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This article from the NEJM meta-Journal (NEJM Journal Watch) The 2020 San Antonio Breast Cancer Symposium2020: William J.
Gradishar, MD to make a rational analysis of several key tests.
The 2020 San Antonio Breast Cancer Symposium (SABCS; December 8-11, 2020) was held entirely online, and speakers reported the latest findings in breast cancer research.
"NEJM Journal Watch Oncology and Hematology" (NEJM Journal Watch Oncology and Hematology) editor-in-chief Dr.
William Gradishar summarized and analyzed several key studies.
If you want to read the abstract, please visit Abstract Viewer.
CDK4/6 inhibitors in the treatment of early-stage ER+ breast cancer evaluation After the results of important randomized trials of all three CDK4/6 inhibitors have been released, the role of CDK4/6 inhibitors as part of the adjuvant treatment of early-stage ER+ breast cancer is changing.
At the ESMO online meeting in 2020 (NEJM JW Oncol Hematol Nov 2020), the PALLAS study on ER+ early-stage high-risk breast cancer patients failed to prove that the addition of piperacillide to standard endocrine therapy has an advantage (Lancet Oncol 2021 January 15; [e-pub]).
The MONARCH-E study, which originally published the results at the same meeting, showed that adding abemaciclib to the standard adjuvant endocrine therapy has advantages.
Both trials enrolled thousands of patients, and recruited high-risk patients based on significant involvement of axillary lymph nodes, but the differences between the two studies may still explain the inconsistent results.
In MONARCH-E, the proportion of patients with grade 3 breast cancer with axillary lymph node pathological stage N2 was higher than that of PALLAS, and the duration of treatment with CDK4/6 inhibitors in the two studies was 1 year and 2 years, respectively.
At the ASCO online meeting in 2020, MONARCH-E updated its results, reporting the entire population and pre-planned patient subgroups (the tumor's value-added index is high [Ki-67≥20%], and there are 1 to 3 positives Invasive disease-free survival (iDFS) of lymph nodes) (J Clin Oncol 2020 Sep 20; 38:3987).
The absolute improvement in iDFS of the above two populations is 3.
0% to 4.
5%, that is, the probability of recurrence in the Abbecini group is relatively reduced by about 30%.
It should be pointed out that at the time of data analysis, only 25% of patients had completed two years of Abesinil treatment, while 58% of patients were still receiving treatment.
The overall survival data of the MONARCH-E study has not yet been obtained, and the application of these results to low-risk patients with early breast cancer has not been supported by data.
We are waiting for the results of the NATALEE trial to understand whether the addition of Rebocinil to adjuvant therapy can improve the outcome of similar high-risk breast cancer populations.
Another data set that indirectly assesses whether CDK4/6 inhibitors can reduce the risk of recurrence is the PENELOPE trial (Abstract GS1-02) released on SABCS in 2020.
The patient received standard adjuvant endocrine therapy for one year, with or without piperacillil.
During a median follow-up of 42.
8 months, there was no difference in iDFS between the two treatment groups.
All these trials have left unanswered questions, and no CDK4/6 inhibitor has been approved for adjuvant therapy.
These trials have a large number of tumor samples, and it is possible to find specific patient subgroups who can benefit from the addition of CDK4/6 inhibitors through them, but these data still need to be analyzed.
The use of recurrence scores to determine patients who can avoid adjuvant chemotherapy may have attracted the most attention on the SABCS presentation on the RxPONDER trial, which analyzed ER+, HER2-breast glands with a maximum of 3 positive axillary lymph nodes and a recurrence score (RS) ≤ 25.
Among cancer patients, whether the 21-gene Recurrence Score is capable of determining whether adjuvant chemotherapy can be safely avoided, and patients who only receive endocrine therapy (Abstract GS3-00).
The TAILORx trial confirmed that women with axillary lymph node-negative breast cancer over the age of 50 are not benefited from chemotherapy and can only receive endocrine therapy (N Engl J Med 2018; 379:111 and N Engl J Med 2019; 380:2395).
However, patients over the age of 50 with an RS of 16-25 can still benefit from chemotherapy in addition to adjuvant endocrine therapy.
If the biological characteristics are more important than the clinical characteristics, then we can speculate that RS may be able to determine that chemotherapy can be safely avoided, and patients with similar axillary lymph node-positive breast cancer who only receive endocrine therapy.
Although the SWOG 8814 trial is small and has insufficient statistical power, its results suggest that RS is indeed possible to identify such patients (Lancet Oncol 2010; 11:55).
The RxPONDER study included patients who had 1 to 3 axillary lymph nodes positive and could receive standard adjuvant chemotherapy.
5,083 patients with an RS of 0-25 were randomly assigned to receive endocrine therapy alone or endocrine therapy combined with chemotherapy (50% of patients received TC [docetaxel/cyclophosphamide] therapy).
In the third preset interim analysis, iDFS incidents have reached 410, so the data release procedure was initiated.
Ovarian suppression is used in a small number of premenopausal patients (16% in the endocrine therapy group alone and 3% in the endocrine therapy combined with chemotherapy group).
About 1/3 of the patients are pre-menopausal and 2/3 are postmenopausal; 43% have RS 0-13, 57% RS 14-25; 66% have 1 positive lymph node, 25% have 2 positive lymph nodes , 9% have 3 positive lymph nodes.
The researchers pointed out that there is no interaction between chemotherapy benefit and RS; in other words, the relative benefit is not smaller because of the lower RS, nor is it larger because of the higher RS.
At a median follow-up of 5.
1 years, the iDFS (primary endpoint) of the chemotherapy group improved by 1.
4% in the entire population.
About 70% of patients under 50 years of age and 30% of patients 50 years of age or older are premenopausal.
Chemotherapy is not beneficial to postmenopausal patients, and an absolute difference of 5.
2% was observed in premenopausal patients, and the chemotherapy group had better results.
In postmenopausal patients, the effect of adjuvant chemotherapy was not different between patients with RS 0-13 and 14-25 (no benefit in both groups), while in premenopausal patients, chemotherapy for patients with RS 14-25 The resulting benefit numerically exceeds the benefit for patients with RS 0-13 (6.
2% vs.
3.
9%).
In premenopausal patients, whether they have 1, 2, or 3 positive lymph nodes, the absolute improvement in iDFS is similar.
There was no difference in the overall survival of postmenopausal patients, but the addition of chemotherapy improved it by about 1.
3%.
These data suggest that in postmenopausal patients with 1 to 3 positive lymph nodes, the addition of chemotherapy is almost useless.
It must be pointed out that only 9% of patients have 3 positive lymph nodes, so for this patient population, physicians must discuss the role of chemotherapy with patients.
Only a few premenopausal patients receive ovarian suppression, which raises the question of whether optimizing endocrine therapy for premenopausal patients can produce similar outcomes to chemotherapy.
Finally, these data suggest that premenopausal patients with 1 to 3 positive lymph nodes can benefit from chemotherapy, which raises the following question: whether genomic testing should be applied to premenopausal women with positive axillary lymph nodes.
Related reading NEJM Journal Watch (NEJM Journal Watch) is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers in Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
Gradishar, MD to make a rational analysis of several key tests.
The 2020 San Antonio Breast Cancer Symposium (SABCS; December 8-11, 2020) was held entirely online, and speakers reported the latest findings in breast cancer research.
"NEJM Journal Watch Oncology and Hematology" (NEJM Journal Watch Oncology and Hematology) editor-in-chief Dr.
William Gradishar summarized and analyzed several key studies.
If you want to read the abstract, please visit Abstract Viewer.
CDK4/6 inhibitors in the treatment of early-stage ER+ breast cancer evaluation After the results of important randomized trials of all three CDK4/6 inhibitors have been released, the role of CDK4/6 inhibitors as part of the adjuvant treatment of early-stage ER+ breast cancer is changing.
At the ESMO online meeting in 2020 (NEJM JW Oncol Hematol Nov 2020), the PALLAS study on ER+ early-stage high-risk breast cancer patients failed to prove that the addition of piperacillide to standard endocrine therapy has an advantage (Lancet Oncol 2021 January 15; [e-pub]).
The MONARCH-E study, which originally published the results at the same meeting, showed that adding abemaciclib to the standard adjuvant endocrine therapy has advantages.
Both trials enrolled thousands of patients, and recruited high-risk patients based on significant involvement of axillary lymph nodes, but the differences between the two studies may still explain the inconsistent results.
In MONARCH-E, the proportion of patients with grade 3 breast cancer with axillary lymph node pathological stage N2 was higher than that of PALLAS, and the duration of treatment with CDK4/6 inhibitors in the two studies was 1 year and 2 years, respectively.
At the ASCO online meeting in 2020, MONARCH-E updated its results, reporting the entire population and pre-planned patient subgroups (the tumor's value-added index is high [Ki-67≥20%], and there are 1 to 3 positives Invasive disease-free survival (iDFS) of lymph nodes) (J Clin Oncol 2020 Sep 20; 38:3987).
The absolute improvement in iDFS of the above two populations is 3.
0% to 4.
5%, that is, the probability of recurrence in the Abbecini group is relatively reduced by about 30%.
It should be pointed out that at the time of data analysis, only 25% of patients had completed two years of Abesinil treatment, while 58% of patients were still receiving treatment.
The overall survival data of the MONARCH-E study has not yet been obtained, and the application of these results to low-risk patients with early breast cancer has not been supported by data.
We are waiting for the results of the NATALEE trial to understand whether the addition of Rebocinil to adjuvant therapy can improve the outcome of similar high-risk breast cancer populations.
Another data set that indirectly assesses whether CDK4/6 inhibitors can reduce the risk of recurrence is the PENELOPE trial (Abstract GS1-02) released on SABCS in 2020.
The patient received standard adjuvant endocrine therapy for one year, with or without piperacillil.
During a median follow-up of 42.
8 months, there was no difference in iDFS between the two treatment groups.
All these trials have left unanswered questions, and no CDK4/6 inhibitor has been approved for adjuvant therapy.
These trials have a large number of tumor samples, and it is possible to find specific patient subgroups who can benefit from the addition of CDK4/6 inhibitors through them, but these data still need to be analyzed.
The use of recurrence scores to determine patients who can avoid adjuvant chemotherapy may have attracted the most attention on the SABCS presentation on the RxPONDER trial, which analyzed ER+, HER2-breast glands with a maximum of 3 positive axillary lymph nodes and a recurrence score (RS) ≤ 25.
Among cancer patients, whether the 21-gene Recurrence Score is capable of determining whether adjuvant chemotherapy can be safely avoided, and patients who only receive endocrine therapy (Abstract GS3-00).
The TAILORx trial confirmed that women with axillary lymph node-negative breast cancer over the age of 50 are not benefited from chemotherapy and can only receive endocrine therapy (N Engl J Med 2018; 379:111 and N Engl J Med 2019; 380:2395).
However, patients over the age of 50 with an RS of 16-25 can still benefit from chemotherapy in addition to adjuvant endocrine therapy.
If the biological characteristics are more important than the clinical characteristics, then we can speculate that RS may be able to determine that chemotherapy can be safely avoided, and patients with similar axillary lymph node-positive breast cancer who only receive endocrine therapy.
Although the SWOG 8814 trial is small and has insufficient statistical power, its results suggest that RS is indeed possible to identify such patients (Lancet Oncol 2010; 11:55).
The RxPONDER study included patients who had 1 to 3 axillary lymph nodes positive and could receive standard adjuvant chemotherapy.
5,083 patients with an RS of 0-25 were randomly assigned to receive endocrine therapy alone or endocrine therapy combined with chemotherapy (50% of patients received TC [docetaxel/cyclophosphamide] therapy).
In the third preset interim analysis, iDFS incidents have reached 410, so the data release procedure was initiated.
Ovarian suppression is used in a small number of premenopausal patients (16% in the endocrine therapy group alone and 3% in the endocrine therapy combined with chemotherapy group).
About 1/3 of the patients are pre-menopausal and 2/3 are postmenopausal; 43% have RS 0-13, 57% RS 14-25; 66% have 1 positive lymph node, 25% have 2 positive lymph nodes , 9% have 3 positive lymph nodes.
The researchers pointed out that there is no interaction between chemotherapy benefit and RS; in other words, the relative benefit is not smaller because of the lower RS, nor is it larger because of the higher RS.
At a median follow-up of 5.
1 years, the iDFS (primary endpoint) of the chemotherapy group improved by 1.
4% in the entire population.
About 70% of patients under 50 years of age and 30% of patients 50 years of age or older are premenopausal.
Chemotherapy is not beneficial to postmenopausal patients, and an absolute difference of 5.
2% was observed in premenopausal patients, and the chemotherapy group had better results.
In postmenopausal patients, the effect of adjuvant chemotherapy was not different between patients with RS 0-13 and 14-25 (no benefit in both groups), while in premenopausal patients, chemotherapy for patients with RS 14-25 The resulting benefit numerically exceeds the benefit for patients with RS 0-13 (6.
2% vs.
3.
9%).
In premenopausal patients, whether they have 1, 2, or 3 positive lymph nodes, the absolute improvement in iDFS is similar.
There was no difference in the overall survival of postmenopausal patients, but the addition of chemotherapy improved it by about 1.
3%.
These data suggest that in postmenopausal patients with 1 to 3 positive lymph nodes, the addition of chemotherapy is almost useless.
It must be pointed out that only 9% of patients have 3 positive lymph nodes, so for this patient population, physicians must discuss the role of chemotherapy with patients.
Only a few premenopausal patients receive ovarian suppression, which raises the question of whether optimizing endocrine therapy for premenopausal patients can produce similar outcomes to chemotherapy.
Finally, these data suggest that premenopausal patients with 1 to 3 positive lymph nodes can benefit from chemotherapy, which raises the following question: whether genomic testing should be applied to premenopausal women with positive axillary lymph nodes.
Related reading NEJM Journal Watch (NEJM Journal Watch) is published by NEJM Group.
Internationally renowned doctors are invited to comment on important papers in the medical field to help doctors understand and use the latest developments.
"NEJM Frontiers of Medicine" is translated several times a week, published on the app and official website, and selected 2-3 articles are published on WeChat.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers in Medicine" jointly created by Jiahui Medical Research and Education Group (JMRE) and "New England Journal of Medicine" (NEJM).
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities.
