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A 40-year-old woman with a breast lump
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The patient is a 40-year-old otherwise healthy woman who came in for a new evaluation of breast cancer. The patient reported that she was well until she noticed a lump in her left breast. She had an unremarkable screening mammogram three months prior. At the time of evaluation of her left breast lump, a 1 cm to 2 cm mass was palpated in the outer quadrant of the left breast.
She was evaluated with mammography and ultrasound, in which a mass in the left breast was identified. She had a breast MRI performed, which revealed a nodular area of 2.3 × 1.5 × 2.0 cm in the left breast. There were also areas of distortion in the architecture involving the right breast. The patient was evaluated with biopsies revealing invasive ductal cancer in the left breast and fibrous tissue in the right breast. The patient opted for a bilateral mastectomy with immediate reconstruction.
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Pathology revealed a 1.1 cm tumor that was grade 1 with no evidence of angiolymphatic invasion in the left breast. Fibrous changes were appreciated in the right breast. Left sentinel node biopsies were negative in one of three lymph nodes. The tumor was ER/PR positive and HER2/neu negative.
Later, the patient came in for a new consultation. She had immediate reconstruction after her bilateral mastectomy, and she reported that she has had significant pain and fatigue since recovering from surgery. She had tissue expanders in place. In general, she felt overwhelmed with the new diagnosis.
The patient had no infectious complications, no fevers or chills, no chest pain or shortness of breath, and no nausea, vomiting or changes in her weight. Her review of systems is otherwise negative.
- Previous gynecological history: The patient underwent menarche at age 13. She had not had any previous breast biopsies. Her previous mammogram was normal. She was on oral contraceptive therapy for a short period of time during college. She had never been on any hormonal treatment otherwise. She had a hysterectomy for a uterine fibroid and had not had any menstrual periods since this surgery one year prior. She had not had any symptoms of menopause. She had two pregnancies and two live births. She breast-fed both of these children.
- Past medical history: Hysterectomy and unilateral oophorectomy.
- Social history: Full-time mother of two children. No tobacco or alcohol use.
- Family history: Maternal grandmother diagnosed with breast cancer in her 80s. No other malignancies.
Her physical examination was significant for a healthy woman in no apparent distress. There were no palpable lymph nodes in the cervical, supraclavicular or axillary region. Her heart and lungs were unremarkable. A chest exam revealed clean incisions with tissue expanders in place. There was no surrounding erythema or warmth, and no evidence of seromas.
What treatment recommendations would you make?
A) Tamoxifen daily for five years.
B) Adjuvant chemotherapy with doxorubicin and cyclophosphamide followed by five years of hormonal treatment.
C) Oophorectomy and five years of an aromatase inhibitor.
D) Perform an Oncotype Dx evaluation.
CASE DISCUSSION
This patient had been diagnosed with a T1cN0Mx, premenopausal invasive ductal carcinoma of the left breast. The tumor was ER/PR positive and negative for HER2-neu.
In this case of stage I breast cancer, the patient has an approximate 10% risk of recurrent disease 10 years after the completion of adjuvant tamoxifen. Without any nodal involvement, the question arises as to whether the patient may benefit from adjuvant chemotherapy in addition to hormonal treatment. In this particular case, an Oncotype Dx analysis was performed and the patient’s score returned as 16.
Oncotype Dx is a 21-gene recurrence score assay. It is an RT–PCR-based multigene assay that can be performed on fixed, paraffin embedded breast tissue. It measures the expression of 16 cancer genes. The results of the test, based on the selection of prognostic genes, may be used to aid in the management of patients with node-negative, HER2-neu-negative, ER-positive breast cancer. The resulting number was derived in order to develop a recurrence score.
Using the results of the NSABP B-20 study in which patients with node negative, ER-positive breast cancer were randomized to tamoxifen or chemotherapy (cyclophosphamide, methotrexate and 5-FU) followed by tamoxifen, Paik and colleagues were able to confirm the likelihood of breast cancer recurrence as well as quantify the magnitude of benefit in receiving adjuvant chemotherapy as opposed to only hormonal therapy.
With these results, patients with a high score (>31) will clearly benefit from the use of systemic chemotherapy; the distant recurrence rate was 40% vs. 12% in those treated with tamoxifen alone as compared with systemic chemotherapy and tamoxifen combined. For patients with a low risk of recurrence (<18) the risk of recurrence after 10 years of tamoxifen is considered to be <3%. As a result, the risks of adjuvant chemotherapy may not outweigh the small potential benefits of these agents.
For patients with an intermediate score, it is really unclear whether systemic adjuvant chemotherapy will provide additional benefit. The TAILORx trial was designed to try to answer this question. Within the TAILORx trial, women with node-negative, ER-positive breast cancer with an Onctype Dx recurrence score of 11 to 25 are eligible to be randomized to hormonal treatment only or adjuvant chemotherapy plus hormonal treatment.
In our patient, the Oncotype Dx score was 16. Although this score is in the low range for recurrent disease, it is the upper end of low. With the use of adjuvant chemotherapy, the patient would likely benefit from reducing her risk of recurrence by an additional few percentage points. Adjuvant chemotherapy options include the use of AC (adriamycin/cyclophosphamide) or TC (docetaxel/cyclophosphamide) or others.
With the use of adjuvant doxorubicin, the patient is at risk for developing myelosuppression, nausea and alopecia. In addition, she has an approximate 3% risk of developing symptomatic cardiomyopathy and a 20% to 25% risk of developing asymptomatic cardiomyopathy, defined as an at least 10% reduction in ejection fraction. There is also a 1% risk of secondary malignancies such as myelodysplastic syndrome and acute leukemia.
With the use of docetaxel, the cardiac risk is removed, but there is the significant risk of neuropathy. Overall, the benefits of adding adjuvant chemotherapy in reducing the patient’s overall risk for breast cancer recurrence needs to be weighed against the risks of developing these secondary complications from chemotherapy. A joint discussion between the oncologist and the patient needs to take place.
For our patient, we recommended enrollment in the TAILORx clinical trial in which case she would be randomized to hormonal treatment alone or systemic adjuvant chemotherapy in conjunction with hormonal therapy. Despite our suggestion, our patient opted for adjuvant systemic chemotherapy followed by adjuvant hormonal treatment.
Anne H. Blaes, MD, is a Fellow at the University of Minnesota and a member of the HemOnc Today Editorial Board.
For more information:
- Hayek ER. N Engl J Med. 2005;352:2456-2457.
- Paik S. N Engl J Med. 2004;351:2817.
- Paik S. J Clin Oncol. 2006; 24:3726-3734.