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Neutropenia

NEUTROPENIA: A SERIOUS AND FREQUENT CHEMOTHERAPY SIDE EFFECT

Many patients with cancer worry about possible side effects of chemotherapy. A Roper Starch survey of chemotherapy patients found that, prior to starting treatment, 32 percent reported surviving cancer as their biggest concern versus 40 percent who said side effects were their biggest concern.

This concern is warranted, as about half of cancer chemotherapy patients develop a condition called neutropenia (new-tro-pee-nee-uh)i that can place them at risk for life-threatening infections. Infections may require hospitalization and can delay chemotherapy treatment and reduce its effectiveness.

For more information about Chemotherapy Side Effects, please see Amgen's "Chemotherapy Guidebook".

What is neutropenia? Neutropenia is a severe drop in infection-fighting white blood cells (neutrophils). A common side effect of some kinds of chemotherapy, neutropenia is serious because:
  • Thousands of patients are hospitalized for neutropenia each year. This in an age when many patients with cancer receive chemotherapy treatment as outpatients.
  • The majority of patients with certain tumors who develop neutropenia will either have their chemotherapy postponed or their dose decreased, both of which can reduce survival rates.ii,iii
  • In some cases, neutropenia can be deadly.

What are its causes? The primary cause of neutropenia is chemotherapy and various other cancer treatments such as radiation therapy, biotherapy, and bone marrow transplantation. Approximately 1.4 million U.S. patients with cancer received chemotherapy in 2001.

Unlike normal, healthy cells that divide and grow according to an orderly pattern, cancer cells grow uncontrollably with no patterns at all. When they come in contact with normal cells, the cancer cells take over and copy themselves multiple times, therefore overburdening the body.

Chemotherapy — the use of drugs to treat cancer — works by seeking out and destroying fast-growing cells. Unfortunately, because chemotherapy cannot differentiate between cancer cells and normal cells, healthy cells are also killed, including the white blood cells that protect against infection. In addition to the white blood cells, other cells most affected include those of the hair follicles, gastrointestinal tract, and reproductive system.

When white blood cells are destroyed, patients become vulnerable to infections, and even a minor case of the flu can become life threatening.

Who is at risk for neutropenia? The risk of neutropenia varies with both the type of cancer and the type, dosage, and schedule of cancer treatment a person receives.

On average, less than 10 percent of chemotherapy patients receive proactive protection from neutropenia, so research is underway to better predict which patients are at the greatest risk. According to the Awareness of Neutropenia in Chemotherapy Study Group — a group of researchers working to develop risk models to help identify at-risk patients — neutropenia and its consequences are more common and severe than reported.

Patients with cancer who are at an increased risk of neutropenia include the elderly, patients with pre-existing neutropenia, prior chemotherapy or radiation treatment, and co-morbid conditions that leave patients immunocompromised.iv Patients aged 70 and older are at high risk for neutropenic infection, and suffer increased severity of infections and longer durations of hospitalization. Within the next 20 years, persons aged 70 and older will represent the majority of patients receiving chemotherapy.v

What are its symptoms? There are some obvious signs and symptoms of neutropenic infection including:
  • Fever greater than 100.4°F
  • Chills/sweating
  • Sore throat or cough
  • Mouth ulcers
  • Diarrhea or burning sensation during urination
  • Redness, pain or swelling around a wound or sore

How is it diagnosed? During cancer treatment, laboratory tests are used to closely monitor a patient's white blood cell count and other indicators for signs of compromised immune function. Neutrophils are measured in terms of an "absolute neutrophil count" (ANC). The normal range for neutrophils in healthy patients is between 2,500 and 6,000 per cubic millimeter of blood. An ANC below 2,000 qualifies as neutropenia, and increases a patient's risk of infection. An ANC below 500 places patients at severe risk for infection.vi White blood cell counts generally reach their lowest point approximately ten to fourteen days after chemotherapy, and it may take three to four weeks, or sometimes longer, for white blood cells to replenish themselves naturally.

How is neutropenia managed?

The management of neutropenia includes strategies to avoid infections, detect them early and respond to them promptly and aggressively, as well as therapies to help restore immune system function.

Patients being treated for cancer must be careful to reduce their risk of infection by taking a variety of precautions such as washing their hands frequently, avoiding exposure to people with infections, and taking care to avoid even small cuts or tears in the skin. Patients must also remain alert to early signs of infection, especially fever. If infection does occur, it is considered a medical emergency. Patients must often be admitted to the hospital and started immediately on broad-spectrum antibiotic or antimicrobial therapy.

A prescription medicine, called Neulasta® (pegfilgrastim), helps stimulate the bone marrow to produce more infection-fighting white blood cells.

Approved by the U.S. Food and Drug Adminstration, Neulasta® is prescribed to reduce the risk of infection (initially marked by fever) in patients with some tumors receiving chemotherapy that may decrease the number of infection-fighting white blood cells.

Important product safety information
Ruptured spleen (including fatal cases), a serious lung problem called acute respiratory distress syndrome, and sickle cell crises have been reported. Call your doctor or seek emergency care right away if you have abdominal or shoulder tip pain, shortness of breath, trouble breathing, or a fast rate of breathing. In rare cases, serious allergic reactions can occur, causing shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. Sometimes these symptoms could come back within days after stopping treatment for the allergic reaction. If you start to have any of these symptoms, call your doctor or seek emergency care right away.

In a clinical study, mild to moderate bone pain occurred in 31% of the patients taking Neulasta® and in 26% of the patients taking a placebo injection. In most cases, bone pain was controlled with a non-narcotic pain reliever, such as acetaminophen. Other common side effects reported by patients in the study taking either Neulasta® or placebo were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain. If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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CONTACT: Amgen, Thousand Oaks — Rebecca Hamm, 805-447-3872 (media); Cary Rosansky, 805-447-4634 (investors)

i ADVANCE: Awareness of Neutropenia in Chemotherapy. 2001;1(1):3-4.
ii Bonadonna G, Valagussa P, Moliterni A, et al. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995;332:901-906.< br> iiiBudman DR, Berry DA, Cirrincione CT, et al. Dose and dose intensity as determinants of outc ome in the adjuvant treatment of breast cancer. The Cancer and Leukemia Group B. Natl Cancer Inst. 1998; 90:1205-12 11.
ivOzer H, Armitage JO, Bennett CL, et al. 2000 Update of Recommendations for the Use of Hemat opoietic Colony-Stimulating Factors: Evidence-Based, Clinical Practice Guidelines. J Clin Oncol. 2000;18:3558-3585 .
v Balducci L, Lyman GH, Ozer H. Patients aged 70+ are at high risk for neutropenic infection a nd should receive hemopoietic growth factors when treated with moderately toxic chemotherapy. J Clin Oncol. 2001; 19:1583-1585.
vi American Cancer Society. Infections in individuals with cancer.



 
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