Guideline:Rituximab in chronic lymphocytic leukemia. Measure Summary

Chronic lymphocytic leukemia

Patients with chronic lymphocytic leukemia (CLL)

Literature Search Strategy

The MEDLINE (Ovid) (1966 to April Week 3 [April 23] 2009), EMBASE (Ovid) (1980 to Week 16 [April 23], 2009), and the Cochrane Library (2006 to 2009) databases were searched. The search strategies are available from the Cancer Care Ontario (CCO) practice guideline #6-8: Rituximab in Lymphoma and Chronic Lymphocytic Leukemia.

In addition, conference proceedings of the American Society of Hematology (ASH) (1998-2008) and the American Society of Clinical Oncology (ASCO) (1997 to 2009) were searched for abstracts of relevant trials. The Canadian Medical Association Infobase (http://mdm.ca/cpgsnew/cpgs/index.asp ), the National Guideline Clearinghouse (http://www.guideline.gov ), and the National Institute for Health and Clinical Excellence (http://www.nice.org.uk/ ) were also searched for existing evidence-based practice guidelines.

Relevant articles and abstracts were selected and reviewed by one reviewer, and the reference lists from these sources were searched for additional trials.

Study Selection Criteria

Inclusion Criteria

Articles were selected for inclusion in this systematic review of the evidence if they were published full report articles or published meeting abstracts involving:

1. Randomized controlled trials (RCTs), systematic reviews, meta-analyses, or evidence-based practice guidelines of patients with chronic lymphocytic leukemia (CLL)
2. Studies comparing rituximab, alone or in combination with other agents, to non-rituximab containing regimens
3. Studies evaluating any of the following outcomes: progression-free survival (PFS), overall survival (OS), time-to-progression, time-to-next treatment, complete response rate (CRR), overall response rate (ORR), time-to-response, duration of response, quality of life, or adverse events.

Exclusion Criteria

Studies were excluded if they were:

1. Letters, comments, books, notes, or editorial publication types.
2. Articles published in a language other than English, because of financial considerations for translation.
3. Studies of patients undergoing stem cell transplantation.
4. Studies with fewer than ten patients.

Three abstracts representing three unique randomized controlled trials (RCTs) met the eligibility criteria and were included.

Not applicable

Synthesizing the Evidence

Data appropriate for meta-analysis were not identified.

This advice report, produced by the Cancer Care Ontario (CCO) Program in Evidence-based Care (PEBC), is a convenient and up-to-date source of the best available evidence on the role of rituximab in the treatment of patients with chronic lymphocytic leukemia (CLL), developed through a systematic review of the available evidence.

The PEBC has a formal standardized process to ensure the currency of each clinical guidance report. This process consists of the periodic review and evaluation of the scientific literature and, where appropriate, integration of this literature with the original clinical guidance report information.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

Not stated

The following recommendations reflect the opinions of the authors of this special advice report:

• In patients with previously untreated chronic lymphocytic leukemia (CLL) who are being considered for fludarabine-based chemotherapy, it is recommended that this treatment be given in combination with rituximab.
• In patients with relapsed or refractory CLL who are being considered for fludarabine-based chemotherapy, it is recommended that this treatment be given in combination with rituximab.

None provided

The recommendations are supported by randomized controlled trials (RCTs).

Appropriate use of rituximab in combination therapy for patients with chronic lymphocytic leukemia (CLL) to improve response rate and disease control

An implementation strategy was not provided.

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

The Program in Evidence-based Care (PEBC) is a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

Cancer Care Ontario

Hematology Disease Site Group

For a current list of past and present members, please see the Cancer Care Ontario Web site .

The authors of this special advice report disclosed potential conflicts of interest relating to the topic of this special advice report. MC is a principal investigator on a study in which Roche provided the drugs. RT reported no conflicts of interest.

This is the current release of the guideline.

The SPECIAL ADVICE report over time will expand to contain new information emerging from their reviewing and updating activities.

Please visit the Cancer Care Ontario Web site  for details on any new evidence that has emerged and implications to the guidelines.

Electronic copies: Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site .

The following is available:

• Browman GP, Levine MN, Mohide EA, Hayward RSA, Pritchard KI, Gafni A, et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol 1995;13(2):502-12.

The following is available:

• Rituximab. Medication information sheet. Toronto (ON): Cancer Care Ontario (CCO); 2010 Jun. 2 p. Electronic copies: Available in Portable Document Format (PDF) from the CCO Web site . Also available in French from the CCO Web site .

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.

This summary was completed by ECRI Institute on December 2, 2010.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please refer to the Copyright and Disclaimer Statements  posted at the Program in Evidence-based Care section of the Cancer Care Ontario Web site.