UPDATE - Issue 18 - Summer 2004
New drug gives new hope
Men with refractory prostate cancer will soon have the opportunity to live for longer and with a better quality of life, according to new data presented on the chemotherapy Taxotere® (docetaxel) at the June meeting of the American Society of Clinical Oncology.
Two large-scale international trials involving 1,776 men with advanced metastatic prostate cancer demonstrated that docetaxel significantly reduced the risk of death by 24 percent and increased overall survival by 20 percent for men with hormone-refractory prostate cancer. This is the very first time that a chemotherapy treatment has been proven to improve survival in advanced prostate cancer patients.
The standard treatment for advanced or metastatic prostate cancer is currently hormone therapy. While decreasing the levels of testosterone in the body causes the tumours to shrink in 85-90 percent of patients, eventually the prostate cancer often escapes hormonal control and starts to grow again. At this stage of the illness the cancer is called hormone-refractory prostate cancer (HRPC).
There are few treatment options available for HRPC. Current treatments, including chemotherapy such as mitoxantrone, manage symptoms of the disease, particularly pain. Now there is mounting evidence to suggest that a certain type of chemotherapy treatment can improve life expectancy.
Commenting on the significance of the clinical trial data, Professor Nick James, Professor of Clinical Oncology at the University of Birmingham, and project leader for the UK centres involved in the docetaxel trial in HRPC, said 'The results of these trials are a significant milestone in the treatment of hormone-refractory prostate cancer. Until now, treatment was aimed at maintaining quality of life but there was little we could do to improve survival or reverse, even temporarily, the progress of the disease, which is frustrating and distressing for the patient, their families and for us as their doctors. Now there is evidence that these patients can be helped to live longer and at the same time have a better quality of life. In other words improved survival is not "bought" at the expense of excessive toxicity. Even though around three months may not seem a very long time to the healthy man on the street, to these patients it means everything - especially because the quality of their life is also improved on Taxotere'.
| View from the front of a patient's chest before treatment (left) with docetaxel and after (right). Some of the dark spots on various ribs and the lower spine indicating cancer sites are much reduced in the after picture. | |
About Taxotere
Manufactured by Aventis, the chemotherapy agent docetaxel is already licensed and commonly used to treat patients with locally advanced or metastatic breast and lung cancers (non-small cell). Research is ongoing in a number of types of cancer and in addition to early and advanced breast, lung and prostate cancer is also being conducted into its use in patients with head and neck, gastric and ovarian cancers.
Docetaxel is not yet licensed for the treatment of HRPC in the UK and the rest of Europe, but it has already been approved, in June of this year, for use in the United States. In the USA its approval was fast-tracked and took a record 113 days from submission to the FDA, which confirms the significance of the evidence from these new studies and the potential benefits docetaxel can possibly offer men with HRPC.
In terms of UK and European approval for docetaxel's use in HRPC, a decision is pending with the European Medicines Evaluation Agency following a submission in February this year. The decision process usually takes a year following submission.
On a positive note, the Department of Health has announced that docetaxel will be reviewed, as soon as it is licensed in the UK, by the National Institute for Clinical Excellence (NICE). NICE was established to provide patients and health professionals with guidance on current 'best practice'. Should the NICE review result in a positive opinion for docetaxel, the NHS would be required to make Taxotere freely available throughout England and Wales to all HRPC patients where appropriate.