Tracks 1-12

Track 1 Clinical implications of the NSABP-B-30 and BCIRG 005 studies of adjuvant chemotherapy for node-positive BC Track 2 Adjuvant anthracyclines and long-term risk of congestive heart failure Track 3 Adjuvant chemotherapy for patients with ER/PR-positive BC Track 4 Case discussion: A 62-year-old woman with a 1.5-cm, Grade II, strongly ER/PR-positive, HER2- negative, node-negative BC and an Oncotype DX Recurrence Score® of 41 Track 5 TransATAC: Oncotype DX predicts distant recurrence risk for postmenopausal patients with node-negative or node-positive BC treated with anastrozole or tamoxifen Track 6 Tolerability of adjuvant chemotherapy in the elderly Track 7 FinXX trial: Adjuvant TX CEX compared to T CEF for high-risk BC Track 8 US Oncology/NSABP collaborative adjuvant trial of TC versus TAC versus TC/bevacizumab Track 9 Incorporation of bevacizumab into adjuvant clinical trials in BC Track 10 Meta-analyses of randomized trials of monotherapy and switching strategies with adjuvant aromatase inhibitors and tamoxifen Track 11 Perspective on the ATAC retrospective analysis of treatment-emergent endocrine symptoms and risk of BC recurrence Track 12 Tamoxifen Exemestane Adjuvant Multinational (TEAM) study: First planned analysis

Select Excerpts from the Interview

Tracks 4-5

DR LOVE: What is your opinion of the data from the TransATAC study presented at San Antonio on Oncotype DX?

DR JONES: The Oncotype DX Recurrence Score proved to be an independent predictor of the risk of distant recurrence in postmenopausal patients with ER-positive, node-negative or node-positive breast cancer treated with either tamoxifen or anastrozole (Dowsett 2008; [2.1]).

The Oncotype DX data have been consistent in a variety of settings, and we haven’t seen any surprises. The assay was consistent in one series with node-positive patients, in which they received tamoxifen or chemotherapy in combination with tamoxifen (Albain 2007). It’s been consistent in all the tamoxifen series. Now it’s consistent in the ATAC series. That’s why I believe this assay is so far along.

This assay humbles us a bit. I consider myself to be an experienced breast oncologist. I’ve done this for 35 years. I think I can tell who needs chemotherapy and who doesn’t. That’s my arrogance, but biology and these tests are starting to trump my personal opinion.

Tracks 10, 12

DR LOVE: In addition to a presentation with the sequencing data for BIG 1-98 (Mouridsen 2008; [2.2]), two other important data sets for adjuvant endocrine therapy were presented on the first morning of the San Antonio meeting (Ingle 2008; Jones 2008). Would you summarize your impressions of the data?

DR JONES: First, Jim Ingle presented a meta-analysis examining two cohorts of patients who were treated with different adjuvant endocrine approaches (Ingle 2008; [2.3]).

The first cohort evaluated up-front aromatase inhibitors versus tamoxifen, comprised predominantly of patients from the ATAC and BIG 1-98 studies. A definite reduction in recurrence rates was evident with the up-front aromatase inhibitors, but no difference in overall survival was noted. The second cohort evaluated switching from two to three years of adjuvant tamoxifen to an aromatase inhibitor. This analysis also demonstrated a reduction in recurrence rates for the switching strategy, but more importantly, an improvement in overall survival.

DR LOVE: I think there has been some confusion about trying to compare the two strategies, because the switching studies focused on patients who completed two to three years of tamoxifen and did not experience relapse. What was shown in your presentation of the TEAM study comparing up-front tamoxifen to exemestane ( Jones 2008; [2.4])?

DR JONES: A message came through loud and clear the first morning of the San Antonio meeting, and I was pleased to be the third one to present that message. The TEAM study has been the missing link in that it was the first study with an up-front comparison of tamoxifen to an aromatase inactivator, which has a different mechanism of action than the other nonsteroidal aromatase inhibitors.

In TEAM, the intent-to-treat hazard ratio was 0.89, or an 11 percent reduction in recurrence. However, when we analyzed the study according to patients who were still receiving the treatment to which they were randomly assigned, the HR was 0.83, or a 17 percent reduction.

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Neil Love, MD

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Edith A Perez, MD
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Stephen E Jones, MD
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Sandra M Swain, MD
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Ian E Krop, MD, PhD
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