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Purpose <p>Clinical trials demonstrated every 3-month goserelin 10.8&#xa0;mg to be non-inferior to monthly goserelin 3.6&#xa0;mg in premenopausal patients with ER-positive breast cancer. However, real-world studies comparing 3-month goserelin 10.8 mg with monthly goserelin 3.6 mg are scarce.</p> Methods <p>Electronic medical records from the ConcertAI Patient360™ database were analyzed in U.S. patients exposed to goserelin 3.6 mg or 10.8 mg post-breast cancer diagnosis. Inverse probability of treatment weighting (IPTW) was used to ensure the comparability between the two cohorts (goserelin 3.6 mg and goserelin 10.8 mg). The non-inferiority of goserelin 10.8 mg compared with goserelin 3.6 mg was assessed by 12-month real-world event-free survival (rwEFS) rates (−&#xa0;15% margin) for the overall group of patients and separately for patients with early-stage/locally advanced and metastatic breast cancer.</p> Results <p>A total of 575 patients received goserelin 3.6&#xa0;mg and 123 received goserelin 10.8&#xa0;mg. Goserelin 10.8 mg was non-inferior to goserelin 3.6 mg based on observed 12-month rwEFS rates (79.2% versus 76.6%, respectively; treatment difference 2.7%). Goserelin 10.8&#xa0;mg was observed to be non-inferior in patients who initiated goserelin in early-stage/locally advanced (treatment difference −&#xa0;2.3%) and metastatic (treatment difference 10.4%) breast cancer.</p> Conclusion <p>This real-world analysis indicates that 3-month goserelin 10.8&#xa0;mg is non-inferior to monthly 3.6&#xa0;mg among premenopausal women with breast cancer in terms of 12-month rwEFS rate. These findings may support the use of the 3-month goserelin 10.8&#xa0;mg as an alternative treatment option to monthly goserelin 3.6&#xa0;mg for this patient population.</p>

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Goserelin 3-month depot shows non-inferiority to the monthly formulation in U.S. patients with premenopausal breast cancer: a real-world evidence study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月6日

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  • Kelly E. McCann,
  • Noran Osman,
  • Joan Cannon,
  • Lonnie Brent,
  • Yuexi Wang,
  • Jon Tepsick,
  • Prithviraj Vikramsinh Mandora,
  • Vincent Miller,
  • Nancy Martin,
  • Virginia G. Kaklamani

摘要

Purpose

Clinical trials demonstrated every 3-month goserelin 10.8 mg to be non-inferior to monthly goserelin 3.6 mg in premenopausal patients with ER-positive breast cancer. However, real-world studies comparing 3-month goserelin 10.8 mg with monthly goserelin 3.6 mg are scarce.

Methods

Electronic medical records from the ConcertAI Patient360™ database were analyzed in U.S. patients exposed to goserelin 3.6 mg or 10.8 mg post-breast cancer diagnosis. Inverse probability of treatment weighting (IPTW) was used to ensure the comparability between the two cohorts (goserelin 3.6 mg and goserelin 10.8 mg). The non-inferiority of goserelin 10.8 mg compared with goserelin 3.6 mg was assessed by 12-month real-world event-free survival (rwEFS) rates (− 15% margin) for the overall group of patients and separately for patients with early-stage/locally advanced and metastatic breast cancer.

Results

A total of 575 patients received goserelin 3.6 mg and 123 received goserelin 10.8 mg. Goserelin 10.8 mg was non-inferior to goserelin 3.6 mg based on observed 12-month rwEFS rates (79.2% versus 76.6%, respectively; treatment difference 2.7%). Goserelin 10.8 mg was observed to be non-inferior in patients who initiated goserelin in early-stage/locally advanced (treatment difference − 2.3%) and metastatic (treatment difference 10.4%) breast cancer.

Conclusion

This real-world analysis indicates that 3-month goserelin 10.8 mg is non-inferior to monthly 3.6 mg among premenopausal women with breast cancer in terms of 12-month rwEFS rate. These findings may support the use of the 3-month goserelin 10.8 mg as an alternative treatment option to monthly goserelin 3.6 mg for this patient population.