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From April 9th to April 10th, 2020, the "2021 National Breast Cancer Conference and Chinese Society of Clinical Oncology (CSCO) Breast Cancer Annual Meeting" meeting was successfully held.
During the meeting, Professor Wang Tao from the Department of Oncology Medicine of the PLA General Hospital interpreted the hot issues in the adjuvant therapy field in the 2021 St.
Gallen International Breast Cancer Conference (hereinafter referred to as SG-BCC), and Yimaitong is organized as follows.
Expert profile Professor Tao Wang, Chief Physician of the Department of Oncology, PLA General Hospital, CSCO Breast Cancer Expert Committee, CSCO Nervous System Tumor Expert Committee, Vice Chairman, Beijing Breast Disease Prevention and Treatment Society Youth Committee, New Research Results, New Issues and Discussion 01CDK4/6 Inhibitors The status of adjuvant therapy When it comes to the status of CDK4/6 inhibitors in adjuvant therapy, monarchE research is inevitable.
The breast cancer patients enrolled in the monarchE study are mostly at high risk, about 60% have 4 or more positive axillary lymph nodes (ALN), and about 40% have 1-3 lymph node metastasis combined with high-risk factors.
After a median follow-up of 19.
1 months, compared with the placebo group, the invasive disease-free survival (iDFS) was better in the abecili group.
However, the adjuvant therapy of another CKD4/6 inhibitor, piperacillil, failed in the PALLAS study and the PENELOPE-B study.
Due to the low consistency of CDK4/6 inhibitors in clinical studies of breast cancer adjuvant therapy, St.
Gallen experts have inconsistent opinions on the status of CDK4/6 inhibitors in breast cancer adjuvant therapy.
Even for ER+ (estrogen receptor positive) patients with positive lymph nodes ≥ 4, only 54% of experts believe that this type of patients needs CDK4/6 inhibitor abesiride adjuvant therapy; and for 1-3 positive lymph nodes, G3 or / And T3, or ER+ patients with high Ki67, more than half of the experts do not support the adjuvant treatment of abexili.
In addition, 60% of experts are opposed to the question of whether to use Ki67 to distinguish high-risk and low-risk ER+/HER2- (HER2 negative) patients to guide the choice of CDK4/6 inhibitors in adjuvant therapy.
Based on existing clinical research, from the point of view of St.
Gallen expert consensus, the status of CDK4/6 inhibitor adjuvant therapy is still controversial, and opinions are not consistent.
02 New results of multi-gene testing tools guide individualized treatment.
In the RxPONDER study, researchers used 21-gene testing to determine whether patients with 1-3 positive lymph nodes need additional chemotherapy in addition to endocrine therapy.
The results of the study showed that for patients with an RS score of <25, even patients with 1-3 lymph node metastases, endocrine therapy + chemotherapy did not significantly benefit this group of patients.
According to the analysis of age characteristics and scoring characteristics of the enrolled patients, the survival benefit of premenopausal patients receiving endocrine therapy + chemotherapy is more obvious, and there are statistical differences.
Based on the RS score, the researchers subdivided patients into two levels: RS 0-13 and RS 14-25.
Research data shows that endocrine therapy + chemotherapy can benefit premenopausal patients more, while postmenopausal patients only need endocrine therapy.
Figure 1.
Results of the RxPONDER study.
In the MINDACT study and the TAILORx study, researchers have carefully grouped patients based on RS score, genetic test results, and age, and analyzed the impact of these factors.
In the MINDACT study, patients less than 50 years old can benefit from increasing chemotherapy regimens; in the TAILORx study, patients with an RS score greater than 15 and age ≤50 years old, especially patients with an RS score in the range of 20-25 Benefit from chemotherapy.
Most patients in the MINDACT study and the TAILORx study were treated with single-agent endocrine therapy without increasing ovarian function suppression (OFS).
Therefore, researchers need to consider, for young patients, whether the increase in chemotherapy is a benefit of chemotherapy itself, or is it a benefit from the suppression of ovarian function caused by chemotherapy? Professor Wang believes that this patient group does not necessarily need to increase chemotherapy.
Increasing the intensity of endocrine therapy and inhibiting ovarian function may also benefit this patient group.
Regarding the question of whether to increase chemotherapy on the basis of endocrine, we should give the corresponding plan according to the situation of the patient group.
Since the overall patients of the 3 studies (MINDACT, TAILORx, RxPONDER study) cannot benefit from chemotherapy, about 80% of St.
Gallen experts commented that "clinical performance meets the low risk and/or recurrence scores of MINDACT, TAILORx, RxPONDER and similar experiments "Whether postmenopausal patients with ≤25 should receive chemotherapy" is opposed to the non-screening question.
When the patient groups are subdivided according to subdivision factors, the opinions of experts change.
For patients with 3 or more lymph nodes that are positive or pT3pN1, some experts believe that this patient group needs chemotherapy.
Therefore, even for patients with low risk and RS score <25, their treatment options cannot be generalized.
Figure 2.
Voting results of experts after subdividing patient groups based on subdivision factors.
Experts’ voting opinions show that: for patients with high anatomical stages and postmenopausal ER+, most experts advocate endocrine therapy + chemotherapy; for low-grade or G1 or G1 or G1 or ER+ patients.
For patients with Ki67<10%, most experts advocate only endocrine therapy; for patients with RS score<25, more than 50% of experts believe that adjuvant therapy should be the first choice for endocrine therapy combined with chemotherapy.
For premenopausal patients with negative lymph nodes, RS scores in the 16-25 range, or low genetic risk, about 22% of experts support tamoxifen (TAM), and about 53% of experts support OFS+TAM or aromatase inhibitors ( AI), about 25% of experts support endocrine therapy + chemotherapy.
For premenopausal patients with 1-3 positive lymph nodes and RS≤25 or low risk of other genes, about 30% of experts choose chemotherapy and oral endocrine therapy, about 17% of experts choose OFS and oral endocrine therapy, and about 26% of experts prefer chemotherapy , About 26% of experts prefer endocrine therapy.
The emergence of genetic tools can help researchers to screen whether patients need chemotherapy, but the treatment plan of the patient group with RS score <25 still needs to be specifically differentiated and analyzed, and cannot be generalized.
03 Status of immune checkpoint inhibitor adjuvant therapy At present, there is no strong evidence-based medical evidence to support immune checkpoint inhibitor (ICI) as adjuvant therapy.
Therefore, 90.
38% of St.
Gallen experts do not support triple-negative breast cancer (TNBC) patients to choose ICI as adjuvant therapy after surgery.
04 The status of PARP inhibitor adjuvant therapy PARP inhibitors have shown good efficacy in advanced breast cancer, and its efficacy in early breast cancer still needs to wait for the publication of OlympiA research results.
In the 2021 St.
Gallen conference, experts gave their own answers to some predictive questions.
Regarding "Based on the tolerance of olaparib to advanced BRCA 1/2-related breast cancer, if the OlympiA study shows which of the following data would you recommend olapar for the adjuvant treatment of BRCA 1/2-related early breast cancer?" this Question, 48.
8% of experts believe that they will choose PARP inhibitors when iDFS increases by more than 5% in 3 years.
This provides more information for the enhancement of adjuvant therapy for patients with BRCA gene mutations in the future, but there is no conclusive basis yet.
Appropriate population for adjuvant therapy For ER+ patients tested by immunohistochemical IHC, 50% of St.
Gallen experts believe that patients with positive ER expression ≥1% should be suitable for adjuvant endocrine therapy, and 50% of experts believe that patients with ER+ expression ≥10% should be suitable for this Program.
This result is simpler than the 2019 voting result.
Figure 2.
Comparison of ER+ expression threshold selection voting results in 2021 and 2019.
When selecting treatment based on tumor size, the selection of tumor size threshold by St.
Gallen experts is similar to clinical selection.
More than 50% of experts believe that patients with microinfiltrating tumors and hormone receptor-positive lymph nodes can choose adjuvant endocrine therapy.
For HER2+ and ER- (ER-negative) lymph node-negative breast cancer patients, about 50% of experts believe that when the tumor is larger than 5mm, the patient can choose anti-HER2 adjuvant therapy; for TNBC and lymph node-negative patients, about 45% of experts believe that the tumor is larger than At 5mm, patients can choose adjuvant chemotherapy.
Figure 3.
Voting results of expert threshold selection when deciding treatment plan based on tumor size.
ER+/HER2-adjuvant endocrine therapy.
At the St.
Gallen meeting in 2021, experts also discussed the length of endocrine therapy.
At present, most experts support that a long course of endocrine therapy is not limited to 5 years.
For high-risk premenopausal patients who have received OFS+TAM for 5 years, most experts choose tamoxifen alone, and some experts choose OFS+AI or AI alone.
For breast cancer patients with positive ER+ or HER2- lymph nodes, most experts believe that the best course of endocrine therapy can exceed 5 years.
The consensus on the use of OFS is compared with the consensus problem on the use of OFS in the St.
Gallen conference in 2019.
Professor Wang found that the problems in the St.
Gallen conference in 2021 are relatively simple, the consensus of experts is higher, and the acceptance of OFS is more and more effective.
The recognition is getting higher and higher.
More than 70% of experts believe that clinical stage 2 ER+ premenopausal patients should receive ovarian function suppression.
For patients under 40 years of age with clinical stage 2 ER+ premenopausal patients, more than 90% of experts believe that patients should receive OFS.
Regarding the effect of chemotherapy-induced ovarian function suppression on the efficacy, most experts believe that the benefits of inducing ovarian function suppression are greater; for patients with clinical stage 2 premenopausal ER+ (assuming that they continue to be in the menopausal hormone state after chemotherapy), most experts It is still believed that OFS should be given to patients.
In addition, the issue of estradiol monitoring has also attracted the attention of experts.
More than half of the experts believe that premenopausal women (ER+/HER2-) receiving ovarian function suppression therapy do not require routine monitoring of estradiol.
The choice of adjuvant chemotherapy for patients with ER-positive/HER2-negative breast cancer In the choice of adjuvant chemotherapy, the St.
Gallen expert consensus is basically consistent with the guidelines of the Chinese Society of Clinical Oncology (CSCO) and existing clinical practice.
For low-risk, lymph node-negative ER+ patients, most experts choose the standard regimen based on anthracycline/cyclophosphamide/yew; for high-risk patients, most experts also choose anthracycline/cyclophosphamide/yew as the basis Standard program.
Adjuvant anti-HER2 treatment options At the 2021 St.
Gallen conference, more than 90% of experts did not advocate for node-negative HER2+ patients to receive dual-target postoperative adjuvant therapy.
For hormone receptor-positive patients who have previously received neoadjuvant therapy but have not reached pCR, about 60% of experts recommend that patients be given adjuvant neratinib postoperative treatment.
Regarding the question of "can T-DM1 replace paclitaxel/trastuzumab in adjuvant therapy for patients with stage 1 HER2-positive breast cancer", about 68% of experts oppose it and suggest that the current plan should be maintained.
Summarize that the thinking of individualized treatment should run through the adjuvant treatment of breast cancer.
Researchers should select patients by stratification and screen according to molecular phenotypes, prognostic markers, predictive efficacy markers, and predictive adverse reaction markers, and give them to individuals suitable for patients Chemical treatment.
During the meeting, Professor Wang Tao from the Department of Oncology Medicine of the PLA General Hospital interpreted the hot issues in the adjuvant therapy field in the 2021 St.
Gallen International Breast Cancer Conference (hereinafter referred to as SG-BCC), and Yimaitong is organized as follows.
Expert profile Professor Tao Wang, Chief Physician of the Department of Oncology, PLA General Hospital, CSCO Breast Cancer Expert Committee, CSCO Nervous System Tumor Expert Committee, Vice Chairman, Beijing Breast Disease Prevention and Treatment Society Youth Committee, New Research Results, New Issues and Discussion 01CDK4/6 Inhibitors The status of adjuvant therapy When it comes to the status of CDK4/6 inhibitors in adjuvant therapy, monarchE research is inevitable.
The breast cancer patients enrolled in the monarchE study are mostly at high risk, about 60% have 4 or more positive axillary lymph nodes (ALN), and about 40% have 1-3 lymph node metastasis combined with high-risk factors.
After a median follow-up of 19.
1 months, compared with the placebo group, the invasive disease-free survival (iDFS) was better in the abecili group.
However, the adjuvant therapy of another CKD4/6 inhibitor, piperacillil, failed in the PALLAS study and the PENELOPE-B study.
Due to the low consistency of CDK4/6 inhibitors in clinical studies of breast cancer adjuvant therapy, St.
Gallen experts have inconsistent opinions on the status of CDK4/6 inhibitors in breast cancer adjuvant therapy.
Even for ER+ (estrogen receptor positive) patients with positive lymph nodes ≥ 4, only 54% of experts believe that this type of patients needs CDK4/6 inhibitor abesiride adjuvant therapy; and for 1-3 positive lymph nodes, G3 or / And T3, or ER+ patients with high Ki67, more than half of the experts do not support the adjuvant treatment of abexili.
In addition, 60% of experts are opposed to the question of whether to use Ki67 to distinguish high-risk and low-risk ER+/HER2- (HER2 negative) patients to guide the choice of CDK4/6 inhibitors in adjuvant therapy.
Based on existing clinical research, from the point of view of St.
Gallen expert consensus, the status of CDK4/6 inhibitor adjuvant therapy is still controversial, and opinions are not consistent.
02 New results of multi-gene testing tools guide individualized treatment.
In the RxPONDER study, researchers used 21-gene testing to determine whether patients with 1-3 positive lymph nodes need additional chemotherapy in addition to endocrine therapy.
The results of the study showed that for patients with an RS score of <25, even patients with 1-3 lymph node metastases, endocrine therapy + chemotherapy did not significantly benefit this group of patients.
According to the analysis of age characteristics and scoring characteristics of the enrolled patients, the survival benefit of premenopausal patients receiving endocrine therapy + chemotherapy is more obvious, and there are statistical differences.
Based on the RS score, the researchers subdivided patients into two levels: RS 0-13 and RS 14-25.
Research data shows that endocrine therapy + chemotherapy can benefit premenopausal patients more, while postmenopausal patients only need endocrine therapy.
Figure 1.
Results of the RxPONDER study.
In the MINDACT study and the TAILORx study, researchers have carefully grouped patients based on RS score, genetic test results, and age, and analyzed the impact of these factors.
In the MINDACT study, patients less than 50 years old can benefit from increasing chemotherapy regimens; in the TAILORx study, patients with an RS score greater than 15 and age ≤50 years old, especially patients with an RS score in the range of 20-25 Benefit from chemotherapy.
Most patients in the MINDACT study and the TAILORx study were treated with single-agent endocrine therapy without increasing ovarian function suppression (OFS).
Therefore, researchers need to consider, for young patients, whether the increase in chemotherapy is a benefit of chemotherapy itself, or is it a benefit from the suppression of ovarian function caused by chemotherapy? Professor Wang believes that this patient group does not necessarily need to increase chemotherapy.
Increasing the intensity of endocrine therapy and inhibiting ovarian function may also benefit this patient group.
Regarding the question of whether to increase chemotherapy on the basis of endocrine, we should give the corresponding plan according to the situation of the patient group.
Since the overall patients of the 3 studies (MINDACT, TAILORx, RxPONDER study) cannot benefit from chemotherapy, about 80% of St.
Gallen experts commented that "clinical performance meets the low risk and/or recurrence scores of MINDACT, TAILORx, RxPONDER and similar experiments "Whether postmenopausal patients with ≤25 should receive chemotherapy" is opposed to the non-screening question.
When the patient groups are subdivided according to subdivision factors, the opinions of experts change.
For patients with 3 or more lymph nodes that are positive or pT3pN1, some experts believe that this patient group needs chemotherapy.
Therefore, even for patients with low risk and RS score <25, their treatment options cannot be generalized.
Figure 2.
Voting results of experts after subdividing patient groups based on subdivision factors.
Experts’ voting opinions show that: for patients with high anatomical stages and postmenopausal ER+, most experts advocate endocrine therapy + chemotherapy; for low-grade or G1 or G1 or G1 or ER+ patients.
For patients with Ki67<10%, most experts advocate only endocrine therapy; for patients with RS score<25, more than 50% of experts believe that adjuvant therapy should be the first choice for endocrine therapy combined with chemotherapy.
For premenopausal patients with negative lymph nodes, RS scores in the 16-25 range, or low genetic risk, about 22% of experts support tamoxifen (TAM), and about 53% of experts support OFS+TAM or aromatase inhibitors ( AI), about 25% of experts support endocrine therapy + chemotherapy.
For premenopausal patients with 1-3 positive lymph nodes and RS≤25 or low risk of other genes, about 30% of experts choose chemotherapy and oral endocrine therapy, about 17% of experts choose OFS and oral endocrine therapy, and about 26% of experts prefer chemotherapy , About 26% of experts prefer endocrine therapy.
The emergence of genetic tools can help researchers to screen whether patients need chemotherapy, but the treatment plan of the patient group with RS score <25 still needs to be specifically differentiated and analyzed, and cannot be generalized.
03 Status of immune checkpoint inhibitor adjuvant therapy At present, there is no strong evidence-based medical evidence to support immune checkpoint inhibitor (ICI) as adjuvant therapy.
Therefore, 90.
38% of St.
Gallen experts do not support triple-negative breast cancer (TNBC) patients to choose ICI as adjuvant therapy after surgery.
04 The status of PARP inhibitor adjuvant therapy PARP inhibitors have shown good efficacy in advanced breast cancer, and its efficacy in early breast cancer still needs to wait for the publication of OlympiA research results.
In the 2021 St.
Gallen conference, experts gave their own answers to some predictive questions.
Regarding "Based on the tolerance of olaparib to advanced BRCA 1/2-related breast cancer, if the OlympiA study shows which of the following data would you recommend olapar for the adjuvant treatment of BRCA 1/2-related early breast cancer?" this Question, 48.
8% of experts believe that they will choose PARP inhibitors when iDFS increases by more than 5% in 3 years.
This provides more information for the enhancement of adjuvant therapy for patients with BRCA gene mutations in the future, but there is no conclusive basis yet.
Appropriate population for adjuvant therapy For ER+ patients tested by immunohistochemical IHC, 50% of St.
Gallen experts believe that patients with positive ER expression ≥1% should be suitable for adjuvant endocrine therapy, and 50% of experts believe that patients with ER+ expression ≥10% should be suitable for this Program.
This result is simpler than the 2019 voting result.
Figure 2.
Comparison of ER+ expression threshold selection voting results in 2021 and 2019.
When selecting treatment based on tumor size, the selection of tumor size threshold by St.
Gallen experts is similar to clinical selection.
More than 50% of experts believe that patients with microinfiltrating tumors and hormone receptor-positive lymph nodes can choose adjuvant endocrine therapy.
For HER2+ and ER- (ER-negative) lymph node-negative breast cancer patients, about 50% of experts believe that when the tumor is larger than 5mm, the patient can choose anti-HER2 adjuvant therapy; for TNBC and lymph node-negative patients, about 45% of experts believe that the tumor is larger than At 5mm, patients can choose adjuvant chemotherapy.
Figure 3.
Voting results of expert threshold selection when deciding treatment plan based on tumor size.
ER+/HER2-adjuvant endocrine therapy.
At the St.
Gallen meeting in 2021, experts also discussed the length of endocrine therapy.
At present, most experts support that a long course of endocrine therapy is not limited to 5 years.
For high-risk premenopausal patients who have received OFS+TAM for 5 years, most experts choose tamoxifen alone, and some experts choose OFS+AI or AI alone.
For breast cancer patients with positive ER+ or HER2- lymph nodes, most experts believe that the best course of endocrine therapy can exceed 5 years.
The consensus on the use of OFS is compared with the consensus problem on the use of OFS in the St.
Gallen conference in 2019.
Professor Wang found that the problems in the St.
Gallen conference in 2021 are relatively simple, the consensus of experts is higher, and the acceptance of OFS is more and more effective.
The recognition is getting higher and higher.
More than 70% of experts believe that clinical stage 2 ER+ premenopausal patients should receive ovarian function suppression.
For patients under 40 years of age with clinical stage 2 ER+ premenopausal patients, more than 90% of experts believe that patients should receive OFS.
Regarding the effect of chemotherapy-induced ovarian function suppression on the efficacy, most experts believe that the benefits of inducing ovarian function suppression are greater; for patients with clinical stage 2 premenopausal ER+ (assuming that they continue to be in the menopausal hormone state after chemotherapy), most experts It is still believed that OFS should be given to patients.
In addition, the issue of estradiol monitoring has also attracted the attention of experts.
More than half of the experts believe that premenopausal women (ER+/HER2-) receiving ovarian function suppression therapy do not require routine monitoring of estradiol.
The choice of adjuvant chemotherapy for patients with ER-positive/HER2-negative breast cancer In the choice of adjuvant chemotherapy, the St.
Gallen expert consensus is basically consistent with the guidelines of the Chinese Society of Clinical Oncology (CSCO) and existing clinical practice.
For low-risk, lymph node-negative ER+ patients, most experts choose the standard regimen based on anthracycline/cyclophosphamide/yew; for high-risk patients, most experts also choose anthracycline/cyclophosphamide/yew as the basis Standard program.
Adjuvant anti-HER2 treatment options At the 2021 St.
Gallen conference, more than 90% of experts did not advocate for node-negative HER2+ patients to receive dual-target postoperative adjuvant therapy.
For hormone receptor-positive patients who have previously received neoadjuvant therapy but have not reached pCR, about 60% of experts recommend that patients be given adjuvant neratinib postoperative treatment.
Regarding the question of "can T-DM1 replace paclitaxel/trastuzumab in adjuvant therapy for patients with stage 1 HER2-positive breast cancer", about 68% of experts oppose it and suggest that the current plan should be maintained.
Summarize that the thinking of individualized treatment should run through the adjuvant treatment of breast cancer.
Researchers should select patients by stratification and screen according to molecular phenotypes, prognostic markers, predictive efficacy markers, and predictive adverse reaction markers, and give them to individuals suitable for patients Chemical treatment.
