Penpulimab is an anti-programmed cell death-1(PD-1)IgG1 antibody with no Fc gamma receptor(FcγR)binding activity,and thus theoretically reduced immune-related adverse events(irAEs)while maintaining efficacy.This sing...Penpulimab is an anti-programmed cell death-1(PD-1)IgG1 antibody with no Fc gamma receptor(FcγR)binding activity,and thus theoretically reduced immune-related adverse events(irAEs)while maintaining efficacy.This single-arm,phase II trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma(NPC)who had failed two or more lines of previous systemic chemotherapy.Patients received 200-mg penpulimab intravenously every 2 weeks(4 weeks per cycle)until disease progression or intolerable toxicities.The primary endpoint was objective response rate(ORR)per RECIST(version 1.1),as assessed by an independent radiological review committee.The secondary endpoints included progression-free survival(PFS)and overall survival(OS).One hundred thirty patients were enrolled and 125 were efficacy evaluable.At the data cutoff date(September 28,2022),1 patient achieved complete response and 34 patients attained partial response.The ORR was 28.0%(95%CI 20.3–36.7%).The response was durable,with 66.8%still in response at 9 months.Thirty-three patients(26.4%)were still on treatment.The median PFS and OS were 3.6 months(95%CI=1.9–7.3 months)and 22.8 months(95%CI=17.1 months to not reached),respectively.Ten(7.6%)patients experienced grade 3 or higher irAEs.Penpulimab has promising anti-tumor activities and acceptable toxicities in heavily pretreated metastatic NPC patients,supporting further clinical development as third-line treatment of metastatic NPC.展开更多
Purpose To evaluate the outcomes in elderly patients with nasopharyngeal carcinoma(NPC)treated by intensity modulated radiation therapy(IMRT).Methods Patients with NPC aged≥70 years old who received intensity-modulat...Purpose To evaluate the outcomes in elderly patients with nasopharyngeal carcinoma(NPC)treated by intensity modulated radiation therapy(IMRT).Methods Patients with NPC aged≥70 years old who received intensity-modulated radiation therapy≥60 Gy were recruited into this study.The overall survival(OS),progression-free survival(PFS),cancer-specific survival(CSS),locoregional recurrence-free rate(LRFR)and distant metastasis-free rate(DMFR)were calculated using the Kaplan–Meier method.The Cox proportional hazards model was applied to perform multivariate analysis for independent prognosticators using meaningful variables from the univariate analysis.Results One hundred ninety seven patients with NPC≥70 years were recruited from the 4351 newly diagnosed NPC patients from January 2011 to December 2020.The 5-year OS,CSS,PFS,LRFR and DMFR were 59.6%,78.9%,51.3%,91.6%and 78.9%,respectively.the plasma EBV DNA was the only prognostic factor for OS,the overall staging was the only prognostic factor for CSS,and plasma EBV DNA and N category were borderline significant factor for DMFR.We did not find any prognosticator for PFS and LRFR.Conclusions The survival after IMRT for elderly patients with NPC is suboptimal.Further study stratified by comorbidity and geriatric assessment is needed.展开更多
文摘Penpulimab is an anti-programmed cell death-1(PD-1)IgG1 antibody with no Fc gamma receptor(FcγR)binding activity,and thus theoretically reduced immune-related adverse events(irAEs)while maintaining efficacy.This single-arm,phase II trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma(NPC)who had failed two or more lines of previous systemic chemotherapy.Patients received 200-mg penpulimab intravenously every 2 weeks(4 weeks per cycle)until disease progression or intolerable toxicities.The primary endpoint was objective response rate(ORR)per RECIST(version 1.1),as assessed by an independent radiological review committee.The secondary endpoints included progression-free survival(PFS)and overall survival(OS).One hundred thirty patients were enrolled and 125 were efficacy evaluable.At the data cutoff date(September 28,2022),1 patient achieved complete response and 34 patients attained partial response.The ORR was 28.0%(95%CI 20.3–36.7%).The response was durable,with 66.8%still in response at 9 months.Thirty-three patients(26.4%)were still on treatment.The median PFS and OS were 3.6 months(95%CI=1.9–7.3 months)and 22.8 months(95%CI=17.1 months to not reached),respectively.Ten(7.6%)patients experienced grade 3 or higher irAEs.Penpulimab has promising anti-tumor activities and acceptable toxicities in heavily pretreated metastatic NPC patients,supporting further clinical development as third-line treatment of metastatic NPC.
文摘Purpose To evaluate the outcomes in elderly patients with nasopharyngeal carcinoma(NPC)treated by intensity modulated radiation therapy(IMRT).Methods Patients with NPC aged≥70 years old who received intensity-modulated radiation therapy≥60 Gy were recruited into this study.The overall survival(OS),progression-free survival(PFS),cancer-specific survival(CSS),locoregional recurrence-free rate(LRFR)and distant metastasis-free rate(DMFR)were calculated using the Kaplan–Meier method.The Cox proportional hazards model was applied to perform multivariate analysis for independent prognosticators using meaningful variables from the univariate analysis.Results One hundred ninety seven patients with NPC≥70 years were recruited from the 4351 newly diagnosed NPC patients from January 2011 to December 2020.The 5-year OS,CSS,PFS,LRFR and DMFR were 59.6%,78.9%,51.3%,91.6%and 78.9%,respectively.the plasma EBV DNA was the only prognostic factor for OS,the overall staging was the only prognostic factor for CSS,and plasma EBV DNA and N category were borderline significant factor for DMFR.We did not find any prognosticator for PFS and LRFR.Conclusions The survival after IMRT for elderly patients with NPC is suboptimal.Further study stratified by comorbidity and geriatric assessment is needed.