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From March 19th to 21st, 2021, the 4th China Chronic Lymphocytic Leukemia Conference and China Chronic Lymphocytic Leukemia Working Group Conference of the Hematology Oncology Committee of the Chinese Anti-Cancer Association was successfully held in Tianjin.
At the meeting, Professor Yi Shuhua from the Hospital of Hematology, Chinese Academy of Medical Sciences gave a special report on the treatment options for newly-treated chronic lymphocytic leukemia (CLL).
Yimaitong compiled the following for the reference of readers.
Professor Yi Shuhua first introduced the standardized diagnosis and treatment process of CLL, including precise diagnosis, prognostic stratification, individualized treatment, and efficacy testing and follow-up.
Next, Professor Yi Shuhua mainly introduced the part of prognostic stratified treatment.
CLL first-line treatment model For the first-line treatment options for CLL, it was reported in the 2019 ASH conference that regardless of age, regardless of whether there is an IGHV mutation, the first-line treatment recommendation is BTK inhibitor.
However, at the 2020 ASH meeting, for low-risk CLL patients, it is recommended that BTK inhibitors be placed after chemotherapy.
Professor Yi Shuhua said that the status of chemotherapy in the treatment of CLL cannot be completely replaced.
In addition, for young Fit CLL patients, data from multiple clinical trials have shown that fludarabine, cyclophosphamide combined with rituximab (FCR) regimen or bendamustine + rituximab (BR) regimen are all treated It has a significant curative effect, with an effective rate of over 90%, and a 5-year median PFS rate of about 50 months.
For elderly or Unfit patients, multiple clinical trials have shown that the efficacy of small molecule targeted drug therapy is better than conventional chemotherapy.
CLL first-line treatment selection 2020 ASH will divide the risk of CLL into low-risk, high-risk (biological marker 11q- or IGHV not mutated, etc.
) and very high-risk (17p- or TP53 mutation, fludarabine resistance or treatment Poor response, dual resistance to BTK inhibitors and BCL-2 inhibitors, etc.
).According to different risk stratification, the choice of treatment plan can be preliminarily guided.
01 Low-risk group patients The low-risk group has better curative effects after conventional chemotherapy, and there is no significant difference in survival from the normal population.
Professor Yi Shuhua said that patients in the low-risk group can choose conventional chemotherapy.
02 Patients in the high-risk group The efficacy of conventional chemotherapy for patients in the high-risk group is relatively unsatisfactory.
Studies have shown that ibrutinib can improve the poor prognosis of newly-treated CLL patients with 11q- and IGHV not mutated, and zebutinib is more effective in treating patients with relapsed/refractory (R/R) CLL as a single agent.
However, the deep remission rate of the "Chemo-free" treatment plan is low, and the elderly patients have poor compliance with long-term medication.
The BTK inhibitor monotherapy mode still faces some unmet needs.
Professor Yi Shuhua said that in order to solve this situation, we can explore a combination of targeted drugs and a time-limited treatment model for the purpose of eliminating minimal residual disease (MRD).
Joint exploration of targeted drugs: A single-arm, multi-center, open-label, phase II clinical trial evaluated the efficacy of Ibrutinib + FCR in the treatment of newly treated young CLL patients.
The results showed that the remission rate was 99%, CR/ The CRi rate is 66%, and the best MRD negative rate is more than 80%.
It shows that the ibrutinib+FCR regimen is a promising combination treatment regimen for first-line young CLL patients with a fixed course of treatment.
In addition, a study of ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (IFCG) first-line treatment of CLL patients with IGHV mutations and without Del(17p)/TP53 mutations showed that a median follow-up of 34.
2 months, 69% of patients The best CR/CRi rate was obtained, and 98% of patients reached MRD negative.
It shows that the IFCG regimen significantly improves the negative rate of MRD in patients with IGHV mutant CLL.
Professor Yi Shuhua said that compared with single-drug targeted drugs, the combined use of targeted drugs can significantly improve the efficacy and deepen the depth of relief.
IFCG study design time-limited treatment model exploration: ICLL-07 FILO study is a new exploration of time-limited treatment model, the research design is as shown in the figure below.
The results showed that after 9 months of treatment with ibrutinib, the ORR reached 100%, the CR rate was 41%, and the bone marrow MRD negative rate was 12.
5%.
After 4 courses of chemotherapy, the negative rate of MRD increased significantly, and the rate of MRD conversion to positive decreased significantly.
Therefore, most patients cannot reach the level of direct discontinuation and need to be treated with IFCG regimen.
ICLL-07 FILO study design, study results 03 Very high-risk patients For the treatment of very high-risk patients, research data shows that for patients with abnormal TP53, Ibrutinib and veneclat alone cannot overcome the poor prognosis.
Professor Yi Shuhua said that the combination of new drugs and new drugs may improve the prognosis of these patients, but more data is still needed.
Finally, Professor Yi Shuhua concluded that with the advent of BTK inhibitors, the treatment of CLL has entered a new level.
For the treatment of CLL, the combination of new and old drugs is an important choice at this stage, and the combination of new drugs and new drugs is the future research direction.
In addition, Professor Yi Shuhua also introduced the clinical trials currently being carried out by the Hematology Hospital of the Chinese Academy of Medical Sciences, hoping that everyone can recommend suitable patients to participate in the corresponding clinical trials, so as to benefit more patients.
Clinical trials of the Hematology Hospital of the Chinese Academy of Medical Sciences: 16 items of lymphoma.
Professor Yi Shuhua Doctor of Medicine, Associate Chief Physician, Master's Tutor, Chinese Academy of Medical Sciences Hematology Hospital (Institute of Hematology), Chinese Medical Association Hematology Branch 10 Member of the Lymphocytic Diseases Group of the First Committee Member of the Hematological Oncology Committee of the Chinese Anti-Cancer Association, Secretary-General, Member of the Hematology and Immunology Branch of the Chinese Society of Immunology, Member of the Lymphoma Professional Committee of the Tianjin Anti-Cancer Association Young member of the Professional Committee of the Chinese and Western Medicine Association, a visiting scholar at the MD Anderson Cancer Center in the United States, and a postdoctoral fellow at the Cityof Hope National Medical Center in the United States.
At the meeting, Professor Yi Shuhua from the Hospital of Hematology, Chinese Academy of Medical Sciences gave a special report on the treatment options for newly-treated chronic lymphocytic leukemia (CLL).
Yimaitong compiled the following for the reference of readers.
Professor Yi Shuhua first introduced the standardized diagnosis and treatment process of CLL, including precise diagnosis, prognostic stratification, individualized treatment, and efficacy testing and follow-up.
Next, Professor Yi Shuhua mainly introduced the part of prognostic stratified treatment.
CLL first-line treatment model For the first-line treatment options for CLL, it was reported in the 2019 ASH conference that regardless of age, regardless of whether there is an IGHV mutation, the first-line treatment recommendation is BTK inhibitor.
However, at the 2020 ASH meeting, for low-risk CLL patients, it is recommended that BTK inhibitors be placed after chemotherapy.
Professor Yi Shuhua said that the status of chemotherapy in the treatment of CLL cannot be completely replaced.
In addition, for young Fit CLL patients, data from multiple clinical trials have shown that fludarabine, cyclophosphamide combined with rituximab (FCR) regimen or bendamustine + rituximab (BR) regimen are all treated It has a significant curative effect, with an effective rate of over 90%, and a 5-year median PFS rate of about 50 months.
For elderly or Unfit patients, multiple clinical trials have shown that the efficacy of small molecule targeted drug therapy is better than conventional chemotherapy.
CLL first-line treatment selection 2020 ASH will divide the risk of CLL into low-risk, high-risk (biological marker 11q- or IGHV not mutated, etc.
) and very high-risk (17p- or TP53 mutation, fludarabine resistance or treatment Poor response, dual resistance to BTK inhibitors and BCL-2 inhibitors, etc.
).According to different risk stratification, the choice of treatment plan can be preliminarily guided.
01 Low-risk group patients The low-risk group has better curative effects after conventional chemotherapy, and there is no significant difference in survival from the normal population.
Professor Yi Shuhua said that patients in the low-risk group can choose conventional chemotherapy.
02 Patients in the high-risk group The efficacy of conventional chemotherapy for patients in the high-risk group is relatively unsatisfactory.
Studies have shown that ibrutinib can improve the poor prognosis of newly-treated CLL patients with 11q- and IGHV not mutated, and zebutinib is more effective in treating patients with relapsed/refractory (R/R) CLL as a single agent.
However, the deep remission rate of the "Chemo-free" treatment plan is low, and the elderly patients have poor compliance with long-term medication.
The BTK inhibitor monotherapy mode still faces some unmet needs.
Professor Yi Shuhua said that in order to solve this situation, we can explore a combination of targeted drugs and a time-limited treatment model for the purpose of eliminating minimal residual disease (MRD).
Joint exploration of targeted drugs: A single-arm, multi-center, open-label, phase II clinical trial evaluated the efficacy of Ibrutinib + FCR in the treatment of newly treated young CLL patients.
The results showed that the remission rate was 99%, CR/ The CRi rate is 66%, and the best MRD negative rate is more than 80%.
It shows that the ibrutinib+FCR regimen is a promising combination treatment regimen for first-line young CLL patients with a fixed course of treatment.
In addition, a study of ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (IFCG) first-line treatment of CLL patients with IGHV mutations and without Del(17p)/TP53 mutations showed that a median follow-up of 34.
2 months, 69% of patients The best CR/CRi rate was obtained, and 98% of patients reached MRD negative.
It shows that the IFCG regimen significantly improves the negative rate of MRD in patients with IGHV mutant CLL.
Professor Yi Shuhua said that compared with single-drug targeted drugs, the combined use of targeted drugs can significantly improve the efficacy and deepen the depth of relief.
IFCG study design time-limited treatment model exploration: ICLL-07 FILO study is a new exploration of time-limited treatment model, the research design is as shown in the figure below.
The results showed that after 9 months of treatment with ibrutinib, the ORR reached 100%, the CR rate was 41%, and the bone marrow MRD negative rate was 12.
5%.
After 4 courses of chemotherapy, the negative rate of MRD increased significantly, and the rate of MRD conversion to positive decreased significantly.
Therefore, most patients cannot reach the level of direct discontinuation and need to be treated with IFCG regimen.
ICLL-07 FILO study design, study results 03 Very high-risk patients For the treatment of very high-risk patients, research data shows that for patients with abnormal TP53, Ibrutinib and veneclat alone cannot overcome the poor prognosis.
Professor Yi Shuhua said that the combination of new drugs and new drugs may improve the prognosis of these patients, but more data is still needed.
Finally, Professor Yi Shuhua concluded that with the advent of BTK inhibitors, the treatment of CLL has entered a new level.
For the treatment of CLL, the combination of new and old drugs is an important choice at this stage, and the combination of new drugs and new drugs is the future research direction.
In addition, Professor Yi Shuhua also introduced the clinical trials currently being carried out by the Hematology Hospital of the Chinese Academy of Medical Sciences, hoping that everyone can recommend suitable patients to participate in the corresponding clinical trials, so as to benefit more patients.
Clinical trials of the Hematology Hospital of the Chinese Academy of Medical Sciences: 16 items of lymphoma.
Professor Yi Shuhua Doctor of Medicine, Associate Chief Physician, Master's Tutor, Chinese Academy of Medical Sciences Hematology Hospital (Institute of Hematology), Chinese Medical Association Hematology Branch 10 Member of the Lymphocytic Diseases Group of the First Committee Member of the Hematological Oncology Committee of the Chinese Anti-Cancer Association, Secretary-General, Member of the Hematology and Immunology Branch of the Chinese Society of Immunology, Member of the Lymphoma Professional Committee of the Tianjin Anti-Cancer Association Young member of the Professional Committee of the Chinese and Western Medicine Association, a visiting scholar at the MD Anderson Cancer Center in the United States, and a postdoctoral fellow at the Cityof Hope National Medical Center in the United States.
