Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride and Topotecan for Second-Line or Subsequent Treatment of Advanced Ovarian Cancer (TA91)

Technology Appraisal Guidance No. 91

Source: National Institute for Health and Care Excellence

This guidance will replace the following guidance issued by the Institute:

  • Ovarian cancer - topotecan; Technology Appraisal Guidance no. 28 (2001)

  • Ovarian cancer (advanced) - pegylated liposomal doxorubicin hydrochloride; Technology Appraisal Guidance no. 45 (2002)

This guidance replaces recommendations 1.3, 1.4 and 1.5 on the second-line treatment of advanced ovarian cancer in the following guidance.

  • Ovarian cancer - paclitaxel (review); Technology Appraisal Guidance no. 55 (2003)

The recommendations for first-line therapy in Technology Appraisal Guidance no. 55 are not affected by this guidance.

The review has resulted in a number of changes in the nature of the recommendations from the original appraisal:

  • Topotecan is now only recommended for the treatment of women with platinum-refractory or platinum-resistant ovarian cancer if PLDH and paclitaxel are considered unsuitable.

  • Paclitaxel in combination with platinum-based therapy is now recommended as a treatment option for women whose disease relapses after 6 months of first-line platinum-based therapy.

  • Within these recommendations, women who have received paclitaxel as part of their first-line treatment may receive paclitaxel as part of their second-line (or subsequent) treatment.

  • PLDH is now recommended as a treatment option for women whose disease does not respond to, and those women whose disease relapses within 12 months from, initial platinum-based therapy.

1. Guidance

This guidance applies only to paclitaxel, pegylated liposomal doxorubicin hydrochloride (PLDH) and topotecan.

For the purposes of this guidance, the following definitions are used:

  • platinum-sensitive ovarian cancer: disease that responds to first-line platinum-based therapy but relapses 12 months or more after completion of initial platinum-based chemotherapy

  • partially platinum-sensitive ovarian cancer: disease that responds to first-line platinum-based therapy but relapses between 6 and 12 months after completion of initial platinum-based chemotherapy

  • platinum-resistant ovarian cancer: disease that relapses within 6 months of completion of initial platinum-based chemotherapy

  • platinum-refractory ovarian cancer: disease that does not respond to initial platinum-based chemotherapy.

1.1 Paclitaxel in combination with a platinum-based compound (carboplatin or cisplatin) is recommended as an option for the second-line (or subsequent) treatment of women with platinum-sensitive or partially platinum-sensitive advanced ovarian cancer, except in women who are allergic to platinum-based compounds.

1.2 Single-agent paclitaxel is recommended as an option for the second-line (or subsequent) treatment of women with platinum-refractory or platinum-resistant advanced ovarian cancer, and for women who are allergic to platinum-based compounds.

1.3 PLDH is recommended as an option for the second-line (or subsequent) treatment of women with partially platinum-sensitive, platinum-resistant or platinum-refractory advanced ovarian cancer, and for women who are allergic to platinum-based compounds.

1.4 Topotecan is recommended as an option for second-line (or subsequent) treatment only for those women with platinum-refractory or platinum-resistant advanced ovarian cancer, or those who are allergic to platinum-based compounds, for whom PLDH and single-agent paclitaxel are considered inappropriate.

1.5 Within these recommendations, the choice of treatment for second-line (or subsequent) chemotherapy should be made after discussion between the responsible clinician and the patient about the risks and benefits of the options.


The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://www.nice.org.uk/guidance/ta91

Copies of the document can also be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N0872. 

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. 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.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride and Topotecan for Second-Line or Subsequent Treatment of Advanced Ovarian Cancer.
Issue Date: May 2005
Review Date: February 2008


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