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The 2021 National Breast Cancer Conference and the Chinese Society of Clinical Oncology Breast Cancer (CSCO BC) Annual Conference opened in Beijing on April 9th in the form of "online + offline".
The CSCO BC Annual Conference is one of the most influential academic events in the field of breast cancer in China.
During the meeting, in the special session of the diagnosis and treatment guidelines, Professor Wang Shusen from the Cancer Center of Sun Yat-sen University interpreted the updated key points of the 2021 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines for the treatment of advanced triple-negative breast cancer.
General The treatment of advanced triple-negative breast cancer should follow the basic treatment principles of advanced breast cancer; emphasize the role of MDT in the whole diagnosis and treatment of triple-negative breast cancer; the systemic treatment plan of advanced triple-negative breast cancer should consider tumor burden, molecular characteristics, and recurrence and metastasis patterns , Previous treatment, patient PS status and willingness and other factors; effective systemic treatment plan is recommended to be used until disease progression or toxicity is intolerable; most advanced triple-negative breast cancers are recommended to receive multi-line systemic treatment, of course, many The formulation of linear system treatment plans should consider the balance of benefits and risks.
Rescue treatment strategy for advanced triple-negative breast cancer: Update of rescue treatment: For patients who have failed anthracycline therapy, level II recommends the addition of albumin paclitaxel + PD-L1/PD-1 inhibitor (category 2A); level III recommends new The level of evidence for olaparib (Class 2A), chemotherapy + PD-1/PD-L1 inhibitor (Class 2B), and paclitaxel liposomes was updated to Class 2A.
For patients who have failed treatment with anthracyclines and taxanes, the level of evidence for eribulin, albumin paclitaxel, and Utidrolone + capecitabine in the level II recommendation is updated to category 2A.
Advanced triple-negative breast cancer rescue treatment 01 chemotherapy-the mainstay BG01-1312L study is a phase III study carried out by the team of Professor Xu Binghe, which explores the treatment of anthracyclines or yews with Utidrolone + capecitabine Efficacy of advanced breast cancer with drug failure.
The results showed that compared with capecitabine, Utidrolone + capecitabine can significantly improve the progression-free survival (PFS) and overall survival (OS) of patients.
On March 12, Utidelone was approved by the NMPA to be used in combination with capecitabine for advanced breast cancer patients who have failed previous anthracycline or taxane therapy.
Study 304 is a phase III study that explored the efficacy of eribulin versus vinorelbine in the treatment of recurrent/metastatic breast cancer.
The results showed that Eribulin significantly prolonged PFS (3.
7 months vs 3.
1 months, P=0.
02) longer than chunrebine.
Many previous studies have confirmed the efficacy of albumin paclitaxel in advanced breast cancer.
Due to the launch of domestic drugs, the consensus of experts has improved.
Therefore, the level of evidence has been adjusted from 2B to 2A.
02 Targeted therapy-a precise breakthrough in the OlympiAD study to explore the efficacy of olaparib versus the chemotherapy regimen selected by doctors for BRCA mutant HER2-negative breast cancer.
The results showed that olaparib can significantly prolong PFS compared with chemotherapy.
The median PFS of the two groups were 7.
0 months and 4.
2 months (HR=0.
58, P=0.
0009).
But at present, Olapali's domestic indications are limited to ovarian cancer.
Therefore, it is classified as a level III recommendation.
03 Immunotherapy-the emergence of a new force Compared with other molecular subtypes, triple-negative breast cancer is the most suitable breast cancer subtype for immunotherapy.
It is manifested in: the expression level and intensity of tumor infiltrating lymphocytes (TILs) in triple-negative breast cancer are the highest; compared with non-triple-negative breast cancer, triple-negative breast cancer has a high expression of PD-L1.
The IMpassion130 study is a landmark study, exploring the efficacy of atelizumab + albumin paclitaxel versus placebo + albumin paclitaxel in patients with unresectable locally advanced or metastatic triple-negative breast cancer.
In the second interim analysis, in the ITT population and PD-L1 positive population, the median PFS of the atilizumab group and the placebo group were 7.
2 months vs 5.
5 months, respectively (HR=0.
80, P=0.
0021) , 7.
5 months vs 5.
3 months (HR=0.
63, P＜0.
0001); median OS was 21 months vs 18.
7 months (HR=0.
86, P=0.
078), 25 months vs 18 months (HR= 0.
71).
Based on this, this guideline update lists albumin paclitaxel+PD-L1/PD-1 inhibitors as a Class II recommendation with Class 2A evidence.
The KEYNOTE-355 study aims to explore the efficacy of chemotherapy plus pembrolizumab or placebo in newly treated patients.
Chemotherapy can choose albumin paclitaxel, paclitaxel, gemcitabine + carboplatin.
The results showed that compared with chemotherapy (5.
6 months), pembrolizumab + chemotherapy (9.
7 months) significantly improved the PFS of newly treated locally recurring inoperable or metastatic triple-negative breast cancer with PD-L1 CPS ≥10 .
04 ADC drugs-a series of ADC drugs can be expected to be recommended by international guidelines for triple-negative breast cancer in the future.
At present, domestic ADC drug research is progressing rapidly.
Trop-2 is expressed in all subtypes of breast cancer and is associated with poor prognosis.
Sacituzumab govitecan (SG) is a new type of antibody-drug conjugate (ADC), which is composed of anti-Trop-2 antibody conjugated with the active metabolite SN-38 of irinotecan through a unique hydrolyzable linker.
The phase I/II IMMU-132-01 study showed that the objective response rate (ORR) of SG in metastatic triple-negative breast cancer was 33%, the median duration of response (DOR) was 7.
7 months, and the median PFS was 5.
5 Months, and with manageable safety, the results of this study enabled SG to obtain accelerated approval from the US FDA for metastatic triple-negative breast cancer. The phase III ASCENT study showed that compared with the TPC group (n = 233), the SG group (n = 235) significantly improved the median PFS, and the median PFS of the two groups were 5.
6 months and 1.
7 months (HR=0.
41) ; P <0.
0001).
The median OS of the SG group and the chemotherapy group were 12.
1 months and 6.
7 months (HR=0.
48, P＜0.
0001), the ORR of the two groups were 35% and 5% (P＜0.
0001), respectively.
The clinical results of the two groups were The benefit rate (CBR) was 45% and 9% (P<0.
0001), and the median duration of response (DOR) in the two groups were 6.
3 months and 3.
6 months, respectively (P=0.
057).
At present, the domestic bridging research has been enrolled in the group, and we look forward to better research results.
Triple-negative breast cancer usually includes people with low HER2 expression.
The DS8201-A-J101 study showed that DS8201 treatment of patients with low HER2 expression can achieve an ORR of 44.
4%, a DCR of 83.
3%, a median DOR of 11 months, and a median PFS of 8.
0 months.
Currently, Phase III clinical studies are underway.
Conclusion Chemotherapy is still the most commonly used basic treatment for advanced triple-negative breast cancer; immunotherapy has entered the clinical practice of triple-negative breast cancer, and PD-L1 positive is the preferred population for first-line immunotherapy; some targeted therapy drugs have specific targets in some parts Accurate breakthroughs have been made in advanced triple-negative breast cancer patients; ADC drugs have broad application prospects in advanced triple-negative breast cancer.
The CSCO BC Annual Conference is one of the most influential academic events in the field of breast cancer in China.
During the meeting, in the special session of the diagnosis and treatment guidelines, Professor Wang Shusen from the Cancer Center of Sun Yat-sen University interpreted the updated key points of the 2021 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines for the treatment of advanced triple-negative breast cancer.
General The treatment of advanced triple-negative breast cancer should follow the basic treatment principles of advanced breast cancer; emphasize the role of MDT in the whole diagnosis and treatment of triple-negative breast cancer; the systemic treatment plan of advanced triple-negative breast cancer should consider tumor burden, molecular characteristics, and recurrence and metastasis patterns , Previous treatment, patient PS status and willingness and other factors; effective systemic treatment plan is recommended to be used until disease progression or toxicity is intolerable; most advanced triple-negative breast cancers are recommended to receive multi-line systemic treatment, of course, many The formulation of linear system treatment plans should consider the balance of benefits and risks.
Rescue treatment strategy for advanced triple-negative breast cancer: Update of rescue treatment: For patients who have failed anthracycline therapy, level II recommends the addition of albumin paclitaxel + PD-L1/PD-1 inhibitor (category 2A); level III recommends new The level of evidence for olaparib (Class 2A), chemotherapy + PD-1/PD-L1 inhibitor (Class 2B), and paclitaxel liposomes was updated to Class 2A.
For patients who have failed treatment with anthracyclines and taxanes, the level of evidence for eribulin, albumin paclitaxel, and Utidrolone + capecitabine in the level II recommendation is updated to category 2A.
Advanced triple-negative breast cancer rescue treatment 01 chemotherapy-the mainstay BG01-1312L study is a phase III study carried out by the team of Professor Xu Binghe, which explores the treatment of anthracyclines or yews with Utidrolone + capecitabine Efficacy of advanced breast cancer with drug failure.
The results showed that compared with capecitabine, Utidrolone + capecitabine can significantly improve the progression-free survival (PFS) and overall survival (OS) of patients.
On March 12, Utidelone was approved by the NMPA to be used in combination with capecitabine for advanced breast cancer patients who have failed previous anthracycline or taxane therapy.
Study 304 is a phase III study that explored the efficacy of eribulin versus vinorelbine in the treatment of recurrent/metastatic breast cancer.
The results showed that Eribulin significantly prolonged PFS (3.
7 months vs 3.
1 months, P=0.
02) longer than chunrebine.
Many previous studies have confirmed the efficacy of albumin paclitaxel in advanced breast cancer.
Due to the launch of domestic drugs, the consensus of experts has improved.
Therefore, the level of evidence has been adjusted from 2B to 2A.
02 Targeted therapy-a precise breakthrough in the OlympiAD study to explore the efficacy of olaparib versus the chemotherapy regimen selected by doctors for BRCA mutant HER2-negative breast cancer.
The results showed that olaparib can significantly prolong PFS compared with chemotherapy.
The median PFS of the two groups were 7.
0 months and 4.
2 months (HR=0.
58, P=0.
0009).
But at present, Olapali's domestic indications are limited to ovarian cancer.
Therefore, it is classified as a level III recommendation.
03 Immunotherapy-the emergence of a new force Compared with other molecular subtypes, triple-negative breast cancer is the most suitable breast cancer subtype for immunotherapy.
It is manifested in: the expression level and intensity of tumor infiltrating lymphocytes (TILs) in triple-negative breast cancer are the highest; compared with non-triple-negative breast cancer, triple-negative breast cancer has a high expression of PD-L1.
The IMpassion130 study is a landmark study, exploring the efficacy of atelizumab + albumin paclitaxel versus placebo + albumin paclitaxel in patients with unresectable locally advanced or metastatic triple-negative breast cancer.
In the second interim analysis, in the ITT population and PD-L1 positive population, the median PFS of the atilizumab group and the placebo group were 7.
2 months vs 5.
5 months, respectively (HR=0.
80, P=0.
0021) , 7.
5 months vs 5.
3 months (HR=0.
63, P＜0.
0001); median OS was 21 months vs 18.
7 months (HR=0.
86, P=0.
078), 25 months vs 18 months (HR= 0.
71).
Based on this, this guideline update lists albumin paclitaxel+PD-L1/PD-1 inhibitors as a Class II recommendation with Class 2A evidence.
The KEYNOTE-355 study aims to explore the efficacy of chemotherapy plus pembrolizumab or placebo in newly treated patients.
Chemotherapy can choose albumin paclitaxel, paclitaxel, gemcitabine + carboplatin.
The results showed that compared with chemotherapy (5.
6 months), pembrolizumab + chemotherapy (9.
7 months) significantly improved the PFS of newly treated locally recurring inoperable or metastatic triple-negative breast cancer with PD-L1 CPS ≥10 .
04 ADC drugs-a series of ADC drugs can be expected to be recommended by international guidelines for triple-negative breast cancer in the future.
At present, domestic ADC drug research is progressing rapidly.
Trop-2 is expressed in all subtypes of breast cancer and is associated with poor prognosis.
Sacituzumab govitecan (SG) is a new type of antibody-drug conjugate (ADC), which is composed of anti-Trop-2 antibody conjugated with the active metabolite SN-38 of irinotecan through a unique hydrolyzable linker.
The phase I/II IMMU-132-01 study showed that the objective response rate (ORR) of SG in metastatic triple-negative breast cancer was 33%, the median duration of response (DOR) was 7.
7 months, and the median PFS was 5.
5 Months, and with manageable safety, the results of this study enabled SG to obtain accelerated approval from the US FDA for metastatic triple-negative breast cancer. The phase III ASCENT study showed that compared with the TPC group (n = 233), the SG group (n = 235) significantly improved the median PFS, and the median PFS of the two groups were 5.
6 months and 1.
7 months (HR=0.
41) ; P <0.
0001).
The median OS of the SG group and the chemotherapy group were 12.
1 months and 6.
7 months (HR=0.
48, P＜0.
0001), the ORR of the two groups were 35% and 5% (P＜0.
0001), respectively.
The clinical results of the two groups were The benefit rate (CBR) was 45% and 9% (P<0.
0001), and the median duration of response (DOR) in the two groups were 6.
3 months and 3.
6 months, respectively (P=0.
057).
At present, the domestic bridging research has been enrolled in the group, and we look forward to better research results.
Triple-negative breast cancer usually includes people with low HER2 expression.
The DS8201-A-J101 study showed that DS8201 treatment of patients with low HER2 expression can achieve an ORR of 44.
4%, a DCR of 83.
3%, a median DOR of 11 months, and a median PFS of 8.
0 months.
Currently, Phase III clinical studies are underway.
Conclusion Chemotherapy is still the most commonly used basic treatment for advanced triple-negative breast cancer; immunotherapy has entered the clinical practice of triple-negative breast cancer, and PD-L1 positive is the preferred population for first-line immunotherapy; some targeted therapy drugs have specific targets in some parts Accurate breakthroughs have been made in advanced triple-negative breast cancer patients; ADC drugs have broad application prospects in advanced triple-negative breast cancer.
