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*Only for medical professionals to read and reference Fudan oncologists will take you to interpret the 2021 ASCO Nasopharyngeal Cancer Special Blockbuster Study! The 2021 American Society of Clinical Oncology (ASCO) Annual Meeting will be held online from June 4 to 8.
As one of the most influential international oncology conferences in the oncology community, it has attracted the attention of many oncology experts and scholars
.
In this 2021 ASCO Nasopharyngeal Cancer Special, the Medical Oncology Channel and Fudan University Affiliated Cancer Hospital invited Professors Hu Chaosu, Ying Hongmei, Dr.
Zhou Xin, Dr.
Ou Xiaomin and Dr.
Xu Tingting from Fudan University Affiliated Cancer Hospital to explain to us 2021 ASCO has several important studies in the field of nasopharyngeal carcinoma
.
Scan the code to watch the wonderful live replay Dr.
Zhou Xin: The JUPITER-02 study on the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma with teriprizumab combined with GP regimen (Abstract No.
: LBA2) for recurrent/metastatic nasopharyngeal carcinoma The current standard first-line treatment is gemcitabine + cisplatin (GP) dual-agent chemotherapy, and immunotherapy has not been included in the first-line treatment recommended by the 2021 National Comprehensive Cancer Network (NCCN) guidelines due to lack of clinical evidence, and is currently only used as a second-line treatment
.
JUPITER-02 is a randomized, double-blind phase III clinical study that included a total of 289 patients with nasopharyngeal carcinoma who were newly treated for metastasis/recurrence from 35 medical centers around the world
.
Among them, 143 cases were randomized into the placebo + GP group, and 149 cases were entered into the teriprizumab + GP group
.
The stratification factors of this study mainly consider the Eastern Cooperative Oncology Group (ECOG) performance status score and the disease baseline status
.
The primary endpoint of the study is the Progression-Free Survival (PFS) assessed by the Blind Independent Review Committee (BIRC), and the secondary endpoints are the PFS assessed by the investigator, overall survival (OS), objective response rate (ORR) and duration of response ( DoR)
.
▌ The baseline characteristics of the patients included in this study are better than those of previous similar studies.
The baseline analysis of the 289 patients included in the study showed that the two groups of patients with newly treated metastases accounted for 42% and 39%, a significant advantage over the previous 20-30%
.
At the beginning of the study, patients were widely accepted for PD-L1 expression level detection, and 3/4 were high expression
.
Baseline characteristics ▌ PFS and OS in the teriplimumab + GP group have more obvious benefits.
The median PFS assessed by BIRC in the triplimumab group and chemotherapy group were 11.
7 and 8.
0 months, respectively, and the PFS rate in one year nearly doubled (27.
9%vs 49.
4%), the risk of disease progression in the teriprizumab group was reduced by 48%, which was statistically different (P=0.
0003)
.
The PFS results evaluated by the main investigator were even more encouraging: the 1-year PFS rate increased nearly three times (20.
0% vs 59.
5%), and the risk of disease progression was reduced by 59% (P<0.
0001)
.
In terms of OS, compared with the chemotherapy group, the risk of death in the teriplizumab group was reduced by nearly 40% (HR=0.
603), and the difference in OS between the two groups increased with time.
The OS in the teriplizumab group was 20 It enters a plateau period around months, and the chemotherapy group has a significant decrease after 2 years
.
The ORR and DoR results also indicated that the teriprizumab group was better than the chemotherapy group
.
▌ There is no significant difference in safety between the two groups.
Teriplimumab combined with the GP regimen has good safety.
The incidence of all treatment-related adverse events (AE) between the two groups is relatively consistent.
No new adverse events were observed, grade 3 or above The incidence of immune-related AEs is low, only 7.
5%
.
Safety analysis Dr.
Xiaomin Au: The CAPTAIN-1ST study is a multi-center, randomized exploration of carrelizumab combined with GP regimen in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (Abstract No.
: 6000) In a controlled, double-blind phase III clinical trial study, patients were randomly divided into carrelizumab + GP regimen group (carrelizumab group) and placebo + GP regimen group (placebo group) , 134 and 129 patients were enrolled, and the baseline characteristics of the two groups were balanced
.
CAPTAIN-1ST study design▌ PFS of Carrelizumab+GP regimen is better than PFS evaluated by independent review committee (IRC) of placebo+GP regimen Carrelizumab+GP regimen group and placebo+GP regimen group It was 10.
8 months and 6.
9 months, P<0.
0001; PFS assessed by the investigator was 12.
0 months and 7.
0 months, P<0.
0001, compared with placebo combined with GP, carrelizumab combined with GP increased PFS, It reduces the risk of disease progression or death by 50%; there is no statistical difference in ORR and disease control rate (DCR); in terms of DoR, the two groups are 9.
9 months and 5.
7 months, respectively, p<0.
0001
.
It can be seen that the contribution of immunotherapy is mainly to enable patients to obtain continuous tumor remission; the OS of the two groups is immature, but it has been observed that the carrelizumab combined with GP group has a survival benefit trend
.
CAPTAIN-1ST study the efficacy of carrelizumab+GP regimen group and placebo+GP regimen group▌ The safety of carrelizumab+GP regimen is controllable, and the adverse events related to treatment above grade 3 in both groups are 90% % Above, there is no significant difference, but in terms of adverse events related to grade 1 or 2 immunotherapy, the carrelizumab + GP regimen is slightly weak, but the overall safety is controllable
.
CAPTAIN-1ST Study Safety Results Dr.
Xu Tingting: Phase III clinical study of the efficacy of capecitabine adjuvant chemotherapy/beat chemotherapy for locally advanced nasopharyngeal carcinoma (Abstract No.
6003,6005) Past adjuvant chemotherapy studies such as PF (cisplatin + 5-Fluorouracil) and GP (gemcitabine + cisplatin) regimens failed due to high toxicity, poor patient compliance, and improper selection of the enrolled population
.
In addition to the anti-tumor effects of conventional chemotherapy, metronomic chemotherapy also has the special effects of anti-angiogenesis, activating immunity and inducing tumor cell dormancy.
Its greatest advantage is that it can use low-dose chemotherapy, reduce treatment toxicity, and improve patient compliance
.
Therefore, the use of capecitabine for late adjuvant chemotherapy/beat chemotherapy for nasopharyngeal carcinoma was launched
.
Traditional adjuvant chemotherapy research rhythm chemotherapy plan ▌ Study design is different.
Abstract No.
6003: 406 patients with locally removed T3-4N0 and T3N1 nasopharyngeal carcinoma were included in the group and randomized after receiving radical radiotherapy and chemotherapy.
204 capecitabine rhythm chemotherapy group The patients received capecitabine 650mg/m² twice a day (bid) for 1 year.
202 patients in the control group were followed up for observation, and the baseline status of the two groups was balanced
.
The primary study endpoint is the 3-year failure-free survival (FFS) rate, and the secondary endpoints include OS rate, distant metastasis-free survival rate, local failure-free survival rate and toxicity
.
Abstract No.
6005: The overall plan is similar to the capecitabine rhythm chemotherapy study.
The enrolled patients were locally advanced except T0-4N0-1 and T1-2N2, or the plasma EBV-DNA concentration before treatment was greater than 20,000 copies/ml or gross primary tumors Volume (GTVnx)>30cm3 or 18FDG PET-CT maximum standard uptake value (SUVmax)>10.
0 and ≥4 cm in primary tumor/multiple neck lymph node metastases
.
The stage of nasopharyngeal carcinoma of the enrolled patients is later than that of rhythm chemotherapy, and the tumor remission indicators will theoretically get better benefits
.
The experimental group received capecitabine 1000mg/m²bid, a 3-week regimen (2 weeks of medication and 1 week stop), no more than 8 cycles in total
.
Comparison of study design ▌ Capecitabine adjuvant chemotherapy FFS and OS have obvious benefits Abstract No.
6003 (Capecitabine beat chemotherapy): The 3-year FFS rate of the capecitabine beat chemotherapy group was 85.
3%, and the control group was 75.
7%, with recurrence /The risk of death was reduced by 50%, and the P value was 0.
002; the 3-year OS rate of the capecitabine-beat chemotherapy group was 93.
3%, and that of the control group was 88.
6%, and the P value was 0.
018.
The risk of death was reduced by 44%
.
It can be seen that FFS and OS have clearly benefited
.
Abstract No.
6005: The 3-year FFS rate of the capecitabine group was 87.
7%, the control group was 73.
3%, the P value was 0.
037, and the risk of recurrence/death was reduced by 48%; in terms of OS rates, the two groups were 92.
6% and 88.
9%, respectively , There is no statistical difference
.
Study endpoint evaluation ▌ The safety of capecitabine adjuvant chemotherapy is controllable.
Both studies suggest that the main adverse reaction of capecitabine is hand-foot syndrome
.
The former study showed that the incidence of hand-foot syndrome was 58%, and the incidence of grade 3 and above AEs was 9%; the latter study showed that the incidence of grade 3 and above hand-foot syndrome was 3.
5%
.
There is no significant difference in other drug toxicity events, so overall the safety of capecitabine adjuvant chemotherapy is controllable and tolerable
.
Toxicity comparison
As one of the most influential international oncology conferences in the oncology community, it has attracted the attention of many oncology experts and scholars
.
In this 2021 ASCO Nasopharyngeal Cancer Special, the Medical Oncology Channel and Fudan University Affiliated Cancer Hospital invited Professors Hu Chaosu, Ying Hongmei, Dr.
Zhou Xin, Dr.
Ou Xiaomin and Dr.
Xu Tingting from Fudan University Affiliated Cancer Hospital to explain to us 2021 ASCO has several important studies in the field of nasopharyngeal carcinoma
.
Scan the code to watch the wonderful live replay Dr.
Zhou Xin: The JUPITER-02 study on the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma with teriprizumab combined with GP regimen (Abstract No.
: LBA2) for recurrent/metastatic nasopharyngeal carcinoma The current standard first-line treatment is gemcitabine + cisplatin (GP) dual-agent chemotherapy, and immunotherapy has not been included in the first-line treatment recommended by the 2021 National Comprehensive Cancer Network (NCCN) guidelines due to lack of clinical evidence, and is currently only used as a second-line treatment
.
JUPITER-02 is a randomized, double-blind phase III clinical study that included a total of 289 patients with nasopharyngeal carcinoma who were newly treated for metastasis/recurrence from 35 medical centers around the world
.
Among them, 143 cases were randomized into the placebo + GP group, and 149 cases were entered into the teriprizumab + GP group
.
The stratification factors of this study mainly consider the Eastern Cooperative Oncology Group (ECOG) performance status score and the disease baseline status
.
The primary endpoint of the study is the Progression-Free Survival (PFS) assessed by the Blind Independent Review Committee (BIRC), and the secondary endpoints are the PFS assessed by the investigator, overall survival (OS), objective response rate (ORR) and duration of response ( DoR)
.
▌ The baseline characteristics of the patients included in this study are better than those of previous similar studies.
The baseline analysis of the 289 patients included in the study showed that the two groups of patients with newly treated metastases accounted for 42% and 39%, a significant advantage over the previous 20-30%
.
At the beginning of the study, patients were widely accepted for PD-L1 expression level detection, and 3/4 were high expression
.
Baseline characteristics ▌ PFS and OS in the teriplimumab + GP group have more obvious benefits.
The median PFS assessed by BIRC in the triplimumab group and chemotherapy group were 11.
7 and 8.
0 months, respectively, and the PFS rate in one year nearly doubled (27.
9%vs 49.
4%), the risk of disease progression in the teriprizumab group was reduced by 48%, which was statistically different (P=0.
0003)
.
The PFS results evaluated by the main investigator were even more encouraging: the 1-year PFS rate increased nearly three times (20.
0% vs 59.
5%), and the risk of disease progression was reduced by 59% (P<0.
0001)
.
In terms of OS, compared with the chemotherapy group, the risk of death in the teriplizumab group was reduced by nearly 40% (HR=0.
603), and the difference in OS between the two groups increased with time.
The OS in the teriplizumab group was 20 It enters a plateau period around months, and the chemotherapy group has a significant decrease after 2 years
.
The ORR and DoR results also indicated that the teriprizumab group was better than the chemotherapy group
.
▌ There is no significant difference in safety between the two groups.
Teriplimumab combined with the GP regimen has good safety.
The incidence of all treatment-related adverse events (AE) between the two groups is relatively consistent.
No new adverse events were observed, grade 3 or above The incidence of immune-related AEs is low, only 7.
5%
.
Safety analysis Dr.
Xiaomin Au: The CAPTAIN-1ST study is a multi-center, randomized exploration of carrelizumab combined with GP regimen in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (Abstract No.
: 6000) In a controlled, double-blind phase III clinical trial study, patients were randomly divided into carrelizumab + GP regimen group (carrelizumab group) and placebo + GP regimen group (placebo group) , 134 and 129 patients were enrolled, and the baseline characteristics of the two groups were balanced
.
CAPTAIN-1ST study design▌ PFS of Carrelizumab+GP regimen is better than PFS evaluated by independent review committee (IRC) of placebo+GP regimen Carrelizumab+GP regimen group and placebo+GP regimen group It was 10.
8 months and 6.
9 months, P<0.
0001; PFS assessed by the investigator was 12.
0 months and 7.
0 months, P<0.
0001, compared with placebo combined with GP, carrelizumab combined with GP increased PFS, It reduces the risk of disease progression or death by 50%; there is no statistical difference in ORR and disease control rate (DCR); in terms of DoR, the two groups are 9.
9 months and 5.
7 months, respectively, p<0.
0001
.
It can be seen that the contribution of immunotherapy is mainly to enable patients to obtain continuous tumor remission; the OS of the two groups is immature, but it has been observed that the carrelizumab combined with GP group has a survival benefit trend
.
CAPTAIN-1ST study the efficacy of carrelizumab+GP regimen group and placebo+GP regimen group▌ The safety of carrelizumab+GP regimen is controllable, and the adverse events related to treatment above grade 3 in both groups are 90% % Above, there is no significant difference, but in terms of adverse events related to grade 1 or 2 immunotherapy, the carrelizumab + GP regimen is slightly weak, but the overall safety is controllable
.
CAPTAIN-1ST Study Safety Results Dr.
Xu Tingting: Phase III clinical study of the efficacy of capecitabine adjuvant chemotherapy/beat chemotherapy for locally advanced nasopharyngeal carcinoma (Abstract No.
6003,6005) Past adjuvant chemotherapy studies such as PF (cisplatin + 5-Fluorouracil) and GP (gemcitabine + cisplatin) regimens failed due to high toxicity, poor patient compliance, and improper selection of the enrolled population
.
In addition to the anti-tumor effects of conventional chemotherapy, metronomic chemotherapy also has the special effects of anti-angiogenesis, activating immunity and inducing tumor cell dormancy.
Its greatest advantage is that it can use low-dose chemotherapy, reduce treatment toxicity, and improve patient compliance
.
Therefore, the use of capecitabine for late adjuvant chemotherapy/beat chemotherapy for nasopharyngeal carcinoma was launched
.
Traditional adjuvant chemotherapy research rhythm chemotherapy plan ▌ Study design is different.
Abstract No.
6003: 406 patients with locally removed T3-4N0 and T3N1 nasopharyngeal carcinoma were included in the group and randomized after receiving radical radiotherapy and chemotherapy.
204 capecitabine rhythm chemotherapy group The patients received capecitabine 650mg/m² twice a day (bid) for 1 year.
202 patients in the control group were followed up for observation, and the baseline status of the two groups was balanced
.
The primary study endpoint is the 3-year failure-free survival (FFS) rate, and the secondary endpoints include OS rate, distant metastasis-free survival rate, local failure-free survival rate and toxicity
.
Abstract No.
6005: The overall plan is similar to the capecitabine rhythm chemotherapy study.
The enrolled patients were locally advanced except T0-4N0-1 and T1-2N2, or the plasma EBV-DNA concentration before treatment was greater than 20,000 copies/ml or gross primary tumors Volume (GTVnx)>30cm3 or 18FDG PET-CT maximum standard uptake value (SUVmax)>10.
0 and ≥4 cm in primary tumor/multiple neck lymph node metastases
.
The stage of nasopharyngeal carcinoma of the enrolled patients is later than that of rhythm chemotherapy, and the tumor remission indicators will theoretically get better benefits
.
The experimental group received capecitabine 1000mg/m²bid, a 3-week regimen (2 weeks of medication and 1 week stop), no more than 8 cycles in total
.
Comparison of study design ▌ Capecitabine adjuvant chemotherapy FFS and OS have obvious benefits Abstract No.
6003 (Capecitabine beat chemotherapy): The 3-year FFS rate of the capecitabine beat chemotherapy group was 85.
3%, and the control group was 75.
7%, with recurrence /The risk of death was reduced by 50%, and the P value was 0.
002; the 3-year OS rate of the capecitabine-beat chemotherapy group was 93.
3%, and that of the control group was 88.
6%, and the P value was 0.
018.
The risk of death was reduced by 44%
.
It can be seen that FFS and OS have clearly benefited
.
Abstract No.
6005: The 3-year FFS rate of the capecitabine group was 87.
7%, the control group was 73.
3%, the P value was 0.
037, and the risk of recurrence/death was reduced by 48%; in terms of OS rates, the two groups were 92.
6% and 88.
9%, respectively , There is no statistical difference
.
Study endpoint evaluation ▌ The safety of capecitabine adjuvant chemotherapy is controllable.
Both studies suggest that the main adverse reaction of capecitabine is hand-foot syndrome
.
The former study showed that the incidence of hand-foot syndrome was 58%, and the incidence of grade 3 and above AEs was 9%; the latter study showed that the incidence of grade 3 and above hand-foot syndrome was 3.
5%
.
There is no significant difference in other drug toxicity events, so overall the safety of capecitabine adjuvant chemotherapy is controllable and tolerable
.
Toxicity comparison
