Breast (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.
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Xiao Jingjing, Huang Meiling, Yan Changjiao, Wang Zhe, Wang Ting
Аннотация
OBJECTIVE: To 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.
METHODS: We 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).
RESULTS: Median 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.
CONCLUSION: After 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.
METHODS: We 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).
RESULTS: Median 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.
CONCLUSION: After 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.