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Early breast cancer is the most important opportunity for patients with breast cancer to obtain high-quality survival. In recent years, a large number of clinical studies on early breast cancer have been published, which has also affected the clinical practice of early breast cancer. At the just-concluded 17th Shanghai International Breast Cancer Forum (SIBCS), from , the First Affiliated Hospital of China Medical University, , Professor Jin Feng, , summarizes important research on the recent changes in the clinical practice of early breast cancer.
four major studies, optimize neoadjuvant/adjuvant treatment
01 Based on PATTERN research, NCCN Guidelines 2022V1 recommends TNBC platinum-containing adjuvant chemotherapy regimen for the first time.
Professor Jin introduced, "In the past, the efficacy of platinum in neoadjuvant/adjuvant therapy for early breast cancer has always been controversial. The main reason is that there are too few researches on platinum in adjuvant therapy for breast cancer." Recently, the PATTERN study published by on the Affiliated Cancer Hospital of Fudan University on in JAMA Oncology for the first time confirmed that the zirconol combined with carboplatin (PCb) regimen is an effective adjuvant chemotherapy regimen in patients with surgical triple-negative breast cancer (TNBC). The
PATTERN study explored the efficacy of cyclophosphamide + epirubicin + fluorouracil (CEF-T) treatment regimen in early TNBC postoperative adjuvant treatment. The main endpoint of the study was disease-free survival (DFS). The results showed that compared with the CEF-T protocol, the PCb protocol increased DFS for 5 years with early surgical TNBC by 6.2% (86.5% vs 80.3%, HR=0.65, 95% CI: 0.44-0.96, P=0.03), and the results of distal disease-free survival (DDFS) and recurrence-free survival (RFS) were consistent (Figure 1).
Figure 1 PATTERN study results (Photo source from Professor Jin Feng ppt)
At the same time, the analysis results of this study subgroup show that young people with high tumor grade prefer PCb regimens, and homologous recombination repair defects (HRD) can better benefit from platinum therapy.
02 Based on KEYNOTE-522, the CSCO-BC guideline uses chemotherapy combined with PD-1 inhibitors as a Class III recommendation for neoadjuvant treatment of TNBC.
KEYNOTE-522 is the first prospective, randomized, placebo-controlled, phase III study of pembolizumab in neoadjuvant and adjuvant treatment of early TNBC. TNBC patients enrolled in this study were divided into experimental group and control group at a ratio of 2:1. The control group was treated with placebo and chemotherapy. The experimental group received the same chemotherapy combined with pembolizumab. After the operation, the two groups received placebo or pembolizumab treatment for 9 cycles. The study adopted a dual-endpoint study design (Figure 2), with the main endpoints including complete neoadjuvant pathological remission (PCR, ypT0/Tis N0) and event-free survival (EFS).
Figure 2 KEYNOTE-522 study design (picture sourced by Professor Jin Feng’s courseware)
study results show that 1. Compared with placebo combined with neoadjuvant chemotherapy, the PCR of pembolizumab combined with neoadjuvant chemotherapy has been significantly improved. 2. Compared with neoadjuvant chemotherapy alone, pembrolizumab combined with neoadjuvant chemotherapy and sequential pembrolizumab can significantly improve EFS (36 months). and the results of the 2022 ASCO study show that pembrolizumab combined with chemotherapy can improve EFS in RCB0, 1, and 2 patients, with the most significant benefit in the RCB-2 category.
03 Based on PHEDRAP research, CSCO-BC Guidelines (2022 Edition) use H+TKI as a Level II recommendation for neoadjuvant treatment for HER-2-positive breast cancer
PHEDRA is a multicenter Phase III study on pyrrolitinib combined with trastuzumab and docetaxel (Py+TH) neoadjuvant treatment for HER2-positive early or locally advanced breast cancer. The study was divided into experimental group and control group at a ratio of 1:1. The control group adopted a placebo combined with docetaxel and trastuzumab (TH) treatment regimen, and the experimental group received a Py+TH treatment regimen. The results of the study show that compared with the TH treatment regimen, the Py+TH treatment regimen can significantly improve the tpCR rate (41.0% vs 22.0%, p <>
04NeoCART study: NCCN Guide 2022V1 first quotes my country's original innovative auxiliary clinical research, providing new evidence for neoadjuvant treatment plans for TNBC patients.
NeoCART study is a domestic exploration of neoadjuvant therapy for platinum. The study was conducted by Professor Wang Shen’s team of at the Guangzhou Provincial People’s Hospital. The study showed that compared with the standard protocol (episorubicin combined with cyclophosphamide sequential docetaxel, EC-D), docetaxel + carboplatin regimen (DCb) can improve the pCR rate of neoadjuvant chemotherapy in TNBC patients, with EFS and OS similar in the two groups.
intensive treatment plan, assisting the "upgrade ladder" of adjuvant therapy
01 Based on Olympia A study, CSCO-BC guidelines recommend 1. Adjuvant treatment of non-pCR after neoadjuvant therapy of TNBC, 2. Follow-up treatment of adjuvant therapy of TNBC (lymph node positive or tumor >2cm) adjuvant therapy: BRCA mutation olaparib is recommended as a Level II recommendation (at present, olaparib has not been approved for indications in China, so it should be considered carefully)
Olympia A study mainly explores the efficacy and safety of olaparib as adjuvant therapy for early breast cancer. The study included patients with early stage breast cancer who had received local treatment and neoadjuvant/adjuvant chemotherapy. The results showed that:
median follow-up for 2.5 years, compared with placebo, and 1 year of standard treatment plus olaparib-assisted intensive treatment can significantly improve the 3-year survival of invasive disease (iDFS) and DDFS in patients with early-stage high-risk BRCA germline mutation HER2-negative breast cancer patients with 3-year invasive disease (iDFS) and DDFS (Figure 3).
Figure 3 Olympia A study results (picture sourced from Professor Jin Feng’s courseware)
Median follow-up for 3.5 years, compared with placebo, after standard treatment plus olaparib assisted intensive treatment, it can significantly improve the OS of patients with early-stage high-risk BRCA germline mutation HER2-negative breast cancer for 4 years.
02SYSUCC-001 study: NCCN Guidelines 2022V1 First cited SYSUCC-001 study capecitabine low-dose maintenance treatment plan
Sun Yat-sen University Tumor Prevention and Treatment Center Professor Yuan Zhongyu In order to evaluate the efficacy and safety of low-dose capecitabine maintenance treatment after standard TNBC treatment, the SYSUCC-001 study was carried out in 2010.
The results of this study show that low-dose capecitabine beat chemotherapy maintenance treatment can significantly prolong DFS and DDFS in early TNBC patients. At median follow-up of 61 months, the 5-year DFS increased from 73.0% to 82.8% compared with placebo (HR: 0.64, 95CI%: 0.42-0.95), and the 5-year DDFS increased from 75.8% to 85.8% (HR: 0.60, 95% CI: 0.38-0.92, p=0.02).
03MonarchE study: Domestic and foreign guidelines unanimously recommend that patients with HR+HER-high risk (with ≥4 positive lymph nodes or 1-3 positive lymph nodes and at least one of the following: and tumor size ≥5 cm, histological grade 3 or center Ki-67 ≥20%) breast cancer, adjuvant treatment of abecili can be considered for 2 years after surgery. At the
meeting, Professor Jin Feng introduced: "CDK4/6 inhibitors have good efficacy in breast cancer after 1, 2 and 2 lines, while the efficacy of CDK4/6 inhibitors in early breast cancer is still unknown. The effect of MonarchE study on CDK4/6 inhibitors (Abecili) combined with endocrine therapy in adjuvant treatment of HR+/HER2-high-risk early breast cancer (Figure 4). "
Figure 4 MonarchE research protocol (Figure sourced by Professor Jin Feng's courseware)
MonarchE study showed that compared with endocrine therapy alone, abecili combined with endocrine therapy can significantly reduce the risk of invasive diseases by 25.3%, and reduce the risk of distant recurrence by 28.3%. In addition, iDFS and DRFS benefits can be obtained by abecili combined with endocrine therapy.
04SUCCESS-A study: CACA-CBCS guide (2021 edition) For patients without bone metastasis imaging evidence, as well as patients with extra-bone metastasis single without bone metastasis, the bisphosphonate
SUCCESS-A study is a clinical study comparing different treatment durations of bisphosphonate. compared the survival outcomes of 5-year and 2-year treatment of zoledronate in patients with adjuvant chemotherapy for early lymph node-positive or high-risk lymph node-negative breast cancer. The study showed that for patients with adjuvant chemotherapy after early stage breast cancer, the survival outcomes did not improve significantly compared with 2 years of zoledronic acid treatment, and the incidence of adverse time was higher, especially bone pain and and joint pain. Therefore, the duration of zoledronic acid can be reduced to 2 years in patients with high risk of postoperative chemotherapy for early stage breast cancer.
polygenic tool "downgrading ladder" of adjuvant chemotherapy
01CSCO-BC Guidelines (2022 Edition) Recommended MammaPrint detection
RxPONDER study shows that: lymph node metastases and 21 gene scores 0-25, the adjuvant chemotherapy department reduces the risk of recurrence by 46%. Postmenopausal patients have little benefit in chemotherapy, and chemotherapy can be exempted.
MINDACT study shows that for some patients at high risk of clinical risk, the 70 gene test results can screen some patients for avoiding chemotherapy.
RxPONDER study is mainly used for the efficacy of 21-gene breast cancer detection in clinical practice for 1-3 early breast cancer adjuvant treatment (endocrine and or chemotherapy). The results of this study showed that compared with chemotherapy combined with endocrine therapy, the IDFS of postmenopausal women with endocrine alone were similar (91.9% vs 01.3%, HR: 1.02, 95CI% 0.82-1.26, p=0.89) and postmenopausal IDFS (91.9% vs 01.3%, HR: 1.02, 95CI% 0.82-1.26, p=0.89). Therefore, it can be concluded that 1-3 lymph nodes are metastasized and 21 gene scores 0-25-female postmenopausal is exempt from chemotherapy.
MINDACT study mainly explores whether adjuvant treatment of early breast cancer with T1-2 or surgical T3 and lymph node metastasis ≤ 3 requires chemotherapy. This study combines 70 gene monitoring to determine genetic risk and the Adjuvant Online v8.0 clinical pathological system to determine clinical risk. The results of this study showed that at 8.7 years of median follow-up, patients with 70 genes with low risk of early-stage breast cancer were treated with endocrine therapy alone without chemotherapy, and had no distant metastasis survival (DMFS). Therefore, for women >50 years old or women <50>
diverse studies, optimize local treatment
01 radiotherapy: CSCO-BC Guidelines (2022 Edition) Guidelines to refer to the single-week ultra-segmentation regimen of whole breast after breast-conservation (pN0) invasive carcinoma as a Level II recommendation (2A evidence)
FAST-Forward study is a multicenter, non-inferior, randomized non-blind controlled III clinical study , which evaluates the efficacy of radiotherapy for early stage breast cancer ultra-segmentation regimen, with the main endpoint being ipsilateral breast cancer tumor recurrence. The results of the study show that in patients with postoperative radiotherapy for early stage breast cancer, the 5-year local tumor control effect of the 26 Gory 5-segmentation regimen within 1 week is not inferior, and the safety effect on normal tissues is similar.
02 Surgical axillary stage: NCCN/ASCO guidelines are negative for clinical physical examinations and abnormal imaging examinations (regardless of whether biopsy is confirmed), and SLNB is still recommended for axillary stage. At the
meeting, Professor Jin preached that ACOSOG Z0011, EORTC AMAROS, and IBCSG23-01 respectively explored the value of dissection, radiotherapy, and micrometastasis of sentinel lymph node biopsy (SLNB). The overall research results show that SLNB is the standard surgical axillary treatment model for patients with early cN0 breast cancer. Those with SLN-negative, SLN-positive and low axillary tumor burden can be safely exempted from axillary dissection (Figure 5).
Figure 5 Surgical axillary staging (picture sourced by Professor Jin Feng’s courseware)
03 cleft: BMJ meta-study may change international guidelines revision
Current standards for invasive breast-conserving margins are still not unanimously recommended by the US SSO/ASTRO/ASCO guidelines: no link on tumor. However, the large sample meta-analysis published by BMJ in 2022 may have an impact on international guidelines revisions and change clinical practice. This study results show that the distal recurrence rate and local recurrence rate that are negative for the resection margin are significantly increased, and systemic treatment can reduce distant recurrence, but cannot reduce the distant recurrence rate of the resection margin less than 1 mm.
Finally, Professor Jin concluded at the meeting that in general, there are many studies that have changed the clinical practice of early breast cancer. Clinicians should maintain the principle of standardizing treatment plans so that patients can have the opportunity to survive for a long time and cure them in the early stage.
This article is first published: Medical community tumor channel
Author: Jiulu
Editor: Sweet
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