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| |  Zoladex Improves Survival In Advanced Prostate Cancer SAN ANTONIO, TX -- November 1, 1999 -- Hormonal therapy with Zoladex® (goserelin acetate implant), a product of AstraZeneca, in patients with locally advanced prostate cancer has been shown to significantly increase the overall survival rates, when administered as adjuvant therapy at the onset of conventional external irradiation and continuing for three years.(1) With a median follow-up of 61 months, overall survival rates for Zoladex with radiotherapy were significantly increased from 62 percent to 78 percent and disease-free survival rates were increased from 40 percent to 75 percent, when compared to the radiotherapy alone group. The study was conducted by the European Organization for Research and Treatment of Cancer (EORTC) Radiotherapy Cooperative Group. Results from this study were presented today, at the American Society for Therapeutic Radiology and Oncology (ASTRO) annual meeting in San Antonio, Texas. "The results from this study should change the way that prostate cancer is treated," said Michel Bolla, MD, Head of Radiotherapy at the Hopital Albert Michallon, France and President of the radiotherapy group of the EORTC. "Prostate cancer is the second leading cause of cancer death among men, after lung cancer. The addition of Zoladex to standard radiotherapy for locally advanced prostate cancer significantly improved survival rates of patients and could save lives. While many clinicians already combine these two treatment options for locally advanced prostate cancer, these data confirm the value of this approach as routine."
Study Methods In the period 1987-1995, 415 patients under the age of 81 (median age 71), with locally advanced prostate cancer, were randomly allocated between the two arms of the study. All patients received standard pelvic radiotherapy at the start of the trial, but half of the patients also received a monthly subcutaneous injection of Zoladex 3.6-mg, which started on the first day of radiation and continued for a period of 3 years. Patients in the combined-treatment group also received 150-mg per day of cyproterone acetate for 1 full month, starting 1 week before the first injection of Zoladex.
Study Results Hormonal treatment with Zoladex significantly improved the 5-year overall survival from 62 percent to 78 percent (p less than 0.001). Clinical disease-free survival was also significantly increased from 40 percent to 75 percent (p less than 0.001) and local control over the 5 year period was significantly increased from 79 percent to 97 percent (p<0.001).
Prostate Cancer Prostate cancer affects one in eight American men(2). It is the second most frequently occurring malignancy in American men, after skin cancer(3), and represents one-quarter of all newly diagnosed cancer cases(3). Every three minutes a man is diagnosed with prostate cancer(2). It is the second leading cause of cancer death among men after lung cancer(4). In 1999, the American Cancer Society estimates 179,300 new cases in the US(4). Zoladex is a luteinizing hormone-releasing hormone analog, or LHRH-A. Zoladex suppresses hormonal signals from the brain that tell the testicles to produce testosterone. When testosterone production is reduced, the prostate cancer cells may stop growing. The drug is administered by simple injection as two formulations, either 3.6-mg depot, which is administered every 28 days, or 10.8-mg depot, which is administered every 12 weeks. Zoladex is indicated in the palliative treatment of advanced carcinoma of the prostate. It is the only LHRH-A indicated for use in combination with flutamide for the management of locally confined T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with Zoladex and flutamide should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. The most frequently reported side effects are hot flashes, unspecified cancer-related pain, impotence, lower urinary tract symptoms, and spinal cord compression, which generally subside when treatment is stopped. Periodic liver function tests should be considered for patients on long-term therapy.
References: (1) Bolla M, Collette L, Gonzalez D, Warde P, Dubois JB, Mirimanoff R, Storme G, Bernier J, Kuten A, Plerart M. Long term results of immediate adjuvant hormonal therapy with goserelin in patients with locally advanced prostate cancer treated with radiotherapy. A phase III EORTC study. Abstract presented at: ASTRO, November 1999; San Antonio, Texas. (2) The ABC’s of Prostate Cancer, Joseph E. Oesterling, MD; Mark A. Moyad, MPH. (3) CaP Cure (Association for the Cure of Cancer of the Prostate). Accessed 8/16/99. (4) American Cancer Society; Cancer Facts & Figures ? 1999; Special Section: Prostate Cancer. (5) IMS Health, Inc.; GERS (France).
Related Links: Zoladex® (goserelin acetate implant) and AstraZeneca.
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