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*For medical professionals only, we can read and track the 2022 CBCS Little Red Book update hotspots to discuss the latest progress of
HER2-positive and HR-positive breast cancer.
Since its release in 2007, after more than 10 years of precipitation and combing, the Breast Cancer Professional Committee (CBCS) of the Chinese Anti-Cancer Association (CBCS) "Guidelines and Norms for the Diagnosis and Treatment of Breast Cancer" has been updated to the eighth edition, becoming one of the most important and authoritative guidelines for Chinese diagnosis and treatment, and its essential version is affectionately called "CBCS Little Red Book" by doctors (that is, CBCS "Breast Cancer Diagnosis and Treatment Guidelines and Standardized Essential Edition", referred to as CBCS Essential Edition Guidelines)
。 Since its first release in 2021, the CBCS Essential Edition Guidelines have been updated for the first time during the SIBCS Conference held on October 28-30, 2022, which closely follows the cutting-edge progress at home and abroad and the national conditions of China, and fully gathers the wisdom and knowledge of scholars in the field of China, which has decisive guiding significance
for clinical diagnosis and treatment.
On the occasion of the conference, the Medical Oncology Channel invited Professor Yu Keda of Fudan University Cancer Hospital to talk about the clinical value and update significance of the CBCS Essential Edition guidelines, and to express his insights
on the relevant updates of HER2-positive and HR-positive breast cancer.
As one of the most authoritative and standardized breast cancer guidelines in China, Professor Yu Keda pointed out that the CBCS guidelines have been released for the first time since 2007 , after that, it is updated every two years
.
Originally, the CBCS guidelines were full-text versions, with many chapters and rich
content.
To further increase the operability of the guidelines, in 2021, the CBCS guidelines were released for the first time in an abridged version, affectionately referred to by clinicians as Little Red Book
。 Professor Yu emphasized that compared with the full text version of the CBCS guide, its condensed version is more clearly defined at several levels: first, the content is more concise and important; Secondly, the process is clearer and more convenient; Third, it is more instructive and practical for clinicians; Fourth, the integration of current artificial intelligence technology, the use of some links or small programs, can enable operators to obtain a good understanding and learning
of specific clinical application background and related references.
The formulation of the CBCS Essential Edition Guidelines can be said to have reached a height of matching, complementing and corroborating with the full-text version, and its essence is streamlined on the basis of the more complex content of the full-text version, and its clinical value lies in the ability to obtain better clinical practicality
on the basis of the relatively poor readability of the original 。 In this regard, Professor Yu Keda further emphasized, "Therefore, we are currently faced with two choices, if you want to understand the simple content, choose Xiaohongshu, if you want to understand a more leveled, richer and more complete content, the full-text version is preferred, these two versions do not have who controls or who is higher than whom, the two are completely consistent
in direction.
"
Regarding the significance of the guideline update, Professor Yu Keda expressed his profound opinion, "I believe that a good guideline must be updated every year, and keep up with the development of new drugs and changes
in new diagnosis and treatment fields every year.
However, due to the large amount of content related to breast cancer diagnosis and treatment, the CBCS full-text guidelines are updated every two years to ensure that we can focus on doing this as much as
possible.
However, the biennial update may be lacking in timeliness, so the current Xiaohongshu is updated once a year, which ensures the timeliness of the CBCS guidelines, and benefits from its more convenient and practical features, which is conducive to clinicians to gain faster insight into the latest progress
in breast cancer diagnosis and treatment.
Therefore, the significance of Xiaohongshu update is to make the latest academic progress and clinical consensus accepted, understood and practiced by the majority of clinicians, and finally let our patients receive the latest drugs and therapies as soon as possible
.
"
Diversity and Merit: Stocktaking Updates and Considerations
of HER2-Positive Breast Cancer Regarding the main update points of the 2022 CBCS Condensed Edition Guidelines in the field of HER2-positive breast cancer, Professor Yu Keda pointed out, The treatment of HER2-positive breast cancer can be divided into three parts, including preoperative neoadjuvant therapy, postoperative adjuvant therapy, and late rescue therapy
.
The purpose of treatment of early-stage breast cancer is very simple, one is to rapidly shrink the tumor, and the second is to understand drug sensitivity
.
In this year's guideline update, in the field of neoadjuvant therapy, pyrrotinib + trastuzumab + docetaxel is considered as a mandatory group "consideration" plan (the preferred population is not recommended for the time being).
This recommendation is based primarily on the results of the PHEDRA study [1], a phase III clinical trial
to evaluate the efficacy and safety of pyrrotinib/placebo + trastuzumab + docetaxel for neoadjuvant therapy for HER2-positive breast cancer 。 According to the results presented at the 2021 San Antonio Breast Cancer Congress (SABCS), the total pathological complete response (tpCR) rate assessed by the Independent Review Committee (IRC) in the pyrrotinib group was 41%, significantly higher than the 22% (P<0.
0001) in the placebo group, and the breast pathological complete response rate (bpCR) in the pyrrotinib group increased by 20.
1% (43.
8% vs 23.
7%) compared with the placebo group; The objective response rate (ORR) in both groups was 91.
6% and 81.
9%,<b22> respectively.
And the overall safety of pyrrotinib group is good and tolerated
by patients.
In this regard, Professor Yu Keda said that pyrrotinib + trastuzumab + docetaxel has been confirmed to have the effect of rapid tumor shrinkage, considering that the treatment regimen of this small molecule tyrosine kinase inhibitor (TKI) combined with macromolecular monoclonal antibody has an impact on the long-term survival of HER2-positive early breast cancer, it will take time to clarify, so it is currently conservative in the recommended level.
The recommended level of this program is temporarily "considered"
in people who require rapid de-escalation.
In the field of adjuvant therapy after HER2-positive breast cancer, the overall update is not rapid, because all guideline recommendations for adjuvant therapy are mostly based on landmark clinical trial data, and studies of just one or two years are unlikely to support a major strategy change
.
"But we've also seen some welcome changes, such as the fact that certain drugs are more likely to be included in the guidelines as access to drugs
improves.
" For example, the tropa bitargeted therapy that originally needed to be recommended in high-risk groups or medium- and high-risk groups, after pertuzumab entered the medical insurance, can also recommend double-targeted therapy for patients whose risk of recurrence is not high, which not only does not increase the economic burden, but also can bring patients better efficacy, so we will make a higher level of recommendation in the guideline update," Professor Yu Keda explained
.
In the field of HER2-positive advanced breast cancer treatment, there are currently two more important drugs at home and abroad, one is the new antibody drug conjugate (ADC) T-DXd, based on DESTINY-Breast03 (DB03) research, T-DXd has moved from the back-line application to the second-line treatment status
.
However, because T-DXd is currently not available in China, the current CBCS Essential Edition guidelines recommend a "consideration"
for late-stage second-line medication.
With the emergence of more research data, the therapeutic status of T-DXd may become higher and higher, but before it is launched in China, the recommendation of the CBCS Condensed Edition Guidelines will remain very cautious
.
Another drug is China's self-developed class 1.
1 new drug pyrrotinib, in this guideline update, pyrrotinib + trastuzumab + docetaxel as a "consideration" recommendation
for advanced first-line medication 。 This recommendation is primarily based on the PHILA study, a randomized, multicenter phase III clinical trial evaluating pyrrotinib + trastuzumab + docetaxel versus placebo + trastuzumab + docetaxel first-line treatment of HER2-positive relapsed/metastatic breast cancer, based on results presented at the 2022 Congress of the European Society of Medical Oncology (ESMO) [2].
The median progression-free survival (PFS) in the pyrrotinib combination group exceeded 2 years [median PFS assessed by investigators (INV) up to 24.
3 months, significantly better than the control group of 10.
4 months (HR = 0.
41, 95% CI 0.
32-0.
53; P<0.
0001)].
<b22>
Professor Yu Keda said that the clinical targeting of advanced first-line drugs is more extensive, and the treatment needs are more urgent, and the efficacy needs are more needs to be confirmed
.
From the current research data, pyrrotinib + trastuzumab + docetaxel treatmentThe longest PFS in the first-line treatment for HER2-positive advanced breast cancer was obtained, and a longer median follow-up period is needed to verify this PFS benefit, but the overall trend of benefit is not controversial
.
"So I look at the treatment recommendation of pyrrotinib update from two directions, first of all, our world is diversified, and the treatment options are also rich and diverse, so in addition to the pursuit of efficacy, more elements need to be added, which are not only based on efficacy considerations, but also drug accessibility, and regional factors
.
" Xiaohongshu's treatment recommendation for pyrrotinib + trastuzumab + docetaxel is also based on diversified considerations, which not only provides a new option for the first-line treatment of HER2-positive advanced breast cancer, but also takes into account the accessibility of Chinese patients
.
Secondly, we also want to emphasize monism, which may sound contradictory, but in fact the ultimate purpose of pluralism is to achieve unification, and ultimately choose the best among many solutions to achieve the highest level of monization
。 Although the era of univariation may be relatively far away, we have now entered the era of multiple treatments, in many programs, pyrrotinib + trastuzumab + docetaxel first-line treatment benefits significantly, and toxic side effects are easy to manage, which means that the continuous upgrading and optimization of anti-HER2 advanced first-line treatment can be said to be in line with our monist concept of ultimately achieving the ultimate best efficacy in the process of selecting the best
.
Steady progress, co-expansion and optimization - elucidating the update hotspots of HR-positive breast cancer and thinking about
the relatively few updates involving HR-positive breast cancer in the 2022 CBCS Essential Edition guidelines, Professor Yu Keda explained, "On the one hand, it may be that there have been more updates in previous years, or that the progress in recent years has been relatively lagging behind"
.
Regarding the specific update of HR-positive breast cancer, Professor Yu Keda further pointed out that based on the results of DESTINY-Breast04 (DB04), new categories of HR-positive and low expression of HER2 have been added, broadening the molecular classification
of treatment-oriented breast cancer treatment.
In addition, for HR-positive breast cancer, CDK4/6 inhibitors play an irreplaceable and important role, Professor Yu Keda emphasized, "CDK4/6 inhibitors as a class of fist or ace products, almost all advanced first-line treatment will recommend CDK4/6 inhibitors combined with endocrine therapy
.
" Although in the field of HR-positive breast cancer treatment, endocrine therapy options ranging from tamoxifen to aromatase inhibitors (AI) to fulvestrant can be
diverse.
But the therapeutic status of CDK4/6 inhibitors has never changed
.
Current clinical guidelines do not make a detailed distinction between the four CDK4/6 inhibitor treatment recommendations, and overall, the industry believes that their overall efficacy is parallel, but toxicity management may vary
。 Clinically, we advocate the use of drugs with clear efficacy as clinical key drugs, and we also recommend reasonable selection according to different regions and drug accessibility and other factors, but considering that pibociclib, abeccilib, rebocilib and the first independently developed CDK4/6 inhibitor in China, darcilib, on the whole, its efficacy is not uneven at present, so there is no grade distinction in the guideline recommendation for the time being, but all are applicable
.
And we also believe that based on diversified considerations, for domestic patients, eventually these drugs will find their own treatment status
.
Expert
profile
Professor Yu Keda
*This article is only for providing scientific information to medical professionals and does not represent the views of this platform
HER2-positive and HR-positive breast cancer.
Since its release in 2007, after more than 10 years of precipitation and combing, the Breast Cancer Professional Committee (CBCS) of the Chinese Anti-Cancer Association (CBCS) "Guidelines and Norms for the Diagnosis and Treatment of Breast Cancer" has been updated to the eighth edition, becoming one of the most important and authoritative guidelines for Chinese diagnosis and treatment, and its essential version is affectionately called "CBCS Little Red Book" by doctors (that is, CBCS "Breast Cancer Diagnosis and Treatment Guidelines and Standardized Essential Edition", referred to as CBCS Essential Edition Guidelines)
。 Since its first release in 2021, the CBCS Essential Edition Guidelines have been updated for the first time during the SIBCS Conference held on October 28-30, 2022, which closely follows the cutting-edge progress at home and abroad and the national conditions of China, and fully gathers the wisdom and knowledge of scholars in the field of China, which has decisive guiding significance
for clinical diagnosis and treatment.
On the occasion of the conference, the Medical Oncology Channel invited Professor Yu Keda of Fudan University Cancer Hospital to talk about the clinical value and update significance of the CBCS Essential Edition guidelines, and to express his insights
on the relevant updates of HER2-positive and HR-positive breast cancer.
As one of the most authoritative and standardized breast cancer guidelines in China, Professor Yu Keda pointed out that the CBCS guidelines have been released for the first time since 2007 , after that, it is updated every two years
.
Originally, the CBCS guidelines were full-text versions, with many chapters and rich
content.
To further increase the operability of the guidelines, in 2021, the CBCS guidelines were released for the first time in an abridged version, affectionately referred to by clinicians as Little Red Book
。 Professor Yu emphasized that compared with the full text version of the CBCS guide, its condensed version is more clearly defined at several levels: first, the content is more concise and important; Secondly, the process is clearer and more convenient; Third, it is more instructive and practical for clinicians; Fourth, the integration of current artificial intelligence technology, the use of some links or small programs, can enable operators to obtain a good understanding and learning
of specific clinical application background and related references.
The formulation of the CBCS Essential Edition Guidelines can be said to have reached a height of matching, complementing and corroborating with the full-text version, and its essence is streamlined on the basis of the more complex content of the full-text version, and its clinical value lies in the ability to obtain better clinical practicality
on the basis of the relatively poor readability of the original 。 In this regard, Professor Yu Keda further emphasized, "Therefore, we are currently faced with two choices, if you want to understand the simple content, choose Xiaohongshu, if you want to understand a more leveled, richer and more complete content, the full-text version is preferred, these two versions do not have who controls or who is higher than whom, the two are completely consistent
in direction.
"
Regarding the significance of the guideline update, Professor Yu Keda expressed his profound opinion, "I believe that a good guideline must be updated every year, and keep up with the development of new drugs and changes
in new diagnosis and treatment fields every year.
However, due to the large amount of content related to breast cancer diagnosis and treatment, the CBCS full-text guidelines are updated every two years to ensure that we can focus on doing this as much as
possible.
However, the biennial update may be lacking in timeliness, so the current Xiaohongshu is updated once a year, which ensures the timeliness of the CBCS guidelines, and benefits from its more convenient and practical features, which is conducive to clinicians to gain faster insight into the latest progress
in breast cancer diagnosis and treatment.
Therefore, the significance of Xiaohongshu update is to make the latest academic progress and clinical consensus accepted, understood and practiced by the majority of clinicians, and finally let our patients receive the latest drugs and therapies as soon as possible
.
"
Diversity and Merit: Stocktaking Updates and Considerations
of HER2-Positive Breast Cancer Regarding the main update points of the 2022 CBCS Condensed Edition Guidelines in the field of HER2-positive breast cancer, Professor Yu Keda pointed out, The treatment of HER2-positive breast cancer can be divided into three parts, including preoperative neoadjuvant therapy, postoperative adjuvant therapy, and late rescue therapy
.
The purpose of treatment of early-stage breast cancer is very simple, one is to rapidly shrink the tumor, and the second is to understand drug sensitivity
.
In this year's guideline update, in the field of neoadjuvant therapy, pyrrotinib + trastuzumab + docetaxel is considered as a mandatory group "consideration" plan (the preferred population is not recommended for the time being).
This recommendation is based primarily on the results of the PHEDRA study [1], a phase III clinical trial
to evaluate the efficacy and safety of pyrrotinib/placebo + trastuzumab + docetaxel for neoadjuvant therapy for HER2-positive breast cancer 。 According to the results presented at the 2021 San Antonio Breast Cancer Congress (SABCS), the total pathological complete response (tpCR) rate assessed by the Independent Review Committee (IRC) in the pyrrotinib group was 41%, significantly higher than the 22% (P<0.
0001) in the placebo group, and the breast pathological complete response rate (bpCR) in the pyrrotinib group increased by 20.
1% (43.
8% vs 23.
7%) compared with the placebo group; The objective response rate (ORR) in both groups was 91.
6% and 81.
9%,<b22> respectively.
And the overall safety of pyrrotinib group is good and tolerated
by patients.
In this regard, Professor Yu Keda said that pyrrotinib + trastuzumab + docetaxel has been confirmed to have the effect of rapid tumor shrinkage, considering that the treatment regimen of this small molecule tyrosine kinase inhibitor (TKI) combined with macromolecular monoclonal antibody has an impact on the long-term survival of HER2-positive early breast cancer, it will take time to clarify, so it is currently conservative in the recommended level.
The recommended level of this program is temporarily "considered"
in people who require rapid de-escalation.
In the field of adjuvant therapy after HER2-positive breast cancer, the overall update is not rapid, because all guideline recommendations for adjuvant therapy are mostly based on landmark clinical trial data, and studies of just one or two years are unlikely to support a major strategy change
.
"But we've also seen some welcome changes, such as the fact that certain drugs are more likely to be included in the guidelines as access to drugs
improves.
" For example, the tropa bitargeted therapy that originally needed to be recommended in high-risk groups or medium- and high-risk groups, after pertuzumab entered the medical insurance, can also recommend double-targeted therapy for patients whose risk of recurrence is not high, which not only does not increase the economic burden, but also can bring patients better efficacy, so we will make a higher level of recommendation in the guideline update," Professor Yu Keda explained
.
In the field of HER2-positive advanced breast cancer treatment, there are currently two more important drugs at home and abroad, one is the new antibody drug conjugate (ADC) T-DXd, based on DESTINY-Breast03 (DB03) research, T-DXd has moved from the back-line application to the second-line treatment status
.
However, because T-DXd is currently not available in China, the current CBCS Essential Edition guidelines recommend a "consideration"
for late-stage second-line medication.
With the emergence of more research data, the therapeutic status of T-DXd may become higher and higher, but before it is launched in China, the recommendation of the CBCS Condensed Edition Guidelines will remain very cautious
.
Another drug is China's self-developed class 1.
1 new drug pyrrotinib, in this guideline update, pyrrotinib + trastuzumab + docetaxel as a "consideration" recommendation
for advanced first-line medication 。 This recommendation is primarily based on the PHILA study, a randomized, multicenter phase III clinical trial evaluating pyrrotinib + trastuzumab + docetaxel versus placebo + trastuzumab + docetaxel first-line treatment of HER2-positive relapsed/metastatic breast cancer, based on results presented at the 2022 Congress of the European Society of Medical Oncology (ESMO) [2].
The median progression-free survival (PFS) in the pyrrotinib combination group exceeded 2 years [median PFS assessed by investigators (INV) up to 24.
3 months, significantly better than the control group of 10.
4 months (HR = 0.
41, 95% CI 0.
32-0.
53; P<0.
0001)].
<b22>
Professor Yu Keda said that the clinical targeting of advanced first-line drugs is more extensive, and the treatment needs are more urgent, and the efficacy needs are more needs to be confirmed
.
From the current research data, pyrrotinib + trastuzumab + docetaxel treatmentThe longest PFS in the first-line treatment for HER2-positive advanced breast cancer was obtained, and a longer median follow-up period is needed to verify this PFS benefit, but the overall trend of benefit is not controversial
.
"So I look at the treatment recommendation of pyrrotinib update from two directions, first of all, our world is diversified, and the treatment options are also rich and diverse, so in addition to the pursuit of efficacy, more elements need to be added, which are not only based on efficacy considerations, but also drug accessibility, and regional factors
.
" Xiaohongshu's treatment recommendation for pyrrotinib + trastuzumab + docetaxel is also based on diversified considerations, which not only provides a new option for the first-line treatment of HER2-positive advanced breast cancer, but also takes into account the accessibility of Chinese patients
.
Secondly, we also want to emphasize monism, which may sound contradictory, but in fact the ultimate purpose of pluralism is to achieve unification, and ultimately choose the best among many solutions to achieve the highest level of monization
。 Although the era of univariation may be relatively far away, we have now entered the era of multiple treatments, in many programs, pyrrotinib + trastuzumab + docetaxel first-line treatment benefits significantly, and toxic side effects are easy to manage, which means that the continuous upgrading and optimization of anti-HER2 advanced first-line treatment can be said to be in line with our monist concept of ultimately achieving the ultimate best efficacy in the process of selecting the best
.
Steady progress, co-expansion and optimization - elucidating the update hotspots of HR-positive breast cancer and thinking about
the relatively few updates involving HR-positive breast cancer in the 2022 CBCS Essential Edition guidelines, Professor Yu Keda explained, "On the one hand, it may be that there have been more updates in previous years, or that the progress in recent years has been relatively lagging behind"
.
Regarding the specific update of HR-positive breast cancer, Professor Yu Keda further pointed out that based on the results of DESTINY-Breast04 (DB04), new categories of HR-positive and low expression of HER2 have been added, broadening the molecular classification
of treatment-oriented breast cancer treatment.
In addition, for HR-positive breast cancer, CDK4/6 inhibitors play an irreplaceable and important role, Professor Yu Keda emphasized, "CDK4/6 inhibitors as a class of fist or ace products, almost all advanced first-line treatment will recommend CDK4/6 inhibitors combined with endocrine therapy
.
" Although in the field of HR-positive breast cancer treatment, endocrine therapy options ranging from tamoxifen to aromatase inhibitors (AI) to fulvestrant can be
diverse.
But the therapeutic status of CDK4/6 inhibitors has never changed
.
Current clinical guidelines do not make a detailed distinction between the four CDK4/6 inhibitor treatment recommendations, and overall, the industry believes that their overall efficacy is parallel, but toxicity management may vary
。 Clinically, we advocate the use of drugs with clear efficacy as clinical key drugs, and we also recommend reasonable selection according to different regions and drug accessibility and other factors, but considering that pibociclib, abeccilib, rebocilib and the first independently developed CDK4/6 inhibitor in China, darcilib, on the whole, its efficacy is not uneven at present, so there is no grade distinction in the guideline recommendation for the time being, but all are applicable
.
And we also believe that based on diversified considerations, for domestic patients, eventually these drugs will find their own treatment status
.
Expert
profile
Professor Yu Keda
Deputy Director of Breast Surgery, Chief Physician, Professor and Doctoral Supervisor of Fudan University Cancer Hospital
Winner of the National Fund for Outstanding Youth
Member of the Standing Committee/Secretary-General/Youth Convener of the Breast Cancer Special Committee of the Chinese Anti-Cancer Association
Secretary of the Breast Group of the Oncology Branch of the Chinese Medical Association/Head of the Youth Expert Group
Member of the Youth Council of China Anti-Cancer Association
Vice Chairman of the Youth Council of Shanghai Anti-Cancer Association
Vice Chairman of the Breast Cancer Special Committee of Shanghai Anti-Cancer Association/Chairman of the Youth Committee
Vice Chairman of the Tumor Target Molecular Branch of Shanghai Medical Association
References:
[1] Wu J; Liu ZZ; Yang HJ,et al.
Pyrotinib in combination with trastuzumab and docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer(PHEDRA):A randomized,double-blind,multicenter ,phase 3 study.
2021 SABCS.
Abstract PD8-08.
[2] Xu BH,Yan M,Ma F,et al.
Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer(PHILA):a randomized phase 3 trial.
2022 ESMO.
Abstract LBA19.
*This article is only for providing scientific information to medical professionals and does not represent the views of this platform
