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ACPE Required Forms: PACULit Literature Updates September 2025: Oncology3 Topics
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Lesson 19,
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Optimal treatment duration in metastatic renal cell carcinoma patients responding to immune checkpoint inhibitors should we treat beyond two years
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Daily Literature Update
Optimal treatment duration in metastatic renal cell carcinoma patients responding to immune checkpoint inhibitors should we treat beyond two years
Decruyenaere A, Christine G, Rottey S, et al. Acta Oncol. 2025;64:979-988. doi:10.2340/1651-226X.2025.43876.
Introduction
This study evaluates whether metastatic renal cell carcinoma patients responding to immune checkpoint inhibitors can safely discontinue therapy after two years without sacrificing outcomes.
Study Overview
Study Type: Multicenter retrospective cohort with causal inference
Population: 95 mRCC responders treated 63;21 months
Intervention: Elective ICPI discontinuation between 21-25 months vs continuous therapy
Outcomes: PFS, OS, CSS; median follow-up 62.1 months
- Median treatment duration was 33.8 months, 60% discontinued ICPIs electively
- 3-year PFS after elective ICPI stop was 57.1%, OS 67.5%, CSS 90%
- No significant increase in progression/death hazard with discontinuation (HR 1.08, p=0.766)
- Discontinuation at 21-25 months linked with metachronous metastases and complete response
- Modest PFS advantage with continuation contrasted with significantly prolonged treatment exposure
Context & Related Research
- Motzer et al., 2024: Fixed 24-month ICPI regimen showed durable 2-year PFS ~58% (PMID: Not provided); informs duration feasibility.
- Gupta et al., 2025: ICB doublet therapy improves treatment-free survival in mRCC (PMID:39743422), supporting elective discontinuation.
- Fransen van de Putte et al., 2023: Durable off-treatment survival after ICPI discontinuation post-deferred nephrectomy (PMID:37693729).
- ESMO & NCCN Guidelines: Recommend elective ICPI cessation after ~2 years in durable responders.
Clinical Implications
- Elective ICPI discontinuation at ~2 years is safe for responding mRCC patients, decreasing toxicity and treatment burden.
- Deep responders (complete response) and metachronous metastatic pattern may predict better outcomes for discontinuation.
- Future research should evaluate biomarkers and prospective trials for optimizing treatment duration.
Strengths & Limitations
| Strengths | Limitations |
|---|---|
| Multicenter cohort; causal inference to reduce bias | Retrospective design; potential unmeasured confounders |
| Long median follow-up; homogenous responder population | Small subgroup discontinuing 2125 months; no central imaging review |
| Detailed adjustment for confounders | No adjusted OS/CSS analyses due to few deaths |
Future Directions
Prospective randomized trials and biomarker validation are warranted to establish firm guidelines on ICPI treatment duration in mRCC responders.
For mRCC patients responding to immune checkpoint inhibitors, elective discontinuation after approximately two years is safe and does not compromise survival outcomes.
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