Evaluating Pneumonitis Incidence in Patients with Non-small Cell Lung Cancer Treated with Immunotherapy and/or Chemotherapy Using Real-world and Clinical Trial Data.

Autor:	Liu Q; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland., Zhang C; Syapse, San Francisco, California., Huang Y; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland., Huang R; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland., Huang SM; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland., Larkins E; Office of Oncologic Diseases, FDA, Silver Spring, Maryland., Stapleford L; Office of Oncologic Diseases, FDA, Silver Spring, Maryland., Rivera DR; Oncology Center of Excellence, FDA, Silver Spring, Maryland., Kluetz PG; Office of Oncologic Diseases, FDA, Silver Spring, Maryland.; Oncology Center of Excellence, FDA, Silver Spring, Maryland., Wang S; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland., Zhu H; Office of Clinical Pharmacology, FDA, Silver Spring, Maryland., Weese J; Advocate Aurora Health, Milwaukee, Wisconsin., Cromartie E; Syapse, San Francisco, California., Teka M; Syapse, San Francisco, California., Walters S; Syapse, San Francisco, California., Wolf F; Syapse, San Francisco, California., Brown TD; Syapse, San Francisco, California.
Jazyk:	angličtina
Zdroj:	Cancer research communications [Cancer Res Commun] 2023 Feb 14; Vol. 3 (2), pp. 258-266. Date of Electronic Publication: 2023 Feb 14 (Print Publication: 2023).
DOI:	10.1158/2767-9764.CRC-22-0370
Abstrakt:	Pneumonitis is a potentially life-threatening complication of anticancer therapy, and future treatment decisions may be informed by characterizing patients receiving therapies in the real-world setting. In this study, the incidence of treatment-associated pneumonitis (TAP) was compared among patients with advanced non-small cell lung cancer receiving immune checkpoint inhibitors (ICI) or chemotherapies in either of two settings: randomized clinical trials (RCT) or real world data (RWD)-based clinical practice. Pneumonitis cases were identified using International Classification of Diseases codes (for RWD), or the Medical Dictionary for Regulatory Activities preferred terms (for RCTs). TAP was defined as pneumonitis diagnosed during treatment or within 30 days of the last treatment administration. Overall TAP rates in the RWD cohort were lower [ICI: 1.9%; 95% confidence interval (CI), 1.2-3.2; chemotherapy: 0.8%; 95% CI, 0.4-1.6] than overall rates in the RCT cohort (ICI: 5.6%; 95% CI, 5.0-6.2; chemotherapy: 1.2%; 95% CI, 0.9-1.5). Overall RWD TAP rates were similar to grade 3+ RCT TAP rates (ICI: 2.0%; 95% CI, 1.6-2.3; chemotherapy: 0.6%; 95% CI, 0.4-0.9). In both cohorts, higher TAP incidence was observed among patients with a past medical history of pneumonitis than those without, regardless of treatment group. On the basis of this sizable study leveraging RWD, TAP incidence was low in the RWD cohort, likely in part due to methodology used for RWD focusing on clinically significant cases. Past medical history of pneumonitis was associated with TAP in both cohorts. Significance: Pneumonitis is a potentially life-threatening complication of anticancer treatment. As treatment options expand, management decisions become increasingly complex, and there is a greater need to understand the safety profiles of the treatment options in the real-world setting. Real-world data serve as an additional source of valuable information to complement clinical trial data and inform understanding of toxicity in patients with non-small cell lung cancer receiving ICIs or chemotherapies. (© 2023 The Authors; Published by the American Association for Cancer Research.)
Databáze:	MEDLINE
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