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ASCO updates guidelines on hematopoietic colony-stimulating factors
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ASCO has updated its clinical practice guidelines regarding the use of hematopoietic colony-stimulating factors to lower the risk for febrile neutropenia associated with certain chemotherapy regimens.
Hematopoietic colony-stimulating factors (CSFs) — also known as white blood cell growth factors — reduce the duration and severity of neutropenia, as well as the risk for febrile neutropenia, enabling the use of more intensive or dose-dense chemotherapy, according to background information provided in the guideline. ASCO developed a clinical practice guideline for the use of CSFs — last updated in 2006 — due to concerns about adverse events and costs.
Thomas J. Smith, MD, professor of oncology and director of palliative medicine at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and James O. Armitage, MD, professor of internal medicine at the University of Nebraska Medical Center, co-chaired the ASCO Update Committee to incorporate relevant new literature in the guideline. The panel conducted a systemic literature review of relevant texts published between October 2005 and September 2014.
Thomas J. Smith
The primary changes to the guideline include the addition of tbo-filgrastim (Granix, Teva Oncology) and filgrastim-sndz (Zarxio; Sandoz, Novartis), a moderation of the recommendation regarding the routine use of CSFs in older patients with diffuse aggressive lymphoma, and the addition of recommendations against routine dose-density chemotherapy in lymphoma and for high–dose-density chemotherapy in urothelial cancer.
Other strong recommendations in the guideline include:
- The administration of primary prophylaxis with CSFs beginning with the first cycle of chemotherapy and continuing through subsequent cycles is recommended for patients with solid tumors or lymphoma who have an approximately 20% or greater risk for febrile neutropenia based on patient-, disease- or treatment-related characteristics. Primary CSF prophylaxis should be administered in patients receiving dose-dense chemotherapy when appropriate; however, alternative regimens should be considered for chemotherapy regimens not requiring CSF support.
- Secondary prophylaxis with CSFs is recommended for patients who experienced a neutropenic complication from prior chemotherapy and for whom a reduced dose may worsen DFS, OS or treatment outcomes.
- CSFs should not be routinely administered in patients with afebrile neutropenia or as an adjunctive treatment with antibiotic therapy for patients with fever and neutropenia. However, CSFs should be considered for patients with fever and neutropenia who face a high risk for infection-related complications or prognostic factors that suggest poor clinical outcomes.
- Dose-dense regimens with CSF support should only be used when supported by convincing efficacy data or within the confines of a clinical trial. The data are insufficient at this time to recommend for dose-dense regimens with CSF support for non-Hodgkin’s lymphoma.
- CSFs are appropriate after autologous stem cell transplantation.
- For the treatment of pediatric patients, the same considerations should be taken as with adult patients. CSFs should be administered in pediatric patients who have a high risk for febrile neutropenia and for patients with diseases for which dose-intense chemotherapy yields a known survival benefit, such as Ewing’s sarcoma.
- Pegfilgrastim (Neulasta; Amgen), filgrastim (Neupogen; Amgen), tbo-filgrastim and filgrastim-sndz — and other biosimilars, as they become available — should be considered for use to prevent treatment-related febrile neutropenia.
The panel also issued a moderate recommendation that CSFs not be given to pediatric patients with non-relapsed acute lymphoblastic lymphoma or acute myeloid leukemia unless an infection is present.
“The 2015 Update Committee has recognized, again, that these are expensive agents with the potential for overuse,” Smith and colleagues concluded. “As stated, when alternative regimens are available that offer equivalent efficacy without the need for CSF support, these alternative regimens should be used.” – by Cameron Kelsall
Disclosure: Smith reports stock ownership in United Healthcare. Armitage reports a leadership role with Tesaro Bio and consultant roles with Celgene, Conatus IDMC, GlaxoSmithKline, Roche, Spectrum Pharmaceuticals and ZIOPHARM Oncology. Please see the full article for a list of all other authors’ relevant financial disclosures.
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