Abstract
BackgroundLuteinizing hormone-releasing hormone (LH-RH) agonists provide effective adjuvant treatment for premenopausal women with endocrine-responsive breast cancer. Here, we investigated appropriate treatment durations of an LH-RH agonist, leuprorelin.MethodsWe conducted an open-label, randomized controlled pilot study to evaluate the safety and efficacy of leuprorelin subcutaneously administered every-3-months for 2 versus 3 or more, up to 5 years, together with daily tamoxifen for 5 years in premenopausal endocrine-responsive breast cancer patients. Primary endpoints were disease-free survival (DFS) and safety.ResultsEligible patients (N = 222) were randomly assigned to receive leuprorelin for either 2 years (N = 112) or 3 or more years (N = 110) with tamoxifen for 5 years after surgery. Leuprorelin treatment for 3 or more years provided no significant difference in DFS rate over 2 years: 94.1 versus 91.8 % at 144 weeks (3 years) after the second year (week 96) and 90.8 versus 90.4 % at the fifth year (week 240). The overall survival rate was 100 % for both groups during the third through fifth year study period. There were no significant differences in the incidence of adverse events (AEs) between the 2 groups: most AEs were rated grade 1 or 2.ConclusionsAdjuvant leuprorelin treatment for 3 or more years with tamoxifen showed a survival benefit and safety profile similar to that for 2 years in premenopausal endocrine-responsive breast cancer patients. No new safety signal was identified for long-term leuprorelin treatment. Longer follow-up observation is needed to determine the optimal duration of leuprorelin treatment.
Highlights
Luteinizing hormone-releasing hormone (LH-RH) agonists are effective adjuvant therapy for premenopausal women with endocrine-responsive breast cancer [1,2,3,4]
Our study suggests that adjuvant leuprorelin treatment for 3 or more up to 5 years with tamoxifen for 5 years resulted in a little higher disease-free survival (DFS) rate at week 240 compared with 2 years of leuprorelin treatment with tamoxifen, in particular, during the third through fifth year study period; there were no significant differences between the 2 groups (Table 2; Fig. 2)
The number of patients in this study was insufficient to clarify the difference between the DFS rates in the 2 groups, only 10 disease events each were found and good efficacy was shown in the 2 groups throughout the 5-year study period
Summary
Luteinizing hormone-releasing hormone (LH-RH) agonists are effective adjuvant therapy for premenopausal women with endocrine-responsive breast cancer [1,2,3,4]. The combination of 5 years of tamoxifen plus 2 years of ovarian ablation with an LH-RH agonist is frequently used as a postoperative adjuvant therapy for premenopausal women with early breast cancer in many countries. The St Gallen international expert consensus on the primary therapy of early breast cancer has recommended 5 years of tamoxifen alone or in combination with 5 years of ovarian suppression as a standard adjuvant therapy for premenopausal breast cancer patients [13, 14]. Luteinizing hormone-releasing hormone (LH-RH) agonists provide effective adjuvant treatment for premenopausal women with endocrine-responsive breast cancer. We investigated appropriate treatment durations of an LH-RH agonist, leuprorelin
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
