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Introduction <p>Immune checkpoint inhibitors are a standard first-line treatment for metastatic renal cell carcinoma (RCC), with combination ipilimumab and nivolumab (ipi–nivo) widely recommended. However, real-world data on its use in Australia remain limited.</p> Objective <p>To evaluate real-world outcomes of ipi–nivo for metastatic RCC in the Australian healthcare setting.</p> Methods <p>We conducted a retrospective cohort study using nationally linked Pharmaceutical Benefits Scheme data and National Death Index records accessed via the Australian Bureau of Statistics DataLab. Patients initiating ipi–nivo for stage IV clear cell RCC between 1 July 2019 and 30 June 2023 were included. Kaplan–Meier analyses and multivariate Cox regression were used to estimate overall survival (OS) and time to treatment discontinuation (TTD). Immune-related adverse events (irAEs) were inferred from incident dispensing of corticosteroids and levothyroxine. Subgroup analyses were performed by age (18–64 versus ≥ 65 years) and sex.</p> Results <p>Among 1334 patients, median OS was 30.0 months with 12- and 24-month survival rates of 72.9% (95% confidence interval [CI] 70.5–75.3) and 56.4% (95% CI 53.7–59.2), respectively. Median TTD was 4.9 months, and 38.5% of patients discontinued treatment during the induction phase. Incident corticosteroid and levothyroxine use occurred in 24.2% and 11.2% of patients, respectively. No significant differences in OS, TTD, or irAE proxies were observed by age or sex.</p> Conclusions <p>In this national, population-based study, real-world survival outcomes with ipi–nivo for metastatic RCC were shorter than those reported in clinical trials. These findings provide population-level benchmarks from a universal healthcare system and highlight the limitations of applying trial outcomes to unselected real-world populations. By contributing robust, large-scale data from routine practice, this study adds to the global evidence base and supports the integration of real-world data into clinical and policy decisions around immunotherapy.</p>

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Real-World Outcomes of Ipilimumab Plus Nivolumab for Metastatic Renal Cell Carcinoma: A National Population-Based Cohort Study

  • 期刊论文

  • 发表日期：

    2025年10月28日

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  • Chin Hang Yiu,
  • Adrian Lee,
  • Christine Y. Lu

摘要

Introduction

Immune checkpoint inhibitors are a standard first-line treatment for metastatic renal cell carcinoma (RCC), with combination ipilimumab and nivolumab (ipi–nivo) widely recommended. However, real-world data on its use in Australia remain limited.

Objective

To evaluate real-world outcomes of ipi–nivo for metastatic RCC in the Australian healthcare setting.

Methods

We conducted a retrospective cohort study using nationally linked Pharmaceutical Benefits Scheme data and National Death Index records accessed via the Australian Bureau of Statistics DataLab. Patients initiating ipi–nivo for stage IV clear cell RCC between 1 July 2019 and 30 June 2023 were included. Kaplan–Meier analyses and multivariate Cox regression were used to estimate overall survival (OS) and time to treatment discontinuation (TTD). Immune-related adverse events (irAEs) were inferred from incident dispensing of corticosteroids and levothyroxine. Subgroup analyses were performed by age (18–64 versus ≥ 65 years) and sex.

Results

Among 1334 patients, median OS was 30.0 months with 12- and 24-month survival rates of 72.9% (95% confidence interval [CI] 70.5–75.3) and 56.4% (95% CI 53.7–59.2), respectively. Median TTD was 4.9 months, and 38.5% of patients discontinued treatment during the induction phase. Incident corticosteroid and levothyroxine use occurred in 24.2% and 11.2% of patients, respectively. No significant differences in OS, TTD, or irAE proxies were observed by age or sex.

Conclusions

In this national, population-based study, real-world survival outcomes with ipi–nivo for metastatic RCC were shorter than those reported in clinical trials. These findings provide population-level benchmarks from a universal healthcare system and highlight the limitations of applying trial outcomes to unselected real-world populations. By contributing robust, large-scale data from routine practice, this study adds to the global evidence base and supports the integration of real-world data into clinical and policy decisions around immunotherapy.