London, 12 December 2006 -- Eighty-four percent of GPs and 76 percent of specialists (uro-oncologists or urologists) agree that there is a significant legal risk associated with off-label prescribing in prostate cancer when there is a licensed alternative available, according to new survey data released today.[1] Despite this, 46 percent of specialists felt that primary care commonly changes the recommended Leutinising Hormone-Replacement Hormone agonist (LHRHa) when referring management of patients to the community.
The Need for a Data Driven Solution
The data show that nearly all (92 percent) specialists, GPs, oncology pharmacists and specialist urology nurses surveyed agree that patients should receive an LHRHa with supporting clinical evidence wherever possible. Zoladex (goserelin) is licensed for all stages of prostate cancer suitable for hormonal manipulation.[2] Also, it is the only LHRHa with a proven survival benefit in adjuvant treatment in high risk localised disease and in adjuvant treatment of locally advanced prostate cancer when compared to surgery or radiotherapy alone.[3],[4],[5] However, when asked to differentiate between goserelin and another LHRHa not licensed for all stages of prostate cancer suitable for hormone manipulation, 75 percent of GPs and 42 percent of specialists felt in their view that the clinical evidence was the same.
Commenting on the data, Dr Heather Payne, Consultant Clinical Oncologist in Urological Tumours, University College Hospital, London stated: "Prostate cancer is a complicated disease and can be treated in several different ways. Depending on the stage of the cancer, a clear understanding of the supporting clinical evidence for treatments should guide prescribing decisions. As healthcare professionals, we need to provide patients with the best evidence-based treatment and care at all times."
Secondary and Primary Care Divide
Although 76 percent of GPs and 94 percent of specialists agree that prescribing decisions in prostate cancer should be left to specialist care, only 46 percent of specialists always recommend an LHRHa by specific molecule name and dose. In addition, only 24 percent of GPs would actually consult the specialist for further advice when they receive a referral / recommendation that indicate an LHRHa class only, indicating a need for improved communication between primary and secondary care in the management of patients with prostate cancer.
Although, only 38 percent of GPs said they would be confident in identifying the different stages of prostate cancer more than half (59 percent) said they felt comfortable prescribing LHRHa’s for patients with prostate cancer, even though not all LHRHa’s are licensed for all stages of prostate cancer.[6],[7],[8],[9],[10] Goserelin is the only LHRHa with the supporting clinical evidence and licensed indications for all stages of prostate cancer suitable for hormone manipulation.2 The data show more awareness of LHRHa clinical evidence and treatment licences is needed amongst healthcare professionals managing ongoing LHRHa treatment.
Continuity and consistency of prescribing in prostate cancer is important to maintain patient confidence and reduce patient anxiety with more than 73 percent of specialists, GPs, oncology pharmacists and specialist uro-oncology nurses agreed that changing the LHRHa in primary care from that referred / recommended in secondary care can be unsettling for patients. Although off-label prescribing is vital in some situations, the GMC requires that patients be informed when an unlicensed product is prescribed.[11] Dr. Payne additionally commented: "Results show that even though healthcare professionals agree that changing the LHRHa treatment could be unsettling for patients, it may occur in practice without informing the patient. It is clear from the data that we need to improve communication between secondary and primary care to ensure patients receive the most appropriate treatment at the right time. In this way, we can avoid unnecessarily unsettling the patient’s treatment routine."
EMBARGO: Tuesday 12 December 2006, 18:30 GMT
Notes to Editors:
- Prostate cancer is the most common form of cancer in men in the UK with over 31,923 new cases diagnosed in 2002.[12] Off-label prescribing’ refers to any prescription that is not within the strict terms approved by the Medicines and Healthcare Product Regulatory Agency (MHRA), which are based on the quality, safety and efficacy of the product.
- When the prostate cancer is confined to the area surrounding the original tumour, it is described as being ‘localised disease’.
- When the prostate cancer has spread into the capsule of the prostate or through the prostate into the surrounding tissue, it is described as being ‘locally advanced’.
- Goserelin, first introduced in 1987 in the UK, is a Luteinising Hormone-Releasing Hormone agonist (LHRHa) which reduces levels of sex hormones (testosterone in men and oestradiol in women) and is used in the treatment of prostate cancer in men and hormone-dependent breast cancer in pre- and peri-menopausal women.
- LHRHa’s work in prostate cancer by providing ‘medical castration’ as opposed to surgical castration (orchidectomy). This avoids the physical and psychological morbidity associated with surgical castration.
About AstraZeneca:
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
‘Zoladex’ is a trademark of the AstraZeneca group of companies.
UK Media Queries Telephone
Ashley Lilly, Hill & Knowlton 020 7973 4457
Isabelle Jouin, AstraZeneca UK 01582 836 000
References
- LHRHa Prostate Cancer Prescribing Survey: Conducted in November 2006 by red kite for AstraZeneca UK Ltd.. Results on file
- Zoladex SmPC
- Pilepich MV, Winter K, Lawton C et al. Androgen suppression adjuvant to definitive radiotherapy in carcinoma of the prostate. International Journal of Radiation Oncology, Biology, Physics 2005; vol 61, No5, 1285-1290
- Bolla M, Collette L, Blank L, et al. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet 2002; 360(9327):103-108
- Messing EM, Manola J, Sarosdy M et al. Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. LancetOncol. 2006 Jun ;7 (6): 472-9.
- Prostap SR SPC
- Decapeptyl SR 3mg SPC
- Prostap 3 SPC
- Decapeptyl SR 11.25mg
- Gonapeptyl SmPC
- General Medical Council (GMC) 2005. Good practice in prescribing medicines. London: General Medical Council)
- Cancer Research UK. Incidence Statistics for Males 2002. http://www.cancerresearch uk.org/cancerstats/incidence/males