Interstitial pneumonitis associated with combined regimen of immunotherapy and conventional therapies-pharmacovigilance database analysis with real-world data validation
© 2022. The Author(s)..
BACKGROUND: Immune checkpoint inhibitor (ICI) therapy combined with conventional therapies is being broadly applied in non-small cell lung cancer (NSCLC) patients. However, the risk of interstitial pneumonitis (IP) following a combined regimen is incompletely characterized.
METHODS: A total of 46,127 NSCLC patients were extracted for disproportionality analyses of IP from the Food and Drug Administration's Adverse Event Reporting System (FAERS) database. A total of 1108 NSCLC patients who received ICI treatment at Nanfang Hospital of Southern Medical University were collected and utilized for real-world validation.
RESULTS: Of the 46,127 patients with NSCLC, 3830 cases (8.3%; 95% confidence interval [CI], 8.05-8.56) developed IP. Multivariable logistic regression analyses revealed that the adjusted ROR of ICI combined with radiation (RT) was the highest (121.69; 95% CI, 83.60-184.96; P < 0.0001) among all therapies, while that of ICI combined with chemotherapy (CHEMO) or targeted therapy (TARGET) was 0.90 (95% CI, 0.78-1.04; P = 0.160) and 1.49 (95% CI, 0.95-2.23; P = 0.065), respectively, using ICI monotherapy as reference. Furthermore, analyses from our validation cohort of 1108 cases showed that the adjusted odds ratio of ICI combined with RT was the highest (12.25; 95% CI, 3.34-50.22; P < 0.01) among all the therapies, while that of ICI combined with CHEMO or TARGET was 2.32 (95% CI, 0.89-7.92; P = 0.12) and 0.66 (95% CI, 0.03-4.55; P = 0.71), respectively, using ICI monotherapy as reference.
CONCLUSIONS: Compared with ICI monotherapy, ICI combined with RT, rather than with CHEMO or TARGET, is associated with a higher risk of IP in NSCLC patients. Hence, patients receiving these treatments should be carefully monitored for IP.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
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| Enthalten in: |
BMC medicine - 21(2023), 1 vom: 05. Jan., Seite 6 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Guo, Xue-Jun [VerfasserIn] |
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| Links: |
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| Themen: |
Conventional therapy |
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| Anmerkungen: |
Date Completed 06.01.2023 Date Revised 06.02.2023 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s12916-022-02713-6 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM351114521 |
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| 100 | 1 | |a Guo, Xue-Jun |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Interstitial pneumonitis associated with combined regimen of immunotherapy and conventional therapies-pharmacovigilance database analysis with real-world data validation |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 06.01.2023 | ||
| 500 | |a Date Revised 06.02.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022. The Author(s). | ||
| 520 | |a BACKGROUND: Immune checkpoint inhibitor (ICI) therapy combined with conventional therapies is being broadly applied in non-small cell lung cancer (NSCLC) patients. However, the risk of interstitial pneumonitis (IP) following a combined regimen is incompletely characterized | ||
| 520 | |a METHODS: A total of 46,127 NSCLC patients were extracted for disproportionality analyses of IP from the Food and Drug Administration's Adverse Event Reporting System (FAERS) database. A total of 1108 NSCLC patients who received ICI treatment at Nanfang Hospital of Southern Medical University were collected and utilized for real-world validation | ||
| 520 | |a RESULTS: Of the 46,127 patients with NSCLC, 3830 cases (8.3%; 95% confidence interval [CI], 8.05-8.56) developed IP. Multivariable logistic regression analyses revealed that the adjusted ROR of ICI combined with radiation (RT) was the highest (121.69; 95% CI, 83.60-184.96; P < 0.0001) among all therapies, while that of ICI combined with chemotherapy (CHEMO) or targeted therapy (TARGET) was 0.90 (95% CI, 0.78-1.04; P = 0.160) and 1.49 (95% CI, 0.95-2.23; P = 0.065), respectively, using ICI monotherapy as reference. Furthermore, analyses from our validation cohort of 1108 cases showed that the adjusted odds ratio of ICI combined with RT was the highest (12.25; 95% CI, 3.34-50.22; P < 0.01) among all the therapies, while that of ICI combined with CHEMO or TARGET was 2.32 (95% CI, 0.89-7.92; P = 0.12) and 0.66 (95% CI, 0.03-4.55; P = 0.71), respectively, using ICI monotherapy as reference | ||
| 520 | |a CONCLUSIONS: Compared with ICI monotherapy, ICI combined with RT, rather than with CHEMO or TARGET, is associated with a higher risk of IP in NSCLC patients. Hence, patients receiving these treatments should be carefully monitored for IP | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Conventional therapy | |
| 650 | 4 | |a Immune checkpoint inhibitors | |
| 650 | 4 | |a Interstitial pneumonitis | |
| 650 | 4 | |a Non-small cell lung cancer | |
| 650 | 4 | |a Radiation therapy | |
| 700 | 1 | |a Cai, Xiao-Ting |e verfasserin |4 aut | |
| 700 | 1 | |a Rong, Zi-Xuan |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Yan-Pei |e verfasserin |4 aut | |
| 700 | 1 | |a Wen, Yu-Xiang |e verfasserin |4 aut | |
| 700 | 1 | |a Bai, Xue |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jian |e verfasserin |4 aut | |
| 700 | 1 | |a Fu, Qiang John |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Ze-Qin |e verfasserin |4 aut | |
| 700 | 1 | |a Long, Li-Li |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Si-Cong |e verfasserin |4 aut | |
| 700 | 1 | |a Tang, Xin-Ran |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Guan, Jian |e verfasserin |4 aut | |
| 700 | 1 | |a Dong, Zhong-Yi |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, De-Hua |e verfasserin |4 aut | |
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