News Release

Study highlights long-term survival & side effect issues of adjuvant breast cancer therapy

New data published in the Journal of Clinical Oncology show ELLENCE® (epirubicin hydrochloride injection) based chemotherapy regimen has survival benefits with low risk of adverse cardiac events

Peer-Reviewed Publication

Edelman Public Relations, New York

New York (August 2, 2004) – Data published today in the Journal of Clinical Oncology shows that two chemotherapy regimens using different doses of ELLENCE are associated with a low risk of heart damage in women with breast cancer. This is the first sub-study to evaluate patients more than eight years after they completed adjuvant treatment with ELLENCE and builds upon results of the FASG-05 study which demonstrated significant 5 and 10 year disease-free and overall survival benefits in patients treated with ELLENCE, an anthracycline cytotoxic agent.

As a result of overall improvements in the treatment of many types of cancer, there are nearly 10 million cancer survivors in America today. This sub-study is part of the emerging movement among healthcare professionals to analyze the long-term side effects associated with commonly used chemotherapy agents and new biologic and targeted therapies.

"Past research indicates that because of its safety profile, including its cardiac safety, ELLENCE is emerging as a standard treatment for women with early-stage breast cancer," said Aman Buzdar, professor of medicine, Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center. "The results of this study demonstrate that the significantly improved disease-free and overall survival associated with higher doses of ELLENCE are not compromised by the potential for cardiotoxicity."

Cardiotoxicity is a harmful side effect that may be caused by breast cancer chemotherapy agents such as anthracyclines.

In this sub-study, which was funded by Pharmacia Corporation, now part of Pfizer Inc., investigators evaluated the long-term effects of two different doses of ELLENCE on cardiotoxicity – a standard dose of 50 mg/m2 and a higher dose of 100 mg/m2. Other recent studies have suggested that higher doses of some chemotherapy agents could improve both disease-free and overall survival. However, the doses received by some patients have been limited by concerns of developing cardiotoxicity which may lead to congestive heart failure (CHF). Meta-analyses have shown that ELLENCE may be associated with less cardiotoxicity than other agents in its class.

"As a survivor, I want a healthy life after breast cancer so the long-term side effects of treatment must figure into the treatment decision," said Zora Brown, founder and chief executive officer of the Breast Cancer Resource Committee, a leading breast cancer advocacy group headquartered in Washington, DC. "This study shows that ELLENCE provides patients with a treatment option that may not weaken a patient's heart."

Study Results and Design

This sub-study, evaluating long-term cardiac function, enrolled 150 relapse-free patients from the FASG-05 trial who had received either standard FEC 50 (fluorouracil 500 mg/m2, epirubicin 50 mg/m2, cyclophosphamide 500 mg/m2) or higher dosed FEC 100 (same regimen with epirubicin 100 mg/m2) every 21 days for six cycles during adjuvant therapy for node-positive breast cancer. The blinded assessment for long-term cardiac injury was performed by a peer-review committee, comprised of three cardiologists and three medical oncologists, and included an evaluation of cardiac events occurring after the end of chemotherapy, vital signs, and concomitant disease among other cardiac parameters. This assessment occurred at a median follow-up of 102 months.

Following the treatment phase of the FASG-05 study, researchers found that at a median follow-up of 67 months, FEC 100 produced a statistically significant improvement in 5-year disease-free (66.3% v 54.8%, P = .03) and overall survival (77.4% v 65.3%, P = .007) compared with FEC 50. A recently presented 10-year update of the FASG-05 trial showed that FEC 100 remained significantly superior to FEC 50 in terms of disease-free (P = .036) and overall survival (P = .038).

During the assessment for long-term cardiac injury, the cardiotoxicity observed after adjuvant treatment with the higher dosed regimen (FEC 100) comprised two cases of well-controlled CHF that were possibly linked to treatment. An additional 18 patients experienced clinically asymptomatic left ventricular dysfunction (LVD), eight where treatment causality was probable. None of these asymptomatic patients developed further cardiac symptoms. In the patients treated with the standard dose regimen (FEC 50), one patient presented with a mild (grade 1) and asymptomatic LVD for which the causality was doubtful.

This sub-study was coordinated by the French Adjuvant Study Group which is comprised of numerous cancer centers conducting breast cancer research in France. A comprehensive article discussing these findings was published in the August issue of The Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology.

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About Breast Cancer and ELLENCE
Breast cancer is the second leading cause of cancer death among women. Breast cancer is the second leading cause of cancer death among women. It is estimated that 213,910 women in the United States will be diagnosed with breast cancer in 2004 and more than 40,921 women will lose their lives to the disease.

ELLENCE is an anthracycline anti-cancer agent and is the first chemotherapy approved by the FDA for use as a component of adjuvant therapy in the treatment of early-stage resectable 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 several 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, heart failure or a type of leukemia can occur.

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 committed $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 involved in the global community, donating hundreds of millions of dollars of medicine to the developing world and to expand drug access in the United States.


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