Year Results Confirm Unique Long-Term Survival Benefits Of Adjuvant Goserelin (Zoladex) In Locally Advanced Prostate Cancer

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology
Article Date: 23 Sep 2008 - 6:00 PST

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Goserelin, when used as adjuvant treatment with radiotherapy, improves 10-year overall survival as compared to radiotherapy alone in patients with locally advanced prostate cancer (when the cancer has spread into the capsule of the prostate or through the prostate into the surrounding tissues), according to results[i] presented for the first time at the American Society of Therapeutic Radiology and Oncology Congress.

The results from the Phase III EORTC study demonstrate that over 10 years the addition of goserelin to radiotherapy compared to radiotherapy alone improves survival:

- The number of men with locally advanced prostate cancer surviving to 10 years increased by 18.3 per cent (39.8 per cent to 58.1 per cent),

- Sixty-two per cent less men with locally advanced prostate cancer will die (the 10 year cumulative incidence of prostate cancer mortality was 31.0 per cent on radiotherapy alone and 11.1 per cent on radiotherapy plus goserelin).

Commenting on the data, Dr Heather Payne, Consultant Clinical Oncologist in Urological Tumours, University College Hospital, London stated: "An extensive body of evidence already exists to support the efficacy of goserelin in the treatment of all stages of prostate cancer. This exciting data provides evidence that adjuvant goserelin therapy can consistently allow patients to outlive their disease and essentially provide a cure for a substantial number of men with locally advanced prostate cancer."

In the study from 1987 to 1995 415 patients with locally advanced prostate cancer under age 81 were randomly allocated to radiotherapy plus goserelin or radiotherapy alone, followed by the same hormonal therapy in the case of relapse. Goserelin 3.6mg was started on the first day of irradiation and continued for a period of three years.

The introduction of goserelin transformed the treatment of prostate cancer as previously men with prostate cancer faced surgical orchidectomy (an operation to remove the testicles). Despite evolving clinical practice and goserelin being launched over 20 years ago, goserelin is still the standard hormonal treatment in the management of prostate cancer today. Goserelin is the only LHRHa with demonstrated survival benefits in all three stages of prostate cancer: localised, locally advanced and metastatic disease. The Medicines and Healthcare products Regulatory Agency (MHRA) recently approved an updated licence to goserelin 3.6mg and goserelin LA 10.8mg[ii] to reflect survival benefits in all three stages of prostate cancer (localised, locally advanced and advanced also called metastatic).

Goserelin (Zoladex®)

- Goserelin is a Luteinizing Hormone-Releasing Hormone agonist (LHRHa) which works in prostate cancer by reducing the levels of testosterone in men stopping prostate cancer growth. This is called 'medical castration' as opposed to a surgical castration (orchidectomy), the removal of the testes.

- Goserelin is given as an injectable implant LHRHa either every 28 days or every 12 weeks, which is implanted into the abdominal wall via subcutaneous injection by nurses or doctors.

Prostate Cancer

- Over 34,000 men in the UK alone are diagnosed with prostate cancer each year.[iii]

- Locally advanced prostate cancer accounts for 27 per cent[iv] of all new presentations of prostate cancer (when the cancer spreads from the capsule of the prostate gland into the surrounding tissues).

- Locally advanced is clinically defined by a Gleason Grade* equal or above 8, a Prostate-Specific Antigen (PSA)** equal or above 20, or the following tumour grading T1/T2 N+ Mo, T3/T4 N0/N+ M0).[v]

*Most common system used to assess on how the cancer cells look under a microscope and how aggressive the cancer cells are)

** Substance produced by both normal and cancerous prostate cells, which is measured using a blood test

References

[i] Bolla M, Collette L, Van Tienhoven G, et al. Ten year results of long term androgen deprivation with goserelin in patients with locally advanced prostate cancer treated with radiotherapy: A Phase III EORTC Study. I.J. Radiation Oncology 2008; 72 (1)

[ii] Goserelin (Zoladex) 3.6mg and LA 10.8mg SPC http://emc.medicines.org.uk

[iii] Prostate Cancer Research UK. Accessed September 2008 http://info.cancerresearchuk.org/cancerstats/types/prostate/incidence/?a=5441.

[iv] Data on File (DOF) ZOL/004/AUG2006

[v] MDT (Multi-disciplinary Team) Guidance for Managing Prostate Cancer. British Uro-Oncology Group. Nov 2000

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