Sarcoma

Issue date: February 2010 Review date: February 2013

Trabectedin for the treatment of advanced soft tissue sarcoma

NICE technology appraisal guidance 185

NICE technology appraisal guidance 185 Trabectedin for the treatment of advanced soft tissue sarcoma

Ordering information
You can download the following documents from www.nice.org.uk/guidance/TA185 The NICE guidance (thisdocument). A quick reference guide – the recommendations. ‘Understanding NICE guidance’ – a summary for patients and carers. Details of all the evidence that was looked at and other background information. For printed copies of the quick reference guide or ‘Understanding NICE guidance’, phone NICE publications on 0845 003 7783 or email publications@nice.org.uk and quote: N2104 (quick reference guide)N2105 (’Understanding NICE guidance’).

This guidance represents the view of NICE, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate tothe circumstances of the individual patient, in consultation with the patient and/or guardian or carer. Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard topromoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.

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© National Institute for Health and Clinical Excellence, 2010. All rights reserved. This material may be freely reproducedfor educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of NICE.

Contents
1 2 3 4 5 6 7 8 Guidance The technology The manufacturer’s submission Consideration of the evidence Implementation Recommendations for further research Related NICE guidance Review of guidance 4 4 5 15 2122 22 22 23 27

Appendix A: Appraisal Committee members and NICE project team Appendix B: Sources of evidence considered by the Committee

1
1.1

Guidance
Trabectedin is recommended as a treatment option for people with advanced soft tissue sarcoma if: treatment with anthracyclines and ifosfamide has failed or they are intolerant of or have contraindications for treatment withanthracyclines and ifosfamide and the acquisition cost of trabectedin for treatment needed after the fifth cycle is met by the manufacturer.

2
2.1

The technology
Trabectedin (Yondelis, PharmaMar) is an alkylating agent, which affects cancer cells by damaging DNA. Trabectedin has a UK marketing authorisation for the treatment of patients with advanced soft tissue sarcoma after failure ofanthracyclines and ifosfamide or who are unsuited to receive these agents. The marketing authorisation was granted under ‘exceptional circumstances’. The summary of product characteristics (SPC) states that ‘efficacy data are based mainly on liposarcoma and leiomyosarcoma patients’.

2.2

Trabectedin is contraindicated in people who have hypersensitivity to trabectedin or to any of the excipients, inthose with concurrent serious or uncontrolled infection, in women who are breast-feeding, and in combination with yellow fever vaccine. The SPC states that trabectedin is not indicated for use in children and adolescents, and that creatine phosphokinase, hepatic function and haematological parameters should be monitored regularly during treatment. The SPC lists precautions for use of trabectedin in...