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The new trend in the treatment of advanced nasopharyngeal carcinoma, come and punch! There are approximately 29,100 newly diagnosed cases and 73,000 deaths of nasopharyngeal cancer worldwide each year
.
Although the survival rate of early and locally advanced disease is significantly improved, about 20%-30% of patients still have recurrence or distant metastasis, and the prognosis of these patients is very poor
.
"Nasopharyngeal cancer is a common malignant tumor in southern China.
In addition to southern China, Southeast Asia is also more common than North America and Canada
.
At present, the main treatment for nasopharyngeal cancer is concurrent radiotherapy and chemotherapy.
The standard treatment for patients with distant metastasis is It is platinum-based chemotherapy
.
" said Zhang Li, professor of Sun Yat-sen University Cancer Center
.
The team of Professor Zhang Li from Sun Yat-sen University Cancer Center has conducted a series of studies in order to explore more effective treatment options and improve the survival status of patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC)
.
At the 2021 American Society of Clinical Oncology (ASCO) annual meeting, Professor Zhang Li brought the title "Camrelizumab versus placebo combined with gemcitabine and cisplatin for recurrent or metastatic nasopharyngeal carcinoma: A randomized, double-blind, phase 3 trial.
" (abstract number : 6000) Appeared in the head and neck tumor special session
.
The "medical community" sincerely invites Professor Zhang Li to give an in-depth interpretation of this research
.
The unique biological characteristics of nasopharyngeal carcinoma open new doors for immunotherapy.
Professor Zhang Li's team took the lead in establishing a global first-line standard treatment plan for the treatment of R/M NPC with gemcitabine and cisplatin (Lancet 2016)
.
"Although we have determined the optimal chemotherapy regimen at the time, the progression-free survival (PFS) of these patients is still relatively short.
How to extend the PFS of patients so that they can have real survival benefits is our team has been working hard And the direction of exploration
.
" Professor Zhang Li said
.
From the point of view of biological characteristics, PD-L1 is highly expressed in nasopharyngeal carcinoma-the expression rate of PD-L1 is as high as 90%.
The underlying mechanism may be related to the induction of PD-L1 expression by Epstein-Barr virus infection
.
At the same time, Professor Zhang Zhang's team found that the continuous release of Epstein-Barr virus during the growth of nasopharyngeal carcinoma caused dense infiltration of non-malignant lymphocytes, which meant that nasopharyngeal carcinoma could be defined as a "hot" tumor
.
The above two basic research results suggest that patients with R/M NPC are likely to benefit from immunotherapy
.
And previously, the first-line treatment of PD-1 monoclonal antibody karelizumab + gemcitabine + cisplatin (GP) has shown encouraging anti-cancer activity (Lancet Oncol 2018)
.
The new standard plan for first-line treatment is finally settled! In order to further verify the conjecture, Professor Zhang Zhang’s team launched a national multi-center phase III clinical trial, which included eligible patients with previously untreated R/M NPC randomly (1:1) to receive carrelizumab (1st 200 mg per day) plus gemcitabine (1000 mg/m2 on day 1, day 8) and cisplatin (80 mg/m2 on day 1) or placebo plus the same chemotherapy regimen Q3W intravenously for up to 6 cycles, then use card Relizumab or placebo for maintenance treatment
.
The primary endpoint is the PFS of the Independent Review Committee (IRC)
.
Secondary endpoints include the investigator-assessed PFS, objective response rate (ORR), disease control rate (DCR), duration of response (DOR), overall survival (OS), and tolerability
.
From November 2018 to November 2019, 263 patients from 28 centers were randomly divided into carrelizumab + GP (n=134, carrelizumab group) or placebo + GP ( n=129, placebo group)
.
At the end of the data on December 31, 2020 (67.
7% expiration date), there were 178 PFS events assessed by IRC, and the median follow-up time was 15.
6 months (range 1.
3-25.
5)
.
The median PFS assessed by IRC in the carrelizumab group was 10.
8 months (95% CI 8.
5-13.
6), and in the placebo group was 6.
9 months (95% CI 5.
9-7.
9) (HR 0.
51; 95% CI 0.
37- 0.
69; one-sided P<0.
0001)
.
The PFS evaluated by the researchers showed similar results
.
Figure 1 PFS results evaluated by the study IRC The ORR evaluated by the IRC in the carrelizumab group was 88.
1% (95% CI 81.
3-93.
0), and the placebo group was 80.
6% (95% CI 72.
7-87.
1), and the median DOR 9.
9 (95% CI 7.
7-12.
5) and 5.
7 months (95% CI 5.
2-6.
9); the DCR of the carrelizumab group was 96.
3% (95% CI 91.
5-98.
8), and the placebo group was 94.
6% (95%CI 89.
1-97.
8)
.
Figure 2 Summary of the study remission rate data Although the OS data is not yet mature, the carrelizumab group has a significant trend of benefit (median did not reach vs 22.
6 months; HR 0.
67, 95% CI 0.
41-1.
11)
.
Figure 3 Study OS data From the perspective of safety, the incidence of treatment-related adverse events (TRAEs) ≥3 in the carrelizumab group was 93%, and that of the placebo group was 90%
.
The most common grades ≥3 TRAEs include: decreased white blood cell count (66% vs 70%), decreased neutrophil count (64% vs 65%), decreased platelet count (40% vs 40%), and anemia (39% vs 43) %)
.
These differences were not statistically significant
.
Professor Zhang Li said: “There is no doubt that immunotherapy combined with chemotherapy will be the standard for the first-line treatment of advanced nasopharyngeal carcinoma in the future
.
And the indication is carrelizumab combined with cisplatin and gemcitabine for the first-line treatment of R/M.
NPC’s marketing application (acceptance number: CXSS2000055) is in the “under review” status and is expected to be approved by the National Medical Products Administration (NMPA) in the near future
.
At the same time, this study has been accepted by the top tumor journal Lancet Oncology and will be published in full soon ; At the same time, this study was also selected as Best of ASCO, and will be on tour around the world
.
"The road to the future, immunotherapy is expected to make a global breakthrough.
The research results announced at this ASCO conference have confirmed the combination of immunotherapy and chemotherapy in advanced nasopharyngeal carcinoma The value of first-line treatment for patients
.
"Then our next step is to explore the efficacy of this treatment model in patients with early and locally advanced nasopharyngeal carcinoma? At present, several studies have been carried out, such as the addition of immunotherapy before concurrent radiotherapy and chemotherapy, whether the efficacy can be improved.
The use of immunotherapy as a consolidation program after radiotherapy and chemotherapy at the same time is more effective, etc.
These studies are in full swing, and it is expected that the front will move forward and benefit more patients with nasopharyngeal cancer
.
" Professor Zhang Li said
.
The biomarkers that have been widely proven effective in immunotherapy are relatively limited.
Therefore, how to "dig out" more biomarkers to determine the precise benefit population of immunotherapy is also one of the future directions
.
"In another study of our team to explore the therapeutic value of tislelizumab combined with chemotherapy, we kept tumor specimens of all enrolled patients, and through the exploration and analysis of translational research, we can provide more effective precision treatment for the next generation.
Clues
.
"Professor Zhang Li said
.
The plan of immunotherapy combined with chemotherapy is about to change the practice of R/M NPC first-line treatment.
Chemotherapy alone is no longer the "dominant family".
I believe that the survival status of Chinese nasopharyngeal cancer patients can be greatly improved in the future! Expert profile Professor Zhang Li, director of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, Ph.
D.
supervisor, chief expert on lung cancer, member-designate of the Cancer Rehabilitation and Palliative Care Professional Committee of the Chinese Anti-Cancer Association Vice-chairman of the Clinical Trial Committee of the Chinese Anti-Cancer Association Chinese Society of Clinical Oncology (CSCO) Standing Director CSCO-Immuno Therapy Expert Committee Designated Chairman Guangdong Anti-Cancer Association Chemotherapy Professional Committee Honorary Chairman Guangdong Anti-Cancer Association Lung Cancer Professional Committee Vice Chairman Guangdong Provincial Clinical Medicine Association Precision Medicine Professional Committee Chairman Guangdong Provincial Medical Leader , "Special support plan" outstanding talent (South Guangdong Baijie), the national key research and development program "precision medicine research" lung cancer diagnosis and treatment specifications and application plan precision research project leader "This article is only used to provide medical and health professionals with scientific information , Does not represent the position of the platform"
.
Although the survival rate of early and locally advanced disease is significantly improved, about 20%-30% of patients still have recurrence or distant metastasis, and the prognosis of these patients is very poor
.
"Nasopharyngeal cancer is a common malignant tumor in southern China.
In addition to southern China, Southeast Asia is also more common than North America and Canada
.
At present, the main treatment for nasopharyngeal cancer is concurrent radiotherapy and chemotherapy.
The standard treatment for patients with distant metastasis is It is platinum-based chemotherapy
.
" said Zhang Li, professor of Sun Yat-sen University Cancer Center
.
The team of Professor Zhang Li from Sun Yat-sen University Cancer Center has conducted a series of studies in order to explore more effective treatment options and improve the survival status of patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC)
.
At the 2021 American Society of Clinical Oncology (ASCO) annual meeting, Professor Zhang Li brought the title "Camrelizumab versus placebo combined with gemcitabine and cisplatin for recurrent or metastatic nasopharyngeal carcinoma: A randomized, double-blind, phase 3 trial.
" (abstract number : 6000) Appeared in the head and neck tumor special session
.
The "medical community" sincerely invites Professor Zhang Li to give an in-depth interpretation of this research
.
The unique biological characteristics of nasopharyngeal carcinoma open new doors for immunotherapy.
Professor Zhang Li's team took the lead in establishing a global first-line standard treatment plan for the treatment of R/M NPC with gemcitabine and cisplatin (Lancet 2016)
.
"Although we have determined the optimal chemotherapy regimen at the time, the progression-free survival (PFS) of these patients is still relatively short.
How to extend the PFS of patients so that they can have real survival benefits is our team has been working hard And the direction of exploration
.
" Professor Zhang Li said
.
From the point of view of biological characteristics, PD-L1 is highly expressed in nasopharyngeal carcinoma-the expression rate of PD-L1 is as high as 90%.
The underlying mechanism may be related to the induction of PD-L1 expression by Epstein-Barr virus infection
.
At the same time, Professor Zhang Zhang's team found that the continuous release of Epstein-Barr virus during the growth of nasopharyngeal carcinoma caused dense infiltration of non-malignant lymphocytes, which meant that nasopharyngeal carcinoma could be defined as a "hot" tumor
.
The above two basic research results suggest that patients with R/M NPC are likely to benefit from immunotherapy
.
And previously, the first-line treatment of PD-1 monoclonal antibody karelizumab + gemcitabine + cisplatin (GP) has shown encouraging anti-cancer activity (Lancet Oncol 2018)
.
The new standard plan for first-line treatment is finally settled! In order to further verify the conjecture, Professor Zhang Zhang’s team launched a national multi-center phase III clinical trial, which included eligible patients with previously untreated R/M NPC randomly (1:1) to receive carrelizumab (1st 200 mg per day) plus gemcitabine (1000 mg/m2 on day 1, day 8) and cisplatin (80 mg/m2 on day 1) or placebo plus the same chemotherapy regimen Q3W intravenously for up to 6 cycles, then use card Relizumab or placebo for maintenance treatment
.
The primary endpoint is the PFS of the Independent Review Committee (IRC)
.
Secondary endpoints include the investigator-assessed PFS, objective response rate (ORR), disease control rate (DCR), duration of response (DOR), overall survival (OS), and tolerability
.
From November 2018 to November 2019, 263 patients from 28 centers were randomly divided into carrelizumab + GP (n=134, carrelizumab group) or placebo + GP ( n=129, placebo group)
.
At the end of the data on December 31, 2020 (67.
7% expiration date), there were 178 PFS events assessed by IRC, and the median follow-up time was 15.
6 months (range 1.
3-25.
5)
.
The median PFS assessed by IRC in the carrelizumab group was 10.
8 months (95% CI 8.
5-13.
6), and in the placebo group was 6.
9 months (95% CI 5.
9-7.
9) (HR 0.
51; 95% CI 0.
37- 0.
69; one-sided P<0.
0001)
.
The PFS evaluated by the researchers showed similar results
.
Figure 1 PFS results evaluated by the study IRC The ORR evaluated by the IRC in the carrelizumab group was 88.
1% (95% CI 81.
3-93.
0), and the placebo group was 80.
6% (95% CI 72.
7-87.
1), and the median DOR 9.
9 (95% CI 7.
7-12.
5) and 5.
7 months (95% CI 5.
2-6.
9); the DCR of the carrelizumab group was 96.
3% (95% CI 91.
5-98.
8), and the placebo group was 94.
6% (95%CI 89.
1-97.
8)
.
Figure 2 Summary of the study remission rate data Although the OS data is not yet mature, the carrelizumab group has a significant trend of benefit (median did not reach vs 22.
6 months; HR 0.
67, 95% CI 0.
41-1.
11)
.
Figure 3 Study OS data From the perspective of safety, the incidence of treatment-related adverse events (TRAEs) ≥3 in the carrelizumab group was 93%, and that of the placebo group was 90%
.
The most common grades ≥3 TRAEs include: decreased white blood cell count (66% vs 70%), decreased neutrophil count (64% vs 65%), decreased platelet count (40% vs 40%), and anemia (39% vs 43) %)
.
These differences were not statistically significant
.
Professor Zhang Li said: “There is no doubt that immunotherapy combined with chemotherapy will be the standard for the first-line treatment of advanced nasopharyngeal carcinoma in the future
.
And the indication is carrelizumab combined with cisplatin and gemcitabine for the first-line treatment of R/M.
NPC’s marketing application (acceptance number: CXSS2000055) is in the “under review” status and is expected to be approved by the National Medical Products Administration (NMPA) in the near future
.
At the same time, this study has been accepted by the top tumor journal Lancet Oncology and will be published in full soon ; At the same time, this study was also selected as Best of ASCO, and will be on tour around the world
.
"The road to the future, immunotherapy is expected to make a global breakthrough.
The research results announced at this ASCO conference have confirmed the combination of immunotherapy and chemotherapy in advanced nasopharyngeal carcinoma The value of first-line treatment for patients
.
"Then our next step is to explore the efficacy of this treatment model in patients with early and locally advanced nasopharyngeal carcinoma? At present, several studies have been carried out, such as the addition of immunotherapy before concurrent radiotherapy and chemotherapy, whether the efficacy can be improved.
The use of immunotherapy as a consolidation program after radiotherapy and chemotherapy at the same time is more effective, etc.
These studies are in full swing, and it is expected that the front will move forward and benefit more patients with nasopharyngeal cancer
.
" Professor Zhang Li said
.
The biomarkers that have been widely proven effective in immunotherapy are relatively limited.
Therefore, how to "dig out" more biomarkers to determine the precise benefit population of immunotherapy is also one of the future directions
.
"In another study of our team to explore the therapeutic value of tislelizumab combined with chemotherapy, we kept tumor specimens of all enrolled patients, and through the exploration and analysis of translational research, we can provide more effective precision treatment for the next generation.
Clues
.
"Professor Zhang Li said
.
The plan of immunotherapy combined with chemotherapy is about to change the practice of R/M NPC first-line treatment.
Chemotherapy alone is no longer the "dominant family".
I believe that the survival status of Chinese nasopharyngeal cancer patients can be greatly improved in the future! Expert profile Professor Zhang Li, director of the Department of Internal Medicine, Sun Yat-sen University Cancer Center, Ph.
D.
supervisor, chief expert on lung cancer, member-designate of the Cancer Rehabilitation and Palliative Care Professional Committee of the Chinese Anti-Cancer Association Vice-chairman of the Clinical Trial Committee of the Chinese Anti-Cancer Association Chinese Society of Clinical Oncology (CSCO) Standing Director CSCO-Immuno Therapy Expert Committee Designated Chairman Guangdong Anti-Cancer Association Chemotherapy Professional Committee Honorary Chairman Guangdong Anti-Cancer Association Lung Cancer Professional Committee Vice Chairman Guangdong Provincial Clinical Medicine Association Precision Medicine Professional Committee Chairman Guangdong Provincial Medical Leader , "Special support plan" outstanding talent (South Guangdong Baijie), the national key research and development program "precision medicine research" lung cancer diagnosis and treatment specifications and application plan precision research project leader "This article is only used to provide medical and health professionals with scientific information , Does not represent the position of the platform"
