08.08.2023 | Original Article
Real clinical outcomes of nivolumab plus ipilimumab for renal cell carcinoma in patients over 75 years old
verfasst von:
Mizuki Kobayashi, Kazuyuki Numakura, Shingo Hatakeyama, Toshiya Ishida, Atsushi Koizumi, Kazuki Tadachi, Ryoma Igarashi, Koichiro Takayama, Yumina Muto, Yuya Sekine, Ryuta Sobu, Hajime Sasagawa, Hideo Akashi, Soki Kashima, Ryohei Yamamoto, Taketoshi Nara, Mitsuru Saito, Shintaro Narita, Chikara Ohyama, Tomonori Habuchi
Erschienen in:
International Journal of Clinical Oncology
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Ausgabe 11/2023
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Abstract
Background
Although nivolumab plus ipilimumab is the standard treatment for metastatic renal cell carcinoma (RCC), its efficacy and safety in older patients remain unclear. Therefore, this study aimed to assess the clinical outcomes of nivolumab plus ipilimumab for metastatic RCC in patients aged ≥ 75 years.
Methods
We enrolled 120 patients with metastatic RCC treated with nivolumab plus ipilimumab from August 2015 to January 2023. Objective response rates (ORRs) were compared between patients aged < 75 and ≥ 75 years. Progression-free survival (PFS), overall survival (OS), and adverse events were compared between the groups. Adverse events were evaluated according to the Response Evaluation Criteria in Solid Tumors 1.1.
Results
Among the patients, 57 and 63 were classified as intermediate and poor risk, respectively, and one could not be classified. The median follow-up duration after the initiation of treatment was 16 months. The patient characteristics between the groups, except for age, were not significantly different. Intergroup differences in ORR (42% vs. 40%; p = 0.818), PFS (HR: 0.820, 95% CI 0.455–1.479; p = 0.510), and median OS (HR: 1.492, 95% CI 0.737–3.020; p = 0.267) were not significant. The incidence of adverse events (50% vs. 67%; p = 0.111) and nivolumab plus ipilimumab discontinuation due to adverse events was not significantly different between the groups (14% vs. 13%; p = 0.877).
Conclusions
The effectiveness of nivolumab plus ipilimumab was comparable between patients with metastatic RCC aged < 75 and those ≥ 75 years with respect to their ORRs, PFS, OS, and adverse event rates.