帕博利珠单抗联合乐伐替尼治疗转移性肾细胞癌患者：来自国际ARON-1研究的真实世界证据
Pembrolizumab plus Lenvatinib in patients with metastatic Renal Cell Carcinoma: real-world evidences from the international ARON- 1 study.
作者信息
Porta Camillo, Massari Francesco, Taha Tarek, Grande Enrique, Bourlon Maria T, Kanesvaran Ravindran, Basso Umberto, Molina-Cerrillo Javier, Alonso-Gordoa Teresa, Myint Zin W, Fornarini Giuseppe, Buttner Thomas, Park Se Hoon, Ürün Yüksel, De Giorgi Ugo, Pichler Renate, Rescigno Pasquale, Buchler Tomas, Studentova Hana, Melichar Bohuslav, Ansari Jawaher, Mollica Veronica, Kucharz Jakub, Rizzo Mimma, Rizzo Alessandro, Kopp Ray Manneh, Buti Sebastiano, Monteiro Fernando Sabino Marques, Soares Andrey, Bamias Aristotelis, Santoni Matteo
机构信息
Interdisciplinary Department of Medicine, University of Bari "A. Moro", Bari, Italy.
Division of Medical Oncology, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Piazzale G. Cesare 11, 70124, Bari, Italy.
出版信息
Cancer Immunol Immunother. 2025 May 9;74(7):196. doi: 10.1007/s00262-025-04019-x.
BACKGROUND
Pembrolizumab plus lenvatinib is a treatment option for metastatic Renal Cell Carcinoma (mRCC). In the ARON-1 study we investigated we the real-world experiences gained from the use of this combination for mRCC.
METHODS
We retrospectively investigated real-world clinical outcomes of mRCC patients receiving pembrolizumab plus lenvatinib within the ARON-1 study. Overall survival (OS) was calculated from the start of pembrolizumab plus lenvatinib to death for any cause. Progression-Free Survival (PFS) was defined as the time from the start of pembrolizumab to progression or death from any cause. Duration of response (DoR) was defined as the time from the start of pembrolizumab to disease progression or death, whichever occurred first, in patients who achieved complete remission (CR) or partial response (PR). Overall Response Rate (ORR) was defined as the proportion of patients who achieve a CR or PR per RECIST criteria. Adverse events were retrospectively collected from electronic and paper charts and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
RESULTS
Overall, we included 202 mRCC patients treated with pembrolizumab plus lenvatinib. The median follow-up time was 15.1 months. The median OS was not reached (NR), with a median PFS of 25.6 months and an Overall Response Rate (ORR) of 59%. The median Duration of Response (DoR) was 26.2 months. G3-G4 adverse events (AEs) were observed in 92 patients (46%), with hypertension being the most common AE (13%).
CONCLUSIONS
Pembrolizumab plus lenvatinib is an effective and tolerable treatment for mRCC also in the real-world setting.
背景
帕博利珠单抗联合乐伐替尼是转移性肾细胞癌（mRCC）的一种治疗选择。在ARON - 1研究中，我们调查了使用这种联合疗法治疗mRCC所获得的真实世界经验。
方法
我们回顾性研究了ARON - 1研究中接受帕博利珠单抗联合乐伐替尼治疗的mRCC患者的真实世界临床结局。总生存期（OS）从开始使用帕博利珠单抗联合乐伐替尼计算至因任何原因死亡。无进展生存期（PFS）定义为从开始使用帕博利珠单抗至因任何原因进展或死亡的时间。缓解持续时间（DoR）定义为在达到完全缓解（CR）或部分缓解（PR）的患者中，从开始使用帕博利珠单抗至疾病进展或死亡（以先发生者为准）的时间。总缓解率（ORR）定义为根据实体瘤疗效评价标准（RECIST）达到CR或PR的患者比例。不良事件通过电子和纸质病历进行回顾性收集，并根据不良事件通用术语标准（CTCAE）v5.0进行分类。
结果
总体而言，我们纳入了202例接受帕博利珠单抗联合乐伐替尼治疗的mRCC患者。中位随访时间为15.1个月。中位总生存期未达到（NR），中位无进展生存期为25.6个月，总缓解率（ORR）为59%。中位缓解持续时间（DoR）为26.2个月。92例患者（46%）出现3 - 4级不良事件（AE），其中高血压是最常见的AE（13%）。
结论
在真实世界中，帕博利珠单抗联合乐伐替尼也是一种有效且耐受性良好的mRCC治疗方法。
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