GRACE :: Breast Cancer

Endocrine/Hormonal Therapy

Dr West

Breast Cancer in Older Women: Surgery and Adjuvant Therapy, by Dr. Hy Muss

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Dr. Hy Muss, breast cancer expert with a special expertise in treatment of older patients with cancer, continues his presentation on breast cancer in older women with a discussion of the evolution of surgery recommendations in breast cancer, along with a wonderful discussion of how he approaches the benefit vs. risk discussion for post-operative (adjuvant) therapy.  I found myself thinking that his explanation was so helpful that I’d want to incorporate elements of his presentation into my own discussions of the complex issues around adjuvant therapy.

Here are the video and audio versions of the program, along with the associated transcript and figures.

Muss BC in Older Women Pt 3 Surgery and Adjuvant Rx Audio Podcast

Muss BC in Older Women Pt 3 Surgery and Adjuvant Rx Transcript

Muss BC in Older Women Pt 3 Surgery and Adjuvant Rx Figures

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New Targeted Therapy approved for ER-positive, HER2-negative Breast Cancer: Afinitor with Aromasin

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On July 20, 2012, the U.S. Food and Drug Administration (FDA) gave us another option for treating postmenopausal patients with metastatic, ER-positive, HER2-negative breast cancer whose disease has progressed on Arimidex or Femara by approving Afinitor (everolimus) in combination with Aromasin (exemestane). This new approval was based on the BOLERO-2 trial which was a randomized, double-blind, multicenter trial conducted in 724 postmenopausal women.  Patients were randomized to receive either Afinitor 10 mg/day plus Aromasin 25 mg/day or to placebo plus Aromasin 25 mg/day. Both Aromasin and Afinitor are oral drugs.

Aromasin is an aromatase inhibitor which works by lowering estrogen levels in postmenopausal women. This trial was based on the observation that resistance (either not responding or stopping responding) to hormonal therapy is associated with a tumor being able to use pathways other than the estrogen pathway to survive and grow. One example of this is activation of the mammalian target of rapamycin (mTOR) signaling pathway in cells. Afinitor targets the mTOR pathway and is classified as an mTOR inhibitor. 

On the BOLERO-2 trial, the median progression-free survival (PFS) was longer for the patients receiving Afinitor (7.8 vs 3.2 months). These results were consistent regardless of age, race, presence or extent of visceral metastases (such as liver metastases), and response to prior hormonal therapy.  The response rate was also better for the patients receiving Afinitor (12.6% vs 1.7%).  The analysis of overall survival (OS) was not significant however this was an interim analysis.  The final OS analysis isn’t expected to become available until June, 2014.

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Drugs for Breast Cancer Prevention

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Large trials testing drugs to prevent breast cancer (chemoprevention) date back to the 1990s, when tamoxifen was first evaluated in this setting. Tamoxifen is a selective estrogen receptor modulator (SERM). SERMs block the effects of estrogen in breast tissue by binding to the estrogen receptors in breast cancer cells leaving no room for estrogen to attach to the receptor. If estrogen can’t attach, it is unable to signal the cell to grow and multiply. The initial, large-scale breast cancer chemoprevention trial was the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial (P-1), initiated in 1992. P-1 randomized approximately 14,000 women who had a risk of at least 1.66% of developing breast cancer in the upcoming 5 years to 5 years of tamoxifen or placebo. Risk was assessed using the Gail model, which is a tool designed by scientists at the National Cancer Institute (NCI) and the NSABP to estimate a woman’s risk of developing invasive breast cancer, both in the next 5 years and in her lifetime (assuming she lives to age 90). Factors included in this tool include current age, age of menarche (first menstrual period) and first live birth, number of first degree relatives with breast cancer, and whether or not a woman has had breast biopsies in the past with or without atypical cells.  In the P-1 trial, 5 years of tamoxifen reduced the risk of breast cancer by almost 50%. Tamoxifen also led to a 32% reduction in the risk of fractures due to osteoporosis however the risk of strokes, blood clots, uterine cancer and cataracts were increased in the tamoxifen group. As a result of this trial, the FDA approved tamoxifen for breast cancer chemoprevention in women aged 35 and older with a 5-year breast cancer risk of 1.67% or higher.

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