The Nurse Navigator Role in the Treatment of Metastatic Castrate-Resistant Prostate Cancer: Highlights from an AONN+ Webinar Prostate Cancer

September 2021 Vol 12, No 9

Categories:

Prostate Cancer

Prostate cancer is the most commonly diagnosed cancer in men, with approximately 248,530 new cases expected in 2021.1 It is also the second leading cause of cancer-related death in men.1 For distant-stage prostate cancer, the 5-year survival rate is less than 30%, compared with nearly 100% for local and regional disease.1 Advanced prostate cancer involves metastases into distant lymph nodes, bone, or viscera.2 It includes metastatic castrate-sensitive prostate cancer and metastatic castrate-resistant prostate cancer (mCRPC).3

In cases of mCRPC, the cancer no longer responds to hormone treatment, and the prognosis is dismal.2 Most prostate cancer deaths are due to mCRPC.4 Treatment options exist for mCRPC, such as chemotherapy, second-line hormone therapies, and radiotherapy; however, most have limited benefit.5 Historically, the median survival for patients with mCRPC has been less than 2 years.4 Recent advances in the treatment of mCRPC include immunotherapies, such as sipuleucel-T, “the first therapeutic cancer vaccine to receive approval from the US Food and Drug Administration.”5

Sipuleucel-T (Provenge), FDA-approved since 2010, is a personalized immunotherapy for prostate cancer that is indicated for the treatment of asymptomatic or minimally symptomatic mCRPC.6 Patients with the following indicators may be eligible for treatment: confirmed metastatic disease, testosterone levels less than 50 ng/dL, not taking narcotics for cancer pain, and progressive disease despite androgen deprivation therapy.6 Approximately 3 days prior to treatment with sipuleucel-T, the patient’s peripheral blood mononuclear cells are collected through a standard leukapheresis procedure.6 The cells are shipped to a manufacturing facility, where they are cultured with a recombinant protein (PAP-GM-CSF), made up of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator.6 Once the patient’s antigen-presenting cells are activated with this complex, they are returned to the patient for infusion.6 Sipuleucel-T infusion activates the patient’s T-cells, which then proliferate and target the PAP antigen on the surface of the prostate cancer cells.7

IMPACT, a double-blind, placebo-controlled trial, showed that sipuleucel-T significantly prolonged overall survival in men with mCRPC.8 In this trial, patients underwent leukapheresis procedures at weeks 0, 2, and 4, each followed by infusion of either sipuleucel-T or placebo approximately 3 days later.8 The median survival in patients treated with sipuleucel-T was 25.8 months, versus 21.7 months in the placebo group (P = .032).8 Adverse events were reported by 98% of patients in the trial.8 Adverse events reported more frequently in patients treated with sipuleucel-T than placebo included chills (54.1%), pyrexia (29.3%), headache (16%), influenza-like illness (9.8%), myalgia (9.8%), hypertension (7.4%), hyperhidrosis (5.3%), and groin pain (5%).8

Additional supportive data on the survival benefits of sipuleucel-T in mCRPC were found in a retrospective observational analysis of over 6000 Medicare beneficiaries.9 As shown in the Figure, patients treated with sipuleucel-T in any line had significantly longer median overall survival compared with patients treated with androgen receptor signaling pathway inhibitors (ASPIs) in any line (35.2 months vs 20.7 months, respectively).9 Model outcomes indicated sipuleucel-T was associated with significantly prolonged overall survival compared with ASPIs: adjusted hazard ratio, 0.59 (95% CI, 0.527-0.651; P <.0001).9 Although this claims analysis is potentially limited by selection bias and confounded by indication, it gives insight into real-world treatment outcomes with sipuleucel-T.

Figure

From diagnosis to treatment with sipuleucel-T, advanced prostate cancer is a complex journey, and nurse navigators support patients each step of the way. An integral role in the multidisciplinary team, navigators review patient clinical data, provide education, help with funding issues and patient assistance programs, and schedule follow-up appointments.10 Cancer patient navigation is associated with increased access to screening, diagnosis, and treatment; however, it is not well studied in prostate cancer.11 Therefore, the individual clinic often creates its own prostate cancer navigation program, recruiting nurses or medical assistants to the navigator role.10

A resource for navigators, Dendreon On Call, provides support throughout the sipuleucel-T treatment process.12 Navigators may enroll patients in this service online.12 Specifically, Dendreon On Call assists with patient enrollment for sipuleucel-T immunotherapy, benefit verification, assistance eligibility, and scheduling infusion appointments.12 It also includes a provider portal for tracking treatment progress.12

Navigators use their strong clinical background to review patients’ charts, identifying key information to share with the multidisciplinary team.10 Following the American Urological Association Guideline Statement on early evaluation and counseling, navigators should review pathology reports, urologist and oncologist consult notes, and pain reporting.13 In mCRPC, the Guideline Statement recommends reviewing baseline labs, location of metastases, disease-related symptoms, performance status, and imaging tests.14 Lastly, genetic testing can aid in prognosis and counseling regarding family risk.14

Navigators also provide patient support by discussing procedures and treatments with patients, such as leukapheresis and sipuleucel-T administration. To prepare the patients in advance, navigators can advise patients of the procedure’s 2- to 4-hour duration; and to come hydrated, eat a calcium-rich breakfast, and avoid caffeine.15 Additionally, patients should bring a caregiver, as the procedure causes fatigue.15 When patients undergo leukapheresis, navigators can provide education on side effects, such as paresthesia, chills, nausea, and fainting.6 Approximately 3 days after leukapheresis, patients will return to receive the sipuleucel-T infusion, which is administered as a 60-minute infusion, every 2 weeks, for a total of 3 doses.6 Navigators can counsel patients on the most common adverse effects from sipuleucel-T, including fever, chills, fatigue, back pain, and nausea.6

Another major role of nurse navigators is in assisting patients with treatment funding issues.10 To locate a provider who administers sipuleucel-T, navigators or patients may use the “Find a Doctor” search tool on the Provenge patient website.16 In addition, navigators can educate patients on insurance coverage and assistance programs for sipuleucel-T.10 Treatment with sipuleucel-T is broadly covered by Medicare and private insurance.17 It is covered by 90% of Medicaid programs as well.17 Prior authorization may be required by certain Medicare Advantage or commercial insurance plans.17 Finally, fee schedules for insurance plans can be checked on CMS.gov (for Medicare plans), the state (for Medicaid plans), or the payer contract (for commercial plans).17

Several programs exist for patients who require financial assistance.17 First, for eligible Medicare patients meeting specific criteria, independent foundations can provide copay and/or travel assistance.17 Second, commercially insured patients may be eligible for up to $6000 through the PROvide Commercial Co-Pay Program.17 Third, uninsured or rendered uninsured patients meeting certain criteria may be eligible to receive treatment free of cost.17 Navigators should contact Dendreon On Call for more information on these programs.12

In brief, immunotherapies such as sipuleucel-T represent a paradigm shift in the treatment of prostate cancer. Compared with other treatment options, the personalized cancer vaccine prolongs the overall survival of mCRPC. Moreover, nurse navigators play a fundamental role in supporting prostate cancer patients and streamlining the treatment process.

References

  1. American Cancer Society. Cancer Facts & Figures 2021. Atlanta, GA: American Cancer Society; 2021.
  2. Urology Care Foundation. Metastatic Castration-Resistant Prostate Cancer (mCRPC). mCRPC-What-You-Should-Know-Fact-Sheet.pdf. Accessed August 10, 2021.
  3. Sartor O, de Bono JS. Metastatic prostate cancer. N Engl J Med. 2018;378:645-657.
  4. Cookson MS, Roth BJ, Dahm P, et al. Castration-Resistant Prostate Cancer: AUA Guideline. American Urological Association; 2013. www.auanet.org/guidelines/archived-documents/prostate-cancer-castration-re sistant-guideline. Updated 2018. Accessed August 18, 2021.
  5. Subudhi SK. New approaches to immunotherapy for metastatic castration-resistant prostate cancer. Clin Adv Hematol Oncol. 2019;17:283-286.
  6. Provenge [package insert]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
  7. Provenge. The Science Behind Provenge: Powerfully Personal. https://provenge.com/hcp/provenge-science. Accessed August 11, 2021.
  8. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.
  9. McKay RR, Hafron JM, Ferro C, et al. A retrospective observational analysis of overall survival with sipuleucel-T in Medicare beneficiaries treated for advanced prostate cancer. Adv Ther. 2020;37:4910-4929.
  10. dela Rama F. Role of a nurse navigator and care pathways in an integrated prostate cancer care program. J Clin Pathways. 2019;5:33-38.
  11. Serrell EC, Hansen M, Mills G, et al. Prostate cancer navigation: initial experience and association with time to care. World J Urol. 2019;37:1095-1101.
  12. Provenge. Dendreon On Call. Enrollment. www.dendreononcall.com/Enrollment. Accessed August 13, 2021.
  13. Lowrance WT, Breau RH, Chou R, et al. Advanced prostate cancer: AUA/ASTRO/SUO Guideline PART I. J Urol. 2021;205:14-21.
  14. Lowrance WT, Breau RH, Chou R, et al. Advanced prostate cancer: AUA/ASTRO/SUO Guideline PART II. J Urol. 2021;205:22-29.
  15. Provenge. Provenge: Immunotherapy in a Month. https://provenge.com/hcp/provenge-immunotherapy-process#patient-education. Accessed August 11, 2021.
  16. Provenge. https://provenge.com. Accessed August 11, 2021.
  17. Provenge. Reimbursement Support Services FAQ. https://provenge.com/hcp/provenge-immunotherapy-process#financial-resources. Accessed August 10, 2021.

This article is funded by Dendreon Pharmaceuticals, LLC.

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Last modified: August 10, 2023

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