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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.
-end-
Full prescribing and safety information, including black box warnings, can be found at http://www.pfizeroncology.com.

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 (www.nabco.org): Facts about breast cancer in the USA, 2003.

Edelman Public Relations

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