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

Sunday, December 16, 2007 General News J E 4
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SAN ANTONIO, Dec. 15 Interim results of the Phase II XeNA(Xeloda in NeoAdjuvant) trial suggest that the combination of oral Xeloda(R)(capecitabine) and Taxotere(R) (docetaxel), with the addition of Herceptin(R)(trastuzumab) in HER2-positive patients, may be an active and well-toleratedneoadjuvant (pre-surgical) treatment option for women with invasive breastcancer. These data were presented today at the San Antonio Breast CancerSymposium (SABCS).

In the multi-center, open-label trial -- designed to investigate theactivity of a short non-anthracycline-based preoperative treatment for earlybreast cancer in both HER2-negative and HER2-positive patients -- promisingresults were achieved after only four cycles of pre-surgical treatment ascompared to the standard eight cycles. The majority of the 156 patientsresponded to the Xeloda-based therapy regardless of HER2 status, and bothpatient groups experienced a clinically significant reduction in tumor size.

"These early XeNA trial results highlight the potential of theXeloda/Taxotere combination, with Herceptin for HER2-positive patients, toprovide an effective and safe treatment option in a shorter period of timebefore surgery among patients with invasive breast cancer," said Dr. DebuTripathy, lead investigator of the XeNA trial and Professor of Medicine andDirector of the Komen/UT Southwestern Breast Cancer Research Program at theUniversity of Texas Southwestern Medical Center at Dallas. "While thesefindings warrant additional studies, the real-world impact of the reduction intumor size could translate into the difference between a lumpectomy instead ofa more drastic mastectomy."

In the interim analysis, following four treatment cycles, the combinationof Xeloda, Taxotere and Herceptin in HER2-positive patients resulted in a 73percent clinical response rate (complete and partial response) and a 50percent pathologic response (pathologic complete response, which is theabsence of histological evidence of cancer cells in the tissue specimen, plusnear pathological complete response, which is less than or equal to 5millimeters of residual cancer). Additionally, HER2-negative patientsexperienced a clinical response rate of 76 percent and 15 percent pathologicalresponse with the combination of solely Xeloda and Taxotere. In patients withHER2-negative tumors, a decrease from 6.1 to 2.8 centimeters was observed; inHER2-positive patients, the reduction was from 5.6 to 1.6 centimeters.

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

Invasive breast cancer, also known as infiltrating breast cancer, iscancer that has spread to surrounding, healthy tissue. Most invasive breastcancers start in the ducts, but can spread to other parts of the body throughthe blood and lymph systems. Breast cancer is the most common canceramong women, other than skin cancer. It is the second leading cause of cancerdeath 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 invasivebreast cancer in 2007 and about 40,460 women will die from the disease thisyear.

About the Study

This multi-center, open-label XeNA trial enrolled 157 (156 evaluable)patients with newly-diagnosed invasive breast cancer (planned sample size 122HER2-negative; 34 HER2-positive) and was designed to investigate the activityof a short non-anthracycline-based preoperative treatment for early breastcancer. Efficacy results for 134 patients as well as toxicity data for thetotal evaluable population (156 patients) were included in this interimanalysis. The primary endpoint was the rate of pathological complete responserate (pCR) plus near pCR in
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