Su Ruopeng, Chen Zeyu, Hu Hailong, Jiang Shuai, Chen Minfeng, Chen Qiong, Gellhaus Paul Thomas, Ornellas Antonio Augusto, Campobasso Davide, Wei Qiang, Huang Jiwei, Bao Yige, Xue Wei
Department of Urology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Urology and Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.
Transl Androl Urol. 2023 Sep 30;12(9):1416-1425. doi: 10.21037/tau-23-404. Epub 2023 Sep 18.
Metastatic upper tract urothelial carcinoma (mUTUC) is a malignant cancer associated with poor prognosis. Few studies have investigated the clinical outcome of a recently developed combination regimen of programmed cell death 1 (PD-1) inhibitor plus nab-paclitaxel in mUTUC.
We retrospectively retrieved data from the electronic medical records of cisplatin-ineligible or cisplatin-refractory mUTUC patients from five participating Chinese centers, who received treatment of PD-1 inhibitor plus nab-paclitaxel between April 2018 and January 2022. Clinical response was assessed according to Response Evaluation Criteria in Solid Tumors criteria version 1.1 (RECIST 1.1). Duration of response (DOR), overall survival (OS), and progression-free survival (PFS) were evaluated by the Kaplan-Meier method.
The confirmed overall response rate (ORR) was 14/34 (41.2%), and the disease control rate (DCR) was 24/34 (70.6%). Complete response (CR) was achieved in one case, partial response (PR) in 13 cases (38.2%), stable disease (SD) in 10 cases (29.4%), and progressive disease (PD) occurred in 10 cases (29.4%). After a median follow-up period of 16.0 months [95% confidence interval (CI): 9.9-22.1], 14 deaths were reported, with a median OS of 15.0 months (95% CI: 9.9-20.1); 22 progressions were reported, with a median PFS of 6.0 months (95% CI: 2.4-9.6). Patients with visceral metastasis had a similar PFS [hazard ratio (HR): 1.28, 95% CI: 0.53-3.09, P=0.574) and OS (HR: 1.94, 95% CI: 0.64-5.83, P=0.279] to patients with lymph node metastasis only.
This real-world study suggests that PD-1 inhibitor plus nab-paclitaxel is effective in cisplatin-ineligible and cisplatin-refractory mUTUC patients with acceptable toxicity, especially for patients with visceral metastasis.
转移性上尿路尿路上皮癌（mUTUC）是一种预后较差的恶性肿瘤。很少有研究调查过最近开发的程序性细胞死亡蛋白1（PD-1）抑制剂联合白蛋白结合型紫杉醇治疗mUTUC的临床疗效。
我们回顾性地从五个参与研究的中国中心的电子病历中检索了不符合顺铂治疗条件或对顺铂耐药的mUTUC患者的数据，这些患者在2018年4月至2022年1月期间接受了PD-1抑制剂联合白蛋白结合型紫杉醇治疗。根据实体瘤疗效评价标准第1.1版（RECIST 1.1）评估临床反应。采用Kaplan-Meier法评估缓解持续时间（DOR）、总生存期（OS）和无进展生存期（PFS）。
确认的总缓解率（ORR）为14/34（41.2%），疾病控制率（DCR）为24/34（70.6%）。1例达到完全缓解（CR），13例达到部分缓解（PR，38.2%），10例病情稳定（SD，29.4%），10例病情进展（PD，29.4%）。中位随访期为16.0个月[95%置信区间（CI）：9.9 - 22.1]，报告了14例死亡，中位OS为15.0个月（95% CI：9.9 - 20.1）；报告了22例病情进展，中位PFS为6.0个月（95% CI：2.4 - 9.6）。内脏转移患者的PFS[风险比（HR）：1.28，95% CI：0.53 - 3.09，P = 0.574]和OS（HR：1.94，95% CI：0.64 - 5.83，P = 0.279）与仅发生淋巴结转移的患者相似。
这项真实世界研究表明，PD-1抑制剂联合白蛋白结合型紫杉醇对不符合顺铂治疗条件及对顺铂耐药的mUTUC患者有效，且毒性可接受，尤其适用于内脏转移患者。
