XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
  Breast
  Skin
  Blood
  Prostate
  Liver
  Colon
  Thyroid
  Endometrial
  Brain
  Therapy
  Risk Factors
  Esophageal
  Bladder
  Lung
  Rectal Cancer
  Pancreatic Cancer
  Bone Cancer
  Cervical Cancer
  Testicular Cancer
  Gastric Cancer
  Ovarian Cancer
  Nerve Tissue
  Renal Cell Carcinoma
 Psychiatry
 Genetics
 Surgery
 Aging
 Ophthalmology
 Gynaecology
 Neurosciences
 Pharmacology
 Cardiology
 Obstetrics
 Infectious Diseases
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
Search

Last Updated: Nov 17th, 2006 - 22:35:04

Colon Channel
subscribe to Colon newsletter

Latest Research : Cancer : Colon

   DISCUSS   |   EMAIL   |   PRINT
FDA Approves Oral Chemotherapy Pill for Colon Cancer
Jun 17, 2005, 09:22, Reviewed by: Dr.

"It provides a safe, effective, alternative means offering patients the opportunity to receive pill therapy in the comfort of their home rather than needing to come into the clinic for repeated IV injections."

 
THE FDA HAS APPROVED THE ORAL CHEMOTHERAPY, XELODA, TO TREAT DUKESí C COLON CANCER PATIENTS WHO HAVE UNDERGONE COMPLETE RESECTION OF THE PRIMARY TUMOR WHEN FLUOROPYRIMIDINE THERAPY ALONE IS PREFERRED.

THE ADJUVANT INDICATION WAS BASED ON DATA FROM THE X-ACT TRIAL. THIS PIVOTAL TRIAL SHOWED THAT XELODA MET ITS PRIMARY ENDPOINT OF NON-INFERIORITY TO 5-FU/LV FOR DISEASE-FREE SURVIVAL. AT THIS TIME, NEITHER XELODA NOR COMBINATION CHEMOTHERAPY HAS BEEN SHOWN TO PROLONG OVERALL SURVIVAL; COMBINATION CHEMOTHERAPY HAS DEMONSTRATED AN IMPROVEMENT IN DISEASE FREE SURVIVAL COMPARED TO 5-FU/LV.

DR. HOWARD BURRIS OF THE SARAH CANNON RESEARCH INSTITUTE IN NASHVILLE SAYS THIS APPROVAL IS IMPORTANT FOR PATIENTS.

"It provides a safe, effective, alternative means offering patients the opportunity to receive pill therapy in the comfort of their home rather than needing to come into the clinic for repeated IV injections."

LIKE ALL CHEMOTHERAPY DRUGS, XELODA MAY NOT BE RIGHT FOR SOME PATIENTS. PATIENTS TAKING WARFARIN SHOULD CONSULT THEIR PHYSICIANS. IíM CHRIS ALLEN.

More about Xeloda

Indication:

Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukesí C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Xeloda was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Although neither Xeloda nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-FU/LV. Physicians should consider these results when prescribing single-agent Xeloda in the adjuvant treatment of Dukesí C colon cancer.

Xeloda is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy. Use of Xeloda instead of 5-FU/LV in combinations has not been adequately studied to assure safety of preservation of the survival advantage.

Xeloda in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracyline- containing chemotherapy.

Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline- containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalence. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within six months of completing treatment with an anthracycline-containing adjuvant regimen.

Safety:

A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended.

Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required. Xeloda can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored. Patients 80 and older receiving Xeloda monotherapy may experience a greater incidence of grade 3 or 4 adverse events. Xeloda may cause fetal harm when given to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Xeloda. It is recommended that nursing be discontinued when using Xeloda. Men should use birth control when using Xeloda.

Common adverse events in the adjuvant setting were: diarrhea (Xeloda 47%, 5-FU/LV 65%), nausea (Xeloda 34%, 5-FU/LV 47%), stomatitis (Xeloda 22%, 5- FU/LV 60%), vomiting (Xeloda 15%, 5-FU/LV 21%), fatigue (Xeloda 16%, 5-FU/LV 16%) and hand-foot syndrome (Xeloda 60%, 5-FU/LV 9%). As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.
 

- FDA
 

www.xeloda.com

 
Subscribe to Colon Newsletter
E-mail Address:

 

Visit http://www.xeloda.com/ or call Roche at 800-526-6367.

ADDITIONAL RESOURCES: Audio version and more available at http://www.prnewswire.com/broadcast/20954/consumer.shtml

AUDIO PROVIDED BY: Roche

Web site: http://www.xeloda.com/


Related Colon News

Regular aerobics protects men from colon cancer
Role for MicroRNAs in Oxygenation, Nourishing of Colon Tumors
New genetic test to spotlight heightened bowel cancer risk
$2.6 million in grants for metastatic colon cancer research
NSAIDs don't reduce colorectal cancer risk in chronic smokers
Timing of radiation treatments for colon cancer may need adjusting
How growth hormone therapy can lead to colon polyps
Review study sets treatment standard for elderly with colon cancer
Eating red meat could damage DNA by N-nitrosocompounds
Diet pattern may effect the development of colon cancer


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

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us