Nearly 60 New Studies Of Oral Xeloda(R) (capecitabine) Featured At The 44th American Society Of Clinical Oncology Annual Meeting

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Conferences;  Pharma Industry / Biotech Industry
Article Date: 23 May 2008 - 2:00 PDT

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Roche announced that a total of 59 U.S. and global abstracts involving its oral chemotherapy Xeloda(R) (capecitabine) have been accepted for presentation at the 44th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 30 to June 3.

A U.S. abstract to be published in The 2008 ASCO Proceedings I, compares the preclinical efficacy of an investigational, seven-days-on/seven-days-off (7-on/7-off) Xeloda regimen versus the current standard Xeloda dosing of fourteen-days-on/seven-days-off (14-on/7-off) in colorectal cancer. Findings from this study appeared to indicate improved tumor growth inhibition with the 7-on/7-off Xeloda regimen; results support clinical testing of this regimen in colorectal cancer patients. [See 2008 ASCO Proceedings I - An alternative preclinical regimen of capecitabine ( C ) enhances single agent & combination activity in a colorectal cancer xenograft model. (Lead Author: Kenneth Kolinsky)]

Among ex-U.S. Xeloda abstracts being presented, 16 breast cancer and 15 colorectal cancer abstracts highlight Xeloda as the cornerstone of combination treatment. The remaining Xeloda abstracts are also ex-U.S. or sponsored by non-Roche entities.

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. An employer of choice, in 2007 Roche was named Top Company of the Year by Med Ad News, one of the Top 20 Employers (Science) and ranked the No. 1 Company to Sell For (Selling Power). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (Fortune). 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 http://www.RocheExchange.com.

Roche announced today that a total of 59 U.S. and global abstracts involving its oral chemotherapy Xeloda(R) (capecitabine) have been accepted for presentation at the 44th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 30 to June 3.

A U.S. abstract to be published in The 2008 ASCO Proceedings I, compares the preclinical efficacy of an investigational, seven-days-on/seven-days-off (7-on/7-off) Xeloda regimen versus the current standard Xeloda dosing of fourteen-days-on/seven-days-off (14-on/7-off) in colorectal cancer. Findings from this study appeared to indicate improved tumor growth inhibition with the 7-on/7-off Xeloda regimen; results support clinical testing of this regimen in colorectal cancer patients. [See 2008 ASCO Proceedings I - An alternative preclinical regimen of capecitabine ( C ) enhances single agent & combination activity in a colorectal cancer xenograft model. (Lead Author: Kenneth Kolinsky)]

Among ex-U.S. Xeloda abstracts being presented, 16 breast cancer and 15 colorectal cancer abstracts highlight Xeloda as the cornerstone of combination treatment. The remaining Xeloda abstracts are also ex-U.S. or sponsored by non-Roche entities.

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. An employer of choice, in 2007 Roche was named Top Company of the Year by Med Ad News, one of the Top 20 Employers (Science) and ranked the No. 1 Company to Sell For (Selling Power). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (Fortune). 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 http://www.RocheExchange.com.

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