RxPG News Feed for RxPG News

Medical Research Health Special Topics World
  Home
 
   Health
 Aging
 Asian Health
 Events
 Fitness
 Food & Nutrition
 Happiness
 Men's Health
 Mental Health
 Occupational Health
 Parenting
 Public Health
 Sleep Hygiene
 Women's Health
 
   Healthcare
 Africa
 Australia
 Canada Healthcare
 China Healthcare
 India Healthcare
 New Zealand
 South Africa
 UK
 USA
 World Healthcare
 
   Latest Research
 Aging
 Alternative Medicine
 Anaethesia
 Biochemistry
 Biotechnology
 Cancer
  Bladder
  Blood
  Bone Cancer
  Brain
  Breast Cancer
  Carcinogens
  Cervical Cancer
  Colon
  Endometrial
  Esophageal
  Gastric Cancer
  Liver Cancer
  Lung
  Nerve Tissue
  Ovarian Cancer
  Pancreatic Cancer
  Prostate Cancer
  Rectal Cancer
  Renal Cell Carcinoma
  Risk Factors
  Skin
  Testicular Cancer
  Therapy
   Pharmacotherapy
   Radiotherapy
   Vaccination
  Thyroid
 Cardiology
 Clinical Trials
 Cytology
 Dental
 Dermatology
 Embryology
 Endocrinology
 ENT
 Environment
 Epidemiology
 Gastroenterology
 Genetics
 Gynaecology
 Haematology
 Immunology
 Infectious Diseases
 Medicine
 Metabolism
 Microbiology
 Musculoskeletal
 Nephrology
 Neurosciences
 Obstetrics
 Ophthalmology
 Orthopedics
 Paediatrics
 Pathology
 Pharmacology
 Physiology
 Physiotherapy
 Psychiatry
 Radiology
 Rheumatology
 Sports Medicine
 Surgery
 Toxicology
 Urology
 
   Medical News
 Awards & Prizes
 Epidemics
 Launch
 Opinion
 Professionals
 
   Special Topics
 Ethics
 Euthanasia
 Evolution
 Feature
 Odd Medical News
 Climate

Last Updated: Oct 11, 2012 - 10:22:56 PM
Pharmacotherapy Channel

subscribe to Pharmacotherapy newsletter
Latest Research : Cancer : Therapy : Pharmacotherapy

   EMAIL   |   PRINT
Pegfilgrastim Significantly Reduces the Incidence of Febrile Neutropenia in Patients on Chemotherapy

Feb 27, 2005 - 1:43:00 PM
"In this study, pegfilgrastim administered 24 hours after chemotherapy profoundly reduced the rate of febrile neutropenia from 17 percent to one percent," said the study's lead investigator Charles Vogel, M.D., Cancer Research Network, Plantation, Fla.

 
[RxPG] Amgen Inc., the world's largest biotechnology company, today announced that data from the largest randomized placebo-controlled study to date for Neulasta(R) (pegfilgrastim) has been published in the February 20 issue of The Journal of Clinical Oncology.

The phase 3 study showed that administering pegfilgrastim beginning in the first and subsequent cycles of chemotherapy reduced the incidence of febrile neutropenia (low white blood cell count with fever), a serious complication of cancer chemotherapy typically associated with infection, by more than 90 percent.

"In this study, pegfilgrastim administered 24 hours after chemotherapy profoundly reduced the rate of febrile neutropenia from 17 percent to one percent," said the study's lead investigator Charles Vogel, M.D., Cancer Research Network, Plantation, Fla. "The high frequency of first-cycle febrile neutropenia in this study emphasizes the need to initiate pegfilgrastim from the first cycle of chemotherapy to significantly reduce the patient's risk of infection."

Febrile (or feverish) neutropenia is the most common presentation of infection in patients receiving chemotherapy. Infection in this setting can be serious and even life threatening because chemotherapy can compromise the patient's ability to fight infection.

Data from the randomized, double-blind, placebo-controlled study of 928 breast cancer patients show that first and subsequent-cycle administration of pegfilgrastim resulted in a 94 percent reduction in the incidence of febrile neutropenia, a 93 percent reduction in the incidence of hospitalization and an 80 percent reduction in the incidence of intravenous anti-infective use in patients receiving myelosuppressive chemotherapy previously considered at moderate risk for neutropenic complications.

Specifically, in all cycles, one percent of patients in the pegfilgrastim arm (6/463) developed febrile neutropenia compared with 17 percent of patients in the placebo arm (78/465). Pegfilgrastim was also associated with a significantly lower incidence of hospitalizations with one percent of patients (6/463) requiring hospitalization versus 14 percent of patients receiving placebo (64/465).

Two percent of patients in the pegfilgrastim arm (7/463) required intravenous anti-infectives versus 10 percent of patients in the placebo arm (48/465). Febrile neutropenia occurred most often in placebo patients during the first cycle of chemotherapy (65 percent). There were two deaths from septic shock on the placebo arm compared to zero in the pegfilgrastim arm.

In addition, first-cycle administration of pegfilgrastim resulted in a 91 percent reduction in the incidence of febrile neutropenia occurring in the first cycle of chemotherapy, an 89 percent reduction in the incidence of hospitalization and an 83 percent reduction in the incidence of intravenous anti-infective use.

Breast cancer patients (Stage 1-4, ECOG performance of 0-2) receiving 100 mg/m(2) docetaxel every three weeks for up to four cycles were randomized to receive either 6 mg pegfilgrastim (n=463) or placebo (n=465) once-per-cycle on the day after docetaxel administration for up to four cycles.

Docetaxel is associated with an average reported febrile neutropenia incidence of approximately 10 to 20 percent in the absence of growth factor support. Febrile neutropenia was defined as fever with a temperature greater than or equal to 38.2 degrees C and an absolute neutrophil count (ANC) less than 0.5 x 10(9)/L measured the same day or the day after fever was documented.

Pegfilgrastim was well-tolerated in this study with an adverse event profile similar to placebo. Bone pain was a frequently observed adverse event in both arms of the study (31 percent with pegfilgrastim versus 27 percent with placebo).

Pegfilgrastim was approved by the U.S. Food and Drug Administration (FDA) in 2002 for decreasing the incidence of infection, as manifested by neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Similar indications for pegfilgrastim were approved in Europe and Australia the same year.

Rare cases of splenic rupture and sickle cell crises have been reported in postmarketing experience. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure.

However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment. In clinical trials, the only serious adverse event not attributed to the underlying disease or chemotherapy was a case of hypoxia.

The most common adverse event attributed to pegfilgrastim was bone pain, reported in 26 percent of patients. While not reported in patients receiving pegfilgrastim, rare events of adult respiratory distress syndrome have been reported in patients receiving the parent compound, Filgrastim.



Publication: Amgen Inc.
On the web: AMGEN 

Advertise in this space for $10 per month. Contact us today.


Related Pharmacotherapy News
Anthracycline induced heart damage can be reduced by prolonging infusion time
Genomic signatures to guide the use of chemotherapeutics
CDK2/FOXO1 as drug target to Prevent Tumors
Gleevec can be toxic to the heart
AS101 protects the testis from the effects of paclitaxel
Fibrasorb - New device that could cut chemotherapy deaths
Serendipity versus planning - cancer drugs of the future?
Sunitinib Approved for Gastrointestinal Stromal Tumors (GIST) and Kidney Cancer
Celecoxib able to control chemotherapy resistant tumor cells
Inhibiting EAT-2 with medications could boost NK cell activity

Subscribe to Pharmacotherapy Newsletter

Enter your email address:


 Additional information about the news article
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.More information can be obtained from the company's website.
 Feedback
For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 
Contact us

RxPG Online

Nerve

 

    Full Text RSS

© All rights reserved by RxPG Medical Solutions Private Limited (India)