Efficacy of Different Leuprolide Administration Schedules in Premenopausal Breast Cancer: A Retrospective Review

Daniel C. Kendzierski, Bryan Schneider, Patrick J. Kiel

Research output: Contribution to journalArticle

Abstract

The efficacy of leuprolide depot in combination with an aromatase inhibitor delivered monthly compared to once every 3 months in premenopausal women with estrogen receptor positive–breast cancer was assessed in a single-center retrospective study. There was no significant difference between the groups with respect to the proportion of patients with ovarian ablation at month 3 of treatment. Leuprolide depot delivered once every 3 months is as effective as therapy delivered monthly. Background: Leuprolide is a safe and effective treatment of estrogen receptor–positive premenopausal breast cancer. Data from the SOFT/TEXT trials solidified leuprolide in combination with an aromatase inhibitor as an effective hormonal treatment for premenopausal breast cancer. However, the efficacy of monthly leuprolide depot compared to leuprolide depot every 3 months in combination with an aromatase inhibitor in this patient population is unclear. Patients and Methods: In this single center retrospective study, 201 patients were enrolled between January 1, 2015, and October 1, 2016; 100 were included in the 7.5 mg leuprolide monthly injection plus aromatase inhibitor group and 101 in the 22.5 mg leuprolide injection every 3 months plus aromatase inhibitor group. The primary end point was the proportion of patients who experienced ovarian ablation, defined as an estradiol concentration less than 40 pg/mL and a follicle-stimulating hormone concentration of 23 to 116 mU/mL after 3 months of treatment. Significance threshold was P <.05 (2 sided). Secondary end points included disease-free survival and overall survival at 1-year follow-up, as well as adverse events reported during treatment. Results: All patients in the monthly leuprolide arm experienced ovarian ablation compared to 100 (99%) of 101 patients in the arm treated every 3 months (P = 1). The disease-free survival rate at 1 year was 95% in the monthly leuprolide arm and 97% in the arm treated every 3 months (P =.75). The overall survival rate at 1 year was 100% in the monthly leuprolide arm and 99% in the arm treated every 3 months (P = 1). The most common treatment-related adverse events between the 2 groups were musculoskeletal pain, hot flashes, fatigue, and insomnia. Conclusion: Leuprolide acetate depot administered every 3 months is as efficacious and tolerable as a monthly injection in combination with an aromatase inhibitor for premenopausal patients with hormone receptor–positive breast cancer.

Original languageEnglish (US)
JournalClinical Breast Cancer
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Leuprolide
Appointments and Schedules
Breast Neoplasms
Aromatase Inhibitors
Therapeutics
Injections
Disease-Free Survival
Survival Rate
Retrospective Studies
Hot Flashes
Musculoskeletal Pain
Sleep Initiation and Maintenance Disorders
Follicle Stimulating Hormone
Estrogen Receptors
Fatigue
Estradiol

Keywords

  • Aromatase inhibitor
  • GnRH analog
  • Ovarian suppression

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Efficacy of Different Leuprolide Administration Schedules in Premenopausal Breast Cancer : A Retrospective Review. / Kendzierski, Daniel C.; Schneider, Bryan; Kiel, Patrick J.

In: Clinical Breast Cancer, 01.01.2018.

Research output: Contribution to journalArticle

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title = "Efficacy of Different Leuprolide Administration Schedules in Premenopausal Breast Cancer: A Retrospective Review",
abstract = "The efficacy of leuprolide depot in combination with an aromatase inhibitor delivered monthly compared to once every 3 months in premenopausal women with estrogen receptor positive–breast cancer was assessed in a single-center retrospective study. There was no significant difference between the groups with respect to the proportion of patients with ovarian ablation at month 3 of treatment. Leuprolide depot delivered once every 3 months is as effective as therapy delivered monthly. Background: Leuprolide is a safe and effective treatment of estrogen receptor–positive premenopausal breast cancer. Data from the SOFT/TEXT trials solidified leuprolide in combination with an aromatase inhibitor as an effective hormonal treatment for premenopausal breast cancer. However, the efficacy of monthly leuprolide depot compared to leuprolide depot every 3 months in combination with an aromatase inhibitor in this patient population is unclear. Patients and Methods: In this single center retrospective study, 201 patients were enrolled between January 1, 2015, and October 1, 2016; 100 were included in the 7.5 mg leuprolide monthly injection plus aromatase inhibitor group and 101 in the 22.5 mg leuprolide injection every 3 months plus aromatase inhibitor group. The primary end point was the proportion of patients who experienced ovarian ablation, defined as an estradiol concentration less than 40 pg/mL and a follicle-stimulating hormone concentration of 23 to 116 mU/mL after 3 months of treatment. Significance threshold was P <.05 (2 sided). Secondary end points included disease-free survival and overall survival at 1-year follow-up, as well as adverse events reported during treatment. Results: All patients in the monthly leuprolide arm experienced ovarian ablation compared to 100 (99{\%}) of 101 patients in the arm treated every 3 months (P = 1). The disease-free survival rate at 1 year was 95{\%} in the monthly leuprolide arm and 97{\%} in the arm treated every 3 months (P =.75). The overall survival rate at 1 year was 100{\%} in the monthly leuprolide arm and 99{\%} in the arm treated every 3 months (P = 1). The most common treatment-related adverse events between the 2 groups were musculoskeletal pain, hot flashes, fatigue, and insomnia. Conclusion: Leuprolide acetate depot administered every 3 months is as efficacious and tolerable as a monthly injection in combination with an aromatase inhibitor for premenopausal patients with hormone receptor–positive breast cancer.",
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N2 - The efficacy of leuprolide depot in combination with an aromatase inhibitor delivered monthly compared to once every 3 months in premenopausal women with estrogen receptor positive–breast cancer was assessed in a single-center retrospective study. There was no significant difference between the groups with respect to the proportion of patients with ovarian ablation at month 3 of treatment. Leuprolide depot delivered once every 3 months is as effective as therapy delivered monthly. Background: Leuprolide is a safe and effective treatment of estrogen receptor–positive premenopausal breast cancer. Data from the SOFT/TEXT trials solidified leuprolide in combination with an aromatase inhibitor as an effective hormonal treatment for premenopausal breast cancer. However, the efficacy of monthly leuprolide depot compared to leuprolide depot every 3 months in combination with an aromatase inhibitor in this patient population is unclear. Patients and Methods: In this single center retrospective study, 201 patients were enrolled between January 1, 2015, and October 1, 2016; 100 were included in the 7.5 mg leuprolide monthly injection plus aromatase inhibitor group and 101 in the 22.5 mg leuprolide injection every 3 months plus aromatase inhibitor group. The primary end point was the proportion of patients who experienced ovarian ablation, defined as an estradiol concentration less than 40 pg/mL and a follicle-stimulating hormone concentration of 23 to 116 mU/mL after 3 months of treatment. Significance threshold was P <.05 (2 sided). Secondary end points included disease-free survival and overall survival at 1-year follow-up, as well as adverse events reported during treatment. Results: All patients in the monthly leuprolide arm experienced ovarian ablation compared to 100 (99%) of 101 patients in the arm treated every 3 months (P = 1). The disease-free survival rate at 1 year was 95% in the monthly leuprolide arm and 97% in the arm treated every 3 months (P =.75). The overall survival rate at 1 year was 100% in the monthly leuprolide arm and 99% in the arm treated every 3 months (P = 1). The most common treatment-related adverse events between the 2 groups were musculoskeletal pain, hot flashes, fatigue, and insomnia. Conclusion: Leuprolide acetate depot administered every 3 months is as efficacious and tolerable as a monthly injection in combination with an aromatase inhibitor for premenopausal patients with hormone receptor–positive breast cancer.

AB - The efficacy of leuprolide depot in combination with an aromatase inhibitor delivered monthly compared to once every 3 months in premenopausal women with estrogen receptor positive–breast cancer was assessed in a single-center retrospective study. There was no significant difference between the groups with respect to the proportion of patients with ovarian ablation at month 3 of treatment. Leuprolide depot delivered once every 3 months is as effective as therapy delivered monthly. Background: Leuprolide is a safe and effective treatment of estrogen receptor–positive premenopausal breast cancer. Data from the SOFT/TEXT trials solidified leuprolide in combination with an aromatase inhibitor as an effective hormonal treatment for premenopausal breast cancer. However, the efficacy of monthly leuprolide depot compared to leuprolide depot every 3 months in combination with an aromatase inhibitor in this patient population is unclear. Patients and Methods: In this single center retrospective study, 201 patients were enrolled between January 1, 2015, and October 1, 2016; 100 were included in the 7.5 mg leuprolide monthly injection plus aromatase inhibitor group and 101 in the 22.5 mg leuprolide injection every 3 months plus aromatase inhibitor group. The primary end point was the proportion of patients who experienced ovarian ablation, defined as an estradiol concentration less than 40 pg/mL and a follicle-stimulating hormone concentration of 23 to 116 mU/mL after 3 months of treatment. Significance threshold was P <.05 (2 sided). Secondary end points included disease-free survival and overall survival at 1-year follow-up, as well as adverse events reported during treatment. Results: All patients in the monthly leuprolide arm experienced ovarian ablation compared to 100 (99%) of 101 patients in the arm treated every 3 months (P = 1). The disease-free survival rate at 1 year was 95% in the monthly leuprolide arm and 97% in the arm treated every 3 months (P =.75). The overall survival rate at 1 year was 100% in the monthly leuprolide arm and 99% in the arm treated every 3 months (P = 1). The most common treatment-related adverse events between the 2 groups were musculoskeletal pain, hot flashes, fatigue, and insomnia. Conclusion: Leuprolide acetate depot administered every 3 months is as efficacious and tolerable as a monthly injection in combination with an aromatase inhibitor for premenopausal patients with hormone receptor–positive breast cancer.

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