ArticleBreast (Edinburgh, Scotland)2026
Analysis of outcomes of nab-paclitaxel compared to other taxanes in early breast cancer: A study revealing the critical role of calendar-time bias in real-world drug comparisons.
Article in Breast (Edinburgh, Scotland), 2026. 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
objectiveTo compare long-term survival outcomes of nab-paclitaxel versus other taxanes in early breast cancer and to evaluate the impact of calendar-time bias in real-world studies.
methodsWe enrolled 9217 early invasive breast cancer patients (2007-2024) divided into nab-paclitaxel (n = 3860) and other taxanes (n = 5357) groups. The primary analysis employed three separate Cox models: Model 1 (unadjusted for time), Model 2 (adjusted for year of diagnosis), and Model 3 (adjusted for COVID-19 periods). Sensitivity analyses included propensity score matching, overlap-period restriction, restricted cubic splines, calendar-period stratification, and multiple imputation. Endpoints were overall survival (OS), disease-free survival (DFS), and distant metastasis-free survival (DMFS).
resultsMedian diagnosis year was 2021 for nab-paclitaxel vs. 2015 for other taxanes (P < 0.001). Without time adjustment, other taxanes showed higher recurrence and metastasis risk (DFS: HR = 1.366, P < 0.001; DMFS: HR = 1.294, P = 0.004). After adjusting for year categories, the effect disappeared (DFS: HR = 1.068, P = 0.536; DMFS: HR = 0.970, P = 0.789; OS: HR = 1.015, P = 0.932). After adjusting for COVID-19 periods, DFS showed HR = 1.259 (P = 0.018), DMFS showed HR = 1.174 (P = 0.125), and OS showed HR = 1.148 (P = 0.378). Year of diagnosis was a strong independent prognostic factor. All sensitivity analyses for survival endpoints consistently confirmed the absence of a significant treatment effect.
conclusionAfter adjusting for calendar-time bias using categorical year adjustment, no significant differences in long-term survival were observed between nab-paclitaxel and other taxanes in patients with early breast cancer. This study highlights the critical role of calendar-time bias in long-term real-world comparative studies, and provides important methodological guidance for future similar research.
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