ABSTRACT

Introduction

Substantial paradigm shifts have been recently registered in metastatic renal cell carcinoma (mRCC), with combination therapies including immunotherapy showing unprecedented results. We performed number needed to treat (NNT) and number needed to harm (NNH) analyses to evaluate these approaches in mRCC.

Areas covered

Clinical data of mRCC patients enrolled in four phase III trials were collected. The rates at 6, 12, 18, and 24 months for overall survival (OS), duration of response (DoR), and progression-free survival (PFS) were considered. At 6 months, the number of patients that should be treated to prevent one death with sunitinib was 20 for both pembrolizumab-lenvatinib or axitinib, 14 for nivolumab-cabozantinib, and 50 for nivolumab-ipilimumab. NNT was 100 (at 6 months) or >100 (at 12 and 18 months) for nivolumab-ipilimumab. The combinations reported peculiar and not superimposable safety profiles at the NNH analysis.

Expert opinion

Although our results should be interpreted with caution, the analysis provides useful insight into the increasingly compelling interpretation of clinical trials. Immune combinations present clinically meaningful differences in terms of efficacy, with some treatments reporting different results at the NNT and the NNH analyses.

中文翻译：

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帕博利珠单抗加乐伐替尼或阿西替尼与纳武单抗加伊匹单抗或卡博替尼治疗晚期肾细胞癌的比较：治疗分析所需的数字

摘要

介绍

最近在转移性肾细胞癌 (mRCC) 中出现了重大的范式转变，包括免疫疗法在内的联合疗法显示出前所未有的结果。我们进行了需要治疗的次数 (NNT) 和需要伤害的次数 (NNH) 分析，以评估 mRCC 中的这些方法。

涵盖的领域

收集了参加四项 III 期试验的 mRCC 患者的临床数据。考虑了 6、12、18 和 24 个月的总生存期 (OS)、缓解持续时间 (DoR) 和无进展生存期 (PFS) 的比率。在 6 个月时，使用舒尼替尼预防死亡的患者人数为：派姆单抗-乐伐替尼或阿昔替尼均为 20 人，纳武单抗-卡博替尼为 14 人，纳武单抗-易普利姆玛为 50 人。对于 nivolumab-ipilimumab，NNT 为 100（在 6 个月时）或 >100（在 12 和 18 个月时）。在 NNH 分析中，这些组合报告了独特且不可叠加的安全性概况。

专家意见

尽管我们的结果应该谨慎解释，但该分析为越来越引人注目的临床试验解释提供了有用的见解。免疫组合在疗效方面具有临床意义的差异，一些治疗在 NNT 和 NNH 分析中报告了不同的结果。