Safety of osimertinib in Chinese patients with non-small cell lung cancer: a multi-center, prospective, observational study.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
700 patients were enrolled from 30 centers, with 706 (41.
I · Intervention 중재 / 시술
osimertinib were enrolled and followed up for 12 months
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[CONCLUSION] This largest real-world safety study of osimertinib in China demonstrated that osimertinib was well-tolerated in a broad NSCLC population, including patients usually not included in randomized clinical trials, without new safety signals identified. [CLINICAL TRIAL REGISTRATION] NCT03485326 (www.clinicaltrials.gov).
[BACKGROUND] This prospective, observational study evaluated the real-world safety of osimertinib in a broad Chinese population with non-small cell lung cancer (NSCLC).
APA
Zhong H, Jiang S, et al. (2025). Safety of osimertinib in Chinese patients with non-small cell lung cancer: a multi-center, prospective, observational study.. Future oncology (London, England), 21(28), 3639-3648. https://doi.org/10.1080/14796694.2025.2579208
MLA
Zhong H, et al.. "Safety of osimertinib in Chinese patients with non-small cell lung cancer: a multi-center, prospective, observational study.." Future oncology (London, England), vol. 21, no. 28, 2025, pp. 3639-3648.
PMID
41164890 ↗
Abstract 한글 요약
[BACKGROUND] This prospective, observational study evaluated the real-world safety of osimertinib in a broad Chinese population with non-small cell lung cancer (NSCLC).
[METHODS] Chinese NSCLC patients who received osimertinib were enrolled and followed up for 12 months. The primary endpoint was the incidence of adverse drug reactions (ADRs).
[RESULTS] From 20 April 2020 to 1 August 2022, 1,700 patients were enrolled from 30 centers, with 706 (41.5%) patients ≥65 years old. Osimertinib was administered as first-line, second-line, third/later-line and adjuvant therapy in 44.9%, 34.2%, 14.3% and 4.5% of the patients, respectively. ADRs, adverse events (AEs), Grade ≥3 AEs, and serious AEs were reported in 627 (36.9%), 959 (56.4%), 165 (9.7%), and 102 (6.0%) patients, respectively. AEs of special interests occurred in 59 (3.5%) patients, with 41 (2.4%) and 19 (1.1%) reporting QTc prolongation and interstitial lung disease/pneumonitis-like events, respectively. The safety profiles in patients ≥65 years old and those usually not included in randomized clinical trials were similar to that in the total population.
[CONCLUSION] This largest real-world safety study of osimertinib in China demonstrated that osimertinib was well-tolerated in a broad NSCLC population, including patients usually not included in randomized clinical trials, without new safety signals identified.
[CLINICAL TRIAL REGISTRATION] NCT03485326 (www.clinicaltrials.gov).
[METHODS] Chinese NSCLC patients who received osimertinib were enrolled and followed up for 12 months. The primary endpoint was the incidence of adverse drug reactions (ADRs).
[RESULTS] From 20 April 2020 to 1 August 2022, 1,700 patients were enrolled from 30 centers, with 706 (41.5%) patients ≥65 years old. Osimertinib was administered as first-line, second-line, third/later-line and adjuvant therapy in 44.9%, 34.2%, 14.3% and 4.5% of the patients, respectively. ADRs, adverse events (AEs), Grade ≥3 AEs, and serious AEs were reported in 627 (36.9%), 959 (56.4%), 165 (9.7%), and 102 (6.0%) patients, respectively. AEs of special interests occurred in 59 (3.5%) patients, with 41 (2.4%) and 19 (1.1%) reporting QTc prolongation and interstitial lung disease/pneumonitis-like events, respectively. The safety profiles in patients ≥65 years old and those usually not included in randomized clinical trials were similar to that in the total population.
[CONCLUSION] This largest real-world safety study of osimertinib in China demonstrated that osimertinib was well-tolerated in a broad NSCLC population, including patients usually not included in randomized clinical trials, without new safety signals identified.
[CLINICAL TRIAL REGISTRATION] NCT03485326 (www.clinicaltrials.gov).
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
- Humans
- Carcinoma
- Non-Small-Cell Lung
- Female
- Male
- Lung Neoplasms
- Aged
- Prospective Studies
- Middle Aged
- Acrylamides
- Aniline Compounds
- 80 and over
- China
- Adult
- Protein Kinase Inhibitors
- Antineoplastic Agents
- Indoles
- Pyrimidines
- East Asian People
- non-small cell lung cancer
- osimertinib
- real-world study
- safety
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