6-Month LHRH Formulations Are a Good Choice During the COVID-19 Pandemic and Beyond

November 2021 Vol 12, No 11
Tina DeNofrio, RN, BSN, OCN
Dana-Farber Cancer Institute
Harvard Medical School
Boston, MA
Stuart N. Atkinson, MB, ChB
Tolmar Pharmaceuticals, Inc.
Buffalo Grove, IL
Deborah M. Boldt-Houle, PhD
Tolmar Pharmaceuticals, Inc.
Buffalo Grove, IL

Background: Prostate cancer (PCa) patients treated with injectable androgen deprivation therapy (ADT) are particularly vulnerable during a pandemic because they may not be able to self-administer treatment and may be required to visit a clinic/hospital for injections. During a pandemic, physician/hospital visits should be lessened as oftentimes PCa patients are elderly with frequent comorbidities, which thereby increase their infection risk. Therefore, patients may be late for/miss scheduled injections. Achieving/maintaining effective testosterone (T) suppression with ADT is fundamental for advanced PCa treatment, but T may exceed castrate level (50/20 ng/dL) with delayed doses.1,2 Muñoz et al found a positive association between oncology nurse navigation and improved outcomes for patients with cancer.3 Therefore, nurses and navigation likely play an important role in ensuring patients with PCa maintain T suppression and a high quality of life.

Objectives: To evaluate the timeliness of luteinizing hormone-releasing hormone (LHRH) agonist injections and rate of T >50/20 ng/dL.

Methods: Analysis (1/1/07-6/30/16) of US oncology/urology electronic medical records of PCa patients receiving LHRH agonist injections (N = 85,030) was conducted to evaluate frequency of late injections and T >50/20 ng/dL. Late dosing was defined as occurring after days 33, 98, 129, and 195 for the 1-, 3-, 4-, and 6-month formulations, respectively. The mean number of late doses/year for 1-, 3-, 4-, and 6-month formulations were calculated by multiplying the proportion of late doses by the number of doses/year for each formulation. T tests prior to a subsequent injection and after the previous injection served as the individual data points to analyze the impact of delayed dosing.

Results: Twenty-seven percent of LHRH agonists were administered late. Mean late doses/year for 1-, 3-, 4-, and 6-month formulations were 5.4, 0.8, 0.8, and 0.6, respectively. Twenty-seven percent of T tests were >50 ng/dL with late dosing versus only 4% with early/on-time doses. Forty-three percent of T tests were >20 ng/dL for late injections versus only 21% for early/on-time injections.

Conclusion: Six-month ADT formulations had the least number of late doses/year compared with the 1-, 3-, and 4-month formulations. Late injections were often correlated with ineffective T suppression and an increased proportion of patients with T >20 ng/dL compared with early/on-time dosing. As 6-month formulations of LHRH agonists require fewer clinic and laboratory visits to maintain optimal T suppression and are associated with fewer late doses, nurses and nurse navigators can advocate for patients by recommending that healthcare teams consider 6-month formulations during a pandemic or other circumstances where limited visits are desirable for patients. Nurses and nurse navigators can also help ensure continuity of care between injection appointments by helping patients to use telemedicine technology and manage the side effects of hormone therapy.

Funding: Tolmar Pharmaceuticals, Inc.

References

  1. Crawford ED, Hafron JM, Tagawa ST, et al. Impact of late dosing on testosterone suppression with 2 different leuprolide acetate formulations: in situ gel and microsphere. An analysis of United State clinical data. J Urol. 2021;205:554-560.
  2. Crawford ED, Twardowski PW, Concepcion RS, et al. The impact of late luteinizing hormone-releasing hormone agonist dosing on testosterone suppression in patients with prostate cancer: an analysis of United States clinical data. J Urol. 2020;203:743-750.
  3. Muñoz R, Farshidpour L, Chaudhary UB, Fathi AH. Multidisciplinary cancer care model: a positive association between oncology nurse navigation and improved outcomes for patients with cancer. Clin J Oncol Nurs. 2018;22:E141-E145.
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Last modified: December 17, 2021

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