Real‐world effectiveness of nivolumab and subsequent therapy in Japanese patients with metastatic renal cell carcinoma (POST‐NIVO study): 36‐month follow‐up results of a clinical chart review

• Published in: International journal of urology 2023-09, Vol.30 (9), p.762-771
• Main Authors: Yonese, Junji, Hinata, Nobuyuki, Masui, Satoru, Nakai, Yasutomo, Shirotake, Suguru, Takeuchi, Ario, Inamoto, Teruo, Nozawa, Masahiro, Ueda, Kosuke, Etsunaga, Toru, Osawa, Takahiro, Uemura, Motohide, Kimura, Go, Numakura, Kazuyuki, Yamana, Kazutoshi, Miyake, Hideaki, Fukasawa, Satoshi, Morishima, Naoto, Ito, Hiroaki, Uemura, Hirotsugu
• Format: Article
• Language: English
• Subjects: Antineoplastic Agents, Immunological - therapeutic use; Carcinoma, Renal Cell - pathology; Diagnosis; East Asian People; Follow-Up Studies; Humans; immunotherapy; Kidney cancer; Kidney Neoplasms - pathology; Metastases; Metastasis; nivolumab; Nivolumab - therapeutic use; Observational studies; observational study; Original; Original : Clinical Investigation; Patients; Protein-tyrosine kinase; Renal cell carcinoma; Retrospective Studies; survival analysis; Vascular endothelial growth factor; Vascular Endothelial Growth Factor A
• ISSN: 0919-8172; 1442-2042; 1442-2042
• DOI: 10.1111/iju.15206

Objectives To examine the long‐term effectiveness of nivolumab monotherapy and following subsequent therapies for metastatic renal cell carcinoma (mRCC) in Japanese real‐world settings. Methods This was a multicenter, retrospective, observational study, with a 36‐month follow‐up, and conducted in Japanese patients with mRCC who initiated nivolumab monotherapy between 1 Feb 2017 and 31 Oct 2017. Endpoints included overall survival (OS), progression‐free survival (PFS), and objective response rate (ORR). Results Of the 208 patients, 36.5% received nivolumab monotherapy as second‐line, 30.8% as third‐line, and 31.7% as fourth‐ or later‐line therapy. By 36 months, 12.0% of patients continued nivolumab monotherapy; 88.0% discontinued, mainly because of disease progression (66.7%). The median (m) OS was not reached irrespective of treatment line, with a 36‐month OS rate of 54.3% (second‐line, 57.4%; third‐line, 52.6%; fourth‐ or later‐line, 52.9%). The ORR was 24.2% and five patients achieved complete response. The OS from first‐line therapy was 8.9 years. In the 95 patients receiving therapy after nivolumab, 87.4% received vascular endothelial growth factor receptor‐tyrosine kinase inhibitors, with mOS and mPFS of 27.4 and 8.1 months, respectively. Irrespective of treatment line, the mOS was not reached in patients with International Metastatic RCC Database Consortium (IMDC) favorable or intermediate risk at mRCC diagnosis. Conclusions This 36‐month real‐world follow‐up analysis showed a survival benefit of nivolumab monotherapy for patients with mRCC. The long‐term effectiveness of sequential therapy from first‐line therapy to therapy after nivolumab was also demonstrated. Additionally, nivolumab monotherapy was beneficial for patients with favorable IMDC risk at the time of mRCC diagnosis.