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Brief Summary

GUIDELINE TITLE

Rituximab for aggressive non-Hodgkin’s lymphoma.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Rituximab for aggressive non-Hodgkin's lymphoma. London (UK): National Institute for Clinical Excellence (NICE); 2003 Sep. 22 p. (Technology appraisal; no. 65).

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • September 11, 2008, Rituxan (Rituximab): Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • Rituximab is recommended for use in combination with a regimen of cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) for the first-line treatment of people with CD20-positive diffuse large-B-cell lymphoma at clinical stage II, III or IV (see Section 2.3 of the original guideline document). Rituximab is not recommended for use when CHOP is contraindicated.
  • The clinical and cost effectiveness of rituximab in patients with localised disease (Stage I, see Section 2.3 of the original guideline document) has not been established. It is recommended that rituximab be used in these circumstances only as part of ongoing or new clinical studies.
  • A specialist in the treatment of lymphomas should supervise the use of rituximab in combination with CHOP for the treatment of diffuse large-B-cell lymphoma.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations for clinical effectiveness are based on one randomised controlled trial.

For cost effectiveness, the Assessment Group developed its own economic model and considered an economic evaluation supplied by the manufacturer.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Clinical Excellence (NICE). Rituximab for aggressive non-Hodgkin's lymphoma. London (UK): National Institute for Clinical Excellence (NICE); 2003 Sep. 22 p. (Technology appraisal; no. 65).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2003 Sep

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Professor Ron Akehurst, Dean, School of Health Related Research, University of Sheffield; Dr Tom Aslan, General Practitioner, Stockwell, London; Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester; Dr Sheila Bird, MRC Biostatistics Unit, Cambridge; Dr Richard Cookson, Senior Lecturer, Health Economics, School of Health Policy and Practice, University of East Anglia, Norwich; Professor Gary A Ford, Professor of Pharmacology of Old Age/Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust; Ms Bethan George, Interface Liaison Pharmacist, Tower Hamlets PCT and Royal London Hospital, Whitechapel; Dr Trevor Gibbs, Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline, Greenford; Mr John Goulston, Director of Finance, St Bartholomew's Hospital and the London NHS Trust; Mr Muntzer Mughal, Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust, Chorley; Ms Judith Paget, Chief Executive, Caerphilly Local Health Board, Torfaen; Mrs Kathryn Roberts, Nurse Practitioner, Hyde, Cheshire; Professor Philip Routledge, Professor of Clinical Pharmacology, College of Medicine, University of Wales, Cardiff; Ms Anne Smith, Lay Representative; Trustee, Long-Term Medical Conditions Alliance; Professor Andrew Stevens (Vice-Chair) Professor of Public Health, University of Birmingham; Dr Cathryn Thomas, General Practitioner/Senior Lecturer, Department of Primary Care and General Practice, University of Birmingham; Dr Norman Vetter, Reader, Department of Epidemiology, Statistics and Public Health, College of Medicine, University of Wales, Cardiff; Dr David Winfield, Consultant Haematologist, Royal Hallamshire Hospital, Sheffield

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N0285. 11 Strand, London, WC2N 5HR.

PATIENT RESOURCES

The following is available:

  • Rituximab for aggressive non-Hodgkin's lymphoma. Understanding NICE guidance--information for people with non-Hodgkin's lymphoma, and the public. London (UK): National Institute for Health and Clinical Excellence (NICE); 2003 Sep. 10 p. (Technology appraisal 65).

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the Department of Health Publications Order Line 0870 1555 455. ref: N0286. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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