我们报告 PADRES（先前阿西替尼作为肾脏手术结果的决定因素，NCT03438708）的结果，该研究研究新辅助阿西替尼（辉瑞，纽约）治疗高度复杂的肿瘤，具有肾部分切除术（PN）的必要指征，其中 PN 具有挑战性即使是在经验丰富的手中，根治性肾切除术 (RN) 也会导致严重或终末期慢性肾脏病。我们对局限性 (cT1b-cT3M0) 透明细胞肾细胞癌 (RCC) 进行了单组 II 期临床试验具有保留肾单位的必要指征的患者，其中 PN 由于复杂性而具有高风险（RENAL 评分 10-12）。阿西替尼 5 mg 每日两次，持续 8 周，完成后重复成像，然后进行手术。主要结局是在阿西替尼后成功完成计划的 PN。次要目标包括肿瘤直径的变化、肾肾测量评分、肾功能、RECIST v1.1 标准和手术并发症。 纳入了 27 名患者（中位年龄 69 岁）。治疗前，20 名 (74.0%) 患者的肿瘤≥临床 T3a 期。阿西替尼导致肿瘤直径减小（7.5 vs. 6.2 cm，p<0.001）和肾评分（11 vs. 10，p <0.001）；根据 RECIST 标准，9 例（33.3%）有部分缓解，9 例（33%）临床降期。 20 例（74.0%）进行了 PN； 25 家 (96.2%) 实现了负利润。六名 (22.2%) 患有 Clavien III-IV 并发症。中位 ΔeGFR（术前至最后一次随访）为 8.5 ml/min/1.73m2。新辅助 axitnib 导致肿瘤大小和复杂性减小，为患有复杂肾肿块和必要适应症的患者提供安全可行的 PN 和功能保留。© 2023年北京和睦家国际学校。

We report results of PADRES (Prior Axitinib as a Determinant of Outcome of Renal Surgery, NCT03438708), which investigates neoadjuvant axitinib (Pfizer, NY) for tumors of high complexity with imperative indication for partial nephrectomy (PN), in which PN would be challenging even in experienced hands and where radical nephrectomy (RN) would result in development of severe or end-stage chronic kidney disease.We conducted a single-arm Phase II clinical trial of Localized (cT1b-cT3M0) clear cell renal cell carcinoma (RCC) patients with imperative indications for nephron preservation where PN is high risk due to complexity (RENAL score 10-12). Axitinib 5 mg was administered twice daily for 8 weeks with repeat imaging at completion, followed by surgery. Primary outcome was successful completion of planned PN following axitinib. Secondary objectives included change in tumor diameter, RENAL Nephrometry score, renal function, RECIST v1.1 criteria, and surgical complications.Twenty-seven patients were enrolled (median age 69 years). Prior to therapy, 20 (74.0%) patients had ≥ clinical T3a staged tumors. Axitinib resulted in reductions in tumor diameter (7.5 vs. 6.2 cm, p<0.001) and RENAL score (11 vs. 10, p <0.001); 9 (33.3%) had partial response by RECIST criteria and 9 (33%) were clinically downstaged. PN was performed in 20 (74.0%); 25 (96.2%) achieved negative margins. Six (22.2%) had Clavien III-IV complications. Median ∆eGFR (preoperative to last follow-up) was 8.5 ml/min/1.73m2.Neoadjuvant axitnib resulted in reductions in tumor size and complexity, enabling safe and feasible PN and functional preservation in patients with complex renal masses and imperative indication.© 2023 BJU International.