Introduction: A 54-Year-Old Woman With ER+/PR+ Breast Cancer

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EP: 1.Introduction: A 54-Year-Old Woman With ER+/PR+ Breast Cancer

EP: 2.Adjuvant Therapy Options for HR+ Breast Cancer

EP: 3.CDK4/6 Inhibitor Breast Cancer Clinical Trials

EP: 4.Common Adverse Events With CDK4/6 Inhibitors

EP: 5.Case Patient Prognosis

EP: 6.ER+ Early Breast Cancer Future Directions and A Note on Ki-67 Analyses

Lowell Hart, MD, FACP: The patient we’re discussing is a 54-year-old woman who’s in excellent health, has an ECOG [Eastern Cooperative Oncology Group] performance status of 0, and she is postmenopausal for several years.

She recently was found to have a right-sided breast mass, had a biopsy done, and eventually underwent a partial mastectomy and axillary node procedure.

Her tumor was found to be 2.4 cm in greatest dimension. It did have positive axillary lymph nodes. There were 3 positive axillary lymph nodes and the histology of the tumor was infantry ductal carcinoma.

It was strongly positive for estrogen receptors at 100% and also strongly positive for progesterone receptors at 97% and was negative for HER2 [human epidermal growth factor receptor 2] amplification. It did have a relatively high Ki-67 on centralized testing at 45%.

The final staging of the patient was a T2N1 stage, which is IIB, and the patients recovered well from surgery. The question to address is what sort of adjuvant treatment should this patient get?

Well, first of all, obviously since the patient had less than a total mastectomy, the patient should have radiation therapy to the intact breast. This patient also did have a recurrence score sent and on that the score was 30. That’s in the high-risk range.

I would offer this patient some adjuvant chemotherapy, assuming that she had no contraindications and recovered well from the surgical procedure. Generally speaking, a patient like this who’s estrogen receptor-positive, obviously, there are several choices for adjuvant chemotherapy that would be appropriate.

I would probably, for a post-menopausal patient like this, offer her cyclophosphamide and docetaxel [Taxotere] every 3 weeks for 4 cycles, avoiding anthracycline [Adriamycin (doxorubicin), Caelyx (liposomal doxorubicin), Cerubidine (daunorubicin)], which I often do in patients like this who are also going to be getting adjuvant endocrine therapy.

At the completion of that, the patient would fall into a group that we would have studied on the monarchE trial, which everyone knows now has been recently presented and published in the JCO [Journal of Clinical Oncology] and has been a follow-up of the trial in the recently completed San Antonio meeting.

This patient would be a candidate after the completion of her adjuvant chemotherapy to go on an aromatase inhibitor plus 2 years of abemaciclib [Verzenio]. That’s where I would personally offer this patient, assuming that the patient was interested in that.

It would be at least 5 years of aromatase inhibitor therapy, although often in patients like this with stage II or higher disease, I’m using more extended adjuvant endocrine therapy and we’d offer them for the first 2 years abemaciclib inhibition. That would my treatment plan for this type of patient.

Patients like this will typically present, at least in the Western countries, as having an abnormality found on a mammogram.

Sometimes the patient does find a mass herself which are typically obviously, somewhat larger, but I would say the majority of the patients we see these days are found with abnormalities on mammograms, which is good because it’s much more of a chance that it’s going to be a stage I cancer.

Sometimes we do find patients that have larger cancers that have either been neglected or the patient is in the assumption that it is benign growth and are larger. We can certainly see that, although happily, it’s less frequent than it was in the earlier days of my practice and training days.

The majority of postmenopausal patients will present with estrogen receptor and present on receptor-positive cancer. This patient is fairly typical for that.

There’s some discordance in what she had because she had an aggressive cancer, which was also strongly positive for hormone receptors, but did have a fairly high growth fraction on the Ki-67 and did have 3 positive lymph nodes.

This is a patient that certainly is at significant risk for both early and late recurrence and does definitely need to get adjuvant therapy.

This patient, I would say is on the more advanced side of the spectrum from what we usually like to see and what we expect to see but certainly, we can see patients like this, and frequently do.

This patient does fall into a range that many of us would send a recurrence score test or other molecular test. There are other tests.

There’s both of the Oncotype DX assay and there’s also data on MammaPrint assay. Both of those have randomized trial data in patients who are stage II. Most frequently in this country, based on how they respond to data, patients like this could get assay sent.

If the patient had a very low-risk profile, this patient could potentially as a postmenopausal woman whose hormone receptor-positive, has 1 to 3 nodes positive, if there was a low-risk profile that came back or even actually an intermediate risk on the recurrent score, the patient could potentially be able to avoid adjuvant chemotherapy and go directly onto hormonal therapy.

In this case, it would be hormonal therapy with aromatase inhibitor plus abemaciclib. If the recurrent score were to be low, we could potentially avoid chemotherapy in this patient. That would be a reason certainly to send it.

In this case, their score was not low so that showed there would be a significant benefit to the addition of adjuvant chemotherapy, which is why I recommended it for this case. Some people will get imaging looking for distant metastatic disease in patients who are node positive.

I usually do this in patients that present luckily advanced, have palpable adenopathy, or something or ultrasound or a mammogram or MRI that suggests there is involved axillary lymph nodes. I will often get a staging with CT or PET [positron emission tomography]. I would say this sort of patient would probably not get that in the standard basis.

If this patient say had 4 nodes positive, or more than 4 nodes positive, then you could make a case for administering the patient or offering the patient chemotherapy without necessarily doing a molecular profile because the patient would then be at a high risk no matter what the molecular profile showed.

With that sort of presentation, with a little more advanced than this, I will usually just go ahead and offer the patient chemotherapy.

Occasionally, there are patients that are very hesitant because of perhaps past experience of other family members about chemotherapy or are very mentally opposed to it.

Sometimes we do use molecular testing on those patients to help give them another piece of information about the potential benefits of it.

This transcript has been edited for clarity.

Case: A 54-Year-Old Woman with ER+/PR+ Breast Cancer

Initial Presentation

• A 54-year-old, postmenopausal woman presents with a newly diagnosed lump in her right breast
• She has no family history of cancer and underwent menopause at age 50

Clinical work-up

• Imaging demonstrated a 2.4-cm solid mass in the right upper quadrant with no suspicious lymphadenopathy identified
• Core biopsy: positive for invasive ductal carcinoma, ER 100%, PR 97%; HER2 1+ and FISH negative; Ki-67 45%; modified Bloom-Richardson grade 3
• Lumpectomy and sentinel lymph node biopsy performed
  • Tumor size is 2.4 cm, and 3 LNs are positive for metastatic disease
• 21-gene assay recurrence score is 30
• pT2N1M0, stage IIB
• ECOG PS is 0

Treatment

• Patient underwent partial mastectomy with no residual disease
• She is given radiation therapy to intact breast
• She is started on adjuvant chemotherapy with cyclophosphamide and docetaxel

Followed by adjuvant therapy with AI + 2 years of abemaciclib