Background:A therapeutic strategy involving combined treatment with lenvatinib plus pembrolizumab(LEP)has demonstrated a relatively high antitumor response in several solid tumors;however,the efficacy and safety of LE...Background:A therapeutic strategy involving combined treatment with lenvatinib plus pembrolizumab(LEP)has demonstrated a relatively high antitumor response in several solid tumors;however,the efficacy and safety of LEP in patients with refractory bile tract carcinoma(BTC)remains unknown.Methods:This is a single-arm study for a preliminary assessment of the efficacy and tolerability of LEP in patients who experienced progression from prior systemic treatments.Pre-treatment tumor tissues were collected to retrospectively evaluate the expression status of PDL1.Results:Thirty-two patients received second-line and above treatment with LEP.Overall,the objective response rate(ORR)was 25%,the disease control rate(DCR)was 78.1%,and the clinical benefit rate(CBR)was 40.5%.The median progression-free survival(PFS)was 4.9 months(95%CI:4.7–5.2 months),and the median overall survival(OS)was 11.0 months(95%CI:9.6–12.3 months).For tolerability,no grade 5 serious adverse events(AEs)were reported.All patients had any-grade AEs,and 59.3%of the patients experienced grade 3 AEs,while only 1 patient experienced a grade 4 AE of stomach bleeding.Fatigue was the most common AE,followed by hypertension and elevated aminotransferase levels.Retrospective analysis for PDL1 expression revealed that PDL1 positive tumor cells were associated with improved clinical benefits and survival outcomes.Conclusions:LEP is a promising alternative as a non-first-line therapeutic regimen for patients with refractory BTC.Furthermore,well-designed prospective clinical trials with a control arm are still needed to obtain more evidences to confirm the efficacy and safety of this particular regimen as well as the role of PDL1 expression.展开更多
Introduction Image-guided liver surgery is the current direction in which‘precision surgery’is developing[1].Clinical doctors can extract the structural information of the liver and perform a geometric analysis of t...Introduction Image-guided liver surgery is the current direction in which‘precision surgery’is developing[1].Clinical doctors can extract the structural information of the liver and perform a geometric analysis of the liver shape using the liver-segmentation technique.This technique provides data for subsequent procedures,including measuring the volume,evaluating the function,locating the lesions and planning the surgery.Nonetheless,the structural extraction and segmentation of the liver are still mostly based on manual outlining of layers in liver CT images,which is subjective and inefficient.In recent years,many methods on automatic segmentation of the liver have been proposed and examined[2].展开更多
基金This work was supported by grants from the International Science and Technology Cooperation Projects(2016YFE0107100 and 2015DFA30650)CAMS Innovation Fund for Medical Science(CIFMS)(2017-I2M-4-003)+1 种基金Beijing Natural Science Foundation(L172055)National Ten-thousand Talent Program,Beijing Science and Technology Cooperation Special Award Subsidy Project and CAMS Initiative for Innovative Medicine(CAMS-2018-I2M-3-001)
文摘Background:A therapeutic strategy involving combined treatment with lenvatinib plus pembrolizumab(LEP)has demonstrated a relatively high antitumor response in several solid tumors;however,the efficacy and safety of LEP in patients with refractory bile tract carcinoma(BTC)remains unknown.Methods:This is a single-arm study for a preliminary assessment of the efficacy and tolerability of LEP in patients who experienced progression from prior systemic treatments.Pre-treatment tumor tissues were collected to retrospectively evaluate the expression status of PDL1.Results:Thirty-two patients received second-line and above treatment with LEP.Overall,the objective response rate(ORR)was 25%,the disease control rate(DCR)was 78.1%,and the clinical benefit rate(CBR)was 40.5%.The median progression-free survival(PFS)was 4.9 months(95%CI:4.7–5.2 months),and the median overall survival(OS)was 11.0 months(95%CI:9.6–12.3 months).For tolerability,no grade 5 serious adverse events(AEs)were reported.All patients had any-grade AEs,and 59.3%of the patients experienced grade 3 AEs,while only 1 patient experienced a grade 4 AE of stomach bleeding.Fatigue was the most common AE,followed by hypertension and elevated aminotransferase levels.Retrospective analysis for PDL1 expression revealed that PDL1 positive tumor cells were associated with improved clinical benefits and survival outcomes.Conclusions:LEP is a promising alternative as a non-first-line therapeutic regimen for patients with refractory BTC.Furthermore,well-designed prospective clinical trials with a control arm are still needed to obtain more evidences to confirm the efficacy and safety of this particular regimen as well as the role of PDL1 expression.
基金supported by the Beijing Natural Science Foundation(No.L172055)the Beijing Municipal Science&Technology Commission Research Fund(No.Z171100000417004)the China Postdoctoral Fund(No.2018M631755).
文摘Introduction Image-guided liver surgery is the current direction in which‘precision surgery’is developing[1].Clinical doctors can extract the structural information of the liver and perform a geometric analysis of the liver shape using the liver-segmentation technique.This technique provides data for subsequent procedures,including measuring the volume,evaluating the function,locating the lesions and planning the surgery.Nonetheless,the structural extraction and segmentation of the liver are still mostly based on manual outlining of layers in liver CT images,which is subjective and inefficient.In recent years,many methods on automatic segmentation of the liver have been proposed and examined[2].