The Journal of medicine publishes study CS21A with new data showing the long term benefits of degarelix for hormonodependiente prostate cancer.

Saint-Prex, Switzerland, 2011-September The number of September in The Journal of medicine publishes results of the study CS21A with new data showing that degarelix, an antagonist of the hormone gonadotropin (GnRH) approved for the treatment of prostate cancer advanced both the EU and USA, continues to be effective and well tolerated after three years of treatment. This new study extends the findings of the study phase III registration (CS21), in which the risk of progression of PSA or death was significantly lower in those patients who received degarelix compared with those who received leuprorelina (an LHRH agonist) up to one (1) year. This extension study demonstrated that patients who continued treatment, the removal of PSA and the impact on PSA progression-free survival remained constant (42 months) (1) long term.

In addition, in the study were investigated patients changed from leuprorelina to degarelix after one year of treatment. With a median of 27.5-month follow-up data showed decreased risk in PSA progression-free survival (p = 0, 003) (1).

It is important to delay time to progression of the PSA as it indicates the time until that prostate cancer becomes hormonoresistente. You can also delay the onset of a second line treatment, which includes chemotherapy (2). The time until the hormone-resistance is also an important indicator of survival (3). These findings support the use of degarelix as first-line (1) androgen deprivation therapy.

CS21A was designed with the aim of collecting more data on the safety and tolerability of degarelix. After the end of the phase III trial offered to all patients the option of receiving degarelix as part of the extension study. All patients who had received such therapy continued with their treatment and be realeatorizó to those who had been previously treated with leuprorelina to receive degarelix.

“to delay the maximum time possible hormonal-resistance is an important result for any first-line therapy,” says e. David Crawford, MD, Chief of the section of Oncology and Professor of Urologic Oncology and Oncology of the University of DenverColorado, United States. UU. «data from the phase III extension study show that degarelix provides patients with prostate cancer effective control of testosterone and PSA in the long term, which in turn may delay the androgen resistance.»

Prostate cancer is the second leading cause of death from cancer in men in the Western world (4). Up to 40% of men who are diagnosed with prostate cancer will develop advanced disease, and although most respond to initial surgical or medical castration, the progression is inevitable until (CPHR) hormone-resistant prostate cancer (5). Half of the patients with CPHR survival is two to three years (5).

Degarelix works by inhibiting immediately GnRH receptors in the pituitary gland by suppressing the luteinizing hormone, which reduces the production of testosterone from testes without causing the initial flare. Prostate cancer depends on testosterone for growth, so the goal of therapy is to quickly reduce testosterone levels to slow the growth of cancer cells. To avoid the initial flare of testosterone prevents the initial exacerbation of clinical status, allowing a more rapid relief of symptoms such as bone pain, urethral obstruction and spinal cord compression, in addition to eliminating the need to manage a concomitant treatment with antiandrogens (6,7,8).

The study of CS21A

The study of extension of the trial of degarelix against leuprorelina (CS21) registration is designed with the aim of gathering more data on their safety and tolerability. After the end of the phase III trial offered to all patients the option of receiving degarelix as part of the extension study. All patients who had received continued with their treatment and be realeatorizó to those who had been previously treated with leuprorelina to receive degarelix 240/80 mg or 240/160 mg.

The primary criterion of assessment was the safety and tolerability and side valuation criteria were the response of testosterone, PSA, luteinizing hormone and follicle stimulating hormone, as well as the progression of PSA and of progression-free survival

CS21A was launched in March 2007 and analysis was performed in March 2010 with a median follow-up of 27.5 months. CS21A continues and will have a duration of five years.

Degarelix

It has unique chemical characteristics and a new mechanism of action, different from conventional hormone therapies. Degarelix is administered as a subcutaneous injection and rapidly reduces the levels of PSA in two weeks immediately blocking GnRH receptors in the pituitary gland. By blocking the receptors suppresses the release of luteinizing hormone and follicle stimulating hormone, so that reduces the production of testosterone in the testes to castration levels at three days. Prostate cancer depends on testosterone for growth and to reduce testosterone levels slows the growth of cancer cells.

In clinical studies, degarelix suppressed testosterone and PSA faster than the leuprorelina, a treatment is already available for advanced prostate cancer (9).

In clinical trials, it was well tolerated in general. The most common side effects were hot flashes, pain and Erythema at the point of injection, weight gain, nasofaringitis, fatigue and pain of back (9.10).

Prostate cancer

Prostate cancer is the most common form of male cancer in the Western world (11) and the second leading cause of death from cancer in men in some countries (4). Each year are diagnosed in Europe about 300,000 new cases of prostate cancer. Globally this figure rises to 670,000 (12) cases. For more information and the latest news about prostate cancer, visit the web site of information on Ferring.

Ferring

Ferring is a biopharmaceutical specialist based in Switzerland that focuses on research and has presence in global markets. The company identifies, develops and commercializes innovative products in the areas of reproductive health, urology, Gastroenterology and endocrinology. In recent years, Ferring has expanded beyond its traditional European base and carries out operations in more than 50 countries.

Bibliography

(1) Crawford, ED et to the. The Journal of medicine September 2011; 186 (3): 889-897

(2) Mahon KL, et to the. Endocr Relat Cancer 2011; 18:R103 – R123

(3) Bournakis E, et to the. Icancer Res 2011: Apr; 31 (4): 1475-82

(4) American Cancer Society. Available here.

(5) Beltran, H et to the. European medicine 60 (2011) 279 – 290

(6) Van Poppel, H et to the. Medicine: June 2009; Volume 71, Issue 6: 1001-1006

(7) B-E Persson, et to the. Neuroendocrinology 2009; 90: 235 – 244

(8) L Boccon-Gibod, et to the. Therap Advisor Ural June 2011

(9) Klotz L, et to the. BJU int. 2008; 102 (11): 1531-1538.

(10) Van Poppel H et to the. Abstract (23) Euro Ural Suppl. 2007; 6 (2): 28

(11) University of Iowa Hospitals and Clinics. available here.

(12) Cancer Research UK. Available here