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Real clinical outcomes of nivolumab plus ipilimumab for renal cell carcinoma in patients over 75 years old

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International Journal of Clinical Oncology Aims and scope Submit manuscript

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.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We are grateful to Satoshi Sato and Ryuji Tabata (Ageo Central Hospital) and Yukiko Sugiyama (Akita University) for their efforts in obtaining the patients’ data.

Funding

This study was partially supported by the Grants-in-Aid for Scientific Research, Japan (Grant No. 20K09553).

Author information

Authors and Affiliations

  1. Department of Urology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan

    Mizuki Kobayashi, Kazuyuki Numakura, Yumina Muto, Yuya Sekine, Ryuta Sobu, Hajime Sasagawa, Soki Kashima, Ryohei Yamamoto, Taketoshi Nara, Mitsuru Saito, Shintaro Narita & Tomonori Habuchi

  2. Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan

    Shingo Hatakeyama & Chikara Ohyama

  3. Department of Urology, Akita City Hospital, Akita, Japan

    Toshiya Ishida

  4. Department of Urology, Japanese Red Cross Hospital Akita, Akita, Japan

    Atsushi Koizumi

  5. Department of Urology, Iwate Prefectural Isawa Hospital, Oshu, Japan

    Kazuki Tadachi

  6. Department of Urology, Hiraka General Hospital, Yokote, Japan

    Ryoma Igarashi

  7. Department of Urology, Yuri Kumiai Hospital, Yurihonjyo, Japan

    Koichiro Takayama

  8. Department of Anatomy, Akita University Graduate School of Medicine, Akita, Japan

    Hideo Akashi

Authors
  1. Mizuki Kobayashi
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  2. Kazuyuki Numakura
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  3. Shingo Hatakeyama
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  4. Toshiya Ishida
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  5. Atsushi Koizumi
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  6. Kazuki Tadachi
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  7. Ryoma Igarashi
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  8. Koichiro Takayama
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  9. Yumina Muto
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  10. Yuya Sekine
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  11. Ryuta Sobu
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  12. Hajime Sasagawa
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  13. Hideo Akashi
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  14. Soki Kashima
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  15. Ryohei Yamamoto
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  16. Taketoshi Nara
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  17. Mitsuru Saito
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  18. Shintaro Narita
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  19. Chikara Ohyama
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  20. Tomonori Habuchi
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Contributions

MK: Study design and manuscript drafting. KN: Study design and manuscript drafting. SH: Data acquisition, analysis, and critical manuscript revision for important intellectual content. TI: Data acquisition. AK: Data acquisition. KT: Data acquisition. RI: Data acquisition. KT: Data acquisition. YM: Data acquisition and analysis. YS: Data acquisition and analysis. RS: Data acquisition and analysis. HS: Data acquisition and analysis. HA: Data acquisition and analysis. RY: Data acquisition and analysis. TN: Data acquisition and analysis. MS: Data acquisition and analysis. SN: Data acquisition and analysis. CO: Critical manuscript revision for important intellectual content. TH: Study design and critical manuscript revision for important intellectual content. All the authors provided final approval for the version to be published.

Corresponding author

Correspondence to Kazuyuki Numakura.

Ethics declarations

Conflict of interest

Dr. Habuchi received honoraria from Novartis Pharma, Pfizer Co., GlaxoSmithKline, and Ono Pharma Co. Other authors have no conflicts of interest.

Ethical approval

Approval of the research protocol by an Institutional Reviewer Board: This study was approved by five institutional review boards (ID: 2245 in the Institutional Review Board of the Akita University Graduate School of Medicine).

Informed consent

Informed consent was not required for this retrospective study; however, efforts were made to obtain it from the participants, or they were notified via websites following the opt-out policy (https://www.mhlw.go.jp/content/000909926.pdf). All procedures were performed in accordance with the ethical standards of the 1964 Declaration of Helsinki.

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Cite this article

Kobayashi, M., Numakura, K., Hatakeyama, S. et al. Real clinical outcomes of nivolumab plus ipilimumab for renal cell carcinoma in patients over 75 years old. Int J Clin Oncol 28, 1530–1537 (2023). https://doi.org/10.1007/s10147-023-02394-y

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  • DOI: https://doi.org/10.1007/s10147-023-02394-y

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