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Background <p>Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment. Previous studies suggested that early time-of-day administration is associated with better outcomes. We performed a retrospective study in patients treated at a large tertiary cancer centre.</p> Methods <p>Patients receiving ICIs between January 2018 and December 2023 were grouped according to whether they had ≥50% (“late group”) or &lt;50% (“early group”) of cycles after the median time of all treatments. The endpoint was overall survival (OS). Hazard ratios (HRs) were estimated using Cox models with and without time-dependent variables.</p> Results <p>2631 patients with advanced/metastatic lung cancer (45%), melanoma (23%), renal carcinoma (18%), head and neck (9%), and urothelial cancer (5%) were included. Median age was 68.2 years and median infusion time was 12:49 h. At a median follow-up of 32 months, median OS was 13.1 (95% CI 11.8–14.4) vs 21.4 (19.8–24.5) months for late and early group. Late group was associated with shorter OS on both the standard analysis (HR 1.48, 1.33–1.63) and the time-dependent model (HR 1.30, 1.16–1.44).</p> Conclusions <p>This study provides further evidence in favour of early ICIs administration with a large sample size and a time-dependent model, which reduces the risk of immortal time bias. Data from randomised trials are required to confirm these findings.</p>

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Overall survival according to timing of immune checkpoint inhibitors administration in patients with advanced cancer: results from a large single-centre cohort analysis

  • 期刊论文

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  • 发表日期：

    2026年7月18日

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  • Tommaso Bosetti,
  • Oliver John Kennedy,
  • Raffaele Califano,
  • Tom Waddell,
  • Rob Metcalf,
  • Sophia Kreft,
  • Rebecca Lee,
  • Paul Lorigan

摘要

Background

Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment. Previous studies suggested that early time-of-day administration is associated with better outcomes. We performed a retrospective study in patients treated at a large tertiary cancer centre.

Methods

Patients receiving ICIs between January 2018 and December 2023 were grouped according to whether they had ≥50% (“late group”) or <50% (“early group”) of cycles after the median time of all treatments. The endpoint was overall survival (OS). Hazard ratios (HRs) were estimated using Cox models with and without time-dependent variables.

Results

2631 patients with advanced/metastatic lung cancer (45%), melanoma (23%), renal carcinoma (18%), head and neck (9%), and urothelial cancer (5%) were included. Median age was 68.2 years and median infusion time was 12:49 h. At a median follow-up of 32 months, median OS was 13.1 (95% CI 11.8–14.4) vs 21.4 (19.8–24.5) months for late and early group. Late group was associated with shorter OS on both the standard analysis (HR 1.48, 1.33–1.63) and the time-dependent model (HR 1.30, 1.16–1.44).

Conclusions

This study provides further evidence in favour of early ICIs administration with a large sample size and a time-dependent model, which reduces the risk of immortal time bias. Data from randomised trials are required to confirm these findings.