In 2024, CSCO plans to release a total of 32 guidelines for the diagnosis and treatment of cancer, one for the first time, and the remaining 31 for republication and update, and the first published guideline is "Guidelines for the Diagnosis and Treatment of Liver Injury Associated with Cancer Drugs". These 32 guidelines cover most common tumor types, effectively promoting the standardization of cancer diagnosis and treatment in mainland China. In order to expand the audience and influence of the CSCO cancer diagnosis and treatment guidelines, under the guidance of the relevant departments and bureaus of the National Health Commission, China Medical Tribune launched a series of activities of "Pilot Plan - Follow the 'National Team' to Learn CSCO Diagnosis and Treatment Guidelines", and invited many domestic experts in the field of oncology and guideline writers to interpret the key points of the CSCO tumor diagnosis and treatment guidelines, answer questions for clinicians, cultivate standardized diagnosis and treatment thinking, and improve the ability and level of cancer diagnosis and treatment in mainland China.
In this event, we are honored to invite Professor Wang Kun from Guangdong Provincial People's Hospital to interpret the updated key points of the early breast cancer part of the CSCO Breast Cancer Diagnosis and Treatment Guidelines 2024. Let's take a quick look at the updated content of the guidelines through this article, so as to better understand the updated guidelines and help standardize clinical diagnosis and treatment!
Key points of the guide update
On the whole, this part adheres to the basic writing principles of CSCO guidelines based on evidence-based medical evidence and resource accessibility to formulate guidelines that are most suitable for the national conditions of mainland China and guide the clinical experience of breast cancer diagnosis and treatment in mainland China.
There was no update on the indications for preoperative neoadjuvant therapy
Preoperative neoadjuvant drug therapy may be selected if one of the following conditions is met:
1. The lump is large
2. Axillary lymph node metastasis
3.HER2+
4. Triple negative
5. Those who are willing to conserve breast, but the ratio of tumor size to breast volume is large and it is difficult to conserve breast
Exegesis:
Neoadjuvant therapy can be considered when the primary breast mass is > 5 cm; If the size is 2~5 cm, other biological indicators should be combined to choose whether to treat with drugs first.
The panelists agreed that tumors should be larger than 2 cm when HER2+ or triple negative were used as the criteria for the selection of preoperative neoadjuvant therapy for breast cancer; Or you can join a rigorously designed clinical study.
HER2+乳腺癌
Update point 1: The THP×4 regimen has been adjusted from the original Level I recommendation to the Level II recommendation, and the THP×6 regimen is the Level I recommendation.
Rationale for update: Dual-target continuous inhibition is the cornerstone of the treatment of HER2+ patients, and the 6-cycle THP regimen can better ensure the full course of treatment for patients.
Update point 2: In the remarks, H and P are trastuzumab, pertuzumab and subcutaneous preparations that have been approved in China.
Reason for update: Based on the acceleration of domestic drug approval, H/P products are constantly enriched, and trastuzumab and pertuzumab with existing indications can be considered.
The pathological complete response (pCR) rate of HER2+ breast cancer has been continuously improved from single-target, double-target to follow-up precision therapy, reaching an average of about 60%.
The development direction of early-stage HER2+ breast cancer has changed to two categories: neoadjuvant stage de-escalation therapy; Failure to achieve pCR as an adjunct to escalated therapy.
Down-order therapy is mainly reflected in exemption from chemotherapy, exemption from surgery, reduction of cycle, and optimization of dosage form.
THE PHERGAIN STUDY SUGGESTS THAT FDG-PET CAN BE EVALUATED TO IDENTIFY POTENTIAL POPULATIONS FOR CHEMOTHERAPY EXEMPTION AND THUS CHEMOTHERAPY EXEMPTION;
Elpis研究提示Ⅰ期HER2+和PAM50 HER2-E/ERBB2高表达患者豁免手术；
The results of WSG ADAPT HER2+/HR- 5-year survival data showed that HER2+ breast cancer patients with pCR could also achieve better efficacy with short-term down-order T+P neoadjuvant therapy, and the reduction cycle was explored.
The HannaH study is a multicenter, randomized, open-label phase III clinical study of trastuzumab subcutaneous injection combined with chemotherapy versus intravenous trastuzumab combined with chemotherapy (neo)adjuvant treatment in stage I.-III HER2-positive breast cancer. Such a new approach also represents a change in the mode of diagnosis and treatment, from a "disease-centered" diagnosis and treatment model to a "patient-centered" one.
Adjuvant step-up therapy that does not reach pCR includes targeted sequential and ADC combinations.
Patients who have not achieved pCR with trastuzumab or trastuzumab plus pertuzumab are recommended for patients who have not achieved pCR with trastuzumab or pertuzumab before preoperative anti-HER2 therapy, i.e., targeted sequential therapy.
The possibility of ADC in combination with other therapies is currently being explored, and this direction may further change clinical practice in the future.
Triple negative breast cancer treatment
Update point 1: Neoadjuvant therapy is adjusted to neoadjuvant chemotherapy and neoadjuvant immunotherapy.
Rationale for update: The status of immunotherapy in triple-negative breast cancer is increasing, and the number of people who are candidates for neoadjuvant immunotherapy is increasing.
Update point 2: In neoadjuvant immunotherapy, TP-AC combined with pembrolizumab and TP+PD-1 inhibitors are included in the level I recommendation.
Reason for update: 基于 KEYNOTE-522 Research Wa cTRIO Study.
KEYNOTE-522 added the PD-1 inhibitor pembrolizumab to TP-AC as a neoadjuvant treatment for triple-negative breast cancer, and the primary endpoints of the study were pCR rate (short-term efficacy) and event-free survival (EFS) phase (long-term efficacy) in the ITT population, both of which achieved good results. The cTRIO study also showed that nab-paclitaxel and carboplatin in combination with tislelizumab were associated with higher pCR rates and were well tolerated in the neoadjuvant setting.
It is known that the neoadjuvant phase emphasizes immunotherapy plus chemotherapy, with platinum-containing regimens used for chemotherapy promotion and PD-1 inhibitors recommended for immunotherapy. Questions that still need to be explored in the future include: (1) Is it necessary to use four-drug combination chemotherapy? (2) Is 8 cycles of treatment standard? (3) How to predict immune efficacy? (4) How to predict adverse immune reactions? (Early prevention, early detection, early treatment, and full cycle)
In the future, it is believed that triple negative breast cancer can achieve similar survival to other types of neoadjuvant immunotherapy combined with chemotherapy plus adjuvant intensive therapy.
HR+ breast cancer
Neoadjuvant therapy
Update point 1: The new CDK4/6 inhibitors in the neoadjuvant therapy annotation refer to the CDK4/6 inhibitors that have been marketed in China, but the indications for adjuvant therapy should be considered.
Reason for update: Based on indications for adjuvant therapy.
Neoadjuvant endocrine therapy may be considered in hormone-dependent patients who require preoperative neoadjuvant therapy but are not candidates for chemotherapy, are temporarily unsuitable for surgery, or do not require immediate surgery, and who are insensitive to neoadjuvant chemotherapy or have an inadequate response to neoadjuvant chemotherapy.
Adjuvant therapy
In the treatment, the level I recommendation of aromatase inhibitor (AI) + abeciclib of 1A in the initial treatment of adjuvant endocrine therapy for postmenopausal HR+ breast cancer was emphasized; Premenopausal axillary lymph node ≥4 positive HR+ breast cancer OFS+AI+abeciclib is a grade I recommendation of 1A; Premenopausal axillary lymph nodes 1~3 positive and one of the following risk factors: T25 cm, G3, Ki-67≥ 20% HR+breast cancer OFS+TAM+abeclib is a grade I recommendation of 1A. Abeciclib is preferred.
Update point 2: Added NATALEE clinical study, and rebociclib can be considered for patients who meet the clinical study; Added "If abeciclib cannot be tolerated due to adverse reactions during treatment, it can be considered to switch to rebociclib".
Rationale for update: The NATALEE study covers all patients with lymph node metastases and patients with node-negative but large tumors (T2 and above) or high-risk factors (G3, Ki-67≥20%, high-risk genetic testing). The study found that compared with non-steroidal aromatase inhibitors (NSAI) alone, rebociclib combined with NSAI significantly reduced the risk of invasive disease, recurrence, and death by 25.2%. Therefore, for patients eligible for the NATALEE clinical study, a non-steroidal aromatase inhibitor (NSAI) can be combined with rebociclib for 3 years.
Interpretation Expert
Prof. Kun Wang
Vice President of Cancer Hospital of Guangdong Provincial People's Hospital
Doctoral supervisor
Director of CSCO, member of the Standing Committee of the Breast Cancer Committee
2019 National Famous Doctor Awardee
In 2021, the NeoCART study was selected into the NCCN breast cancer guidelines in the United States
Winner of the 2023 People's Good Doctor - Outstanding Contribution Award in the field of breast cancer
Review丨Guangdong Provincial People's Hospital, Wang Kun
Editor丨China Medical Tribune Gui Jingjing