| アブストラクト | BACKGROUND: An increased risk of infection has been suggested for patients with triple-negative breast cancer (TNBC) treated with atezolizumab plus nab-paclitaxel based on the IMpassion130 trial. METHODS: This Japanese postmarketing study aimed to compare the incidence of severe infections in patients with TNBC treated with atezolizumab plus nab-paclitaxel versus nab-paclitaxel alone. Anonymized patient records regarding medical claims and laboratory tests were extracted from the Japanese Medical Data Vision database. Patients with a drug index date of November 27, 2019,-May 31, 2022, were included in the analysis. Based on the published literature, severe infections were declared when a patient had a confirmed diagnosis of infection, a hospitalization record, infection as the primary reason for hospitalization, and a record of immunological infection tests. In the sensitivity analysis, the definition of severe infections was modified as a combination of confirmed infection diagnosis and intravenous antibacterial drug prescription records. RESULTS: Overall, 321 and 319 patients were included in the exposure (atezolizumab plus nab-paclitaxel) and control (nab-paclitaxel alone) groups, respectively. After adjusting for standardized mortality/morbidity ratio weighting, the baseline characteristics were balanced between the groups. The incidence rate ratio (exposure/control) of severe infections was estimated at 3.29 (95% confidence interval [CI]: 0.93-13.53) originally and 1.05 (95% CI: 0.56-1.84) in the sensitivity analysis. Additional analyses supported the appropriateness of the revised definition of severe infections. CONCLUSIONS: Overall, our results did not indicate a significant increase in the risk of severe infections with atezolizumab plus nab-paclitaxel in daily clinical practice. Further research is required. |
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| ジャーナル名 | International journal of clinical oncology |
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| Pubmed追加日 | 2025/10/30 |
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| 投稿者 | Yuri, Akinori; Nakane, Sayuri; Miyano, Yuki; Yamada, Kana; Sugano, Hiroshi; Nakatsuji, Erika; Aoki, Masahiko; Murayama, Ayako |
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| 組織名 | Safety Science 2 Department, Drug Safety Division, Chugai Pharmaceutical Co.,;Ltd., 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku, Tokyo, 103-8324, Japan.;yuri.akinori58@chugai-pharm.co.jp.;Safety Science 1 Department, Drug Safety Division, Chugai Pharmaceutical Co.,;Ltd, Tokyo, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41162823/ |
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