Post-marketing surveillance data for avelumab + axitinib treatment in patients with advanced renal cell carcinoma in Japan: Subgroup analyses by pathological classification.

IF 1.8 3区医学 Q3 UROLOGY & NEPHROLOGY International Journal of Urology Pub Date : 2024-12-19 DOI:10.1111/iju.15646

Norio Nonomura, Taito Ito, Masashi Sato, Makiko Morita, Masahiro Kajita, Mototsugu Oya

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Abstract

Objective: Clinical trials have demonstrated the efficacy and safety of avelumab + axitinib in patients with advanced clear cell renal cell carcinoma (ccRCC). However, information is limited regarding the activity of avelumab + axitinib in patients with non-clear cell RCC (nccRCC). In Japan, post-marketing surveillance (PMS) of patients with RCC receiving avelumab + axitinib treatment in general clinical practice was undertaken. We report ad hoc analyses of PMS data according to RCC pathological classification.

Methods: Of 328 patients with RCC who received ≥1 dose of avelumab and were enrolled between December 2019 and May 2021, 271 (82.6%) had ccRCC, 22 (6.7%) had nccRCC, and 35 (10.7%) had missing or unknown RCC pathology. Among patients with nccRCC, pathological subtypes were papillary in 12 (3.7%), translocation in 3 (0.9%), acquired cystic disease associated in 3 (0.9%), chromophobe in 2 (0.6%), mucinous tubular and spindle cell in 1 (0.3%), and Bellini duct in 1 (0.3%).

Results: Among patients with ccRCC or nccRCC, any-grade adverse drug reactions of safety specifications occurred in 140 (51.7%) and 15 (68.2%), and of grade ≥3 in 48 (17.7%) and 6 (27.3%), respectively. The objective response rate in patients with ccRCC or nccRCC was 36.9% and 22.7%, respectively; in patients with papillary tumors, it was 33.3%. Median overall survival was not reached in patients with ccRCC or nccRCC, and 12-month overall survival rates were 86.8% and 76.7%, respectively.

Conclusions: Overall, subgroup analyses of PMS data suggest that avelumab + axitinib improved clinical outcomes in nccRCC in addition to ccRCC.

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日本晚期肾细胞癌患者avelumab + axitinib治疗的上市后监测数据：病理分类亚组分析

目的：临床试验证明了avelumab + axitinib治疗晚期透明细胞肾细胞癌（ccRCC）的有效性和安全性。然而，关于avelumab + axitinib在非透明细胞RCC （nccRCC）患者中的活性的信息有限。在日本，在一般临床实践中对接受avelumab + axitinib治疗的RCC患者进行了上市后监测（PMS）。我们报告了根据RCC病理分类的PMS数据的特别分析。方法：在2019年12月至2021年5月期间接受≥1剂量avelumab治疗的328例RCC患者中，271例（82.6%）患有ccRCC， 22例（6.7%）患有nccRCC， 35例（10.7%）患有缺失或未知的RCC病理。在nccRCC患者中，病理亚型为乳头状12例（3.7%），易位3例（0.9%），获得性囊性疾病相关3例（0.9%），厌色2例（0.6%），粘液管和梭形细胞1例（0.3%），Bellini导管1例（0.3%）。结果：在ccRCC或nccRCC患者中，发生安全规格的任何级药物不良反应的患者分别为140例（51.7%）和15例（68.2%），发生≥3级药物不良反应的患者分别为48例（17.7%）和6例（27.3%）。ccRCC和nccRCC患者的客观缓解率分别为36.9%和22.7%；在乳头状肿瘤患者中，这一比例为33.3%。ccRCC或nccRCC患者的中位总生存期未达到，12个月总生存率分别为86.8%和76.7%。结论：总体而言，PMS数据的亚组分析表明，除了ccRCC外，avelumab + axitinib还能改善nccRCC的临床结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Urology 医学-泌尿学与肾脏学

CiteScore

4.70

自引率

11.50%

发文量

340

审稿时长

3 months

期刊介绍： International Journal of Urology is the official English language journal of the Japanese Urological Association, publishing articles of scientific excellence in urology. Submissions of papers from all countries are considered for publication. All manuscripts are subject to peer review and are judged on the basis of their contribution of original data and ideas or interpretation.