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Results Show XELOX (Xeloda(R) Plus Oxaliplatin) Provides Equivalent Overall Patient Survival Compared To FOLFOX In Advanced Colorectal Cancer
Overall survival results from an
international, Phase III study (NO16966) suggest that XELOX (Xeloda(R) plus
oxaliplatin) is an effective alternative to the current standard treatment,
FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin), for advanced
(metastatic) colorectal cancer. In the study, XELOX -- a more convenient
therapy including Roche's oral Xeloda -- provides equivalent patient
survival compared to FOLFOX-4. These data were presented at the American
Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI) in
Orlando, FL.
The Independent Review Committee (IRC) analysis also confirmed previous
results indicating that the addition of Avastin to combination chemotherapy
(XELOX or FOLFOX) significantly improved the chance of delaying the
progression of the disease (progression-free survival, or PFS).
"These important survival results continue to affirm our initial
hypothesis that XELOX is a viable, effective alternative to the current
standard of care for advanced colorectal cancer," said Professor Jim
Cassidy, co-lead investigator for the study and Cancer Research UK
Professor of Oncology and Chair of Medical Oncology, Beatson Oncology
Centre, at the University of Glasgow, Scotland. "These data underscore the
tremendous promise of combinations using cornerstone therapies such as
Xeloda, and the potential benefit of adding Avastin to achieve greater
progression-free survival."
Additional analysis of these data is ongoing and will be presented at
an upcoming international scientific meeting.
"Now, with evidence of overall survival in addition to progression-free
survival, we can move closer to offering patients a convenient option of an
oral component to their chemotherapy treatment," said Lars Birgerson, Vice
President, Medical Affairs, Roche. "Based on these findings and results
from international Phase III study (NO16967), Roche will submit a
supplemental new drug application for XELOX (Xeloda plus oxaliplatin) in
advanced colorectal cancer."
In 2004, colorectal cancer was one of the leading cancers and accounted
for 13 percent of all cancers; it is estimated that more than 394,000
people die worldwide from colorectal cancer each year. Colorectal cancer is
the third most common cancer in the United States. The American Cancer
Society estimated in 2006 that more than 148,000 people in the U.S. would
be diagnosed and about 55,000 people would die from the disease.
About the Study
Study NO16966 is a large, randomized, international, Phase III trial of
2,034 advanced colorectal cancer patients that initially compared
first-line XELOX (Xeloda + oxaliplatin) versus FOLFOX-4 (intravenous bolus
and infusional 5-fluorouracil + oxaliplatin). After release of Avastin data
in colorectal cancer in 2003, the protocol was amended to investigate,
using a 2 by factorial design, XELOX + placebo versus XELOX + Avastin (7.5
mg/kg q3w) versus FOLFOX-4 + placebo versus FOLFOX-4 + Avastin (5.0 mg/kg
q2w).
The primary study objectives were to answer two questions: 1) whether
the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of
Avastin to chemotherapy improved results compared to chemotherapy alone.
The secondary endpoints included overall survival, overall response rates,
time to, and duration of, response and safety profile.
The results presented at ASCO GI represent only the original arm of the
study, which recruited 634 patients.
About XELOX
XELOX is an abbreviation for a type of combination chemotherapy used to
treat colorectal cancer; it contains Xeloda (capecitabine) plus
oxaliplatin.
About XELODA (capecitabine)
Xeloda is the only FDA-approved oral chemotherapy for both metastatic
breast cancer and adjuvant and metastatic colorectal cancer. Inactive in
pill form, Xeloda is enzymatically activated within the body; when it comes
into contact with a naturally occurring protein called thymidine
phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic
(cell-killing) drug. Because many cancers have higher levels of TP than
does normal tissue, more 5-FU is delivered to the tumor than to other
tissue.
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.
The most common adverse events (greater than or equal to 20%) of Xeloda
monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As
with any cancer therapy, there is a risk of side effects, and these are
usually manageable and reversible with dose modification or interruption.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years, the Roche Group has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2005, Roche was named
one of Fortune magazine's Best Companies to Work For in America, one of the
Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to
Work For in NJ (NJ Biz magazine), the No. 1 Company to sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For additional
information about the U.S. pharmaceuticals business, visit our websites:
http://www.rocheusa.com or http://www.roche.us.
Roche
http://www.roche.us
View drug information on Avastin; Warfarin Sodium tablets; Xeloda.
Rezultatele aratã XELOX (Xeloda (R), plus Oxaliplatin) prevede echivalent de supravieþuire generalã de pacienþi, comparativ cu FOLFOX avansate de cancer colorectal în - Results Show XELOX (Xeloda(R) Plus Oxaliplatin) Provides Equivalent Overall Patient Survival Compared To FOLFOX In Advanced Colorectal Cancer - articole medicale engleza - startsanatate