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▎Nasopharyngeal carcinoma is one of the common malignant tumors of the head and neck.
Nearly half of them occur in China
.
Although most patients with locally advanced nasopharyngeal carcinoma can achieve complete clinical remission after receiving standard treatment (branch concurrent chemotherapy with or without induction chemotherapy), the risk of recurrence is still high
.
Regardless of whether induction chemotherapy is used, about 30% of patients will subsequently relapse locally or at a remote site
.
These patients still need additional and effective adjuvant therapy to further reduce the risk of recurrence and death
.
The beat capecitabine adjuvant chemotherapy program brought by the team of Professor Ma Jun from the Cancer Center of Sun Yat-sen University is expected to add effective treatment options for locally advanced nasopharyngeal carcinoma
.
The results of a phase 3 randomized controlled trial showed that the addition of beat capecitabine to adjuvant therapy with radiotherapy and chemotherapy can significantly improve the survival rate of locally advanced nasopharyngeal carcinoma with controllable safety and will not affect the quality of life of patients
.
This study was selected for the oral report of the 2021 American Society of Clinical Oncology (ASCO) annual meeting, and was simultaneously published in The Lancet on June 7
.
Professor Ma Jun is the corresponding author of the paper, and Professor Tang Linglong, Professor Xie Fangyun, and Professor Sun Ying from Sun Yat-sen University Cancer Center are co-senior authors
.
A review article published in the same period of "The Lancet" pointed out that this trial may change clinical practice, and that oral medications and rhythm chemotherapy using old drugs have high accessibility and low cost, which are particularly helpful for patients, especially primary patients
.
Screenshot source: The Lancet study was carried out in 14 hospitals in China and included 406 cases of high-risk locally advanced nasopharyngeal carcinoma (stage Ⅲ to IVA, excluding T3-4N0 and T3N1), and there were no local regional lesions or distant diseases after radical radiotherapy and chemotherapy.
Patients with metastases
.
Within 12 to 16 weeks after the last radiotherapy, patients were randomized 1:1 to receive oral beat capecitabine (dose of 650 mg/m², 2 times a day for 1 year) or standard treatment (observation only)
.
Beating chemotherapy refers to the frequent and regular use of chemotherapeutic drugs at a much lower dose than usual without prolonging the drug-free withdrawal period, which has the advantages of low toxicity and good compliance
.
A major challenge in the treatment of nasopharyngeal carcinoma is the poor tolerability of adjuvant therapy in the first 6 months after the completion of radiotherapy and chemotherapy, partly due to the lack of efficacy of traditional cisplatin adjuvant chemotherapy
.
Beat chemotherapy may be an ideal auxiliary choice for patients with nasopharyngeal carcinoma
.
After a median follow-up of 38 months, among the intention-to-treat population, the cumulative incidence of disease recurrence or death in the beat capecitabine group was 16.
6%, and that in the standard treatment group was 29.
0%
.
The 3-year failure-free survival rate (FFS, enrollment to treatment failure) in the beat capecitabine treatment group was significantly higher (85.
3% vs 75.
7%), and the stratification risk of recurrence or death was reduced by 50% (HR 0.
50 [95% CI 0.
32–0.
79]; p=0.
0023)
.
In the per-protocol population, the 3-year FFS results were similar
.
In addition, the beat capecitabine adjuvant chemotherapy also improved the overall survival rate, the distant failure-free survival rate and the local failure-free survival rate
.
The 3-year overall survival rate of the beat capecitabine group was higher (93.
3% vs 88.
6%), and the stratified mortality risk was reduced by 56% (HR 0.
44 [95% CI 0.
22–0.
88]; p=0.
018)
.
The 3-year distant failure-free survival rate in the beat capecitabine group was higher (82.
1% vs 89.
4%); the stratification risk of distant recurrence or death was reduced by 48% (HR 0.
52 [95% CI 0.
30–0.
88]; p =0.
01)
.
The 3-year local failure-free survival rate of the beat capecitabine group was higher (87.
8% vs 92.
6%); the stratification risk of local recurrence or death was reduced by 50% (HR 0.
50 [95% CI 0.
25–0.
98]; p=0.
041 )
.
▲The failure-free survival rate, overall survival rate, distant failure-free survival rate, and local failure-free survival rate of the beat capecitabine adjuvant chemotherapy group were higher (picture source: reference [1]) in all patient subgroups , Have observed the consistent benefit of beat capecitabine for improving the failure-free survival rate, including patients with different tumor and lymph node stages, and patients with different disease stages
.
It is worth noting that, regardless of whether induction chemotherapy is received, the adjuvant chemotherapy with capecitabine can bring benefits
.
17% of patients in the beat capecitabine group and 6% of the standard treatment group reported grade 3 adverse events; hand-foot syndrome was the most common adverse event associated with capecitabine (9% of patients with grade 3 hand-foot syndrome), In
addition, .
One patient (<1%) in the beat capecitabine group developed grade 4 neutropenia
.
No treatment-related deaths were reported in either group
.
During treatment, the health-related quality of life associated with the assisted beat capecitabine did not deteriorate significantly
.
The research team pointed out that in the future, it is necessary to further explore the optimal duration of beat-adjuvant chemotherapy.
The recurrence rate of nasopharyngeal cancer patients reaches a peak in the first 2 years after radiotherapy and chemotherapy.
It is not clear whether 1 year of treatment is sufficient for these patients
.
In addition, the effectiveness and safety of the combined use of beat chemotherapy and immunotherapy are also worthy of further exploration
.
Related reading Professor Xu Ruihua's ASCO plenary meeting announced the achievements of new Chinese drugs.
Zhongzong has obtained 5 oral reports for nasopharyngeal cancer.
Can neoadjuvant targeted therapy of lung cancer prolong overall survival? Professor Wu Yilong ASCO announces new options for advanced breast cancer treatment, Chinese innovative drug research shines on the international stage | ASCO 2021 has similar efficacy and lower toxicity, Professor Yuan Zhongyu brings better first-line treatment of HR+/HER2+ advanced breast cancer | ASCO 2021 prolongs survival of liver cancer, Sun Yat-sen University Cancer Prevention Center Brings Two Effective Solutions | ASCO 2021 Reference Materials [1] Yu-Pei Chen, et al.
, (2021).
Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: a multicentre, open-label, parallel- group, randomised, controlled, phase 3 trial.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)01123-5[2] obert S Kerbel, Nicolas Andre.
(2021).
Adjuvant metronomic chemotherapy for locoregionally advanced nasopharyngeal carcinoma.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)01240-X Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
Nearly half of them occur in China
.
Although most patients with locally advanced nasopharyngeal carcinoma can achieve complete clinical remission after receiving standard treatment (branch concurrent chemotherapy with or without induction chemotherapy), the risk of recurrence is still high
.
Regardless of whether induction chemotherapy is used, about 30% of patients will subsequently relapse locally or at a remote site
.
These patients still need additional and effective adjuvant therapy to further reduce the risk of recurrence and death
.
The beat capecitabine adjuvant chemotherapy program brought by the team of Professor Ma Jun from the Cancer Center of Sun Yat-sen University is expected to add effective treatment options for locally advanced nasopharyngeal carcinoma
.
The results of a phase 3 randomized controlled trial showed that the addition of beat capecitabine to adjuvant therapy with radiotherapy and chemotherapy can significantly improve the survival rate of locally advanced nasopharyngeal carcinoma with controllable safety and will not affect the quality of life of patients
.
This study was selected for the oral report of the 2021 American Society of Clinical Oncology (ASCO) annual meeting, and was simultaneously published in The Lancet on June 7
.
Professor Ma Jun is the corresponding author of the paper, and Professor Tang Linglong, Professor Xie Fangyun, and Professor Sun Ying from Sun Yat-sen University Cancer Center are co-senior authors
.
A review article published in the same period of "The Lancet" pointed out that this trial may change clinical practice, and that oral medications and rhythm chemotherapy using old drugs have high accessibility and low cost, which are particularly helpful for patients, especially primary patients
.
Screenshot source: The Lancet study was carried out in 14 hospitals in China and included 406 cases of high-risk locally advanced nasopharyngeal carcinoma (stage Ⅲ to IVA, excluding T3-4N0 and T3N1), and there were no local regional lesions or distant diseases after radical radiotherapy and chemotherapy.
Patients with metastases
.
Within 12 to 16 weeks after the last radiotherapy, patients were randomized 1:1 to receive oral beat capecitabine (dose of 650 mg/m², 2 times a day for 1 year) or standard treatment (observation only)
.
Beating chemotherapy refers to the frequent and regular use of chemotherapeutic drugs at a much lower dose than usual without prolonging the drug-free withdrawal period, which has the advantages of low toxicity and good compliance
.
A major challenge in the treatment of nasopharyngeal carcinoma is the poor tolerability of adjuvant therapy in the first 6 months after the completion of radiotherapy and chemotherapy, partly due to the lack of efficacy of traditional cisplatin adjuvant chemotherapy
.
Beat chemotherapy may be an ideal auxiliary choice for patients with nasopharyngeal carcinoma
.
After a median follow-up of 38 months, among the intention-to-treat population, the cumulative incidence of disease recurrence or death in the beat capecitabine group was 16.
6%, and that in the standard treatment group was 29.
0%
.
The 3-year failure-free survival rate (FFS, enrollment to treatment failure) in the beat capecitabine treatment group was significantly higher (85.
3% vs 75.
7%), and the stratification risk of recurrence or death was reduced by 50% (HR 0.
50 [95% CI 0.
32–0.
79]; p=0.
0023)
.
In the per-protocol population, the 3-year FFS results were similar
.
In addition, the beat capecitabine adjuvant chemotherapy also improved the overall survival rate, the distant failure-free survival rate and the local failure-free survival rate
.
The 3-year overall survival rate of the beat capecitabine group was higher (93.
3% vs 88.
6%), and the stratified mortality risk was reduced by 56% (HR 0.
44 [95% CI 0.
22–0.
88]; p=0.
018)
.
The 3-year distant failure-free survival rate in the beat capecitabine group was higher (82.
1% vs 89.
4%); the stratification risk of distant recurrence or death was reduced by 48% (HR 0.
52 [95% CI 0.
30–0.
88]; p =0.
01)
.
The 3-year local failure-free survival rate of the beat capecitabine group was higher (87.
8% vs 92.
6%); the stratification risk of local recurrence or death was reduced by 50% (HR 0.
50 [95% CI 0.
25–0.
98]; p=0.
041 )
.
▲The failure-free survival rate, overall survival rate, distant failure-free survival rate, and local failure-free survival rate of the beat capecitabine adjuvant chemotherapy group were higher (picture source: reference [1]) in all patient subgroups , Have observed the consistent benefit of beat capecitabine for improving the failure-free survival rate, including patients with different tumor and lymph node stages, and patients with different disease stages
.
It is worth noting that, regardless of whether induction chemotherapy is received, the adjuvant chemotherapy with capecitabine can bring benefits
.
17% of patients in the beat capecitabine group and 6% of the standard treatment group reported grade 3 adverse events; hand-foot syndrome was the most common adverse event associated with capecitabine (9% of patients with grade 3 hand-foot syndrome), In
addition, .
One patient (<1%) in the beat capecitabine group developed grade 4 neutropenia
.
No treatment-related deaths were reported in either group
.
During treatment, the health-related quality of life associated with the assisted beat capecitabine did not deteriorate significantly
.
The research team pointed out that in the future, it is necessary to further explore the optimal duration of beat-adjuvant chemotherapy.
The recurrence rate of nasopharyngeal cancer patients reaches a peak in the first 2 years after radiotherapy and chemotherapy.
It is not clear whether 1 year of treatment is sufficient for these patients
.
In addition, the effectiveness and safety of the combined use of beat chemotherapy and immunotherapy are also worthy of further exploration
.
Related reading Professor Xu Ruihua's ASCO plenary meeting announced the achievements of new Chinese drugs.
Zhongzong has obtained 5 oral reports for nasopharyngeal cancer.
Can neoadjuvant targeted therapy of lung cancer prolong overall survival? Professor Wu Yilong ASCO announces new options for advanced breast cancer treatment, Chinese innovative drug research shines on the international stage | ASCO 2021 has similar efficacy and lower toxicity, Professor Yuan Zhongyu brings better first-line treatment of HR+/HER2+ advanced breast cancer | ASCO 2021 prolongs survival of liver cancer, Sun Yat-sen University Cancer Prevention Center Brings Two Effective Solutions | ASCO 2021 Reference Materials [1] Yu-Pei Chen, et al.
, (2021).
Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: a multicentre, open-label, parallel- group, randomised, controlled, phase 3 trial.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)01123-5[2] obert S Kerbel, Nicolas Andre.
(2021).
Adjuvant metronomic chemotherapy for locoregionally advanced nasopharyngeal carcinoma.
The Lancet, DOI: https://doi.
org/10.
1016/S0140-6736(21)01240-X Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
