Topotecan As 1st-Line Ovarian Cancer Drug

SmithKline Beecham is starting a major trial of its topoisomerase I inhibitor Hycamtin (topotecan), in combination with cisplatin, for the first-line treatment of ovarian cancer. The drug is currently in the latter stages of clinical development in the USA and Europe as a second-line drug for ovarian and non-small cell lung cancers.

The new protocol will compare topotecan with Bristol-Myers Squibb's Taxol (paclitaxel) when both agents are used in combination with cisplatin. This comparison will be made because current data suggests that cisplatin/paclitaxel is the best regimen to date.

The decision to move onto a first-line study was taken on the basis of encouraging data from Phase II and III second-line studies, according to Colin Broom, head of clinical development for oncology at SB. An open-label Phase III study comparing topotecan with paclitaxel as single-agent therapy for ovarian cancer has yielded some interim data, according to Dr Broom, although he cautioned that this had yet to be checked by the independent review body. Study 039 completed enrollment in January 1995 and has revealed an overall response to topotecan of 45%.