Pembrolizumab联合阿西替尼治疗转移性肾细胞癌在真实世界中的有效性和安全性：来自前瞻性 ProPAXI 研究的数据

IF 2.3 3区医学 Q3 ONCOLOGY

Clinical genitourinary cancer Pub Date : 2024-09-14 DOI:10.1016/j.clgc.2024.102225

Annalisa Guida , Alessio Gili , Claudia Mosillo , Marco Maruzzo , Eleonora Lai , Francesco Pierantoni , Davide Bimbatti , Umberto Basso , Giuseppe Fornarini , Sara Elena Rebuzzi , Fabio Calabrò , Linda Cerbone , Claudia Caserta , Grazia Sirgiovanni , Debora Serafin , Orazio Caffo , Sarah Scagliarini , Sergio Bracarda

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引用次数: 0

摘要

背景Pembrolizumab/Axitinib联合疗法被批准作为mRCC的一线疗法。本研究的目的是评估 PAXI 联合疗法在意大利真实世界中的疗效。方法这是一项前瞻性研究，包括在意大利招募中心接受联合疗法一线治疗的 mRCC 患者。结果从2020年12月到2023年9月，170名患者接受了治疗。大多数患者为透明细胞组织学（83%）。33%的病例具有肉瘤样特征。约一半的患者（55%）有同步转移。58%的病例进行了肾切除术，其中27%为细胞切除术，4%为延期肾切除术。106名患者（62%）发现肺转移，66名和29名患者（38.8%和17.1%）分别发现骨和肝转移。根据IMDC标准进行分层，32名患者（18.8%）风险较高，106名患者（62.4%）风险中等，32名患者（18.8%）风险较低。分析时，49%的患者正在接受治疗。45%的患者病情出现进展。中位 PFS 为 19.2 个月（95% CI：15-NR）。中位随访时间为 19.3 个月（1.3-34.5 个月），在 24 个月和 36 个月的地标分析中，分别有 62% （95% CI，53-70）和 58% （95% CI，47-69）的治疗患者仍然存活。84.6%的患者达到了疾病控制率：4.3%的患者获得完全应答，52%的患者获得部分应答，28.8%的患者病情稳定。15.3%的患者出现了原发性病情进展。在多变量分析中，年龄≥65岁、非透明细胞组织学、IMDC评分、不良事件和性别交互作用作为较差OS的预测因素，其预后意义得到了证实。我们的研究结果表明，在 mRCC 中，一线联合用药既有效又安全，并发现性别是不良事件发生的预后因素。

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Efficacy and Safety of Pembrolizumab plus Axitinib combination for Metastatic Renal Cell Carcinoma in a Real-World Scenario: Data From the Prospective ProPAXI Study

Background

Pembrolizumab/Axitinib combination is approved as first-line therapy in mRCC. The aim of this study is to evaluate outcomes of PAXI combo in the real-world in Italy.

Methods

This is a prospective study including patients diagnosed with mRCC who received combination as first-line therapy in recruiting Italian Centers. Data about patient characteristics, safety and outcome were collected.

Results

170 pts have been treated from December 2020 to September 2023. The majority had clear-cell histology (83%). Sarcomatoid feature was present in 33%of available cases. About one half of patients (55%) had synchronous metastasis. In 58% of cases nephrectomy was performed, of which 27% were cytoreductive and 4% were deferred nephrectomies. Lung metastases were identified in 106 patients (62%), bone and liver involvement in 66 and 29 patients (38.8% and 17.1%) respectively. Stratifying by IMDC criteria, 32 patients (18.8%) were at favorable-risk, 106 (62.4%) at intermediate-risk, and 32 (18.8%) at poor-risk. At time of analysis, treatment was ongoing in 49% of patients. Progression occurred in 45% of patients. Median PFS was 19.2 months (95% CI: 15-NR). With a median follow-up of 19.3 months (range 1.3-34.5), at 24-months and 36-months landmark analysis 62% (95% CI, 53-70) and 58% (95% CI, 47-69) of treated patients are still alive respectively. Disease control rate was achieved in 84.6% of patients: 4.3% reached a complete response, 52% had a partial response and 28.8% a stable disease. Primary progression was observed in 15.3% of patients. In the multivariate analysis, the prognostic significance of age ≥ 65 years, non-clear cell histology, IMDC score, and adverse events and gender interaction as predictors of worse OS were confirmed.

Conclusion

This is the first available prospective study on first-line Pembrolizumab/Axitinib combination in real world scenario. Our findings support the effectiveness and safety of first-line this combination in mRCC and reveal that gender emerged as a prognostic factor in relation to the occurrence of adverse events.

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来源期刊

Clinical genitourinary cancer 医学-泌尿学与肾脏学

CiteScore

5.20

自引率

6.20%

发文量

201

审稿时长

54 days

期刊介绍： Clinical Genitourinary Cancer is a peer-reviewed journal that publishes original articles describing various aspects of clinical and translational research in genitourinary cancers. Clinical Genitourinary Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of genitourinary cancers. The main emphasis is on recent scientific developments in all areas related to genitourinary malignancies. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.