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Biopharmaceuticals Oncology

 News Release - December 15, 2007

Xeloda(R), Taxotere(R) and Herceptin(R) Combination Study Suggests Clinical Benefit in Invasive Breast Cancer with Shortened Treatment Cycle

SAN ANTONIO, Dec. 15 (HSMN NewsFeed) -- Interim results of the Phase II XeNA (Xeloda in NeoAdjuvant) trial suggest that the combination of oral Xeloda® (capecitabine) and Taxotere® (docetaxel), with the addition of Herceptin® (trastuzumab) in HER2-positive patients, may be an active and well-tolerated neoadjuvant (pre-surgical) treatment option for women with invasive breast cancer. These data were presented today at the San Antonio Breast Cancer Symposium (SABCS).

In the multi-center, open-label trial -- designed to investigate the activity of a short non-anthracycline-based preoperative treatment for early breast cancer in both HER2-negative and HER2-positive patients -- promising results were achieved after only four cycles of pre-surgical treatment as compared to the standard eight cycles. The majority of the 156 patients responded to the Xeloda-based therapy regardless of HER2 status, and both patient groups experienced a clinically significant reduction in tumor size.

"These early XeNA trial results highlight the potential of the Xeloda/Taxotere combination, with Herceptin for HER2-positive patients, to provide an effective and safe treatment option in a shorter period of time before surgery among patients with invasive breast cancer," said Dr. Debu Tripathy, lead investigator of the XeNA trial and Professor of Medicine and Director of the Komen/UT Southwestern Breast Cancer Research Program at the University of Texas Southwestern Medical Center at Dallas. "While these findings warrant additional studies, the real-world impact of the reduction in tumor size could translate into the difference between a lumpectomy instead of a more drastic mastectomy."

In the interim analysis, following four treatment cycles, the combination of Xeloda, Taxotere and Herceptin in HER2-positive patients resulted in a 73 percent clinical response rate (complete and partial response) and a 50 percent pathologic response (pathologic complete response, which is the absence of histological evidence of cancer cells in the tissue specimen, plus near pathological complete response, which is less than or equal to 5 millimeters of residual cancer). Additionally, HER2-negative patients experienced a clinical response rate of 76 percent and 15 percent pathological response with the combination of solely Xeloda and Taxotere. In patients with HER2-negative tumors, a decrease from 6.1 to 2.8 centimeters was observed; in HER2-positive patients, the reduction was from 5.6 to 1.6 centimeters.

"The XeNA results demonstrate the potential for oral Xeloda to serve as the cornerstone of combination chemotherapy in the treatment of early invasive breast cancer," said Lars Birgerson, M.D., PhD, Vice President of Global Head Medical Affairs at Roche.

Invasive breast cancer, also known as infiltrating breast cancer, is cancer that has spread to surrounding, healthy tissue. Most invasive breast cancers start in the ducts, but can spread to other parts of the body through the blood and lymph systems. Breast cancer is the most common cancer among women, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. According to the American Cancer Society (ACS), about 178,480 women in the United States will be found to have invasive breast cancer in 2007 and about 40,460 women will die from the disease this year.

About the Study

This multi-center, open-label XeNA trial enrolled 157 (156 evaluable) patients with newly-diagnosed invasive breast cancer (planned sample size 122 HER2-negative; 34 HER2-positive) and was designed to investigate the activity of a short non-anthracycline-based preoperative treatment for early breast cancer. Efficacy results for 134 patients as well as toxicity data for the total evaluable population (156 patients) were included in this interim analysis. The primary endpoint was the rate of pathological complete response rate (pCR) plus near pCR in the affected breast after preoperative administration of Xeloda and Taxotere for HER2-negative patients and in combination with Herceptin for HER2-positive patients. Secondary endpoints included safety profile; quality of life; local recurrence; disease-free survival; distant disease-free survival; and overall survival. Other secondary endpoints included pCR in sentinel and axillary, or underarm, lymph nodes; clinical response rate; ability of blood and tissue markers; genomic profiling of the tumors; circulating tumor cells for HER2-neu positive patients; and p53 gene mutations to predict short-term clinical and pathological responses.

Study participants were limited to female outpatients, aged 18 and older, who were diagnosed with HER2-negative or HER2-positive breast cancer, with no evidence of metastatic disease except ipsilateral axillary lymph nodes, or axillary lymph nodes found on the same side of the body, and no prior history of treatment.

Patients received four three-week cycles of the treatment regimen. HER2-negative patients received Xeloda 825 mg/m2 twice a day for 14 days with seven days off, and also received Taxotere 75 mg/m2 IV on the first day. HER2-positive patients were on the same regimen, but also received Herceptin each week with a loading dose of 4 mg/kg for 90 minutes followed by 2 mg/kg for 30 minutes for a total of 12 weeks before definitive surgery.

The most frequent adverse events (AEs) were hematologic toxicities and hand-foot syndrome. Five HER2-neu negative patients and one HER2-positive patient experienced progression before surgery. There were no treatment- related deaths prior to surgery, nor were there clinical or subclinical cardiac events.

About Xeloda

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 and one of the Top 20 Employers (Science magazine).

In 2006, Roche was ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our Web sites: or

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Source: Roche Group

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