Tracks 1-11

Track 1 Introduction Track 2 NSABP-B-32: Sentinel node biopsy with or without axillary node dissection Track 3 Impact of preoperative biopsy technique on SLNB false-negative rate Track 4 Injection techniques to improve SLNB Track 5 Paresthesias associated with SLNB Track 6 Completion of axillary dissection after positive SLNB Track 7 Development, importance and clinical use of the Oncotype DX assay Track 8 Utility of Oncotype DX to facilitate decision-making regarding adjuvant chemotherapy Track 9 NSABP-B-35: Anastrozole versus tamoxifen for DCIS Track 10 Tolerability of aromatase inhibitors versus tamoxifen Track 11 Background and rationale for current and future NSABP neoadjuvant trials

Select Excerpts from the Interview

Track 2

DR JULIAN: NSABP-B-32 was one of our largest trials. Women with clinically node-negative disease were randomly assigned to receive a sentinel node biopsy with an axillary node dissection or a sentinel node biopsy alone. In the group assigned to a sentinel node biopsy alone, if the sentinel node biopsy was negative, the patient was observed, and if the sentinel node biopsy was positive, the patient went on to have an axillary dissection (Julian 2004).

The trial accrued 5,611 patients in a little less than five years, something that was not thought to be possible at the time. The first technical report came out at the 2004 San Antonio Breast Cancer Symposium. In both groups, we reported a sentinel node identification rate of about 97 percent, and the positive sentinel node rate was 26 percent. In the group assigned to sentinel node biopsy and axillary dissection, the false-negative rate was 9.7 percent (Julian 2004).

Tracks 7-8

DR JULIAN: The Oncotype DX is a great story of using molecular technology and taxonomy to try to select patients who should or should not receive chemotherapy, where previously we may have just used a best-guess estimate to advise them (Paik 2004). This is a very important step in the march toward individualizing treatment for patients.

In fact, it’s even been carried one step further because Terry Mamounas reported data at San Antonio this past year (Mamounas 2005) evaluating the ability of using that type of molecular assay to predict for local recurrences. If you have a high recurrence score, then there’s a strong likelihood that you will have an in-breast local recurrence as well.

DR LOVE: Is there a patient in your practice who you could present in a deidentified way that would make the point about the practical utility of the Oncotype assay?

DR JULIAN: I evaluated a woman in her mid-forties. She had a lesion that was identified mammographically, and she was totally asymptomatic. You could not palpate the lesion, and she was clinically node-negative. She had her core biopsy, and it was an invasive, estrogen receptor-positive, progesterone receptor-positive, HER2-negative ductal cancer. She went on to have a partial mastectomy, and we performed a sentinel node biopsy at the same time.

The tumor was roughly 1.2 centimeters in diameter, and the two sentinel nodes were both negative on final H&E analysis. She did not have any lymphovascular invasion in her tumor, and there were no other tumor parameters that looked worrisome. But, given her age and premenopausal status, we subjected the tumor to an Oncotype DX, and it came back with a recurrence score of 38, which was in the high range. That was important because normally this is a patient who might have gotten a very strong benefit of just being placed on tamoxifen. For her, the recommendation was, “You should also receive adjuvant chemotherapy,” and she’s very much in favor of doing that.

DR LOVE: Did you feel that in your discussions with her that the Oncotype DX was going to decide whether she was going to receive chemotherapy?

DR JULIAN: It was really to provide guidance to her and the medical oncologist because this is a tumor that very easily could have just been treated in the past with antihormonal therapy and, of course, breast irradiation, especially if patients were somewhat hesitant to receive chemotherapy because of the concern about side effects or toxicities. This is a tool that now presents them with very dramatic evidence to say, “It is important for you to know that you’ve got this very strong chance that this cancer will come back beyond what we could predict by using a computerized model.”

Track 9

DR JULIAN: The background includes the prior two DCIS trials — NSABPB-17 and NSABP-B-24. NSABP-B-17 showed the benefit of whole breast radiation therapy with lumpectomy as opposed to lumpectomy alone in reducing the rate of both invasive and noninvasive cancer in the treated breast (Fisher 1998). NSABP-B-24 carried that one step further with the comparison of tamoxifen versus placebo in patients receiving radiation therapy following their lumpectomy (Fisher 1999).

NSABP-B-24 showed a decrease in all breast cancer events with the use of tamoxifen and a reduction in invasive cancers in the ipsilateral breast. Based on those trials and the work performed by Craig Allred suggesting that the impact of the tamoxifen was the greatest in patients with ER-positive disease (Allred 2002), we then carried it one step further to evaluate the use of an aromatase inhibitor in postmenopausal women with DCIS.

The ATAC trial demonstrated a reduction in invasive breast cancers in both the ipsilateral and the contralateral breast with the use of anastrozole compared to tamoxifen (Howell 2005). We believed that the next step would be to compare an aromatase inhibitor to tamoxifen for DCIS in a randomized setting. That was the background and basis for launching NSABP-B-35.

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Editor:
Neil Love, MD

Interviews
Monica Morrow, MD
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Kevin R Fox, MD
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Thomas B Julian, MD
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Robert W Carlson, MD
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Richard M Elledge, MD
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