Accurate assessment of recurrence risk in 15 years: breast cancer polygenic detection

Shuwen Bio's EndoPredict (Wang Pter, EPclin, 12 genes) long-term prognosis to help individualized diagnosis and treatment Huzhou, April 8, 2022 /PRNewswire/ -- Determining the direction of postoperative treatment for patients with early breast cancer is crucial
.
For Luminal type (ER+/HER2-) breast cancer, endocrine therapy is the basis for 5 years after surgery.
As for whether to add chemotherapy, it is necessary to comprehensively consider the risk of distant recurrence and patient tolerance
.
Clinicians judge the risk of distant recurrence by comprehensive analysis of clinical factors and genetic evaluation results of patients with early-stage luminal breast cancer
.
The clinical factors included age, histological grade (G), tumor size (T), lymph node status (N), KI67, vascular invasion (LVI) and so on
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Multi-gene detection can accurately predict the risk of distant recurrence in patients with early breast cancer, and guide subsequent treatment decisions based on clinical factors.
It has been recognized and recommended by domestic and foreign guidelines, including oncotype Dx (original research 21 genes), EndoPredict (question spectrum) Special, EPclin, 12 genes), etc.
At present, EndoPredict has been exclusively introduced by Shuwen Biology
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The 2021 edition of the Chinese Anti-Cancer Association Breast Cancer Diagnosis and Treatment Guidelines and Specifications (CACA Guidelines) [1] mentioned that it is necessary to comprehensively consider clinical factors and genetic testing results to evaluate the risk of patients (risk of distant recurrence), and make adjuvant treatment decisions
.
As shown in the figure: At present, there is a lack of oncotype DX original research products in China.
Most laboratories or pathology departments use self-made testing tools.
There may be differences or disagreements between the results of different units.
Therefore, when it is necessary to refer to polygenic testing, it is recommended to use original research products.
Or have corresponding qualified laboratory and pathology department
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Guidelines interpretation: 1.
When the clinical factors are lymph node negative, tumor less than 2cm, histological grade I, no vascular tumor thrombus, HER2 negative, age >35 years old, ER/PR positive, Ki-67≤20% or laboratory At the median value, judged as low risk
.
When ER positive and HER2 negative, if any of the above items are not met, genetic testing can also be performed.
If the genetic test is low risk, it is judged as low risk, and if the genetic test is high risk, it is judged as high risk
.
2.
When there are 1-3 metastases in the lymph nodes, if the tumor is larger than 5cm or histological grade III, or the polygenic test is high risk, and any of the conditions are met, it will be judged as high risk
.
3.
If there are ≥4 lymph node metastases, all of them are judged as high risk
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Generally, high-risk patients refer to patients with high risk of recurrence and need adjuvant chemotherapy to avoid undertreatment; low-risk patients refer to patients with low risk of recurrence, and chemotherapy exemption can be considered to avoid overtreatment
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According to the guideline, the prediction of recurrence risk of early-stage luminal breast cancer requires a comprehensive analysis of multi-gene testing on the basis of clinical factors, especially for intermediate-risk groups that cannot be directly assessed by clinical factors
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The internationally renowned multi-center randomized controlled study ABCSG-6&8[2] published by CCR, an authoritative journal of oncology, showed that EndoPredict could still screen 122 (14.
5%) high-risk patients out of 843 patients who were assessed as clinical low-risk by clinical factors.
patients (risk of distant recurrence >10%); of the 859 patients who were assessed as clinically high risk by clinical factors, EndoPredict screened 345 (40.
2%) low-risk patients (10-year distant recurrence rate of about 5%)
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It is not difficult to find from the research data that when the clinical factors are inconsistent with the EndoPredict risk assessment, the 10-year recurrence risk of the patient's actual follow-up is more in line with the EndoPredict assessment results
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In addition, the study analyzed in the Lumianl subgroup, histological grade subgroup, and lymph node subgroup, and obtained similar results.
Patients who were assessed as low risk by EndoPredict had a 10-year distant recurrence rate of nearly 5%.
In high-risk patients, the 10-year distant recurrence rate is close to 20%, or even higher
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Of note: In the node-positive subgroup, EndoPredict was able to screen 160 (30%) low-risk patients (5% 10-year distant recurrence rate) out of 537 node-positive patients, whereas node-positive patients are often considered High-risk patients require intensive treatment to reduce the risk of recurrence
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Assessment of breast cancer recurrence risk: not only accuracy, but also long-term
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According to authoritative literature reports[3], at present, patients with N0 and N1-3 positive ER-positive breast cancer who are only evaluated based on clinical indicators and molecular typing (ER-positive), after 5 years of endocrine therapy discontinuation, their follow-up 5- The 15-year distant recurrence rate still reached 8% and 14%.
It can be seen that ER-positive patients have a certain recurrence risk not only in the 0-5 years after surgery, but also in the subsequent 10 years and 15 years
.
In addition, the 2021 edition of the Chinese Anti-Cancer Association Guidelines and Standards for the Diagnosis and Treatment of Breast Cancer (CACA Guidelines) mentioned that both premenopausal and postmenopausal patients with intermediate risk and no lymph node metastasis need to rely on the evaluation of long-term risk and treatment sensitivity.
Determine the need for prolonged endocrine therapy
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Therefore, the prediction of the risk of distant recurrence of breast cancer should not only be accurate, but also long-term, especially for early-stage Luminal type (ER+/HER2-) breast cancer, it is necessary to evaluate whether to exempt chemotherapy and prolong endocrine therapy according to the risk of distant recurrence.
, to avoid undertreatment or overtreatment
.
The 15-year follow-up data of the ABCSG-6 & 8 studies [4] prove that EndoPredict can accurately distinguish the target patient prognosis on a longer time scale
.
For all postoperative patients, patients with low risk assessed by EndoPredict had a 15-year recurrence-free survival rate of 93.
6%, while the high-risk group had a 15-year recurrence-free survival rate of 74.
6%.
There was a significant difference in recurrence rates between the two groups ( P < 0.
001); in addition, among patients who received only 5 years of endocrine therapy and no recurrence after surgery, EndoPredict screened 65% of low-risk patients, and their 5-15-year distant recurrence rate was only 4.
3%, while the high-risk group of 5 The -15-year distant recurrence rate reached 15.
9%, and there was a significant difference in the recurrence rate between the two groups (P < 0.
001)
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Conclusion: Breast cancer polygenic testing plays a crucial role in assessing the risk of distant recurrence in patients with early-stage luminal breast cancer
.
EndoPredict (EPclin, Askspect, 12 Gene) can accurately predict the prognosis for 15 years, help predict the long-term distant recurrence risk of patients in 10-15 years, assist clinical chemotherapy and prolong endocrine therapy decision-making
.
References: 1.
2021 edition of Chinese Anti-Cancer Association Breast Cancer Diagnosis and Treatment Guidelines and Specifications (Essential Edition) 2.
EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer[J].
Annals of oncology Official Journal of the European Society for Medical Oncology, 2013, 24(3):640-647.
3.
Pan H, Gray R, Braybrooke J, et al.
20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years.
[J].
N Engl J Med, 2017, 377(19):1836-1846.
4.
Filipits M, Dubsky P, Rudas M, et al.
Prediction of Distant Recurrence using EndoPredict among Women with ER+, HER2 - Node-Positive and Node-Negative Breast Cancer Treated with Endocrine Therapy Only[J].
Clinical Cancer Research, 2019, 25(13):clincanres.
0376.
2019.
Source: Shuwen Bio