Six-month gonadotropin releasing hormone (GnRH) agonist depots provide efficacy, safety, convenience, and comfort

Abstract

Two different 6-month GnRH agonist depot formulations approved for palliative treatment of advanced and metastatic prostate cancer in the United States – leuprolide acetate 45 mg and triptorelin pamoate 22.5 mg – provide patients with efficacy and safety comparable to those of existing 1-, 3-, and 4-month GnRH agonist depots. However, the 6-month formulations can increase patient convenience, comfort, and compliance by reducing the number of physician visits and injections required. At the conclusion of their pivotal trials, the 6-month formulations demonstrated efficacy rates in achieving chemical castration (serum testosterone ≤50 ng/dL) that ranged between 93% and 99%. As with existing GnRH agonist depot formulations, hot flashes represented the most common adverse event reported in trials of 6-month leuprolide acetate or triptorelin. As such, these products may prove useful not only for their labeled indication, but also as adjuncts to other treatments such as radical prostatectomy, radiotherapy, and chemotherapy. We recommend further research, including head-to-head trials between the 6-month GnRH depots, to refine our understanding of these products.

Selection criteria for initiation and renewal of luteinizing hormone-releasing hormone agonist therapy in patients with prostate cancer: a French prospective observational study

“…Perceived advantages of 6-monthly injections included less discomfort/pain, better quality of life, fewer reminders of the disease, and greater ability to undertake activities without restriction [Schulman, 2007]. The findings of our study also support recent published data showing that 6-month formulations can increase patient convenience, comfort and compliance by reducing the number of physician visits and injections required [Crawford and Phillips, 2011].…”

“…To date, clinical trials have shown that LHRH agonists are generally well tolerated, with generally mild side effects stemming from testosterone suppression, and a very low rate of withdrawal due to adverse events [De Jong et al 2007;Crawford and Phillips, 2011]. The high proportion of patients renewing prescriptions at 3 or 6 months and 12 months in our study may confirm this low withdrawal rate.…”

Six-month leuprorelin acetate depot formulations in advanced prostate cancer: a clinical evaluation

“…This required daily visits to the oncologist or urologist and greatly increased the chance of adverse effects, such as injection site reactions and injection site pain, but also made patient compliance with therapy more difficult 9. Over the last 20 years, extended release formulations of 1, 3, 4, and 6 months have been developed, significantly increasing patient acceptance to therapy and easing treatment burdens for physicians.…”

Leuprolide acetate 1-, 3- and 6-monthly depot formulations in androgen deprivation therapy for prostate cancer in nine European countries: evidence review and economic evaluation

“…Even though the patient reported advantage of the 3 M LHRH agonist was the high satisfying quality of medical follow-up, the 6 M formulation had the advantages of flexibility and the freedom from worrying about their cancer for up to 6 months. Among the advantages reported for the 6 M depot were reduced anxiety, decreased emotional burden, improved flexibility with scheduling, less frequent injections, improved comfort, fewer doctor visits, decreased site reactions, decreased cost, fewer missed visits and, in theory, decreased risk of breakthrough 31. In Germany the long dosing interval of 6 M leuprolide was the main reason given by urologists for making the prescribing decision with regard to the hormone deprivation therapy 32.…”