Press Release

PRESS STATEMENT

NEW LANDMARK TRIAL INDICATES BENEFIT OF AROMASIN (EXEMESTANE)
IN EARLY BREAST CANCER

International trial of almost 10,000 women shows that use of exemestane is linked to a reduction in relative* risk of cancer recurrence of up to 17% compared to more established treatment
San Antonio, US – The aromatase inhibitor (AI) exemestane given to women with early breast cancer reduces the relative risk of breast cancer recurrence (measured by disease free survival or ‘DFS’) by 11 per cent, (p=0.12), compared to tamoxifen, a landmark worldwide study involving nearly 10,000 postmenopausal women has found. While the result from the primary analysis was not statistically significant, this DFS relative risk benefit with exemestane increased further to a statistically significant 17 per cent (p=0.022) when patients who discontinued or crossed over early from the tamoxifen to exemestane arm were removed from the analysis.

The multi-centre Tamoxifen and Exemestane Adjuvant Multicenter (TEAM) trial, presented at the San Antonio Breast Cancer Symposium (SABCS), US, compares early events by measuring disease-free survival (DFS: disease progression or death) at 2.75 years in patients randomized to initial therapy with either tamoxifen or exemestane. An exploratory analysis also found that women on exemestane had a 19 per cent lower relative risk of developing tumours in other parts of their body compared to those on tamoxifen.

“TEAM is the largest trial of aromatase inhibitors vs. tamoxifen in the critical phase following surgery for early breast cancer,” commented Dr. Daniel Rea, Honorary Consultant in Medical Oncology at University Hospital Birmingham and Principal Investigator of the UK arm of TEAM. “TEAM convincingly demonstrates that distant recurrence, a feared outcome after surgery, is reduced in the first few years after diagnosis when Aromasin is used initially instead of tamoxifen.”
*The relative risk reduction is the proportionate reduction in risk between the drug under investigation and a placebo or comparator drug. For example, if treatment A results in 5% cancer recurrences per year and treatment B results in 10% cancer recurrences per year, the relative risk reduction would be 5/10 =50%.
Absolute risk reduction refers to the difference in new events between the treatment under investigation and the placebo or comparator drug. For example, if treatment A results in 5% cancer recurrences per year and treatment B results in 10% cancer recurrences per year, the absolute risk reduction would be 10% minus 5% =5%.
Exemestane is currently unlicensed for initial therapy but indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor-positive invasive early breast cancer, following two to three years of initial adjuvant tamoxifen therapy. It has been licensed for the treatment of advanced breast cancer in patients that have progressed on anti-oestrogen therapy since 1999.

“In my opinion, TEAM is a trial that is large enough to determine reliably whether this benefit of an AI is sustained when the AI is given for a full five years or if an AI is started after two to three years of tamoxifen,” Dr Rea continued. “TEAM is designed ultimately to identify which of these two strategies – switching from tamoxifen to an AI, or using an AI up front for five years - is most suited to individual patients.”

It is estimated that more than 90,000 women with breast cancer have been prescribed tamoxifen in the UK in the last 12 months . While tamoxifen has successfully treated many thousands of women, the TEAM data show that a further benefit can be derived from exemestane.

Dr Rajiv Agrawal, Consultant Oncologist at Royal Shrewsbury Hospital and a UK investigator in the TEAM trial, said: “The TEAM results are very exciting for women with breast cancer, because they add to the growing knowledge supporting the use of aromatase inhibitors in early breast cancer.”

Exemestane is known to be beneficial in the switch setting and is the only AI with a demonstrated overall survival benefit. The Intergroup Exemestane Study (IES) trial showed that switching to exemestane reduces the relative risk of dying by 17 per cent, compared with remaining on tamoxifen for five years . In 2006, NICE issued guidance recommending that postmenopausal women with oestrogen receptor-positive early breast cancer who are currently on tamoxifen are considered for a switch to exemestane after two to three years .

The TEAM trial
TEAM is an open-label, randomised, multinational, phase 3 trial that commenced in 2001. The data presented at SABCS are from the first 2.75 years of the five-year trial, which involved 9,775 women in nine countries, including 1,275 in the UK and Ireland. TEAM is the largest trial to directly compare the efficacy and safety of tamoxifen with exemestane.

For further information, please contact:

Pfizer Limited
Phillippa Manning
Communications Manager, Pfizer UK
Tel: 01737 331 264
Email: phillippa.manning@pfizer.com Reynolds MacKenzie
Alison MacKenzie / Anna Radnavale
Tel: 020 7031 4360 / 4404
Mobile: 07989 353 779 / 07971 313 240
Email: alison@reynoldsmackenzie.com
anna@reynoldsmackenzie.com

Notes to Editors:

Cancer Research UK has supported this trial since 2001.

TEAM trial side effects
The most common side effects reported in the TEAM trial were consistent with the expected safety profile of these treatments. Side effects were coded by NCI CTC (version 2), and included for tamoxifen and Aromasin (all grades), respectively: hot flushes (33 per cent, 28.5 per cent); arthralgias (9.2 per cent, 18.4 per cent); fatigue (16 per cent, 16.8 per cent); pain (13.2 per cent, 14.6 per cent); infection (13 per cent, 11.9 per cent). The incidence of bone-related side effects for tamoxifen and Aromasin, respectively, were: osteoporosis (2.2 per cent, 4.9 per cent); and spine/wrist/hip fractures (0.5 per cent, 0.6 per cent).

Aromasin (exemestane) indication
Aromasin (exemestane) is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor-positive invasive early breast cancer, following two to three years of initial adjuvant tamoxifen therapy. It has been licensed for the treatment of advanced breast cancer in patients that have progressed on anti-oestrogen therapy since 1999. The most common side effects of exemestane are hot flushes, osteoporosis and fatigue.

Breast cancer facts
• Breast cancer is the most common cancer in women – more than 45,600 women were diagnosed in the UK in 2005
• It is estimated that 31,000 postmenopausal women are diagnosed with breast cancer every year in the UK3
• The strongest risk factor for breast cancer is age: the older the woman, the higher the risk4
• Most cases of breast cancer are in postmenopausal women – more than 80 per cent of cases occur in women aged over 504

Pfizer Oncology
Pfizer Oncology is committed to advancing the scientific understanding of cancer and to bringing new medicines to address unmet medical needs in cancer patients. Oncology is a research priority for Pfizer, with 22 percent of the company’s research and development investment devoted to discovering and developing innovative therapies for treating breast, colorectal and other cancers.

For more information:
http://www.pfizer.com