An Emerging Opportunity for Pharmacies: Fighting Prostate Cancer with Oral Itraconazole

An Emerging Opportunity for Pharmacies: Fighting Prostate Cancer with Oral Itraconazole

Oral ItraconazoleProstate cancer is the most commonly diagnosed cancer and the second leading cancer-related cause of death in American men. Every year, more than 27,000 men in the United States lose their lives to metastatic and advanced forms of prostate cancer, even as scientists continue to pursue cures for this and other forms of deadly cancers.

In recent years, oncology has shifted away from infusion-based therapy and toward more oral-based treatment, offering an increasing role for specialty pharmacies. The development of compound itraconazole, originally intended for antifungal treatments, offers a ray of hope for men diagnosed with advanced-stage prostate cancer.1

Compound Oral Itraconazole for Advanced Prostate Cancer Treatment

One of the major advancements in oral therapy for prostate cancer treatment has been the exploration of antifungal compound itraconazole for advanced-stage prostate cancer treatment for those whose cancers have proven to be resistant to hormonal therapy.

Traditionally, advanced-stage prostate cancer treatments were limited to androgen deprivation therapy (ADT) or chemotherapy, typically with docetaxel, both of which come with significant adverse effects and quality-of-life loss for patients. Once a patient exhausts hormonal therapy options and the prostate cancer remains, pharmacists’ options for treating the lingering cancer, now known as “castrate-resistant prostate cancer,” are even slimmer.2

Now, though, itraconazole has entered the oncology arena. The compound is FDA-approved for treatment of fungal infections, usually in fingernails and toenails, and the idea for using the anti-fungal for prostate cancer treatment came to Johns Hopkins researcher Dr. Jun Liu in 2011 after going through a vast database of FDA-approved drugs to try to avoid the costs and hurdles associated with developing a cancer drug from scratch.

Upon realizing that one of itraconazole’s qualities was to block Hedgehog chemical signaling, Liu consulted oncology colleagues to general excitement. Oncological pharmacists will know that prostate cancer growth relies mainly on angiogenesis, which is addressed by hormonal therapy, and cancer cells hijacking the chemical messages sent along the Hedgehog pathway to promote cancer metastasis.3

Trials in mice and in humans followed. The human clinical trials consisted of testing 46 men with castration-resistant prostate cancer to receive either low dose (200 mg/day) or high-dose (600 mg/day) itraconazole until their cancer progressed or they developed unacceptable toxicity. The results showed that itraconazole thus far has functioned just as scientists envisioned, working as an agonist for Hedgehog signaling pathways and blocking the signals hijacked by cancer cells from being spread further in cases where hormonal therapy no longer worked, and in which the men were not undergoing active ADT. Itraconazole is also safe for immunocompromised patients in an oncological setting, which might be a difference-maker for seniors and other higher-risk populations.4

The latest clinical trials just concluded in late 2014, and itraconazole has since gone off-patent in its current approved form for antifungal treatments. There are further trials planned and an effort to gain FDA approval for itraconazole use in cancer treatments. Specialty pharmacies should soon be able to offer advanced-stage prostate cancer patients an oral treatment to manage their cancer and improve their quality of life.

What Pharmacists Should Know About Trend Toward Oral-Based Cancer Therapy

The success thus far of itraconazole as a prostate cancer treatment epitomizes why innovations in cancer therapy are trending away from infusion-based regimens and toward oral-based therapies. Just in the past few years, oral Gleevec has commuted what was frequently a death sentence for chronic myeloid leukemia to a manageable illness. Sunitinib has offered extended and improved lives for patients suffering from renal-cell carcinoma. Tarceva has improved the standard of care for a variety of lung cancers. All of these oral medications have replaced intravenous chemotherapies and hormonal treatments.5

Infusion and hormonal therapies can be invasive and require long hours being supervised under treatment, all to leave the patient weakened and lowering quality of life. Oral medications, while still with toxicity and side effect risks, generally serve both pharmacists and patients much better, providing effective treatment while not requiring frequent visits to a clinic. The vast majority of patients (89 percent) prefer oral therapy to intravenous chemotherapy, either due to convenience (57 percent) or due to fear of the intravenous lines or needles (55 percent).6

The future is bright for compound medications for prostate cancer containing itraconazole, which is now off-patent in its most common antifungal form. It remains to be seen whether the movement toward more oral-based therapy and repurposing existing drugs for cancer treatments continues. If both continue, as signs indicate, specialty pharmacies will have an opportunity to be more involved than ever in developing and compounding oncological treatments. The pace of discovery has been careful but swift, and pharmacies should look forward to playing a growing and meaningful role in treating and managing quality of life for cancer patients.

Pharmaceutica North America supplies the highest-quality APIs to pharmacists and physicians looking to provide the best patient care for illnesses like advanced prostate cancer. Contact us to learn more about our bulk itraconazole and other ways compounding can assist your patients.

Show 6 footnotes

  1. “Prostate Cancer Statistics,” Aug. 20, 2015, http://www.cdc.gov/cancer/prostate/statistics/
  2. “Understanding Prostate Cancer, “ Sept. 13, 2012, http://www.pharmacytimes.com/publications/issue/2012/september2012/understanding-prostate-cancer
  3. “Can an Antifungal Drug Work on Advanced Prostate Cancer?” Winter 2013, http://urology.jhu.edu/newsletter/2013/prostate_cancer_2013_223.php; “Itraconazole, a Commonly Used Antifungal that Inhibits Hedgehog Pathway Activity and Cancer Growth,” April 13, 2010, http://www.sciencedirect.com/science/article/pii/S153561081000070X
  4. “Specialty pharmacy’s expanding role in prostate cancer management,” Oct. 1, 2013, http://www.pharmacist.com/specialty-pharmacy%E2%80%99s-expanding-role-prostate-cancer-management
  5. “Oral/Infusion Cancer Drug Parity Begins to Raise Health Plan Costs,” Jan. 2012, http://www.managedcaremag.com/content/oralinfusion-cancer-drug-parity-begins-raise-health-plan-costs
  6. “Answering Patients’ Needs: Oral Alternatives to Intravenous Therapy,” July 19, 2010, http://theoncologist.alphamedpress.org/content/6/suppl_4/12.full
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