دورية أكاديمية
Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial
| العنوان: | Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial |
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| المؤلفون: | Naidoo, Jarushka, Vansteenkiste, Johan F., Faivre-Finn, Corinne, Ozguroglu, Mustafa, Murakami, Shuji, Hui, Rina, Antonia, Scott J. |
| بيانات النشر: | Elsevier Ireland Ltd |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Locally advanced NSCLC, Pneumonitis, Immune checkpoint inhibition, Thyroid disorders, Chemoradiotherapy, PACIFIC, Docetaxel, Nivolumab, Pembrolizumab, Chemotherapy, Inhibitor, Anti-Pd-1 |
| الوصف: | Introduction: Immune-mediated adverse events (imAEs), including all-cause immune-mediated pneumonitis, were reported in approximately 25% of patients in the placebo-controlled, phase III PACIFIC trial of durvalumab monotherapy (for up to 12 months) in patients with unresectable, stage III NSCLC and no disease progression after concurrent chemoradiotherapy; only 3.4% of patients experienced grade 3/4 imAEs. With broad application of the PACIFIC regimen (consolidation durvalumab after chemoradiotherapy), now standard-of-care in this setting, there is a need to better characterize the occurrence of imAEs with this regimen. Methods: We performed descriptive, post-hoc, exploratory analyses to characterize the occurrence of imAEs (pneumonitis and non-pneumonitis) in PACIFIC in terms of: incidence, severity, and timing; clinical management and outcomes; and associations between the occurrence of imAEs and (1) all-cause AEs and (2) baseline patient, disease, and treatment characteristics. Results: Any-grade immune-mediated pneumonitis (9.4%) and non-pneumonitis imAEs (10.7%) occurred infrequently and were more common with durvalumab versus placebo. Grade 3/4 immune-mediated pneumonitis (1.9%) and non-pneumonitis imAEs (1.7%) were uncommon with durvalumab, as were fatal imAEs (0.8%; all pneumonitis). The most common non-pneumonitis imAEs with durvalumab were thyroid disorders, dermatitis/ rash, and diarrhea/colitis. Dermatitis/rash had the shortest time to onset (from durvalumab initiation), followed by pneumonitis; dermatitis/rash had the longest time to resolution, followed by thyroid disorders. Most patients with immune-mediated pneumonitis (78.4%) and non-pneumonitis imAEs (56.3%) had these events occur <= 3 months after initiating durvalumab. ImAEs were well managed with administration of systemic corticosteroids, administration of endocrine replacement therapy, and interruption/discontinuation of durvalumab. Time elapsed from completion of prior radiotherapy to trial randomization (< 14 vs. >= 14 days) did ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0169-5002 1872-8332 |
| العلاقة: | Lung Cancer; Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı; https://doi.org/10.1016/j.lungcan.2022.02.003Test; https://hdl.handle.net/20.500.12831/7781Test; 166; 84; 93; WOS:000791997800011; 2-s2.0-85125438748 |
| DOI: | 10.1016/j.lungcan.2022.02.003 |
| الإتاحة: | https://doi.org/10.1016/j.lungcan.2022.02.003Test https://doi.org/20.500.12831/7781Test https://hdl.handle.net/20.500.12831/7781Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.DE146FF9 |
| قاعدة البيانات: | BASE |
| تدمد: | 01695002 18728332 |
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| DOI: | 10.1016/j.lungcan.2022.02.003 |