Trial reportJournal for immunotherapy of cancer2023
Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study.
Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 11 citations in OpenAlex.
- Risk factors for relapse of immune-related pneumonitis after 6-week oral prednisolone therapy: a follow-up analysis of a phase II study.BMC pulmonary medicine · 2024Trial
- Immune Checkpoint Inhibitor-Related Pneumonitis in Renal Cell Carcinoma: Clinical Features, Mechanisms, and Lessons from Lung Cancer.Biomolecules · 2026Review
- Narrative review of the similarities and differences between immune checkpoint inhibitor- and antibody-drug conjugate-associated pneumonitis.Translational lung cancer research · 2026Review
- The price of immune awakening: bridging knowledge gaps in checkpoint inhibitor-related pneumonitis in lung cancer.Breathe (Sheffield, England) · 2026Article
- Assessment of pneumonitis in patients with lung cancer undergoing radioimmunotherapy and immune checkpoint inhibitor rechallenge.Communications medicine · 2026Article
- Corticosteroid Taper Duration and Relapse Rate in Immune Checkpoint Inhibitor-Induced Pneumonitis: A Meta-Analysis.Cureus · 2026Review
- Associations between Immune-related Adverse Events and Prognosis in Cancer Patients Receiving Immune Checkpoint Inhibitor Therapy.Internal medicine (Tokyo, Japan) · 2026Review
- Review
- Long-survival of a patient with esophageal cancer benefited from comprehensive treatment and MDT: a case report.Journal of thoracic disease · 2024Article
- The application of bronchoscopy in the assessment of immune checkpoint inhibitor-related pneumonitis severity and recurrence.Scientific reports · 2024Article
- Sequential severe immune-related adverse events induced by PD-1 inhibitor: a case report and literature review.Frontiers in oncology · 2024Article
- Anti‑PD‑1/PD‑L1 and anti‑CTLA‑4 associated checkpoint inhibitor pneumonitis in non‑small cell lung cancer: Occurrence, pathogenesis and risk factors (Review).International journal of oncology · 2023Article
Corrections and comments
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Authors and funding
24 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere has been no prospective trial for treatment of immune-related pneumonitis (irP) occurred after immune checkpoint inhibitors (ICIs).
methodsIn this single-arm phase II study, patients with cancer with grade ≥2 irP received oral prednisolone (1 mg/kg/day), tapered over 6 weeks. The primary endpoint was a pneumonitis control rate at 6 weeks from the start of the study treatment, defined as complete disappearance or partial improvement of irP in high-resolution CT of the chest.
resultsAmong 57 patients enrolled, 56 were included in the final analysis. The most frequent cause of irP was single ICI therapy (51.8%), followed by combination with chemotherapy plus ICI (39.3%). Thirty-five (62.5%) patients had grade 2 irP and 21 (37.5%) had grade ≥3. Fifty-one (91.1%) patients completed the study treatment while 5 discontinued the study treatment because of relapse of irP (n=1), death from cancer (n=1), occurrence of immune-related hepatitis (n=1), extension of the treatment duration more than 6 weeks (n=1), and attending physician's decision (n=1). Six weeks after the start of the study treatment, 16 (28.5%) patients demonstrated complete recovery from irP, 35 (62.5%) had a partial improvement in irP, 1 (1.8%) had a relapse of irP, and 4 (7.1%) were not evaluable. The pneumonitis control rate at 6 weeks was 91.1% (95% CI, 80.7% to 96.1%). Twelve weeks after the start of the study treatment, 5 (8.9%), 27 (48.2%), and 15 (26.8%) patients demonstrated complete recovery, partial improvement, and relapse, respectively, and 9 (16.1%) were not evaluable. The pneumonitis control rate at 12 weeks was 57.1% (95% CI, 44.1% to 69.2%). During the observation period, 18 (32.1%) patients experienced a relapse of irP, and of those, 17 received re-treatment with corticosteroids. Grade ≥3 adverse events occurred in 10 (17.9%) patients, in which hyperglycemia was most frequent (n=6). There was no treatment-related death.
conclusionsIn this first prospective study for irP, prednisolone at 1 mg/kg/day, tapered over 6 weeks, demonstrated a promising clinical benefit and manageable toxicity, suggesting a potential treatment option for irP. TRIAL REGISTRATION NUMBER: jRCT: 1041190029.
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