Navigation Links
New Overall Survival Study Results Confirm Oral Xeloda(R) plus Oxaliplatin (XELOX) is Comparable to FOLFOX-4 for the First-Line Treatment of Advanced Colorectal Cancer
Date:1/13/2009

-Growing Body of Data Supports XELOX as Effective Alternative to Standard of Care-

NUTLEY, N.J., Jan. 13 /PRNewswire-FirstCall/ -- Overall survival results from a 14-month follow-up of the international, Phase III NO16966 study confirm that oral Xeloda(R) plus oxaliplatin (XELOX) is comparable to a current standard treatment, FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin) in the first-line treatment of advanced (metastatic) colorectal cancer.

In the study, patients receiving XELOX lived for a median of 19.0 months, while patients receiving FOLFOX-4 lived for a median of 18.5 months. The consistency of these results were also further demonstrated in a subset population from the original two-arm part of the study (XELOX v. FOLFOX). These data will be presented later this week at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, Calif.

"These compelling data validate previous studies showing that XELOX is comparable to FOLFOX-4 for the treatment of advanced colorectal cancer, while providing the added flexibility of the proven oral component Xeloda," said Edward Chu, M.D., chief of medical oncology, Yale Cancer Center. "Together, these studies confirm the value and importance of combination therapy with oral Xeloda for the thousands of patients with this insidious disease."

Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimated that in 2008 more than 148,000 people in the U.S. would be diagnosed and about 50,000 people would die from the disease. (1)

Previous data reported from the NO16966 study showed that XELOX is comparable to FOLFOX-4 in terms of progression-free survival, and the addition of Avastin to chemotherapy (FOLFOX-4 and XELOX) significantly improved progression-free survival by investigator assessment compared to chemotherapy alone. Furthermore, results from a separate international, Phase III study (NO16967) of 627 previously-treated patients with advanced colorectal cancer showed that XELOX is comparable to FOLFOX-4 in delaying disease progression.

"We're excited to see the continued promise of Xeloda as a cornerstone of combination cancer treatments," said Lars Birgerson, M.D., Ph.D., Vice President, Global Head, Medical Affairs, Roche. "With these overall survival data in advanced colorectal cancer, we have strong evidence that XELOX may offer an important new option for a difficult-to-treat patient population."

The ASCO GI meeting also will feature five additional Roche U.S. Xeloda abstracts, including a second XELOX abstract. All other Xeloda abstracts are ex-U.S. or non-Roche sponsored studies.

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 two 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 two-arm study recruited 634 patients; after transition to the two by factorial design, an additional 1,400 patients were recruited.

The primary protocol objectives were to answer: 1) whether the XELOX regimen was comparable to FOLFOX-4 in terms of clinical efficacy and 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.

Both study arms had acceptable and similar safety profiles, with no unexpected toxicities. There was a lower incidence of grade 3/4 adverse events (AEs) and hematologic AEs in the pooled XELOX group compared to the FOLFOX-4 group. Grade 3/4 gastrointestinal disorders and hand-foot syndrome were more common with XELOX compared to FOLFOX-4.

Results regarding overall survival in addition to progression-free survival were previously presented at ASCO GI in 2007. These 14-month follow-up data result from the overall survival analysis and include all patients involved in the trial (pooled XELOX-containing arms vs. pooled FOLFOX-4-containing arms).

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 in the U.S., Roche 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. For additional information about the U.S. pharmaceuticals business, visit our website http://www.rocheusa.com. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com.

All trademarks used or mentioned in this release are protected by law.

(1) Cancer Facts & Figures 2008. American Cancer Society. Atlanta, GA, 2008. 5-6, 12

    Contact:
    Ginny Valenze
    Roche
    Office: 973-562-2783
    Cell: 973-943-9219
    Virginia.Valenze@roche.com


'/>"/>
SOURCE Roche
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma
2. Isis Announces That OGX-011 Has Shown Overall Survival Advantage in Prostate Cancer Compared to Standard Therapy in a Randomized Phase 2 Study
3. The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
4. DaVita Strives to Improve Quality of Life and Reduce Overall Costs of Kidney Care Through Community-Based Education
5. ADVENTRX Announces CoFactor(R) Phase 2b Clinical Trial Overall Survival Results
6. Karmanos Cancer Institute Researchers Show Phase I Immunotherapy with Armed T Cells Improve Overall Survival of Metastatic Breast Cancer Patients
7. New Eloxatin(R) (oxaliplatin injection) Prescribing Information in the U.S. Includes Six-Year Overall Survival Data
8. Data Published at ASCO Find Correlation Between ChemoFx(R) Assay and Significantly Improved Overall Survival in Patients With Ovarian Cancer
9. New AMITIZA 8 mcg Phase III Studies Demonstrated Overall Symptom Improvement in Adult Women with Irritable Bowel Syndrome with Constipation (IBS-C)
10. TAP Pharmaceutical Products Inc. Announces Phase 3 TAK-390MR Data Demonstrating Higher Overall Healing Versus Lansoprazole in Patients with Erosive Esophagitis
11. Nexavar Significantly Improves Overall Survival by 47 Percent in Asia-Pacific Liver Cancer Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... 2022" report to their offering. ... with kidney failure, it replaces the function of kidneys by ... and thus the treatment helps to keep the patient body,s ... Increasing number of ESRD patients & substantial healthcare ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released ... failing their residents by lacking a comprehensive, proven plan to eliminate ... a definitive ranking of how states are tackling the worst drug ... only four states – Kentucky , ... Vermont . Of the 28 failing states, three – ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment center ... Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This annual ... the world’s leading providers of cereal and other breakfast foods. Its residents often refer ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. ... his M.D from the David Geffen School of Medicine at UCLA. He trained in ... to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
Breaking Medicine News(10 mins):