San Antonio, TX–(HISPANIC PR WIRE)–December 12, 2002–Women with early stage breast cancer who were given an adjuvant chemotherapy regimen after surgery that included the drug ELLENCE® (epirubicin hydrochloride injection) were significantly more likely to survive cancer-free for 10 years than women who received an older, standard chemotherapy regimen, researchers announced today. Being disease-free at the 10-year time point is a major milestone for patients in their quest for a potential cure. Historically, more than half of breast cancer patients will relapse by 10 years after initial diagnosis.
Results of long-term follow up of patients in a landmark international study presented at a symposium at the 25th Annual San Antonio Breast Cancer Meeting showed that disease-free survival rates in the groups treated with the regimen containing ELLENCE and with the standard regimen were 52 percent and 45 percent, respectively. Overall 10-year survival rates were 62 percent in women treated with the ELLENCE-based regimen, compared with 58 percent in the comparison group. In addition, risk reductions for mortality and disease recurrence were 15 percent and 24 percent, respectively, for the group treated with ELLENCE.
This trial is important, as the oncology community has now learned that patients can achieve a survival advantage at 10 years when comparing an ELLENCE-based chemotherapy regimen with a non-ELLENCE-based regimen, CMF, for treating node-positive breast cancer in the adjuvant setting (chemotherapy given after surgery or radiation).
“We are striving to find a cure for breast cancer,” said Mark Levine, MD, Professor, Departments of Clinical Epidemiology and Biostatistics and Medicine, Buffett Taylor Chair, Breast Cancer Research, McMaster University, Ontario, Canada, and the lead investigator of the study. “When we first reported results from this study, known as the MA5 trial, there was an improvement in five-year survival in favor of the ELLENCE-based regimen. This follow-up study has shown, quite importantly, that the survival advantage persists out to 10 years.
“The MA5 trial has the longest follow up of any trial that has compared an anthracycline-based chemotherapy regimen to CMF,” added Dr. Levine.
The Phase III multicenter study funded by Pharmacia Oncology and coordinated by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), entitled “CEF vs. CMF as Adjuvant Therapy for Patients with Node-Positive Breast Cancer, MA5 Trial,” enrolled its first patient in 1989, and recruitment closed in 1993. The follow-up period now has extended to a median of 106 months.
The study randomly assigned 710 women with node-positive breast cancer (early-stage, operable breast cancer that has spread to the lymph nodes) after lumpectomy or mastectomy to receive one of two adjuvant chemotherapy regimens. One regimen, CMF, included the drug methotrexate; the other, an anthracycline-based regimen dubbed CEF, included ELLENCE. Both regimens included the chemotherapy drugs cyclophosphamide and fluorouracil. In each treatment group, therapy was administered over six four-week cycles.
With long-term follow up, rates of secondary leukemia were unchanged from the original MA5 study (1.1 percent of patients in the CEF group versus 0.4 percent treated with CMF), while rates of congestive heart failure were slightly higher but acceptable in the CEF group (1.1 percent of patients, versus 0.3 percent in the CMF group).
“Earlier results from this trial showed that at five years, we could provide patients with a survival advantage,” said Kathy Pritchard, MD, FRCPC, Co-Chair, Breast Cancer Site Group, NCIC CTG, and a co-investigator in the MA5
trial. “These new data enable us to re-quantify breast cancer survival to 10 years, suggesting an advance in patient outcomes and the possibility of a healthy future.”
“Oncology research is driven by ongoing investigation of the best ways to use available treatments to enhance survival rates,” said Gabe Leung, Group Vice President, Global Oncology Franchise, Pharmacia Corporation. “Studies such as the MA5 trial provide essential information that helps us advance in breast cancer care.”
Breast cancer is the second leading cause of cancer death among women. It is estimated that 203,500 women in the United States will be diagnosed with breast cancer in 2002 and more than 40,000 women will lose their lives to the disease. In Canada, an estimated 20,700 women will be diagnosed with breast cancer this year and 5,400 will die from the disease.
ELLENCE is the first chemotherapy approved by the FDA for use as a component of adjuvant therapy, in combination with cyclophosphamide and fluorouracil (CEF), in the treatment of early-stage breast cancer that has spread to the lymph nodes. It works in part by uncoiling the strands of genetic material that make up DNA (genetic information of a cell), which prevents cells from reproducing.
ELLENCE has generally manageable side effects. In this and other Phase III clinical trials, the most common side effects were nausea, vomiting, mouth sores, and hair loss. Because chemotherapy can damage the blood-producing cells of the bone marrow, patients may experience low blood cell counts, and the reduction in white blood cells may become severe in some patients. As noted above, few patients experienced damage to the heart muscle or a type of leukemia.
About NCIC CTG
The National Cancer Institute of Canada Clinical Trials Group is an independent research organization that carries out clinical trials in cancer therapy
and supportive care across Canada and internationally. It is one of the national programs and networks for the National Cancer Institute of Canada, and is supported by the NCIC with funds raised by the Canadian Cancer Society.
Pharmacia Corporation (NYSE:PHA) is a top-tier global pharmaceutical company whose innovative medicines and other products save lives and enhance health and wellness. Pharmacia’s 43,000 people work together with
many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future. On July 15, 2002, Pharmacia and Pfizer Inc. (NYSE: PFE) announced the signing of a definitive agreement providing for Pfizer to acquire Pharmacia in a stock-for-stock transaction that is expected to close in the first quarter of 2003.
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