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Purpose <p>Understanding real-world treatment patterns and their effectiveness in HR + HER2- advanced breast cancer (aBC) in Canadian patients.</p> Patient and Methods <p>This was a multi-center, observational, prospective cohort study including men and pre-/peri-/postmenopausal women with HR + HER2- aBC receiving endocrine therapy (ET) or ET + targeted therapy (ET + TT). The primary objective was duration of treatment (DOT) with ET and ET + TT. Sequence of therapies, treatment patterns, and Overall Survival (OS) were also evaluated.</p> Results <p>DOT was prolonged in patients receiving ET + TT compared to ET (median DOT: ET + TT 397&#xa0;days vs ET 192&#xa0;days; Log-Rank test <i>p value</i> &lt; .0001; <i>HR</i> = 0.66; 95% CI; 0.52, 0.85). An extended DOT was observed in ET + CDK4/6i subgroup when compared to ET (median DOT: ET + CDK4/6i 601&#xa0;days vs ET 192&#xa0;days; Log-Rank test <i>p value</i> &lt; .0001). This increase was statistically significant irrespective of line of therapy at baseline (1L: median DOT: ET + CDK4/6i: 649&#xa0;days vs ET: 217&#xa0;days, <i>p value</i> =  &lt; .0001; 2L: median DOT: ET + CDK4/6i: 487&#xa0;days vs ET: 203&#xa0;days, <i>p value</i> = 0.0013; 3L: median DOT: ET + CDK4/6i: 597&#xa0;days vs ET: 143&#xa0;days therapy: <i>p value</i> = 0.0006). ET alone and ET + CDK4/6i were the most frequently administered therapies in both 1st (ET alone: 43.5% and ET + CDK4/6i: 43.3%) and 2nd lines (ET alone: 36.3% and ET + CDK4/6i: 24.6%). Among patients who received at least one CDK4/6i in 1st, 2nd, or 3rd line, CDK4/6i were mostly administered in 1st line (61.9%) and 2nd line (38.5%). ClinicalTrials.gov ID: NCT02753686; Registration Date:20–04-2016.</p> Conclusion <p>Results support current treatment recommendations of early introduction of CDK4/6i in HR + /HER2- aBC.</p>

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A Canadian real-world, multi-center, prospective, observational study assessing the treatment duration, the treatment sequence, and the overall survival for patients treated with endocrine therapy ± targeted therapy in HR + HER2-negative advanced breast cancer

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  • 发表日期：

    2025年1月23日

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  • Catherine Doyle,
  • Ana Elisa Lohmann,
  • Nayyer Iqbal,
  • Jan-Willem Henning,
  • Swati Kulkarni,
  • Nadia Califaretti,
  • John Hilton,
  • Cristiano Ferrario,
  • Nathaniel Bouganim,
  • Mihaela Mates,
  • Stephanie Guillemette,
  • Ricardo Leite,
  • Marc-Andre Caron,
  • Francois Thireau,
  • Andres Machado,
  • Stephen Chia

摘要

Purpose

Understanding real-world treatment patterns and their effectiveness in HR + HER2- advanced breast cancer (aBC) in Canadian patients.

Patient and Methods

This was a multi-center, observational, prospective cohort study including men and pre-/peri-/postmenopausal women with HR + HER2- aBC receiving endocrine therapy (ET) or ET + targeted therapy (ET + TT). The primary objective was duration of treatment (DOT) with ET and ET + TT. Sequence of therapies, treatment patterns, and Overall Survival (OS) were also evaluated.

Results

DOT was prolonged in patients receiving ET + TT compared to ET (median DOT: ET + TT 397 days vs ET 192 days; Log-Rank test p value < .0001; HR = 0.66; 95% CI; 0.52, 0.85). An extended DOT was observed in ET + CDK4/6i subgroup when compared to ET (median DOT: ET + CDK4/6i 601 days vs ET 192 days; Log-Rank test p value < .0001). This increase was statistically significant irrespective of line of therapy at baseline (1L: median DOT: ET + CDK4/6i: 649 days vs ET: 217 days, p value =  < .0001; 2L: median DOT: ET + CDK4/6i: 487 days vs ET: 203 days, p value = 0.0013; 3L: median DOT: ET + CDK4/6i: 597 days vs ET: 143 days therapy: p value = 0.0006). ET alone and ET + CDK4/6i were the most frequently administered therapies in both 1st (ET alone: 43.5% and ET + CDK4/6i: 43.3%) and 2nd lines (ET alone: 36.3% and ET + CDK4/6i: 24.6%). Among patients who received at least one CDK4/6i in 1st, 2nd, or 3rd line, CDK4/6i were mostly administered in 1st line (61.9%) and 2nd line (38.5%). ClinicalTrials.gov ID: NCT02753686; Registration Date:20–04-2016.

Conclusion

Results support current treatment recommendations of early introduction of CDK4/6i in HR + /HER2- aBC.