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Track 8

DR LOVE: Edith, what are your thoughts about the use of the Oncotype DX assay in this case?

DR PEREZ: Typically I would not order Oncotype DX for this patient because my usual approach is AC followed by weekly paclitaxel and then hormonal therapy. I would order the assay only if I thought it would change my management.

For example, if the patient were willing to forgo chemotherapy and receive only hormonal therapy if her Recurrence Score was low, I would order it. However, if the decision had already been made to use chemotherapy, then I would not.

DR LOVE: If the sentinel node were completely negative, would you feel differently?

DR PEREZ: Yes, in that case I would order the Oncotype DX assay. With a 1.4-cm, Grade I, strongly ER-positive, PR-positive tumor, the likelihood of a high Recurrence Score is low, but I believe the information is helpful when treating patients like this.

DR LOVE: Eric, it sounds as though Edith has reservations about the use of the Oncotype DX assay for patients with positive nodes. What do we know about this assay for patients with node-positive disease?

DR WINER: We know less than we would like, but we do have a moderate amount of information. We have data from Dr Albain’s study that randomly assigned postmenopausal patients with ER-positive, node-positive breast cancer to receive tamoxifen with or without CAF (Albain 2001, 2007).

They found the assay was not only prognostic of outcome but also predictive of chemotherapy benefit. For the patients with low Recurrence Scores, the added benefit of CAF was essentially nil.

DR LOVE: What about the TransATAC data that were presented at San Antonio, evaluating Oncotype DX for patients who received aromatase inhibitors and those who received tamoxifen?

DR WINER: The suggestion had been made that perhaps Oncotype DX would work differently for patients on aromatase inhibitors than for those receiving tamoxifen. However, the TransATAC data showed the assay to be prognostic for patients on either endocrine therapy, and some of those patients had node-positive disease (Dowsett 2008; [1.12]).

DR LOVE: How would you treat this patient?

DR WINER: I would not administer chemotherapy to this patient unless she twisted my arm or she had a high Oncotype DX Recurrence Score. With a strongly ER-positive, PR-positive, low-grade tumor with minimal node involvement, she fits into the category in which the benefit associated with chemotherapy was particularly modest in multiple studies and retrospective analyses.

It’s not important to me whether I obtain an Oncotype score for a patient like this. If the test has been ordered, I’ll review it and if the score is high, which I believe is extremely unlikely, I will administer chemotherapy.

However, if the patient said she wouldn’t receive chemotherapy anyway, I wouldn’t order the test and I’d happily administer endocrine therapy alone.

DR LOVE: Kathy, what would you do?

DR MILLER: I agree with Eric entirely about not using chemotherapy for this patient. I would order the assay only with the thought that a high score would change my management, but I believe that is unlikely with this patient — although not inconceivable.

DR LOVE: Dr Tsarwhas, was the Oncotype DX assay performed for this patient?

DR TSARWHAS: Yes. The Recurrence Score was 14, the ER was strongly positive at 8.6 and the PR was 7.5. I treated her with tamoxifen and goserelin. My plan was to administer goserelin for a couple of years because she was perimenopausal at the time of diagnosis, then five years of tamoxifen followed by five years of letrozole.

DR LOVE: How does each of you feel about the choice of hormonal therapy for this patient?

DR WINER: Other than the ABCSG trial, I’m not aware of any data from the adjuvant aromatase inhibitor trials that address using an aromatase inhibitor up front for a woman who is premenopausal at diagnosis. So I would use tamoxifen initially for this patient, regardless of whether she received it alone or with ovarian suppression or even whether she chose to have her ovaries removed.

In the ABCSG trial, the two arms — ovarian suppression with tamoxifen versus ovarian suppression with an aromatase inhibitor — were equivalent with regard to benefit (Gnant 2009). The ongoing SOFT and TEXT studies are both evaluating ovarian suppression with tamoxifen versus suppression with an aromatase inhibitor for premenopausal patients.

DR MILLER: I certainly use ovarian suppression, but I don’t do it for everyone because ovarian suppression in a young woman is not easy from a quality-of-life standpoint. I tend to consider it for a patient who is 50 years old and may be menopausal naturally within the next couple of years, although I would also consider it for 30- and 40-year-old patients who are at high risk.

DR PEREZ: In our practice, we would not routinely recommend ovarian suppression for premenopausal women with ER-positive tumors. We strongly believe in conducting the SOFT study, and until it is completed, tamoxifen is our standard outside of a clinical trial.

DR LOVE: Eric, would you consider bisphosphonate therapy for this patient?

DR WINER: Yes, because this is the specific situation that was evaluated in the ABCSG-12 trial. After the bisphosphonate data were presented (1.13), we decided as a group to discuss bisphosphonate therapy with these patients. However, we do not consider the treatment standard.

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