazopanib in patients diagnosed with metastatic renal cell carcinoma (mRCC) have been demonstrated by a Chinese subgroup analysis of the COMPARZ (Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma) trial. However, the real-world data are still unknown. This single-center, retrospective study was designed to verify the real-world effects of pazopanib in Chinese patients with mRCC.

METHODS

Patients with mRCC and a clinical decision to initiate pazopanib as first-line therapy were eligible. The primary endpoint was progression-free survival (PFS), with overall survival (OS), objective response rate (ORR), and safety being evaluated as secondary endpoints. The effectiveness according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk model, number of risk factors in the intermediate risk group, age, Eastern Cooperative Oncology Group (ECOG) performance status (PS), and the number and site of organ metastasis were also assessed.

RESULTS

A total of 32 patients were enrolled, including 23 (71.9%) males and 9 (28.1%) females. The median age was 57 years (range 29-75 years). With a median follow-up time of 23.8 months, a median PFS of 18.3 months, and an ORR of 37.5%. Median OS was not reached, and the 1-, 2-, and 3-year overall survival rates were 90.6%, 78.1, and 65.6%, respectively. According to IMDC risk model, 37.5% were placed in the favorable risk (FR) subgroup, 56.2% (the majority) were placed in the intermediate risk (IR) subgroup, and 6.3% were placed in the poor risk (PR) subgroup. Compared with the IR and PR groups, the FR group achieved the best ORR (58.3%) and median PFS (22.1 months). Having 1 risk factor, ECOG PS <2, 1 organ metastasis site, and only lung metastasis associated with a higher ORR and better median PFS. The IMDC risk model and number of metastases were associated with PFS. The most common adverse events were change in hair color (69.0%), diarrhea (63%), and hypertension (50%).

CONCLUSIONS

Pazopanib showed efficacy and safety in real-world Chinese mRCC patients.

摘要

背景

COMPARZ（帕唑帕尼与舒尼替尼治疗局部晚期和/或转移性肾细胞癌）试验的中国亚组分析已证明帕唑帕尼对诊断为转移性肾细胞癌（mRCC）患者的疗效和安全性。然而，真实世界的数据仍然未知。这项单中心回顾性研究旨在验证帕唑帕尼在中国mRCC患者中的真实世界疗效。

方法

符合条件的患者为患有mRCC且临床决定将帕唑帕尼作为一线治疗药物。主要终点是无进展生存期（PFS），总生存期（OS）、客观缓解率（ORR）和安全性作为次要终点进行评估。还评估了根据国际转移性肾细胞癌数据库联盟（IMDC）风险模型的疗效、中危组风险因素数量、年龄、东部肿瘤协作组（ECOG）体能状态（PS）以及器官转移的数量和部位。

结果

共纳入32例患者，其中男性23例（71.9%），女性9例（28.1%）。中位年龄为57岁（范围29 - 75岁）。中位随访时间为23.8个月，中位PFS为18.3个月，ORR为37.5%。未达到中位OS，1年、2年和3年总生存率分别为90.6%、78.1%和65.6%。根据IMDC风险模型，37.5%被归入低危（FR）亚组，56.2%（大多数）被归入中危（IR）亚组，6.3%被归入高危（PR）亚组。与IR组和PR组相比，FR组的ORR最佳（58.3%），中位PFS最长（22.1个月）。具有1个风险因素、ECOG PS<2、1个器官转移部位且仅肺转移与更高的ORR和更好的中位PFS相关。IMDC风险模型和转移灶数量与PFS相关。最常见的不良事件是头发颜色改变（69.0%）、腹泻（63%）和高血压（50%）。