HOUSTON, Dec. 11 /PRNewswire/ -- The final analysis of an AC/TC adjuvant chemotherapy trial showed that TC (Docetaxel/Cyclophosphamide, 4 cycles) produced a superior disease-free survival compared to four cycles of standard AC (Doxorubicin/Cyclophosphamide) in 1,016 women at five years of observation.
“At five years, the disease-free survival rate was significantly superior for TC compared to AC,” said Dr. Stephen Jones, medical director of US Oncology Research and director of breast cancer research at the Texas Oncology - Sammons Cancer Center in Dallas. “Overall survival differences between treatments were not yet statistically significant, but there is a strong trend in favor of TC.”
Dr. Jones, the lead researcher for the study, presented the findings in a presentation Sunday at the 28th Annual San Antonio Breast Cancer Symposium. He explained that researchers designed a trial to test the efficacy of the non- anthracycline-based regimen of TC, marketed as Taxotere by sanofi aventis, compared to standard AC in the adjuvant setting. Patients were eligible if they had Stage I, II or operable Stage III invasive-breast cancer; had complete surgical excision of the primary tumor; were over 18 years old; had adequate renal, hepatic and hematologic functions; and had Karnofsky PS of 80 percent or greater. Exclusion criteria included other significant malignancies or illness or neoadjuvant chemotherapy.
Between June 1997 and December 1999, 1,016 patients were randomized to four cycles of either standard-dose AC (60/600/mg/m2) [n=510], or TC (75/600mg/m2) [n=506], administered intravenously every three weeks as adjuvant treatment. All chemotherapy was administered before radiation therapy (XRT) if XRT was indicated. Tamoxifen was administered to all patients with hormone receptor-positive breast cancer after chemotherapy.
Eighty-five percent of patients were Caucasian and both treatment groups (TC and AC) were well balanced with respect to major prognostic features. Overall, 71 percent of cancers were hormone receptor positive. Nodal status included: negative (48%), 1-3 positive (41%) and 4 or more positive (11%). Patients were followed through April 2005, and 165 events occurred which prompted this statistical analysis. At five years, the disease-free survival (DFS) was significantly better for TC compared to AC (86% vs. 80%, p=0.01, HR=0.67). Survival at five years also favored TC (90% vs. 87% for AC, HR=0.76, p=0.13). TC is the first adjuvant regimen given for 4 courses to prove superior to standard AC. TC can now be considered a standard nonanthracycline adjuvant regimen for appropriate patients with early breast cancer.
TC was associated with more low-grade myalgia, arthalgia, edema and febrile neutropenia than AC. AC was associated with more severe nausea and vomiting than TC.
This study is the first US Oncology adjuvant study focused on early breast cancer. Past US Oncology efforts have helped bring many new drugs to market to help in the fight against breast cancer.
About Breast Cancer
While early detection efforts have decreased mortality rates for breast cancer, roughly 220,000 women were diagnosed with the disease in 2004, according to the American Cancer Society. One of nearly every three cancers diagnosed in the United States is breast cancer, and it’s the most common cancer among women. Survival rates have increased significantly for cancers that have not spread to lymph nodes or locations outside the breast (97 percent survival rate today vs. 72 percent in 1940). However, survival after diagnosis continues to decline beyond five years. In women with distant metastases, the five-year survival rate is 23 percent.
About the US Oncology Research Network
The US Oncology Cancer Research Network is an established community-based research operation specializing in all phases of cancer clinical trials. The network currently has more than 300 physicians actively enrolling patients, and 88 regulatory sites, and is currently involved in approximately 88 research trials. The network has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the FDA for use. Since 1993, nearly 30,000 patients have participated in clinical trials managed by US Oncology network practices. For more information visit: http://www.usoncology.com .
About US Oncology, Inc.
US Oncology, headquartered in Houston, Texas, is one of the nation’s largest healthcare services networks dedicated exclusively to cancer treatment and research. US Oncology provides extensive services and support to its affiliated cancer care sites nationwide to help them expand their offering of the most advanced treatments and technologies, build integrated community- based cancer care centers, improve their therapeutic drug management programs, and participate in many of the new cancer-related clinical research studies. US Oncology is affiliated with 985 physicians operating in 494 locations, including 97 radiation oncology facilities in 33 states.
US Oncology, Inc.
CONTACT: Kimberly Rutherford of US Oncology, Inc., +1-832-601-6193, orkimberly.rutherford@usoncology.com
Web site: http://www.usoncology.com/
