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Recently, Professor Zhu Xiaofan’s research group from the Hospital of Hematology of the Chinese Academy of Medical Sciences and CCCG-ALL (Child Oncology Committee of the Chinese Anti-Cancer Association-Acute Lymphocytic Leukemia Collaborative Group) conducted a report on "Vincristine + Dexamethasone in Children's Acute Lymphocytes The latest study on the role and safety of maintenance therapy in leukemia (ALL) patients was published
.
This open-label, randomized, controlled Phase III clinical study included more than 6000 children with ALL patients in 20 centers of CCCG-ALL
.
The results confirmed that during maintenance treatment for children with low-risk ALL, the two chemotherapeutic drugs with the greatest adverse reactions—vincristine and dexamethasone—can not be used without increasing the recurrence rate of the disease and lower adverse reactions
.
This study provides strong evidence for discontinuing two treatments with greater adverse effects and less convenient use in the conventional treatment of children with low-risk ALL, and explores a more economical approach for the majority of ALL patients, who account for 2/3 of childhood leukemia.
, Safe and convenient treatment
.
A reporter from "Physician Daily" also connected with Professor Zhu Xiaofan, director of the Children's Hematology Diagnosis and Treatment Center of the Hematology Hospital of the Chinese Academy of Medical Sciences, and asked her to interpret the research
.
(Lancet onco.
2021, 9:1322) Research results: Non-inferiority in the low-risk ALL group and borderline inferiority in the middle/high-risk group From January 1, 2015 to February 20, 2020, 6141 newly diagnosed children with ALL The patient is enrolled in this study
.
About 1 year after diagnosis and treatment, 5,054 patients in continuous remission were assigned to the low-risk ALL group and the middle/high-risk ALL group according to their disease risk.
Each group was based on the combination and non-combination of 7 cycles of vincristine + dexamethasone.
Divided into test group (no combination, only 6-mercaptopurine + methotrexate) and control group (after 7 cycles of combined use of 4 drugs, vincristine + dexamethasone was stopped)
.
The results showed that there was no statistically significant difference in 5-year event-free survival (EFS) with and without the combined use of vincristine + dexamethasone for 7 cycles of maintenance treatment in children with low-risk ALL patients (90.
3% vs.
90.
2%, P=0.
90), the one-sided 95% upper limit of confidence is 0.
024, to determine non-inferiority; the overall survival (OS) rates of the combination and non-combination groups were 97.
8% and 97.
3% (P=0.
70)
.
Figure 1 The results of the middle/high-risk group of low-risk ALL patients were similar.
The 5-year EFS of ALL children with and without the combination of two drugs was 82.
8% and 80.
8% (P=0.
90).
The unilateral 95% confidence limit was 0.
055.
Considered a marginal inferiority
.
The 5-year OS was 92.
3% and 93.
4% (P=0.
40)
.
Figure 2 A preliminary study on adverse reactions in patients with medium/high-risk ALL.
The results show that there is no significant difference in the occurrence of infection, osteonecrosis and other complications between the low-risk patient trial and the control group, while the medium/high-risk group 3/4 severe pneumonia and peripheral nerves The lesions increased significantly in the vincristine + dexamethasone group
.
After expert interviews are accurately stratified, low-risk ALL children can boldly reduce their drugs.
According to Professor Zhu Xiaofan, this study was initiated by the CCCG-ALL collaboration group in China.
It is the world’s first multi-center, open, randomized, phase III conducted by 20 centers within the United Nations.
Non-inferior clinical research
.
Leukemia is the malignant tumor with the highest incidence in children, of which ALL is the main form, accounting for 2/3 of all children with leukemia
.
At present, the cure rate of childhood ALL has reached more than 85%.
This part of newly-treated children with ALL only needs 2.
5 years of full treatment for boys and 2 years for girls
.
In children with ALL, a leukemia with a high cure rate, how to reduce adverse reactions during maintenance treatment so that ALL children do not have to go to the hospital frequently, and oral chemotherapy drugs can treat the disease has become a top priority for clinical researchers
.
Children's ALL treatment process Children's ALL treatment, the first choice is the treatment of four types of drugs combined with chemotherapy, including glucocorticoids, daunorubicin, asparaginase, and vincristine; and intrathecal injections are needed to prevent central nervous system leukemia
.
The whole course of treatment includes: relief treatment, consolidation treatment and maintenance treatment
.
The patients included in this study were those who entered maintenance treatment after the first two stages of treatment
.
In addition to 6-mercaptopurine and methotrexate, the previous maintenance treatment regimen also requires 7 cycles of vincristine and dexamethasone
.
Adverse drug reactions Vincristine needs to be injected intravenously in the hospital.
It should not leak when using it.
If it leaks outside the blood vessel, it will cause local skin necrosis
.
In addition, neurotoxicity cannot be ignored, such as peripheral neuritis of the fingers, large and small thenar muscle atrophy and so on
.
Children's use of glucocorticoids can also cause growth inhibition and other problems
.
In response to the results of the study, Professor Zhu Xiaofan explained that the median follow-up time of the study was 3.
7 years.
The separation of the EFS curve was observed in the medium/high-risk group, and follow-up observations are needed
.
"These two drugs can be removed boldly for maintenance treatment of low-risk patients.
Our center is already doing this
.
However, it is not recommended to remove these two drugs for intermediate/high-risk patients .
.
"Low-risk children with ALL portraits In this study, the patients who benefited from low-risk children with ALL are low-risk children.
How to judge the patients as low-risk? One of the following three criteria needs to be met: ①1≤age≤9.
9 years old and total number of white blood cells ≤50,000; ②number of chromosomes ≥50, or DNA index ≥1.
16; ③ETV6–RUNX1 (TEL-AML 1) fusion gene positive; also need to exclude the following three: ①Central nervous system leukemia, testicular leukemia; ②Translocation of chromosomes 1-19 and 9-22 Or MLL fusion gene positive, chromosome number <44, iAMP21; ③On the 19th day, minimal residual disease ≥1% can be called a low-risk ALL patient
.
Professor Zhu Xiaofan suggested that the results of the CCCG-ALL2015 program suggest that before using this program, Necessary examinations and precise risk stratification are required to truly screen out low-risk patients in order to benefit them
.
Expert profile Professor Zhu Xiaofan ●Children's Hematology Diagnosis and Treatment Center, Hematology Hospital (Institute of Hematology), Chinese Academy of Medical Sciences Director, Chief Physician, Doctoral Supervisor ●Vice Chairman of the Pediatric Hematology Committee of the Chinese Anti-Cancer Association
.
Chairman
of the Hematology Group of the Pediatric Branch of Tianjin Medical Association, Vice Chairman of the Tianjin Pediatric Oncology Committee
.
Chinese Journal of Pediatrics, Member of the editorial board of "Chinese Journal of Hematology", "Chinese Journal of Contemporary Pediatrics", "Chinese Journal of Practical Pediatrics", "International Journal of Pediatrics" and other magazines
.
●Undertake a number of national and provincial-level projects
.
Won the first prize of Tianjin Natural Science First prize, third prize of Tianjin Science and Technology Progress Award, Wuzhou Women's Science and Technology Award, Soong Ching Ling Pediatric Medicine Award and other awards
.
Published more than 100 papers in the past five years as the first author and corresponding author in "Nature Genetics", "JAMA Oncology", "Lancet Oncology", "Nucleic Acids Research", "Blood", "BMC Med Genomics" and other magazines Many papers
.
END Typesetting: Li Hui Editor: Qin Miao Review: Wang Lina For more content, please click: Academician Dai Kerong: Life is to find a way, recognize the way, hurry, lead the way, give way to the Chinese Physician's Day·Healthy China subway train poster story ㊹ | Luo Xiaoping: catch Good children's health means grasping the future of China.
"Physician Daily" submission public email: yishibao2017@163.
com [Note] Some pictures are from the Internet and WeChat Moments.
If there is any infringement, please contact to delete, thank you! Tel: 010-58302828-6808 Currently 1130000+ doctors have been following to join us
.
This open-label, randomized, controlled Phase III clinical study included more than 6000 children with ALL patients in 20 centers of CCCG-ALL
.
The results confirmed that during maintenance treatment for children with low-risk ALL, the two chemotherapeutic drugs with the greatest adverse reactions—vincristine and dexamethasone—can not be used without increasing the recurrence rate of the disease and lower adverse reactions
.
This study provides strong evidence for discontinuing two treatments with greater adverse effects and less convenient use in the conventional treatment of children with low-risk ALL, and explores a more economical approach for the majority of ALL patients, who account for 2/3 of childhood leukemia.
, Safe and convenient treatment
.
A reporter from "Physician Daily" also connected with Professor Zhu Xiaofan, director of the Children's Hematology Diagnosis and Treatment Center of the Hematology Hospital of the Chinese Academy of Medical Sciences, and asked her to interpret the research
.
(Lancet onco.
2021, 9:1322) Research results: Non-inferiority in the low-risk ALL group and borderline inferiority in the middle/high-risk group From January 1, 2015 to February 20, 2020, 6141 newly diagnosed children with ALL The patient is enrolled in this study
.
About 1 year after diagnosis and treatment, 5,054 patients in continuous remission were assigned to the low-risk ALL group and the middle/high-risk ALL group according to their disease risk.
Each group was based on the combination and non-combination of 7 cycles of vincristine + dexamethasone.
Divided into test group (no combination, only 6-mercaptopurine + methotrexate) and control group (after 7 cycles of combined use of 4 drugs, vincristine + dexamethasone was stopped)
.
The results showed that there was no statistically significant difference in 5-year event-free survival (EFS) with and without the combined use of vincristine + dexamethasone for 7 cycles of maintenance treatment in children with low-risk ALL patients (90.
3% vs.
90.
2%, P=0.
90), the one-sided 95% upper limit of confidence is 0.
024, to determine non-inferiority; the overall survival (OS) rates of the combination and non-combination groups were 97.
8% and 97.
3% (P=0.
70)
.
Figure 1 The results of the middle/high-risk group of low-risk ALL patients were similar.
The 5-year EFS of ALL children with and without the combination of two drugs was 82.
8% and 80.
8% (P=0.
90).
The unilateral 95% confidence limit was 0.
055.
Considered a marginal inferiority
.
The 5-year OS was 92.
3% and 93.
4% (P=0.
40)
.
Figure 2 A preliminary study on adverse reactions in patients with medium/high-risk ALL.
The results show that there is no significant difference in the occurrence of infection, osteonecrosis and other complications between the low-risk patient trial and the control group, while the medium/high-risk group 3/4 severe pneumonia and peripheral nerves The lesions increased significantly in the vincristine + dexamethasone group
.
After expert interviews are accurately stratified, low-risk ALL children can boldly reduce their drugs.
According to Professor Zhu Xiaofan, this study was initiated by the CCCG-ALL collaboration group in China.
It is the world’s first multi-center, open, randomized, phase III conducted by 20 centers within the United Nations.
Non-inferior clinical research
.
Leukemia is the malignant tumor with the highest incidence in children, of which ALL is the main form, accounting for 2/3 of all children with leukemia
.
At present, the cure rate of childhood ALL has reached more than 85%.
This part of newly-treated children with ALL only needs 2.
5 years of full treatment for boys and 2 years for girls
.
In children with ALL, a leukemia with a high cure rate, how to reduce adverse reactions during maintenance treatment so that ALL children do not have to go to the hospital frequently, and oral chemotherapy drugs can treat the disease has become a top priority for clinical researchers
.
Children's ALL treatment process Children's ALL treatment, the first choice is the treatment of four types of drugs combined with chemotherapy, including glucocorticoids, daunorubicin, asparaginase, and vincristine; and intrathecal injections are needed to prevent central nervous system leukemia
.
The whole course of treatment includes: relief treatment, consolidation treatment and maintenance treatment
.
The patients included in this study were those who entered maintenance treatment after the first two stages of treatment
.
In addition to 6-mercaptopurine and methotrexate, the previous maintenance treatment regimen also requires 7 cycles of vincristine and dexamethasone
.
Adverse drug reactions Vincristine needs to be injected intravenously in the hospital.
It should not leak when using it.
If it leaks outside the blood vessel, it will cause local skin necrosis
.
In addition, neurotoxicity cannot be ignored, such as peripheral neuritis of the fingers, large and small thenar muscle atrophy and so on
.
Children's use of glucocorticoids can also cause growth inhibition and other problems
.
In response to the results of the study, Professor Zhu Xiaofan explained that the median follow-up time of the study was 3.
7 years.
The separation of the EFS curve was observed in the medium/high-risk group, and follow-up observations are needed
.
"These two drugs can be removed boldly for maintenance treatment of low-risk patients.
Our center is already doing this
.
However, it is not recommended to remove these two drugs for intermediate/high-risk patients .
.
"Low-risk children with ALL portraits In this study, the patients who benefited from low-risk children with ALL are low-risk children.
How to judge the patients as low-risk? One of the following three criteria needs to be met: ①1≤age≤9.
9 years old and total number of white blood cells ≤50,000; ②number of chromosomes ≥50, or DNA index ≥1.
16; ③ETV6–RUNX1 (TEL-AML 1) fusion gene positive; also need to exclude the following three: ①Central nervous system leukemia, testicular leukemia; ②Translocation of chromosomes 1-19 and 9-22 Or MLL fusion gene positive, chromosome number <44, iAMP21; ③On the 19th day, minimal residual disease ≥1% can be called a low-risk ALL patient
.
Professor Zhu Xiaofan suggested that the results of the CCCG-ALL2015 program suggest that before using this program, Necessary examinations and precise risk stratification are required to truly screen out low-risk patients in order to benefit them
.
Expert profile Professor Zhu Xiaofan ●Children's Hematology Diagnosis and Treatment Center, Hematology Hospital (Institute of Hematology), Chinese Academy of Medical Sciences Director, Chief Physician, Doctoral Supervisor ●Vice Chairman of the Pediatric Hematology Committee of the Chinese Anti-Cancer Association
.
Chairman
of the Hematology Group of the Pediatric Branch of Tianjin Medical Association, Vice Chairman of the Tianjin Pediatric Oncology Committee
.
Chinese Journal of Pediatrics, Member of the editorial board of "Chinese Journal of Hematology", "Chinese Journal of Contemporary Pediatrics", "Chinese Journal of Practical Pediatrics", "International Journal of Pediatrics" and other magazines
.
●Undertake a number of national and provincial-level projects
.
Won the first prize of Tianjin Natural Science First prize, third prize of Tianjin Science and Technology Progress Award, Wuzhou Women's Science and Technology Award, Soong Ching Ling Pediatric Medicine Award and other awards
.
Published more than 100 papers in the past five years as the first author and corresponding author in "Nature Genetics", "JAMA Oncology", "Lancet Oncology", "Nucleic Acids Research", "Blood", "BMC Med Genomics" and other magazines Many papers
.
END Typesetting: Li Hui Editor: Qin Miao Review: Wang Lina For more content, please click: Academician Dai Kerong: Life is to find a way, recognize the way, hurry, lead the way, give way to the Chinese Physician's Day·Healthy China subway train poster story ㊹ | Luo Xiaoping: catch Good children's health means grasping the future of China.
"Physician Daily" submission public email: yishibao2017@163.
com [Note] Some pictures are from the Internet and WeChat Moments.
If there is any infringement, please contact to delete, thank you! Tel: 010-58302828-6808 Currently 1130000+ doctors have been following to join us
