GRACE :: Breast Cancer

Dr. Hy Muss on Breast Cancer in Older Women: Advanced/Metastatic Cancer and Importance of Functional Status

Dr. Muss closes his presentation with a discussion of the importance of assessing functional status of older patients with breast cancer, as well as other cancers, in making recommendations for the optimal treatment approach.  Here he describes the potential value of more aggressive treatments, along with the need to be judicious in our recommendations in order to reduce the risk of patients developing prohibitive side effects from the therapy.

Below you’ll find the video and audio versions of the podcast along with the transcript and figures for this program.

Muss BC in Older Women Pt 4 Advanced BC and Functional Assessment Audio Podcast

Muss BC in Older Women Pt 4 Advanced BC and Functional Assessment Transcript

Muss BC in Older Women Pt 4 Advanced BC and Functional Assessment Figs

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

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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Dr. Hy Muss on Breast Cancer Prevention, Screening, and Goals of Therapy in Older Women

Here’s the second podcast from Dr. Hy Muss’s great presentation on breast cancer in older women. In this portion, he discusses considerations in prevention, the controversial role of breast cancer screening as women get older and may not benefit from further screening, and also defining the goals of therapy once breast cancer is diagnosed.

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

Muss Breast Ca in Older Women Pt 2 Prevention, Screening, Goals of Rx Audio Podcast

Muss Breast Ca in Older Women Pt 2 Prevention, Screening, Goals of Rx Transcript

Muss Breast Ca in Older Women Pt 2 Prevention, Screening, Goals of Rx Figures

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Dr. Hy Muss on Breast Cancer in Older Women: Population Trends by Age

Dr. Hy Muss, medical oncologist and Director of the Geriatric Oncology Program at the University of North Carolina, Chapel Hill, is both a renowned expert in breast cancer and among the world’s leading luminaries on the important topic of cancer care in older patients.  Though many times it’s young celebrities with breast or other cancer who gather the attention of the media, in truth cancer is a disease that still disproportionately affects older people.  Much of the cancer in the real world of our oncology clinics is elderly patients, who are also understudied in our research relative to their importance as a population.

Dr. Muss was kind enough to sit down with our own very excellent Dr. Jared Weiss, also at UNC-Chapel Hill, to do a slide-based presentation of the leading important points on breast cancer in older women. Here’s the first part of that presentation, including video and audio versions of the podcast, along with the associated transcript and figures.

Muss Breast Ca in Older Women Pt 1 Pop Trends by Age Audio Podcast

Muss Breast Ca in Older Women Pt 1 Pop Trends by Age Transcript

Muss Breast Ca in Older Women Pt 1 Pop Trends by Age Figures

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Is One Year of Adjuvant Herceptin for Early Stage Breast Cancer Really Optimal?

Since the FDA approval of Herceptin in the adjuvant setting for HER2-positive, early stage breast cancer, one year of Herceptin has been the standard length of therapy. This was based on the design of multiple, large, randomized trials that were published in 2005. Many people, however, argued that the choice of one year was not based on scientific data, and that is was somewhat arbitrary. Two studies presented at the 2012 Congress of the European Society for Medical Oncology (ESMO) in Vienna this past week, however, supported the belief that one year of therapy is optimal. In the two studies presented at ESMO, investigators evaluated both shorter and longer durations of Herceptin treatment.

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Molecular Subtypes of Breast Cancer

Breast cancer is a remarkably diverse disease.  In terms of gene expression there are multiple different molecular subtypes of breast cancer.  Dr. Chuck Perou and his colleagues demonstrated that the way an individual breast cancer behaved was associated with differences in the expression of various genes in the tumor. From the genes in the tissue samples, they selected a subset of 456 genes which they named the “intrinsic” gene subset. This subset contained genes that were significantly different among different breast cancers. Using this subset, they were then able to identify 5 very different molecular subtypes of breast cancer:

  • ER-positive/luminal A
  • ER-positive/luminal B
  • Basal-like
  • HER2-positive
  • Normal breast

These five molecular subtypes have been confirmed in independent data sets, and importantly, the individual gene expression subtype appears to remain consistent between the original tumor and subsequent metastatic lesions occurring years later.  Furthermore, these subtypes are associated with differences in clinical outcome. Sorlie and his colleagues examined a subset of 49 locally advanced breast cancers that had been treated with adriamycin and found that both relapse-free (RFS) and overall survival (OS) differed significantly among the breast cancer subtypes.  Luminal A tumors had the longest survival times, the basal-like and HER2+/ER- subtypes had the shortest survival times and the luminal B tumors had intermediate survival times

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

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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Perjeta (Pertuzumab) Approved by FDA for HER2-Positive Advanced Breast Cancer

On June 8, The U.S. Food and Drug Administration (FDA) approved Perjeta (pertuzumab) to treat patients with metastatic, HER2-positive breast cancer who have not received previous treatment with either chemotherapy or HER2-targeted therapy. Approximately 20-30% of breast cancer is HER2-positive.

Herceptin is a monoclonal antibody that works by blocking HER2. While Perjeta also targets HER2, it binds to a different area of the HER2 protein and prevents the HER2 protein from combining with other HER receptors (HER1, HER3, and HER4). This prevents tumor growth and survival. Perjeta’s mechanism of action is therefore believed to be complimentary to that of Herceptin. In fact, Perjeta by itself has very little activity; its real use is in combination with Herceptin.

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Antibody-Drug Conjugate T-DM1 Offers New Mechanism and Significant Benefit in HER2-Positive Breast Cancer

Right at the top of the list of the most exciting news from the 2012 American Society of Clinical Oncology (ASCO) meeting in Chicago this week involved using T-DM1 to treat metastatic, HER2-positive breast cancer.  T-DM1 is an “antibody-drug conjugate” (ADC).

ADCs combine a tumor-specific antibody with a chemotherapy drug. They are therefore specifically designed to be able to deliver chemotherapy drugs directly to tumor cells (like a “smart bomb”), potentially increasing efficacy and decreasing damage to normal cells. T-DM1 combines the anti-HER2 antibody Herceptin (trastuzumab), a stable linker and a chemotherapy agent, DM1, also known as emtansine.

Befitting its importance, the EMILIA trial was presented at the high profile Plenary Session. In this study almost 1000 patients with metastatic, HER2-positive breast cancer whose disease had progressed after treatment with a taxane and Herceptin were randomized to receive Xeloda (capecitable) plus Tykerb (HER2-inhibiting tyrosine kinase inhibitor lapatinib) or T-DM1. Xeloda and Tykerb are oral drugs; the T-DM1 was given intravenously every 3 weeks. There was no “cross-over”, meaning that patients whose disease progressed on Xeloda and Tykerb did not have access to T-DM1.

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Drugs for Breast Cancer Prevention

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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