News: NICE endorses topotecan as second-line treatment for ovarian cancer

The Pharmaceutical Journal Vol 267 No 7160 p181-186
11 August 2001

NICE endorses topotecan as second-line treatment for ovarian cancer

The National Institute for Clinical Excellence (NICE) has endorsed the use of topotecan (Hycamtin) as a second-line treatment for ovarian cancer in England and Wales.

In guidance issued this week, the NICE says 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 prevents DNA replication in cancer cells by inhibiting the enzyme topoisomerase I.

The NICE issued guidance on the use of taxanes for ovarian cancer in May 2000. It recommended that standard initial therapy after surgery should be paclitaxel in combination with cisplatin or carboplatin. The NICE says that this combination is given to over 75 per cent of patients and that 70 to 80 per cent of them respond. However, 55 to 75 per cent of responders relapse within two years. Repeated first-line chemotherapy is successful in some patients but others will need a second-line treatment.

Six drugs are licensed in the United Kingdom for second-line treatment. While the NICE only formally appraised topotecan, it says that the effectiveness of chlorambucil and treosulfan has not been proven. In addition, while response rates are similar for paclitaxel, caelyx, topotecan, hexamethylmelamine, treosulfan and etoposide, it notes that toxicity may be a problem with hexamethylmelamine, treosulfan and etoposide.

A spokeswoman for Cancer BACUP told The Journal on 8 August that implementation of the guidance is key. In November, 2000, Cancer BACUP conducted a survey to investigate how many health authorities were offering taxanes in accordance with the NICE guidance. It found that 86 per cent of health authorities had made funds available so that women with ovarian cancer could be offered treatment with paclitaxel. The spokeswoman stressed the importance of transparency so that the public could see whether or not NICE guidance had been implemented by health authorities.

The NICE guidance says: “In terms of clinical effectiveness, topotecan appears to be equivalent to paclitaxel. Since it is of similar cost, it is therefore appropriate that topotecan is made available for second-line treatment now that paclitaxel is indicated for first-line treatment.” Topotecan is not recommended for all women including those with a bowel obstruction caused by cancer. In addition, it is not recommended for women who have previously been treated with topotecan or another drug in the same class.

In England and Wales, 6,000 cases of ovarian cancer are diagnosed each year. Most are not diagnosed until they are advanced, and the five-year survival rate for ovarian cancer is about 30 per cent.

The NICE estimates that the cost to the National Health Service of implementing the guidance will be £7m per annum. It bases its cost on £4,500 per patient, which is four courses of treatment and allows for some wastage. Approximately 360 women in England and Wales currently receive topotecan and the NICE expects that it will be given to a further 1,500 women.

The NICE guidance, which will be reviewed in June 2002, is available on its website (www.nice.org.uk).