CAELYX FOR OVARIAN CANCER

A rapid and systematic review of the clinical effectiveness and cost effectiveness of pegylated liposomal doxorubicin hydrochloride for ovarian cancer

Background

Ovarian cancer is the most common gynaecological cancer with an annual incidence of 21.6 per 100,000 in England and Wales. As the early stages of ovarian cancer are often asymptomatic, most cases are not detected until the advanced stages. Consequently, prognosis after diagnosis is poor with 5-year survival in the UK of only about 30%. Paclitaxel and platinum-based (cisplatin/carboplatin) therapy are currently recommended as first-line chemotherapy for ovarian cancer. However, most patients develop resistant or refractory disease eventually requiring second-line therapy. Patients may respond to re-challenge with platinum agents if the treatment-free interval is > 6 months, but an alternative is often required. Topotecan has recently been recommended as one agent to be considered for second-line therapy, and pegylated liposomal doxorubicin hydrochloride is one of three other drugs currently licensed in the UK for use in second-line therapy.

The aim of this review was to examine the clinical effectiveness and cost-effectiveness of intravenous pegylated liposomal doxorubicin hydrochloride as second-line treatment for advanced ovarian cancer after failure of first-line platinum-based therapy.

Findings

The main results of this review suggested that there is little RCT evidence for assessment of the effectiveness of pegylated liposomal doxorubicin hydrochloride as second-line therapy for advanced ovarian cancer. Data from only one RCT was included in the final assessment of clinical effectiveness, and only two economic evaluations relevant to the UK NHS were identified and included in the cost-effectiveness assessment.

The evidence suggested that there were no differences between pegylated liposomal doxorubicin hydrochloride and topotecan in the main clinical outcomes. However, significant differences were observed in the incidence of adverse events. The clinical significance of these findings was not discussed. Overall, the clinical effects of pegylated liposomal doxorubicin hydrochloride could at best be described as modest, however, the only other comparator considered in this review offered no real advantages. If anything, pegylated liposomal doxorubicin hydrochloride offered possible clinical advantages over topotecan due to fewer adverse events.

Based on existing data, pegylated liposomal doxorubicin hydrochloride is less costly than topotecan. When effectiveness was based on survival duration, pegylated liposomal doxorubicin hydrochloride had a high probability of being cost-effective. However, differences between the two therapies are likely to exist in overall HRQoL, which, when expressed in terms of QALYs, could alter these cost-effectiveness results markedly.

Conducted by: C Forbes1, J Wilby1, G Richardson2, M Sculpher2, L Mather1, R Riemsma1

1. NHS Centre for Reviews and Dissemination; 2. Centre for Health Economics

Further details

Project page on HTA Programme website

Related guidance

Commissioned to inform NICE Technology Appraisal 45: Topotecan, pegylated liposomal doxorubicin hydrochloride and paclitaxel for the treatment of advanced ovarian cancer. London: National Institute for Clinical Excellence; 2002

Publications

Forbes C, Wilby J, Richardson G, M Sculpher, Mather L, Riemsma R. A systematic review and economic evaluation of pegylated liposomal doxorubicin hydrochloride for ovarian cancer. Health Technol Assess. 2001;6(23)

Funding

Commissioned by the HTA Programme on behalf of NICE