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Risk factors for relapse of immune-related pneumonitis after 6-week oral prednisolone therapy: a follow-up analysis of a phase II study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2024年10月8日

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  • Masato Karayama,
  • Naoki Inui,
  • Yusuke Inoue,
  • Hideki Yasui,
  • Hironao Hozumi,
  • Yuzo Suzuki,
  • Kazuki Furuhashi,
  • Tomoyuki Fujisawa,
  • Noriyuki Enomoto,
  • Kazuhiro Asada,
  • Koji Nishimoto,
  • Masato Fujii,
  • Takashi Matsui,
  • Shun Matsuura,
  • Dai Hashimoto,
  • Mikio Toyoshima,
  • Masaki Ikeda,
  • Hiroyuki Matsuda,
  • Nao Inami,
  • Yusuke Kaida,
  • Satoshi Funayama,
  • Shintaro Ichikawa,
  • Satoshi Goshima,
  • Takafumi Suda

摘要

Background

Immune-related pneumonitis (irP) is one of the most important immune-related adverse events caused by immune checkpoint inhibitors (ICIs). After corticosteroid therapy irP frequently relapses, which can interfere with cancer therapy. However, risk factors for irP relapse are unknown.

Methods

This study was a follow-up analysis of a phase II study that evaluated 56 patients with grade ≥ 2 irP treated with oral prednisolone, 1 mg/kg/day, tapered over 6 weeks. Clinical factors including patient characteristics, blood test findings, and response to prednisolone therapy were assessed to identify risk factors for irP relapse using the Fine–Gray test.

Results

Among 56 patients with irP, 22 (39.3%) experienced irP relapse after 6 weeks of prednisolone therapy during the follow-up observation period. Radiographic organising pneumonia (OP) pattern and duration to irP onset ≥ 100 days from ICI initiation were determined to be significant risk factors for irP relapse in a multivariate Fine–Gray test (hazard ratio [HR] = 3.17, 95% CI 1.37–7.32, p = 0.007, and HR = 2.61, 95% CI 1.01–6.74, p = 0.048, respectively). Other patient characteristics, blood test findings, irP severity, and response to prednisolone therapy were not associated with irP relapse.

Conclusions

In irP patients treated with 6-week prednisolone tapering therapy, OP pattern and duration to irP onset ≥ 100 days were associated with relapse risk. Assessment of the risk factors for irP relapse will be helpful for irP management.