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Health Canada-Approved Treatment Reduces Potentially Fatal Chemotherapy Side-Effect by as Much as 94%

New product monograph for NeulastaŽ incorporates important new data for breast cancer patients

MISSISSAUGA, CANADA -- September 13, 2006 -- Results from a study on the early administration of NeulastaŽ (pegfilgrastim) in breast cancer patients receiving chemotherapy are now part of a new, Health Canada-approved, product monograph.

The data, published in the Journal of Clinical Oncology in early 2005, supports the early administration of NeulastaŽ in the first and all subsequent cycles of a moderately myelosuppressive chemotherapy regimen.[i] The study demonstrates the strong positive impact of first cycle protection with NeulastaŽ to reduce febrile neutropenia in breast cancer patients.[ii] Febrile neutropenia (FN) is a condition that puts patients at increased risk of infection.

In the latest edition of the Journal of Clinical Oncology, the American Society for Clinical Oncology (ASCO) updated its guidelines on the use of hematopoietic colony-stimulating factors (CSF) to reflect the conclusions of the study. The 2005 Update Committee agreed unanimously that "reduction in febrile neutropenia is an important clinical outcome that justifies the use of CSFs when the risk of FN is approximately 20 per cent and no other equally effective regimen that does not require CSFs, is available."[iii]

"Febrile neutropenia is a common and potentially deadly side-effect of anti-cancer drugs. It poses a serious threat to the lives of our patients and to our ability to administer chemotherapy on time and at the optimal dose. It leads in most cases to hospitalisations that further reduce our patients' quality of life. It is therefore important to evaluate the risk of febrile neutropenia related each chemotherapy protocol and consider an early intervention approach to prevent this complication when this is justified," said Dr. Normand Blais, hematologist and medical oncologist at the CHUM.

Expanded Options Reduce Risk
Prevention of febrile neutropenia reduces the need for hospitalization, the use of intravenous anti-infective medications and interruptions in cancer treatment.[iv],[v] Previously first cycle protection with NeulastaŽ was considered for patients receiving highly myelosuppressive chemotherapy with a 40 per cent risk of developing febrile neutropenia. First cycle protection with NeulastaŽ should now be considered for patients receiving moderately myelosuppressive chemotherapy with more than a 20 per cent[vi] risk of developing febrile neutropenia. The expanded treatment option means incidence of febrile neutropenia can be reduced from an average of 46 per cent to as much as 94 per cent with some chemotherapy treatments.[vii],[viii]

A Dangerous Side-Effect to Chemotherapy
Myelosuppressive chemotherapy is lethal to the bone marrow where red blood cells, white blood cells and platelets are produced.[ix] In addition to killing cancer cells, chemotherapy can also kill healthy cells in the body. These include white blood cells, the body's defense mechanism against infection. When a large number of a chemotherapy patient's white blood cells are destroyed, the patient may develop neutropenia. Febrile neutropenia is a combination of a low white blood cell count and a fever higher than 38°C.[x] It may prevent chemotherapy patients from receiving their cancer-fighting treatment at the appropriate dose and time.[xi] These delays may compromise treatment outcomes.[xii]

About NeulastaŽ
NeulastaŽ is a white blood cell growth factor. It works by stimulating the production of infection-fighting white blood cells (neutrophils) that are destroyed by chemotherapy. In Canada, NeulastaŽ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.2

The recommended dosage of NeulastaŽ is a single subcutaneous injection of 6mg, administered once per cycle of chemotherapy. NeulastaŽ should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy.2

Important Safety Information
Although the most common reported adverse effects reported were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, rare cases of splenic rupture and sickle cell crises have been reported in post-marketing experience. Allergic reactions, including anaphylaxis and acute respiratory distress syndrome, have also been reported. 2

REFERENCES:
[i] Vogel CL, et al. First and Subsequent Cycle Use of Pegfilgrastim Prevents Febrile Neutropenia in Patients With Breast Cancer: A Multicenter, Double-Blind, Placebo-Controlled Phase III Study. J Clinical Oncology 23: 1178-1184.
[ii] NeulastaŽ (pegfilgrastim). Health Canada approved product monograph [prescribing information]. Amgen; 2006.
[iii] Thomas J. Smith et al., 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline. J Clinical Oncology 24, Number 19, July 1, 2006.
[iv] Vogel CL, et al. First and Subsequent Cycle Use of Pegfilgrastim Prevents Febrile Neutropenia in Patients With Breast Cancer: A Multicenter, Double-Blind, Placebo-Controlled Phase III Study. J Clinical Oncology 23: 1178-1184.
[v] Crawford J, Dale DC, Lyman GH. Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer 2004 Jan 15;100(2):228-37.
[vi] Smith Thomas J, et al., 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline. J Clinical Oncology 24, Number 19, July 1, 2006.
[vii] Vogel CL, et al. First and Subsequent Cycle Use of Pegfilgrastim Prevents Febrile Neutropenia in Patients With Breast Cancer: A Multicenter, Double-Blind, Placebo-Controlled Phase III Study. J Clinical Oncology 23: 1178-1184.
[viii] Thomas J. Smith et al., 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline. J Clinical Oncology 24, Number 19, July 1, 2006.
[ix] University of Washington website, http://depts.washington.edu/registry/glossary.htm, accessed March 24, 2006.
[x] BC Cancer Agency website, http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/SupportiveCare/FebrileNeutropenia/default, accessed February 16, 2006.
[xi] Crawford J, Dale DC, Lyman GH. Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer 2004 Jan 15;100(2):228-37.
[xii] Crawford J, Dale DC, Lyman GH. Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer 2004 Jan 15;100(2):228-37.


SOURCE: Amgen Canada

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