NICE 2001/ 028
Issued: Monday 6th August 2001

Press Release

The National Institute for Clinical Excellence has today issued guidance to the NHS on the use of topotecan for the treatment of ovarian cancer. In summary, the guidance indicates that:

  • Topotecan should be considered as one of the treatment options for women with advanced ovarian cancer if first-line chemotherapy has not been successful.
  • Topotecan is not recommended for women who have an ECOG (Eastern Cooperative Oncology Group) score of 3 or below (see notes for editors for further details)
  • Topotecan is also not recommended for women who have an obstruction in their bowel which is caused by the cancer or who have already been treated with topotecan or another drug of the same type.
  • Only oncologists who specialise in the use of chemotherapy for the treatment of ovarian cancer should supervise the use of topotecan treatment.
  • A woman's response to treatment should be monitored carefully. If there is evidence that the cancer has progressed, then treatment with topotecan should be stopped. Also a reduction in the ECOG (described above) may also be a reason to stop treatment.

Professor Peter Littlejohns (NICE Clinical Director and Executive Lead for this appraisal) said, "Ovarian cancer is a common tumor, affecting 6000 women in England and Wales each year. For some of these women the cancer will return after their initial chemotherapy and at this stage of their disease the women and their doctors will consider the benefits of further treatment. Our guidance will help to inform their decision by carefully positioning topotecan as one treatment option."

Ends

Notes for Editors

Background

1. NICE has previously issued guidance on the use of Taxanes for Ovarian Cancer. (May 2001). This guidance recommended that:
 
  • Paclitaxel (Taxol) in combination with either cisplatin or carboplatin should be the standard initial therapy for patients with ovarian cancer following surgery. This means that patients with ovarian cancer should be offered paclitaxel (Taxol) combined with either cisplatin or carboplatin following their surgery.
  • If the patient's ovarian cancer re-occurs or is resistant to treatment and the patient has not previously received the combination of paclitaxel/platinum, then the combination treatment should be offered.
  • If the patient's ovarian cancer re-occurs or is resistant to treatment and the patient has previously received paclitaxel and a platinum therapy, then the combination treatment should not be used, unless it is part of a clinical trial.
2. Ovarian cancer is one of the more common cancers of women. The number of cases diagnosed each year in England and Wales is about 6,000.
   
3. The early stages of the disease often produce no symptom. Therefore most cases are not detected until they are advanced. The five-year survival rate for women diagnosed with ovarian cancer is only about 30%. About 4,500 women die each year of ovarian cancer in England and Wales.
   
4. Radiotherapy treatment for ovarian cancer is usually of limited effectiveness and has side-effects on organs within the abdominal cavity. First-line chemotherapy (given to over 75% patients with ovarian cancer) usually consists of paclitaxel and a platinum-based therapy (cisplatin or carboplatin). While most patients (70 to 80%) initially respond to such therapy, most responders eventually relapse (55 to 75% within 2 years). Responses can occur when first-line chemotherapy is repeated for a second and sometimes a third time, although they occur proportionately less frequently and do not last as long. (A complete response means that malignant disease is not detectable for at least four weeks. A partial response means that tumour size is reduced by at least 50% for more than four weeks.)
   
5. The ECOG scale is used by doctors to assess a patients overall health and ability:
   
  0 = fully active, the same as before having cancer
  1 = unable to do strenuous activities but still able to do tasks such as light housework or office work
  2 = able to walk and carry out self care (e.g. washing dressing) but not able to work
  3 = only able to carry out limited self care, mainly confined to bed
  4 = completely confined to bed and not able to carry out self care
   
The Technology
   
6. Topotecan (Hycamtin™, produced by GlaxoSmithKline) is derived from the oriental tree Camptotheca acuminata. It prevents DNA replication in cancer cells by inhibiting the enzyme topoisomerase I. Launched in 1997, it is licensed for use in ovarian cancer after the failure of first-line or subsequent therapy.
   
7. Topotecan is administered by a drip for periods of 30 minutes over five consecutive days, with a three-week interval between the start of each course. If well tolerated, treatment may continue until disease progression occurs.
   
Implications for the NHS
   
8. The drug cost of topotecan depends on both the number of five-day courses the patient undertakes and whether the complete contents of the 4 mg vial is used:
 
  • If only 2.7 mg of each 4 mg vial is used (the amount required for the average size patient), the cost of the recommended minimum four courses would be £6,250. The cost of 5.92 courses (the average for patients in a recent trial) would be £9,250.
  • If no wastage of the drug occurs, the cost of the recommended minimum four courses would fall to £4,220. The cost of 5.92 courses (the average for patients in a recent trial) would be £6,240.
9. Approximately 360 women in England and Wales already receive topotecan. It is assumed that, on the basis of this guidance, topotecan would be prescribed to an additional 1,500 women following the failure of platinum-based therapy. If the drug cost were about £4,500 per patient (based on the administration of four courses with some wastage) then the costs to the NHS are expected to be in the region of £7 million per annum.
   
General Information
   
10. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from 11am on Monday 6th August 2001.
   
11. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgment for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
   
12. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.
   
13. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
   
14. NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, NICE will produce audit tools for use in the clinical setting.