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Authoritative intensive reading of "CSCO Breast Cancer Diagnosis and Treatment Guidelines 2024 Edition"
撰文 | Lily
The 2024 National Breast Cancer Conference and the Annual Meeting of the Chinese Society of Clinical Oncology for Breast Cancer (CSCO BC) was held in Beijing from April 12 to 13, and the "CSCO Breast Cancer Diagnosis and Treatment Guidelines 2024 Edition" (hereinafter referred to as the "Guidelines") was released at the conference.
At the conference, Professor Jiang Zefei, Chairman of the CSCO Conference, summarized the key points of the update of the Guidelines. The medical community has compiled the essence of the content for the benefit of readers.
Highlights of the 2024 CSCO BC Guide Update
One
HR+ breast cancer
1. Late HR+ postmenopausal endocrine rescue therapy
Update Highlights:
- In endocrine therapy, the level I recommendation no longer distinguishes between CDK4/6 inhibitors, and it is recommended to rely on the patient's previous treatment benefit, adverse reaction tolerance, etc
- AI+everolimus, the level of evidence was adjusted from 2A to 1A
- In the failure stratification of CDK4/6 inhibitors, the "new AKT inhibitor + endocrine regimen" is recommended for level III
Since CDK4/6 inhibitors are fully included in the national medical insurance catalog, the new version of the guidelines no longer lists the names of specific CDK4/6 inhibitors, but includes all CDK4/6 inhibitors currently with international and domestic data and included in the medical insurance into the recommendation of first-line treatment, and the recommendations are ranked in no particular order.
IN THE PALOMA-2, MONARCH-3, DAWNA-2, AND MONALEESA SERIES OF STUDIES, ALL CDK4/6 INHIBITORS DEMONSTRATED PFS BENEFIT IN THE FIRST-LINE SETTING, WITH OS BENEFIT IN THE MONALEESA SERIES.
Fig.1 HR+ late postmenopausal endocrine rescue treatment regimen
With the comprehensive application of CDK4/6 inhibitors in the first line of clinical practice, the treatment of CDK4/6 inhibitors after progression has also become a major concern, but there is still no standard treatment regimen.
Regarding the treatment options after the failure of CDK4/6 inhibitors, Professor Jiang Zefei said:
- For patients who have benefited from previous endocrine sensitivity and CDK4/6 inhibitor therapy after failure of CDK4/6 inhibitors, endocrine can be switched to another CDK4/6 inhibitor.
- If CDK4/6 inhibitors fail, chemotherapy, endocrine combined with another mechanism of action, and novel antibody-drug conjugates (ADCs) can be selected, and the specific selection can be combined with endocrine therapy and the sensitivity of chemotherapy, while chemotherapy can be preferred for patients who have not benefited from CDK4/6 inhibitors, have benefited from previous chemotherapy or have not been treated with chemotherapy for recurrence and metastasis.
- In patients with low HER2 expression, T-Dxd may be an option after failure of CDK4/6 inhibitors.
2. Initial endocrine adjuvant endocrine therapy after advanced HR+ menopause
Update Highlights:
- Added "If abeciclib cannot be tolerated due to adverse reactions during treatment, it can be considered to switch to rebociclib"
Fig.2 HR+ late postmenopausal endocrinology-naïve treatment
The new guidelines further define the status of CDK4/6 inhibitors, such as abeciclib, as intensive adjuvant therapy. Which patients need abeciclib adjuvant augmentation?
Professor Jiang Zefei pointed out:
- For patients with ≥ 4 lymph node metastases, or 1-3 lymph node metastases with any of the risk factors of mass ≥5 cm, histologic grade 3, Ki-67≥20%, it is recommended to combine abeciclib on the basis of adjuvant endocrine therapy;
- For axillary node-positive patients who have received neoadjuvant chemotherapy, regardless of Ki-67 or high or low pathology, whether there is complete pathological remission, and TAM or AI in the adjuvant endocrine therapy phase, the combination of abeciclib can be considered.
In addition, median follow-up results from the NATALEE study showed that rebociclib in addition to a nonsteroidal aromatase inhibitor (NSAI) significantly improved 3-year invasive disease-free survival (iDFS) in the ITT population (90.4 versus 87.1 percent, HR=0.75, p=0.003), suggesting that rebociclib may be considered in patients who cannot tolerate abeciclib. Pending regulatory approval, the clinic will follow up on new treatment options in a timely manner.
Two
HER2-positive breast cancer
1. Treatment of HER2-positive recurrent and metastatic breast cancer
Update Highlights:
- H treatment sensitivity: the evidence level of TH+ pyrotinib was adjusted from 2A to 1A, and the evidence level of THP regimen was adjusted from 1B to 1A
- H treatment failure: T-DM1 regimen adjusted from level I to level II recommendation, T-Dxd adjusted from level II to level I recommendation (1A)
- TKI treatment failure: Evidence for T-Dxd in the tier II recommendation was adjusted from 2A to 1A
- HP recommends the addition of a subcutaneous formulation
After the evolution of trastuzumab single target, trastuzumab + pertuzumab "to" dual target, TKI and ADC series, there will be new changes in the field of HER2-positive breast cancer treatment in 2023. The guidelines further emphasize the status of "totu dual-target" as the standard of care, based on the phase III PHENIX study and the PHOEBE study, pyrotinib has become the standard of care after trastuzumab treatment failure in HER2-positive metastatic breast cancer, and based on the positive results of key studies such as DESTINY-Breast 03 and the further improvement of drug access, the T-Dxd recommendation level has been upgraded to a level I recommendation. For patients who failed TKI therapy, T-Dxd received a priority recommendation of Level II when the Level I recommendation was still vacant.
Fig.3 Treatment of HEL-positive recurrent and metastatic breast cancer
2. Neoadjuvant therapy for HER2-positive breast cancer
Update Highlights:
- The THP×4 regimen has been adjusted from the original Level I recommendation to the Level II recommendation
- In the remarks, H and P are trastuzumab, pertuzumab and subcutaneous preparations that have been approved in China.
Dual-target combined continuous inhibition is the cornerstone of the treatment of HER2-positive breast cancer patients, and the 6-cycle THP regimen (docetaxel + trastuzumab + pertuzumab) can better ensure the full course of treatment for patients.
3. HER2-positive neoadjuvant therapy followed by adjuvant therapy
Update Highlights:
-
For patients with non-pCR stratification, the level of evidence for T-DM1 was adjusted from 2B to 2A, and "subsequent intensive nerratinib (2B)" was recommended as III
Three
TNBC
1. Advanced TNBC rescue therapy
Update Highlights:
- The original rescue treatment recommendation form was adjusted to two forms: chemotherapy and rescue immunotherapy
- In rescue immunotherapy, "TP-AC combined with pembrolizumab" and "TP+PD-1 inhibitor" were included in the level I recommendation, based on the KEYNOTE-355 and TORCHLIGHT studies
In the KEYNOTE-522 study, which explored pembrolizumab in combination with chemotherapy in the neoadjuvant treatment of TNBC, the addition of pembrolizumab to chemotherapy increased pCR from 51.2% to 64.8%. Based on the KEYNOTE-522 study, cTRIO and other studies, TP-AC combined with pembrolizumab and TP+PD-1 inhibitors were added to the level I recommendation for neoadjuvant immunotherapy.
Four
HER2-low expression breast cancer
Update Highlights:
- Patients with low HR-negative HER2 expression should be treated with TNBC breast cancer, and chemotherapy or chemotherapy combined with immunotherapy should be recommended, and after first-line therapy failure, ADC drug therapy can be considered, and gosatuzumab or T-Dxd can be selected
- PARP inhibitors (BRCA1/2 mutants) and anti-angiogenic drugs can be options for such patients
Results from the DESTINY Breast-04 study suggest that T-DXd is significantly more effective than physician-selected chemotherapy in patients who have received 1-2 prior lines of therapy;
The TROPiCS-02 study showed that gosatuzumab significantly improved PFS and OS in patients who failed HR+/HER2- breast cancer, paclitaxel, and CDK4/6 inhibitors after failure of single-agent chemotherapy, and also achieved PFS benefits in people with low HER2 expression.
Fig.4 HR+/HER2 low expression rescue therapy
Five
Breast cancer bone metastases, brain metastases
Update Highlights:
- Bone metastasis: denosumab is preferentially recommended, and new denosumab biosimilars have been published
- Brain metastases: Based on the available data, the content of T-Dxd has been updated to include radiotherapy in combination with pyrotinib
The Phase III equivalence trial confirmed the similarity of the efficacy, safety and population pharmacokinetics of the denosumab biosimilar MW032 with the innovator in patients with solid tumor bone metastases, and the DB01/02/03 pooled retrospective study explored the efficacy of T-Dxd in breast cancer brain metastases, and the analysis showed that T-Dxd achieved a significant PFS benefit in both treatment-experienced/stable brain metastases and untreated/active brain metastases (T-Dxd vs In the control group, median PFS was 12.3 vs 8.7 months and 18.5 vs 4.0 months, respectively). Pyrotinib in combination with radiotherapy has been shown to reduce the risk of intracranial progression in breast cancer patients.
Expert Profile
Professor Jiang Zefei
- Deputy Director of the Department of Oncology of the PLA General Hospital
- Chairman of the Breast Disease Branch of Beijing Medical Association
- Vice President and Secretary General of the Chinese Society of Clinical Oncology (CSCO).
- Chairman of the Breast Cancer Committee of the Chinese Anti-Cancer Association (CACA).
- Chairman of the Breast Cancer Committee of the Chinese Society of Clinical Oncology (CSCO).
Exciting information is waiting for you
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