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Brief Summary

GUIDELINE TITLE

The use of chemotherapy and growth factors in older patients with newly diagnosed, advanced-stage, aggressive histology non-Hodgkin's lymphoma.

BIBLIOGRAPHIC SOURCE(S)

  • Hematology Disease Site Group. The use of chemotherapy and growth factors in older patients with newly diagnosed, advanced-stage, aggressive histology non-Hodgkin's lymphoma [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Jun 25. 28 p. (Practice guideline; no. 6-7). [75 references]

GUIDELINE STATUS

** 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.
  • January 24, 2008, Leukine (sargramostim): Voluntary market suspension of the current liquid formulation of sargramostim, a granulocyte-macrophage colony-stimulating factor (GM-CSF), because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting). The lyophilized form of the drug is not affected. See the U.S. Food and Drug Administration (FDA) web site for more information.

BRIEF SUMMARY CONTENT

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

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • Combination chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) is recommended for patients with no apparent cardiac disease or significant comorbidity. Dose and schedule should be the same as that used in younger patients.
  • The addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) is recommended for patients with diffuse large B-cell lymphoma.
  • There is insufficient evidence to support the routine use of granulocyte colony-stimulating factor as primary therapy.
    • While use of granulocyte colony-stimulating factor shortens the duration of neutropenia and decreases the infection rate in these patients, no differences in disease control or survival have been detected.
    • The primary use of granulocyte colony-stimulating factor is recommended for older patients who are at a particularly high risk of experiencing neutropenic fever. These patients are best identified as those with a poor performance status (Eastern Cooperative Oncology Group [ECOG] 2 or greater), neutropenia prior to therapy, or an ongoing infection; there are insufficient data to recommend the primary use of granulocyte colony-stimulating factor for patients whose sole risk factor is bone marrow involvement with lymphoma.
    • The use of granulocyte colony-stimulating factor as secondary prophylaxis is recommended for patients who have previously experienced an episode of neutropenic fever or a treatment delay resulting from persisting neutropenia.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

Including the updated searches, 23 publications (13 full papers, 10 abstracts) met the eligibility criteria for chemotherapy trials and were reviewed. Two systematic reviews were also found, one of which represents a portion of this document published as a systematic review.

Quality Assessment Scores

Of the 23 studies assessing the role of chemotherapy (see Table 2 in the original guideline document), three scored 3 on the Jadad quality scale, ten scored 2, and ten scored 1. The studies assessing the use of colony-stimulating factors scored 2 points and 1 point. One study assessing the role of rituximab scored 2 points.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Hematology Disease Site Group. The use of chemotherapy and growth factors in older patients with newly diagnosed, advanced-stage, aggressive histology non-Hodgkin's lymphoma [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Jun 25. 28 p. (Practice guideline; no. 6-7). [75 references]

ADAPTATION

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

DATE RELEASED

2003 Jun 25

GUIDELINE DEVELOPER(S)

Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]

GUIDELINE DEVELOPER COMMENT

The Practice Guidelines Initiative (PGI) is the main project of the Program in Evidence-based Care (PEBC), a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

SOURCE(S) OF FUNDING

Cancer Care Ontario, Ontario Ministry of Health and Long-Term Care

GUIDELINE COMMITTEE

Provincial Hematology Disease Site Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Members of the Hematology Disease Site Group (DSG) disclosed potential conflict of interest information.

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on January 23, 2004. The information was verified by the guideline developer as of February 23, 2004. This summary was updated by ECRI on January 12, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Rituxan (Rituximab). This summary was updated by ECRI Institute on February 26, 2008 following the U.S. Food and Drug Administration advisory/voluntary market withdrawal of the liquid formulation of Leukine (sargramostim). This summary was updated by ECRI Institute on October 8, 2008 following the U.S. Food and Drug Administration advisory on Rituxan (rituximab).

COPYRIGHT STATEMENT

DISCLAIMER

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