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The 2021 National Breast Cancer Conference and the Chinese Society of Clinical Oncology Breast Cancer (CSCO BC) Annual Conference were held in Beijing from April 9th to 10th in the form of "online + offline".
As one of the most influential academic events in the field of breast cancer in China, domestic and foreign celebrities gathered together to participate in the grand event.
During the meeting, Professor Hao Chunfang from the Cancer Hospital of Tianjin Medical University introduced the updated key points and progress of hormone receptor (HR)-positive breast cancer in the "2021 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines".
HR+ Breast Cancer Treatment Strategy Update Points For those without endocrine therapy, fulvestrant is adjusted to level I recommendation, and the newly added fulvestrant + CDK4/6 inhibitor is level II recommendation; patients with tamoxifen (TAM) treatment failure Among them, the level of evidence of aromatase inhibitor (AI) and fulvestrant was adjusted from 1A to 2A; in the level I recommendation for patients with non-steroidal AI (NSAI) treatment failure, fulvestrant + CDK4/6 inhibitors are refined Fulvestrant + Abbecilide (1A) and Fulvestrant + Pipercillide (2A); HDAC inhibitor is clearly Chidamide; steroidal AI (SAI) treatment failure in patients with level I recommendation, fluoride Vestrant+CDK4/6 inhibitors were adjusted to Fulvestrant+Abexiride (1A) and Fulvestrant+pipericide (2A).
Professor Hao said that the HR+ postmenopausal patients' late endocrine treatment guidelines in 2021 have less changes than in 2020, and they are still stratified according to 4 groups of people, which are characterized by diversity of options and high levels of evidence.
Next, Professor Hao introduced the research progress involved in each change of the guidelines.
Evidence-based evidence-based AI+CDK4/6 inhibitor PALOMA-2 study compared pipercillil+letrozole vs placebo+letrozole for postmenopausal ER+, HER2- advanced breast cancer patients Efficacy, the results showed that the median progression-free survival (PFS) of the piperacillil group was significantly better than that of the placebo group (30.
5 months vs 19.
3 months; HR=0.
65, 95% CI: 0.
51-0.
84; P=0.
0005) , Became the first AI+CDK4/6 inhibitor to be used in postmenopausal HR+ advanced breast cancer research to bring significant benefits.
The MONALEESA-2 study further consolidated the PFS advantage of AI+CDK4/6 inhibitors in postmenopausal HR+ advanced breast cancer.
The MONALEESA-7 study proved the PFS and PFS of AI+CDK4/6 inhibitors in premenopausal HR+ advanced breast cancer.
The overall survival (OS) advantage.
The above studies have established the status of AI+CDK4/6 inhibitor as a level I recommendation (1A).
Fulvestrant + CDK4/6 inhibitor and fulvestrant monotherapy in the MONALEESA-3 study included patients without endocrine therapy and progression of endocrine therapy, and evaluated Ribociclib + fulvestrant vs fulvestrant Efficacy of drug treatment.
The results showed that in the overall population, Ribociclib + Fulvestrant significantly improved patients' PFS and OS; in the first-line treatment subgroup of Ribociclib + Fulvestrant, PFS was up to 33.
6 months.
The FALCON study compared the efficacy of fulvestrant vs.
anastrozole in patients with HR+ advanced breast cancer without endocrine therapy, showing the good benefit of fulvestrant monotherapy.
Professor Hao said that because fulvestrant was not covered by medical insurance last year, it was only recommended as a level II recommendation; this year, fulvestrant is available for medical insurance, so the recommendation was adjusted from level II to level I recommendation.
In the field of endocrine therapy, most of them are the follow-up results of phase III studies, and a series of phase II clinical studies are also ongoing.
The FLIPPER study is a randomized, double-blind, parallel-controlled phase II study that compared the efficacy of fulvestrant + piperacillil vs fulvestrant monotherapy for postmenopausal HR + advanced breast cancer.
The study found that 1 year PFS The rate is close to the results of previous studies, and Fulvestrant + Pipercillide has a higher benefit.
Based on the above studies, the experts unanimously decided to recommend Fulvestrant + CDK4/6 inhibitor as the second level recommendation (2A).
AI and fulvestrant are the second-level recommendations for patients with TAM treatment failure.
Professor Hao said that AI and fulvestrant were used as the first choice for monotherapy.
Now, AI+CDK4/6 inhibitor, fulvestrant+ Combination treatment options such as CDK4/6 inhibitors are developing vigorously and bring higher benefits to patients.
Therefore, the monotherapy of AI and fulvestrant has been adjusted to a level II recommendation.
HDAC inhibitor is determined to be Chidamide Chidamide, as the only HDAC inhibitor marketed in China, is included in the guideline recommendation.
The drug is marketed based on the ACE study, which evaluated the efficacy of chidamide + exemestane vs placebo + exemestane for postmenopausal HR + advanced breast cancer.
The results showed that chidamide + exemestane Significantly prolonged PFS (9.
2 months vs 3.
8 months).
In the Class I recommendation for patients with AI treatment failure, CDK4/6 inhibitor + Fulvestrant is used as the Class I recommendation.
In the Class I recommendation for patients with AI treatment failure, in addition to steroidal AI + Chidamide, CDK4/6 inhibitor + Fulvestrant occupies an important position.
Abexicil and piperacillil are two CDK4/6 inhibitors available in China, and their recommended levels are differentiated based on the research data of the two drugs.
The PALOMA-3 study, the MONARCH 2 study and the MONALEESA-3 study all included HR+ advanced breast cancer patients who had failed AI treatment and received endocrine therapy with a CDK4/6 inhibitor.
The results of the three studies all showed that CDK4/6 inhibitors significantly improved PFS (HR about 0.
5) and OS (HR about 0.
7).
The MONARCH plus study supports the application of Abexicil in HR+ advanced breast cancer in China.
The study was divided into cohort A and cohort B.
Patients in cohort A were randomly assigned to abesicil+AI group and placebo+AI group at 2:1, and patients in cohort B were randomly assigned to abesicride+fulvex at 2:1 Group and placebo+fulvex group.
The study achieved consistent results with international multi-center clinical studies, confirming the benefits of Abexicil in the Chinese population.
Finally, Professor Hao concluded that the characteristics of CSCO BC endocrine therapy in 2020 are "a lot of changes, fast steps, high expectations, and great challenges", while the characteristics of 2021 are "accepting changes, speeding up research, facing challenges, Look forward to more".
The role of CDK4/6 inhibitor combination therapy in the treatment of breast cancer has been clear, and treatments such as chidamide can also be used as an option.
Clinicians have accepted the rapid changes brought about by breast cancer endocrine therapy.
At the same time, the progress of breast cancer research is also accelerating.
Faced with a variety of clinical options, clinicians need to face up to the challenge and are full of expectations for future research progress.
As one of the most influential academic events in the field of breast cancer in China, domestic and foreign celebrities gathered together to participate in the grand event.
During the meeting, Professor Hao Chunfang from the Cancer Hospital of Tianjin Medical University introduced the updated key points and progress of hormone receptor (HR)-positive breast cancer in the "2021 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines".
HR+ Breast Cancer Treatment Strategy Update Points For those without endocrine therapy, fulvestrant is adjusted to level I recommendation, and the newly added fulvestrant + CDK4/6 inhibitor is level II recommendation; patients with tamoxifen (TAM) treatment failure Among them, the level of evidence of aromatase inhibitor (AI) and fulvestrant was adjusted from 1A to 2A; in the level I recommendation for patients with non-steroidal AI (NSAI) treatment failure, fulvestrant + CDK4/6 inhibitors are refined Fulvestrant + Abbecilide (1A) and Fulvestrant + Pipercillide (2A); HDAC inhibitor is clearly Chidamide; steroidal AI (SAI) treatment failure in patients with level I recommendation, fluoride Vestrant+CDK4/6 inhibitors were adjusted to Fulvestrant+Abexiride (1A) and Fulvestrant+pipericide (2A).
Professor Hao said that the HR+ postmenopausal patients' late endocrine treatment guidelines in 2021 have less changes than in 2020, and they are still stratified according to 4 groups of people, which are characterized by diversity of options and high levels of evidence.
Next, Professor Hao introduced the research progress involved in each change of the guidelines.
Evidence-based evidence-based AI+CDK4/6 inhibitor PALOMA-2 study compared pipercillil+letrozole vs placebo+letrozole for postmenopausal ER+, HER2- advanced breast cancer patients Efficacy, the results showed that the median progression-free survival (PFS) of the piperacillil group was significantly better than that of the placebo group (30.
5 months vs 19.
3 months; HR=0.
65, 95% CI: 0.
51-0.
84; P=0.
0005) , Became the first AI+CDK4/6 inhibitor to be used in postmenopausal HR+ advanced breast cancer research to bring significant benefits.
The MONALEESA-2 study further consolidated the PFS advantage of AI+CDK4/6 inhibitors in postmenopausal HR+ advanced breast cancer.
The MONALEESA-7 study proved the PFS and PFS of AI+CDK4/6 inhibitors in premenopausal HR+ advanced breast cancer.
The overall survival (OS) advantage.
The above studies have established the status of AI+CDK4/6 inhibitor as a level I recommendation (1A).
Fulvestrant + CDK4/6 inhibitor and fulvestrant monotherapy in the MONALEESA-3 study included patients without endocrine therapy and progression of endocrine therapy, and evaluated Ribociclib + fulvestrant vs fulvestrant Efficacy of drug treatment.
The results showed that in the overall population, Ribociclib + Fulvestrant significantly improved patients' PFS and OS; in the first-line treatment subgroup of Ribociclib + Fulvestrant, PFS was up to 33.
6 months.
The FALCON study compared the efficacy of fulvestrant vs.
anastrozole in patients with HR+ advanced breast cancer without endocrine therapy, showing the good benefit of fulvestrant monotherapy.
Professor Hao said that because fulvestrant was not covered by medical insurance last year, it was only recommended as a level II recommendation; this year, fulvestrant is available for medical insurance, so the recommendation was adjusted from level II to level I recommendation.
In the field of endocrine therapy, most of them are the follow-up results of phase III studies, and a series of phase II clinical studies are also ongoing.
The FLIPPER study is a randomized, double-blind, parallel-controlled phase II study that compared the efficacy of fulvestrant + piperacillil vs fulvestrant monotherapy for postmenopausal HR + advanced breast cancer.
The study found that 1 year PFS The rate is close to the results of previous studies, and Fulvestrant + Pipercillide has a higher benefit.
Based on the above studies, the experts unanimously decided to recommend Fulvestrant + CDK4/6 inhibitor as the second level recommendation (2A).
AI and fulvestrant are the second-level recommendations for patients with TAM treatment failure.
Professor Hao said that AI and fulvestrant were used as the first choice for monotherapy.
Now, AI+CDK4/6 inhibitor, fulvestrant+ Combination treatment options such as CDK4/6 inhibitors are developing vigorously and bring higher benefits to patients.
Therefore, the monotherapy of AI and fulvestrant has been adjusted to a level II recommendation.
HDAC inhibitor is determined to be Chidamide Chidamide, as the only HDAC inhibitor marketed in China, is included in the guideline recommendation.
The drug is marketed based on the ACE study, which evaluated the efficacy of chidamide + exemestane vs placebo + exemestane for postmenopausal HR + advanced breast cancer.
The results showed that chidamide + exemestane Significantly prolonged PFS (9.
2 months vs 3.
8 months).
In the Class I recommendation for patients with AI treatment failure, CDK4/6 inhibitor + Fulvestrant is used as the Class I recommendation.
In the Class I recommendation for patients with AI treatment failure, in addition to steroidal AI + Chidamide, CDK4/6 inhibitor + Fulvestrant occupies an important position.
Abexicil and piperacillil are two CDK4/6 inhibitors available in China, and their recommended levels are differentiated based on the research data of the two drugs.
The PALOMA-3 study, the MONARCH 2 study and the MONALEESA-3 study all included HR+ advanced breast cancer patients who had failed AI treatment and received endocrine therapy with a CDK4/6 inhibitor.
The results of the three studies all showed that CDK4/6 inhibitors significantly improved PFS (HR about 0.
5) and OS (HR about 0.
7).
The MONARCH plus study supports the application of Abexicil in HR+ advanced breast cancer in China.
The study was divided into cohort A and cohort B.
Patients in cohort A were randomly assigned to abesicil+AI group and placebo+AI group at 2:1, and patients in cohort B were randomly assigned to abesicride+fulvex at 2:1 Group and placebo+fulvex group.
The study achieved consistent results with international multi-center clinical studies, confirming the benefits of Abexicil in the Chinese population.
Finally, Professor Hao concluded that the characteristics of CSCO BC endocrine therapy in 2020 are "a lot of changes, fast steps, high expectations, and great challenges", while the characteristics of 2021 are "accepting changes, speeding up research, facing challenges, Look forward to more".
The role of CDK4/6 inhibitor combination therapy in the treatment of breast cancer has been clear, and treatments such as chidamide can also be used as an option.
Clinicians have accepted the rapid changes brought about by breast cancer endocrine therapy.
At the same time, the progress of breast cancer research is also accelerating.
Faced with a variety of clinical options, clinicians need to face up to the challenge and are full of expectations for future research progress.
