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Intergroup Exemestane Study (IES): A Large Landmark Switch Trial
Hormonal therapy strategy for postmenopausal women with ER+ breast cancer
Patient Profile: AROMASIN® in Postmenopausal Women with Advanced Breast Cancer
AROMASIN® Safety and Tolerability Data
Read More about Ongoing Clinical Research with AROMASIN®
LINK to the latest IES published studies

  Burden of Breast Cancer

Full Prescribing Information
Important Safety Information
  AROMASIN InfoSite Home

Burden of Breast Cancer

Approximately 3 million women in the US are living with breast cancer[1]





AROMASIN® (exemestane tablets)

AROMASIN is indicated for adjuvant treatment of postmenopausal women with estrogen receptor-positive early breast cancer who have received 2 to 3 years of tamoxifen and are switched to AROMASIN for completion of a total of 5 consecutive years of adjuvant hormonal therapy.

AROMASIN is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

Important Safety Information

AROMASIN (exemestane tablets) should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking estrogen-containing agents.

Dose modification is recommended for patients who are receiving certain medications, including strong CYP 3A4 inducers such as rifampicin and phenytoin.

In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving exemestane than either tamoxifen or placebo.

Reductions in bone mineral density over time are seen with AROMASIN use.

Incidence of adverse events (AEs; %) occurring in ≥10% of patients in any treatment group (AROMASIN vs tamoxifen) in the Intergroup Exemestane Study (IES): hot flushes (21.2 vs 19.9), fatigue (16.1 vs 14.7), arthralgia (14.6 vs 8.6), headache (13.1 vs 10.8), insomnia (12.4 vs 8.9), and increased sweating (11.8 vs 10.4).

In IES, discontinuation rate due to AEs was similar between AROMASIN and tamoxifen (6.3% vs 5.1%). Incidence of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia): AROMASIN 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: AROMASIN 0.4%, tamoxifen 0.3%.

Most common adverse events reported for advanced breast cancer were mild to moderate and included hot flashes (13%), nausea (9%), fatigue (8%), increased sweating (4%), and increased appetite (3%).



References

  1. Facts about breast cancer in the United States: Year 2007. National Breast Cancer Coalition Web Site. http://www.natlbcc.org/bin/index.asp?strid=427&depid= . Accessed March 29, 2007.
  2. Jemal A, Murray T, Ward E, et al. Cancer statistics, 2005. CA Cancer J Clin. 2005;55:10-30.
  3. Li CI, Daling JR, Malone KE. Incidence of invasive breast cancer by hormone receptor status form 1992 to 1998. J Clin Oncol. 2003; 21:28-34
  4. Yabroff KR, Lawrence WF, Clauser S, Davis WW, Brown ML. Burden of illness in cancer survivors: findings from a population-based national sample. J Natl Cancer Inst. 2004;96:1322-1330.
  5. Veronesi U, Boyle P, Goldhirsch A, Orecchia R, Viale G. Breast cancer. Lancet. 2005;365:1727-1741.
  6. Clemons M, Goss P. Mechanisms of disease: Estrogen and the risk of breast cancer. N Engl J Med. 2001;344:276-285.
  7. Sasser AC, Rousculp MD, Birnbaum HG, Oster EF, Lufkin E, Mallet D. Economic burden of osteoporosis, breast cancer and cardiovascular disease among postmenopausal women in an employed population. Women's Health Issues. 2005;15:97-108.
  8. Warren JL, Brown ML, Fay MP, Schussler N, Potosky AL, Riley GF. Costs of treatment for elderly women with early-stage breast cancer in fee-for-service settings. J Clin Oncol. 2002;20:307-316.
  9. Arozullah AM, Calhoun EA, Wolf M, et al. The financial burden of cancer: estimates from a study of insured women with breast cancer. J Support Oncol. 2004;2:271-278.