Tracks 1-13

Track 1 Neoadjuvant endocrine therapy Track 2 Tumor response and biology as prognostic factors after neoadjuvant endocrine therapy Track 3 Extended adjuvant endocrine therapy with aromatase inhibitors Track 4 Preliminary ATLAS results: Ten years versus five years of adjuvant tamoxifen Track 5 Switching from tamoxifen to an aromatase inhibitor when patients become amenorrheic Track 6 European perspective on the Oncotype DX assay Track 7 Pathologic complete response rate with neoadjuvant chemotherapy and trastuzumab for HER2-positive tumors Track 8 Considerations in selecting an adjuvant chemotherapy/trastuzumab regimen Track 9 Treatment of small, node-negative, HER2-positive tumors Track 10 Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) trial Track 11 Increased investigation of combined biologic therapies Track 12 CIRG/NSABP BETH trial: Chemotherapy and trastuzumab with or without bevacizumab in HER2-positive early breast cancer Track 13 Increasing treatment options for HER2-positive breast cancer

Select Excerpts from the Interview

Track 1-2

DR LOVE: Can you summarize what we currently know about neoadjuvant endocrine therapy?

PROF SMITH: Nearly all the work conducted with neoadjuvant endocrine therapy has been with postmenopausal women. Three large trials have compared the aromatase inhibitors to tamoxifen (Cataliotti 2006; Dowsett 2005; Ellis 2003; Smith 2005), all of which demonstrated that the aromatase inhibitors are more effective in terms of tumor regression and reducing the need for a mastectomy.

DR LOVE: How do you approach the choice between neoadjuvant chemotherapy and endocrine therapy?

PROF SMITH: That’s the real crunch. The more I administer neoadjuvant endocrine therapy, the more I wonder why we don’t utilize it more frequently. When it works, it’s extremely effective. Anecdotally, I recently treated a woman in her sixties with a 5-cm, hormone receptor-positive tumor who did not want to receive chemotherapy but wished to avoid mastectomy. I treated her disease with an aromatase inhibitor, and she underwent breast-conserving surgery with only a small, 1-cm residual tumor.

The question was whether or not she needed chemotherapy. Until recently, no data existed to address this question, but we are beginning to evaluate our results from the IMPACT trial, which compared neoadjuvant anastrozole to tamoxifen. Matt Ellis is also evaluating the data from the P-024 trial of letrozole versus tamoxifen.

We are putting together an algorithm that suggests that patients with node-negative breast cancer, a good tumor response (smaller than one centimeter at surgery) and good suppression of Ki-67 while the tumor remains hormone receptor-positive have an excellent long-term outcome (Dowsett 2007). Patients with node-negative breast cancer at surgery with these parameters almost never experience relapse.

Track 3

DR LOVE: Can you discuss the issue of extended adjuvant endocrine therapy beyond five years?

PROF SMITH: The cleanest, most important data of the aromatase inhibitor trials addressing this issue are from MA17, which demonstrated that patients who had received tamoxifen for five years and were switched to letrozole fared better than those who received placebo (Goss 2008; Ingle 2008). The evidence suggests that the longer you treat beyond five years, the greater the benefit.

Another interesting aspect of MA17 is that when the results were first presented after two and a half years — because the benefit was more dramatic than imagined — patients on the placebo were offered the opportunity to switch. Some switched and some did not, but those who did had worse prognostic features in their original disease. Those patients are now faring better than the ones who didn’t switch, even though they had poorer prognoses (2.1). That’s a powerful message regarding the long-term use of aromatase inhibitors. Some women may need to receive these agents for an extended period of time.

Tracks 7-8

DR LOVE: Can you provide an overview of neoadjuvant therapy for patients with HER2-positive tumors?

PROF SMITH: For surgeons dealing with large tumors, the most spectacular data on trastuzumab are in the neoadjuvant setting. A small but influential MD Anderson study showed a pathologic complete response rate of approximately 60 percent with the use of trastuzumab in addition to neoadjuvant chemotherapy (Buzdar 2007; [2.2]).

The results were almost too good to be true, but now a large European trial in inflammatory breast cancer (NOAH) has also demonstrated a high pathologic complete response rate with the addition of trastuzumab compared to neoadjuvant chemotherapy alone (Gianni 2007).

If a patient has a large, HER2-positive breast tumor and you are considering neoadjuvant treatment, then you must administer trastuzumab up front with the chemotherapy rather than waiting until after surgery.

Track 9

DR LOVE: What is your approach for the patient with a node-negative, HER2-positive tumor (Press 1997; [2.3])?

PROF SMITH: The issue that’s beginning to emerge — and I’ve been impressed because it’s changed my thinking — is that the prognosis with HER2-positive tumors of one centimeter or less is approximately a 15 to 20 percent risk of relapse within 10 years (Press 1997). So we probably need to be more aggressive with these small, node-negative, HER2-positive tumors and bias ourselves toward using chemotherapy and trastuzumab.

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INTERVIEWS

Neil Love, MD
Editor

Monica Morrow, MD
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Ian E Smith, MD
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Robert W Carlson, MD
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Soonmyung Paik, MD
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Breast Cancer Update
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