The study reviewed here found that a tool that looks at four breast cancer characteristics seems to do a good job of predicting whether early-stage hormone-receptor-positive breast cancer is likely to come back (recurrence). The tool assessed recurrence in women diagnosed with early-stage hormone-receptor-positive breast cancer that had been treated with hormonal therapy before surgery.
Hormonal therapy and chemotherapy are used before and after surgery to improve the prognosis of early-stage hormone-receptor-positive breast cancer. Treatments given before surgery:
After surgery, the treatments weaken any cancer cells that may have been left behind and reduce the risk of the cancer coming back.
Many women diagnosed with early-stage hormone-receptor-positive breast cancer wonder if they need chemotherapy after lumpectomy or mastectomy. Since chemotherapy can have uncomfortable or potentially serious side effects, doctors want to give chemotherapy only to women with a high risk of the cancer coming back. The tool evaluated in this study, called PEPI (preoperative endocrine prognostic index), may help women and their doctors make more informed decisions about chemotherapy.
The PEPI tool predicts the risk of breast cancer coming back in women who got hormonal therapy before surgery by looking at four breast cancer characteristics:
The PEPI tool looks at these characteristics AFTER hormonal therapy, when the cancer is removed during surgery. Based on the characteristics, the PEPI tool assigns a score -- the higher the score, the greater the risk the cancer will come back. Women with higher scores are more likely to benefit from chemotherapy after surgery.
In this study, the researchers found:
The link between PEPI scores and the risk of recurrence was similar when the tool was used to evaluate other groups of women. Looking at the PEPI score AND the stage of the cancer helped better predict recurrence risk: the higher the PEPI score and the more advanced the cancer was at surgery, the greater the risk of recurrence.
The researchers concluded that among women who got hormonal therapy before breast cancer surgery, women with a PEPI score of 4 or higher are most likely to benefit from additional treatments after surgery, including chemotherapy, to reduce the risk of the cancer coming back. This is especially true when the breast cancer is stage II or III.
While the PEPI tool looks promising, it needs to be studied in many more women before doctors can routinely use the tool to help make decisions about chemotherapy after surgery.
Another chemotherapy decision-making tool is the Oncotype DX test. This test is used in post-menopausal women diagnosed with hormone-receptor-positive breast cancer. The Oncotype DX test measures the levels of 21 genes in breast cancer cells from a cancer tissue sample. These genes can affect how the breast cancer will behave and respond to certain treatments. These measurements are used to calculate a recurrence score. The higher the recurrence score, the more likely the cancer is to come back or spread. Women with a high recurrence score are more likely to benefit from chemotherapy in addition to hormonal therapy. Women with a low recurrence score may be able avoid chemotherapy that probably won't give them any additional benefits.
If you've been diagnosed with early-stage hormone-receptor-positive breast cancer, you may want to ask your doctor about how chemotherapy decisions will be made. Every woman's situation is unique. Your treatment plan should look at all available information and include a thorough discussion of the pros and cons of all options being considered. Together, you and your doctor will make the best decisions for YOU.
ST. LOUIS, Sept. 23 (MedPage Today) -- A risk prediction tool can help assess the chance of relapse for patients with early stage breast cancer and may be used to determine which women can safely avoid post-op chemotherapy, researchers said.
A patient's score based on tumor size, node status, tumor cell proliferation marker levels, and estrogen receptor status after neoadjuvant endocrine therapy independently predicted relapse-free survival (P=0.002), reported Matthew J. Ellis, M.B., B.Chir., Ph.D., of Washington University here, and colleagues, online in the Journal of the National Cancer Institute.
In their study validating the PEPI (preoperative endocrine prognostic index) score, women with a score of 0 had 3% relapse risk at three years whereas those with a score of 4 or more had 17% relapse risk.
The model may be useful for making clinical decisions, Dr. Ellis' group said.
Patients with low, pathological stage 1 or 0 and a favorable biomarker profile as indicated by a PEPI score of 0 at surgery "had such a low rate of relapse that further adjuvant systemic therapy beyond continuation of an endocrine agent appears unnecessary," they noted.
However, patients with a higher pathological stage at surgery and a PEPI score of 4 or higher should be offered all appropriate adjuvant treatments available, the investigators said.
Neoadjuvant endocrine therapy has been widely adopted as a practical means to improve surgical outcomes for postmenopausal women with estrogen receptor-positive stage 2 and 3 breast cancer, Dr. Ellis' group said.
Prediction of outcomes typically focuses on analysis of the tumor specimen collected for diagnosis, they said, although endocrine therapy responsiveness is assumed to indicate which patients are at lower relapse risk.
Because little has been know about how tumor factors after neoadjuvant hormonal therapy could be used to make decisions on other adjuvant treatments, the researchers examined outcomes in one of the few such trials with sufficient follow-up to address this question.
The P024 trial randomized patients to treatment with four months of letrozole (Femara) and tamoxifen (Nolvadex) before surgery, but found no significant difference in relapse-free or breast cancer-specific survival by treatment group.
Overall, patients with low stage after endocrine treatment appeared to have better outcomes with no relapses and only one death without known relapse compared with a 30% relapse rate in those patients who continued to have pathological stage 2 or 3 breast cancer after treatment (P<0.001).
"The pathological-stage 1 or 0 status appeared to reflect downstaging of a group of endocrine therapy-responsive tumors," Dr. Ellis' group said.
In the multivariate analysis, other factors associated with survival included:
These factors were combined into a prognostic classification model that divided patients into three groups with low (risk score 0), intermediate (score 1 to 3), and high risk (score 4 or higher).
The three groups significantly predicted increasing relapse risk (10%, 23%, and 48%, respectively, P<0.001) and breast cancer mortality risk (2%, 11%, and 17%, respectively, P<0.001).
When the researchers ran the model on a separate group of neoadjuvant endocrine therapy-treated patients in the IMPACT study for external validation, they found that relapse rates corresponded with PEPI risk scores (3% for low, 5% for intermediate, and 17% for high risk at 37 months).
Again, outcomes were favorable for patients with low stage disease (P=0.03 for stage 1 or 0 versus 2 or 3).
Together, a low pathological stage and PEPI score of 0 was associated with 100% relapse-free survival at five years. Too few patients had died in the trial to assess breast-cancer-specific survival.
Adjuvant chemotherapy was used in too few patients to account for the favorable outcomes in this group (12% in P024 and 3% in IMPACT), the researchers said.
However, they cautioned, prospective validation studies in larger samples are needed to confirm their risk stratification tool for clinical use in making decisions about adjuvant chemotherapy treatment, particularly for the intermediate risk patients.
"Pending the results from such a trial," they said, "we can state with confidence that analysis of post-neoadjuvant endocrine therapy surgical samples with Ki67 and estrogen receptor [status] provides additional useful prognostic information that is not provided by an analysis of the baseline sample alone."
The research was funded by Novartis and AstraZeneca. Representatives from Novartis Pharmaceuticals coauthored, edited, reviewed, and approved parts of the study.
Dr. Ellis reported being a consultant for, on the speaker's bureau of, and currently doing research sponsored by Novartis Pharmaceuticals and AstraZeneca.
Several coauthors were employees of Novartis Pharmaceuticals and held stock in the company; others reported conflicts of interest for Novartis, Pfizer, and AstraZeneca.
Additional source: Journal of the National Cancer InstituteSource reference: Ellis MJ, et al "Outcome Prediction for Estrogen Receptor-Positive Breast Cancer Based on Postneoadjuvant Endocrine Therapy Tumor Characteristics" J Natl Cancer Inst 2008; 100: 1380-1388.
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