ASCO late breaker - breast cancer- dose dense

June 05, 2004

New Orleans, LA (June 5, 2004) - New data presented at the 2004 meeting of the American Society of Clinical Oncology suggest that a chemotherapy regimen including ELLENCE (epirubicin) may significantly improve survival in breast cancer patients at highest risk of recurrence. Results from the German AGO multi-center Phase III trial show that a sequential dose-dense chemotherapy regimen of ELLENCE, paclitaxel and cyclophosphamide (ETC) as adjuvant therapy in high-risk breast cancer patients significantly improves disease-free survival (DFS) and overall survival (OS).

Interim results of a study with over 1,200 patients having 4 or more positive nodes, comparing the dose-dense ETC arm to a standard regimen of ELLENCE/cyclophosphamide (EC) followed by paclitaxel (T), were reported at a median follow up of 28 months. Estimated 3-year relapse-free survival (RFS) is 80% in the ETC arm vs. 70% in the standard arm (p=0.0009) and estimated 3-year OS is 90% in the ETC arm vs. 87% in the standard arm (p=0.030). For patients, this means that over 35% more women remain alive and disease free when on the ETC regimen. Moreover, these results confirm the dose dense approach seen in another study and demonstrate that women at the highest risk of recurrence benefit from this optimal dose dense therapy.

"These study results are a significant advancement in the treatment of breast cancer and confirms that dose-dense sequential regimens will become a standard option in the adjuvant treatment of node positive breast cancer patients," said V.J. Möbus, Professor and Department Head, University of Frankfurt and lead investigator of the study. "The dose-dense treatment approach of ELLENCE, paclitaxel and cyclophosphamide (ETC) used in this study allows patients to receive their chemotherapy doses more frequently, without incremental toxicities versus the standard treatment. Using this treatment approach, patients significantly improve their chances of disease-free and overall survival."

In this trial 1,284 patients were randomized to receive either 3 courses each of E (150 mg/m2, q2wks), T (225 mg/m2, q2wks), and C (2,500 mg/m2, q2wks) or the standard regimen of 4 courses EC (90/600 mg/m2, q3wks) followed by 4 courses of T (175 mg/m2, q3wks). Patients were under 65 years of age with at least 4 involved axillary lymph nodes. 1,169 were fully available for evaluation. These patients were at a high risk of recurrence with a median number of 8 positive nodes, 59% percent had 4 - 9 positive nodes and 41% had ³10 infiltrated nodes. No unusual toxicities were observed, especially no severe cardiotoxicity. Hematological toxicity (anemia, neutropenia and thrombocytopenia) was more frequent in the ETC arm (p<0.0001) and varied distinctly between each of the drugs within this combination. The incidence of hematological toxicity was highest during treatment with cyclophosphamide and lowest during treatment with paclitaxel. Seven percent of patients in the ETC arm vs. 2% in the standard arm were hospitalized for febrile neutropenia (p<0.0001). There were no treatment-related deaths during therapy.

The majority of patients completed treatment with 82% of patients in the ETC arm and 90% in the standard arm receiving the planned number of cycles. The number of dose reductions was relatively small, ranging from 6.5% on the ETC arm to 2% on the standard arm. About Breast Cancer and ELLENCE

Breast cancer is the second leading cause of cancer death among women. It is estimated that 211,300 women in the United States will be diagnosed with breast cancer in 2003 and more than 39,800 women will lose their lives to the disease.[i] ELLENCE is the first chemotherapy approved by the FDA for use as a component of adjuvant therapy, in combination with cyclophosphamide and fluorouracil (FEC), 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 a generally manageable side effect profile. 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. Some patients may experience a severe reduction in white blood cells. Rarely, damage to the heart muscle or a type of leukemia can occur.
Full prescribing and safety information, including black box warnings, can be found at

About Pfizer
Pfizer Inc is the world's leading research-based pharmaceutical company, providing a broad range of human and animal pharmaceuticals, as well as consumer products. In 2003, the company will commit $7.1 billion to R&D, involving its scientists in more than 33 major research projects across 10 major therapeutic categories. With 120,000 employees worldwide, Pfizer is also deeply engaged in the global community, donating hundreds of millions of dollars of medicines to treat AIDS patients in Africa, to eliminate blinding trachoma in the developing world and to expand drug access in the United States.

[i] According to NABCO ( Facts about breast cancer in the USA, 2003.

Edelman Public Relations

Related Breast Cancer Articles from Brightsurf:

Oncotarget: IGF2 expression in breast cancer tumors and in breast cancer cells
The Oncotarget authors propose that methylation of DVDMR represents a novel epigenetic biomarker that determines the levels of IGF2 protein expression in breast cancer.

Breast cancer: AI predicts which pre-malignant breast lesions will progress to advanced cancer
New research at Case Western Reserve University in Cleveland, Ohio, could help better determine which patients diagnosed with the pre-malignant breast cancer commonly as stage 0 are likely to progress to invasive breast cancer and therefore might benefit from additional therapy over and above surgery alone.

Partial breast irradiation effective treatment option for low-risk breast cancer
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast irradiation for many women with low-risk, early stage breast cancer, according to new clinical data from a national clinical trial involving researchers from The Ohio State University Comprehensive Cancer Center - Arthur G.

Breast screening linked to 60 per cent lower risk of breast cancer death in first 10 years
Women who take part in breast screening have a significantly greater benefit from treatments than those who are not screened, according to a study of more than 50,000 women.

More clues revealed in link between normal breast changes and invasive breast cancer
A research team, led by investigators from Georgetown Lombardi Comprehensive Cancer Center, details how a natural and dramatic process -- changes in mammary glands to accommodate breastfeeding -- uses a molecular process believed to contribute to survival of pre-malignant breast cells.

Breast tissue tumor suppressor PTEN: A potential Achilles heel for breast cancer cells
A highly collaborative team of researchers at the Medical University of South Carolina and Ohio State University report in Nature Communications that they have identified a novel pathway for connective tissue PTEN in breast cancer cell response to radiotherapy.

Computers equal radiologists in assessing breast density and associated breast cancer risk
Automated breast-density evaluation was just as accurate in predicting women's risk of breast cancer, found and not found by mammography, as subjective evaluation done by radiologists, in a study led by researchers at UC San Francisco and Mayo Clinic.

Blood test can effectively rule out breast cancer, regardless of breast density
A new study published in PLOS ONE demonstrates that Videssa® Breast, a multi-protein biomarker blood test for breast cancer, is unaffected by breast density and can reliably rule out breast cancer in women with both dense and non-dense breast tissue.

Study shows influence of surgeons on likelihood of removal of healthy breast after breast cancer dia
Attending surgeons can have a strong influence on whether a patient undergoes contralateral prophylactic mastectomy after a diagnosis of breast cancer, according to a study published by JAMA Surgery.

Young breast cancer patients undergoing breast conserving surgery see improved prognosis
A new analysis indicates that breast cancer prognoses have improved over time in young women treated with breast conserving surgery.

Read More: Breast Cancer News and Breast Cancer Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to