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Objective:To explore the effect of chemotherapy administration sequence combined with programmed cell death protein-1(PD-1)monoclonal antibody on the efficacy and immune-related adverse events(irAEs)in patients with advanced non-small cell lung cancer(NSCLC).Methods:The clinical data of 110 patients with advanced NSCLC treated at The First Affiliated Hospital of Zhengzhou University between November 2019 and January 2022 were retrospectively collected.The factors influencing irAEs were analyzed by univariate and multivariate Logistic regression analyses,while those influencing curative effect were analyzed by Kaplan-Meier curve analysis,Log-rank test,and univariate and multivariate Cox regression analyses.Results:Treatment with PD-1 monoclonal antibody after 2 days of chemotherapy(sequential treatment group,n=36)significantly prolonged progression-free survival(PFS)compared with PD-1 monoclonal antibody admin-istration on the same day of chemotherapy(simultaneous treatment group,n=74)(17.2 months vs.11.3 months,respectively;P＜0.05).The disease control rate(DCR)was better in the sequential treatment group than in the simultaneous treatment group(94.4％vs.79.7％,re-spectively;P=0.045),while the objective response rate(ORR)did not differ significantly(69.4％vs.51.4％,respectively;P=0.072).The Cox re-gression analysis showed that cytokerat in 19 fragment(Cyfra21-1)and d-dimer(D-dimer)affected the efficacy of combination therapy(P＜0.05).The Logistic regression analysis showed that age and lactic dehydrogenase(LDH)influenced the occurrence of irAEs(P＜0.05),while the administration sequence did not significantly affect the occurrence of irAEs(P=0.130).Conclusions:Administration sequence influences the efficacy of combination therapy,and patients with advanced NSCLC who receive sequential therapy may experience better efficacy.Age and LDH are negatively correlated with the occurrence of irAEs.
RESUMO
Objective:To evaluate the efficacy and safety of a novel domestic pulmonary thromoboectomy system Tendvia TM in the treatment for high-risk patients complicated with acute pulmonary embolization (APE). Methods:The study was designed as a prospective single-center clinical trial. Twenty-four high-risk patients with APE were recruited and underwent percutaneous mechanical thromoectomy (PMT) with the Tendvia TM pulmonary thromoboectomy system. The primary efficacy endpoint was the reduction of RV/LV ratio at the post-operative 48 h. The secondary efficacy endpoints included technical success rate, mean pulmonary arterial pressure (mPAP), arterial PaO 2 and the instant post-operative thrombus clearance rate. The evaluation of the safety included the intraoperative complications and related complications during the follow-up period associated with the PMT operation and the major adverse event (MAE) rate within the post-operative 48 h. The pre-and post-operative data were compared with paired sample t-test or Wilcoxon rank sum test to evaluate the efficacy and safety of Tendvia TM pulmonary thromoboectomy system. Results:The technical success rate of PMT with Tendvia TM pulmonary thromoboectomy system was 100% (24/24). The 48 h pre-operative RV/LV ratio was 1.19±0.25 and the post-operative RV/LV ratio was 0.82±0.16. The mean RV/LV ratio of the patients was decreased by 0.37±0.25 at post-operative 48 h with significant statistical difference ( t=7.03, P<0.001). The 48 h pre-operative mPAP was (31.09±6.09) mmHg and the post-operative mPAP was (25.91±4.36) mmHg. The mPAP of the patients was reduced by 5.18 mmHg at post-operative 48 h with significant statistical difference ( t=6.73, P<0.001). The pre-operative PaO 2 was (74.66±11.28) mmHg and the post-operative PaO 2 was (88.01±10.57) mmHg. The pressure of oxygen in artery was increased by 13.36 mmHg. The differences were statistically significant( t=-4.08, P<0.001). The rate of thrombus removal was 68.17%±22.66%. 87.5% (21 cases) of patients achieved a thrombus removal greater than grade Ⅱ. One patient underwent catheter directed thrombolysis (CDT) after PMT based on the evaluation of operator. The patient′s thrombus removal achieved grade Ⅲ after 48 h and the CDT was ceased. Hemoptysis occurred intra-operatively in one case underwent PMT and the symptom of the patient was alleviated with conservative medication. The MAE incidence within the post-operative 48 h was 4.17% (1/24). No device-related mortality or all-cause mortality occurred in the trial. Conclusions:The Tendvia TM pulmonary thromoboectomy system is a safe and effective device to remove the pulmonary arterial thrombus for the treatment of patients with APE. The Tendvia TM pulmonary thromoboectomy system can be a new choice in the treatment for the patients with APE.