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Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer.

Publication ,  Journal Article
George, DJ; Saad, F; Cookson, MS; Saltzstein, DR; Tutrone, R; Bossi, A; Brown, B; Selby, B; Lu, S; Buckley, D; Tombal, B; Shore, ND
Published in: Clin Genitourin Cancer
June 2023

BACKGROUND: To characterize the impact of concomitant prostate cancer treatments with the use of relugolix, the oral GnRH receptor antagonist, in advanced prostate cancer, a subgroup and pharmacokinetic/pharmacodynamic analyses of the HERO study was undertaken. PATIENTS AND METHODS: Overall, 934 patients were randomized 2:1 to receive relugolix 120 mg orally once daily or leuprolide injections every 12 weeks for 48 weeks. In the setting of rising PSA, patients could receive enzalutamide or docetaxel 2 months after study initiation. Assessments included sustained testosterone suppression to castrate levels (<50 ng/dL) through 48 weeks and safety parameters. Subgroups analyzed included patients with or without concomitant enzalutamide or docetaxel. A sensitivity analysis of the primary endpoint was performed excluding patients who received concomitant therapies that may affect testosterone. Pharmacokinetic/pharmacodynamic analyses of 20 participants in the relugolix treatment group assessed the net effect of enzalutamide on exposure to relugolix. RESULTS: Overall, 125 patients (13.4%) took concomitant therapies that could impact testosterone levels. Enzalutamide (n = 23) was the most frequently used therapy in the relugolix (2.7%) and leuprolide groups (1.9%). Docetaxel (n = 13) was used by 1.3% and 1.6% of patients in the relugolix and leuprolide groups, respectively. All other relevant concomitant therapy were used in <1% of population. Sensitivity analysis showed concomitant therapy did not impact the testosterone levels. Castration rates were similar with and without concomitant use of enzalutamide or docetaxel. No clinically relevant differences in adverse events were observed between subgroups in either treatment group. No differences in relugolix Ctrough or testosterone concentrations were observed, suggesting that any induction or inhibition properties of enzalutamide on relugolix metabolism result in a neutral net effect on relugolix exposure and testosterone suppression. CONCLUSION: Treatment with relugolix was associated with similar efficacy and safety profiles with and without concomitant enzalutamide or docetaxel. Standard-of-care use of relugolix in combination with these agents is supported by these data.

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Published In

Clin Genitourin Cancer

DOI

EISSN

1938-0682

Publication Date

June 2023

Volume

21

Issue

3

Start / End Page

383 / 392.e2

Location

United States

Related Subject Headings

  • Testosterone
  • Prostatic Neoplasms
  • Oncology & Carcinogenesis
  • Male
  • Leuprolide
  • Humans
  • Docetaxel
  • Antineoplastic Agents, Hormonal
  • 3211 Oncology and carcinogenesis
  • 1117 Public Health and Health Services
 

Citation

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George, D. J., Saad, F., Cookson, M. S., Saltzstein, D. R., Tutrone, R., Bossi, A., … Shore, N. D. (2023). Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer. Clin Genitourin Cancer, 21(3), 383-392.e2. https://doi.org/10.1016/j.clgc.2023.03.009
George, Daniel J., Fred Saad, Michael S. Cookson, Daniel R. Saltzstein, Ronald Tutrone, Alberto Bossi, Bruce Brown, et al. “Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer.Clin Genitourin Cancer 21, no. 3 (June 2023): 383-392.e2. https://doi.org/10.1016/j.clgc.2023.03.009.
George DJ, Saad F, Cookson MS, Saltzstein DR, Tutrone R, Bossi A, et al. Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer. Clin Genitourin Cancer. 2023 Jun;21(3):383-392.e2.
George, Daniel J., et al. “Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer.Clin Genitourin Cancer, vol. 21, no. 3, June 2023, pp. 383-392.e2. Pubmed, doi:10.1016/j.clgc.2023.03.009.
George DJ, Saad F, Cookson MS, Saltzstein DR, Tutrone R, Bossi A, Brown B, Selby B, Lu S, Buckley D, Tombal B, Shore ND. Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer. Clin Genitourin Cancer. 2023 Jun;21(3):383-392.e2.
Journal cover image

Published In

Clin Genitourin Cancer

DOI

EISSN

1938-0682

Publication Date

June 2023

Volume

21

Issue

3

Start / End Page

383 / 392.e2

Location

United States

Related Subject Headings

  • Testosterone
  • Prostatic Neoplasms
  • Oncology & Carcinogenesis
  • Male
  • Leuprolide
  • Humans
  • Docetaxel
  • Antineoplastic Agents, Hormonal
  • 3211 Oncology and carcinogenesis
  • 1117 Public Health and Health Services