ArticleInternational journal of clinical oncology2025
Risk of severe infections in patients with triple-negative breast cancer treated with atezolizumab plus nab-paclitaxel: a real-world, postmarketing database study in Japan.
Article in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAn 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.
methodsThis 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.
resultsOverall, 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.
conclusionsOverall, 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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