Cargando…
Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study
BACKGROUND: There has been no prospective trial for treatment of immune-related pneumonitis (irP) occurred after immune checkpoint inhibitors (ICIs). METHODS: In 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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10387737/ https://www.ncbi.nlm.nih.gov/pubmed/37500182 http://dx.doi.org/10.1136/jitc-2023-007056 |
_version_ | 1785081950581555200 |
---|---|
author | Karayama, Masato Inui, Naoki Inoue, Yusuke Yasui, Hideki Hozumi, Hironao Suzuki, Yuzo Furuhashi, Kazuki Fujisawa, Tomoyuki Enomoto, Noriyuki Asada, Kazuhiro Uto, Tomohiro Fujii, Masato Matsui, Takashi Matsuura, Shun Hashimoto, Dai Toyoshima, Mikio Ikeda, Masaki Matsuda, Hiroyuki Inami, Nao Kaida, Yusuke Funayama, Satoshi Ichikawa, Shintaro Goshima, Satoshi Suda, Takafumi |
author_facet | Karayama, Masato Inui, Naoki Inoue, Yusuke Yasui, Hideki Hozumi, Hironao Suzuki, Yuzo Furuhashi, Kazuki Fujisawa, Tomoyuki Enomoto, Noriyuki Asada, Kazuhiro Uto, Tomohiro Fujii, Masato Matsui, Takashi Matsuura, Shun Hashimoto, Dai Toyoshima, Mikio Ikeda, Masaki Matsuda, Hiroyuki Inami, Nao Kaida, Yusuke Funayama, Satoshi Ichikawa, Shintaro Goshima, Satoshi Suda, Takafumi |
author_sort | Karayama, Masato |
collection | PubMed |
description | BACKGROUND: There has been no prospective trial for treatment of immune-related pneumonitis (irP) occurred after immune checkpoint inhibitors (ICIs). METHODS: In 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. RESULTS: Among 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. CONCLUSIONS: In 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. |
format | Online Article Text |
id | pubmed-10387737 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-103877372023-08-01 Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study Karayama, Masato Inui, Naoki Inoue, Yusuke Yasui, Hideki Hozumi, Hironao Suzuki, Yuzo Furuhashi, Kazuki Fujisawa, Tomoyuki Enomoto, Noriyuki Asada, Kazuhiro Uto, Tomohiro Fujii, Masato Matsui, Takashi Matsuura, Shun Hashimoto, Dai Toyoshima, Mikio Ikeda, Masaki Matsuda, Hiroyuki Inami, Nao Kaida, Yusuke Funayama, Satoshi Ichikawa, Shintaro Goshima, Satoshi Suda, Takafumi J Immunother Cancer Clinical/Translational Cancer Immunotherapy BACKGROUND: There has been no prospective trial for treatment of immune-related pneumonitis (irP) occurred after immune checkpoint inhibitors (ICIs). METHODS: In 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. RESULTS: Among 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. CONCLUSIONS: In 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. BMJ Publishing Group 2023-07-27 /pmc/articles/PMC10387737/ /pubmed/37500182 http://dx.doi.org/10.1136/jitc-2023-007056 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Clinical/Translational Cancer Immunotherapy Karayama, Masato Inui, Naoki Inoue, Yusuke Yasui, Hideki Hozumi, Hironao Suzuki, Yuzo Furuhashi, Kazuki Fujisawa, Tomoyuki Enomoto, Noriyuki Asada, Kazuhiro Uto, Tomohiro Fujii, Masato Matsui, Takashi Matsuura, Shun Hashimoto, Dai Toyoshima, Mikio Ikeda, Masaki Matsuda, Hiroyuki Inami, Nao Kaida, Yusuke Funayama, Satoshi Ichikawa, Shintaro Goshima, Satoshi Suda, Takafumi Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study |
title | Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study |
title_full | Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study |
title_fullStr | Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study |
title_full_unstemmed | Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study |
title_short | Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study |
title_sort | six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase ii study |
topic | Clinical/Translational Cancer Immunotherapy |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10387737/ https://www.ncbi.nlm.nih.gov/pubmed/37500182 http://dx.doi.org/10.1136/jitc-2023-007056 |
work_keys_str_mv | AT karayamamasato sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT inuinaoki sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT inoueyusuke sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT yasuihideki sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT hozumihironao sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT suzukiyuzo sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT furuhashikazuki sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT fujisawatomoyuki sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT enomotonoriyuki sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT asadakazuhiro sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT utotomohiro sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT fujiimasato sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT matsuitakashi sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT matsuurashun sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT hashimotodai sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT toyoshimamikio sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT ikedamasaki sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT matsudahiroyuki sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT inaminao sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT kaidayusuke sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT funayamasatoshi sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT ichikawashintaro sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT goshimasatoshi sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy AT sudatakafumi sixweekoralprednisolonetherapyforimmunerelatedpneumonitisasinglearmphaseiistudy |