Nab-paclitaxel plus capecitabine as first-line treatment for advanced biliary tract cancers:An open-label,non-randomized,phase II clinical trial

BACKGROUND Biliary tract cancers(BTCs)are a heterogeneous group of tumors with high malignancy,poor prognosis,and limited treatment options.AIM To explore the efficacy and safety of nab-paclitaxel plus capecitabine as first-line treatment for advanced and metastatic BTCs.METHODS This open-label,non-randomized,double-center,phase II clinical trial recruited systemic therapy-naive patients with unresectable or metastatic BTCs between April 2019 and June 2022 at Beijing Cancer Hospital and the First Hospital of China Medical University.Eligible patients were administered nab-paclitaxel(150 mg/m^(2),day 1)and capecitabine(2000 mg/m^(2),twice daily,days 1-7)in 14-day cycles until experiencing intolerable toxicity or disease progression.The primary outcome was the objective response rate(ORR).The secondary outcomes included the disease control rate(DCR),overall survival(OS),progression-free survival(PFS),and safety.RESULTS A total of 44 patients successfully completed the trial,with a median age of 64.00 years(interquartile range,35.00-76.00),and 26(59.09%)were females.Tumor response assessment was impeded for one patient due to premature demise from tumor hemorrhage.Among the remaining 43 patients undergoing at least one imaging assessment,the ORR was 23.26%[95%confidence interval(CI):11.80%-38.60%],and the DCR was 69.77%(95%CI:53.90%-82.80%).The median OS was 14.1 months(95%CI:8.3-19.9),and the median PFS was 4.4 months(95%CI:2.5-6.3).A total of 41 patients(93.18%)experienced at least one adverse event(AE),with 10 patients(22.73%)encountering grade≥3 AEs,and the most frequent AEs of any grade were alopecia(79.50%),leukopenia(54.55%),neutropenia(52.27%),and liver dysfunction(40.91%),and no treatment-related deaths were documented.CONCLUSION Nab-paclitaxel plus capecitabine may be an effective and safe first-line treatment strategy for patients with advanced or metastatic BTCs.

Comparison of efficacy and safety of nab-paclitaxel and oxaliplatin+S-1 and standard S-1 and oxaliplatin chemotherapy regimens for treatment of gastric cancer

BACKGROUND Gastric cancer(GC)is a relatively frequent clinical phenomenon,referring to ma-lignant tumors emerging in the gastric mucosal epithelial cells.It has a high mor-bidity and mortality rate,posing a significant threat to the health of patients.Hence,how to diagnose and treat GC has become a heated topic in this research field.AIM To discuss the effectiveness and safety of nab-paclitaxel in combination with oxaliplatin and S-1(P-SOX)for the treatment of GC,and to analyze the factors that may influence its outcomes.METHODS A total of 219 eligible patients with advanced GC,who were treated at Qinghai University Affiliated Hospital Gastrointestinal Oncology between January 2018 and March 2020,were included in the study.Among them,149 patients received SOX regimen and 70 patients received S-1 regimen.All patients underwent both preoperative and postoperative chemotherapy consisting of 2-4 cycles each,totaling 6-8 cycles,along with parallel D2 radical surgical treatment.The patients were followed up for a period of three years or until reaching the event endpoint.RESULTS The short-term and long-term efficacy of the P-SOX group was significantly higher than that of the SOX group,and the safety was manageable.Cox multivariate analysis revealed that progression-free survival was associated with perioperative chemotherapy efficacy,tumor diameter≤2cm,high differentiation,and early cTNM(T stands for invasion depth;N stands for node metastasis;M stands for distant invasion)stage.CONCLUSION In comparison to the SOX regimen,the P-SOX regimen demonstrates improved short-term and long-term efficacy with tolerable adverse reactions.It is anticipated that the P-SOX regimen will emerge as a first-line chemotherapy option for GC.Patients with GC who receive effective perioperative chemotherapy(Response Evaluation Criteria in Solid Tumors 1.1,Tumor Regression Grade),have a tumor diameter≤2cm,exhibit high degree of differentiation,and are at an early cTNM stage show better prognosis.

Efficacy and safety of gemcitabine plus S-1 vs. gemcitabine plus nab-paclitaxel in treatment-na?ve advanced pancreatic ductal adenocarcinoma

Objective:Gemcitabine plus nab-paclitaxel(GnP)is the standard first-line therapy for advanced pancreatic ductal adenocarcinoma(PDAC).S-1,an oral fluoropyrimidine derivative,as compared with gemcitabine,is non-inferior in terms of overall survival(OS)and is associated with lower hematologic toxicity.Accordingly,S-1 is a convenient oral alternative treatment for advanced PDAC.This study was aimed at comparing the efficacy and safety of gemcitabine plus S-1(GS)vs.GnP as first-line chemotherapy for advanced PDAC.Methods:Patients with advanced PDAC who received first-line GS or GnP at the Peking Union Medical College Hospital between March 2011 and November 2022 were evaluated.Results:A total of 300 patients were assessed,of whom 84 received GS and 216 received GnP.The chemotherapy completion rate was higher with GS than GnP(50.0%vs.30.3%,P=0.0028).The objective response rate(ORR)was slightly higher(14.3%vs.9.7%,P=0.35),and the median OS was significantly longer(17.9 months vs.13.3 months,P=0.0078),in the GS group than the GnP group.However,the median progression-free survival(PFS)did not significantly differ between groups.Leukopenia risk was significantly lower in the GS group than the GnP group(14.9%vs.28.1%,P=0.049).Conclusions:As first-line chemotherapy for advanced PDAC,the GS regimen led to a significantly longer OS than the GnP regimen.The PFS,ORR,and incidence of severe adverse events were comparable between the GS and GnP groups.

Nab-paclitaxel(abraxane)-based chemotherapy to treat elderly patients with advanced non-small-cell lung cancer:a single center,randomized and open-label clinical trial

Background： The purpose of this study is to evaluate the clinical efficacy and safety of abraxane-based chemotherapy with/without nedaplatin in elderly patients with non-small-cell lung cancer （NSCLC）. Materials and methods： From October 2009 to January 2013, 48 elderly patients （≥65 years） with NSCLC were investigated in this clinical trial. The patients were randomized and equally allocated into arms A and AP- （A） abraxane （130 mg/m2, days 1, 8）; （B） abraxane ＋ nedaplatin （20 mg/m2 days 1-3, q3w）. The parameters of objective response rate （ORR）, disease control rate （DCR）, progression-free survival （PFS）, overall survival （OS） and side effects were evaluated between two arms. Results： Over 80% of the patients completed four cycles of chemotherapy. The total ORR was 21.3 %, DCR was 55.3%, PFS 4.5 months and OS 12.6 months. No significant difference was found between arms A and AP in terms of ORR （16.7% vs. 26.1%, P=0.665） or DCR （55.3% vs. 56.5%, P=0.871）. The median PFS in arm A was 3.3 months [25-75% confidence interval （CI）： 3.1-7.2] and 5.5 months （25-75% CI： 3.2-7.0） in arm AP with no statistical significance （P=0.640）. The median OS in arm A was 12.6 months （25-75% CI： 5.7-26.2） and 15.1 months （25-75% CI： 6.4-35.3） in arm AP with no statistical significance （P=0.770）. The side effects were mainly grade 1-2. The incidence of grade 3-4 toxicities was 29.1% in arm A and 62.5% in arm AP with a statistical significance （P=0.020）. Conclusions： Compared with combined therapy, abraxane alone chemotherapy was beneficial for elderly NSCLC patients with better tolerability and less adverse events, whereas did not significantly differ in terms of ORR, DCR, PFS or OS.

Optimize the combination regimen of Trastuzumab and Nab-paclitaxel in HER2-positive tumors via modulating Caveolin-1 expression by lovastatin

The combination regimen of trastuzumab(Tras)plus Nab-paclitaxel(Nab)is recommended to treat HER2-positive(HER2+)cancers.However,they exert effects in different mechanisms:Tras need to stay on cell membranes,while Nab need to be endocytosed,therefore the concurrent combination regimen may not be the best one in HER2+tumors treatment.Caveolin-1(Cav-1)is a key player in mediating their endocytosis and is associated with their efficacy,but few researches noticed the opposite effect of Cav-1 expression on the combination efficacy.Herein,we systematically studied the Cav-1 expression level on the combination efficacy and proposed an optimized and clinically feasible combination regimen for HER2+Cav-1 High tumor treatment.In the regimen,lovastatin(Lova)was introduced to modulate the Cav-1 expression and the results indicated that Lova could downregulate Cav-1 expression,increase Tras retention on cell membrane and enhance the in vitro cytotoxicity of Tras in HER2+Cav-1 High cells but not in HER2+Cav-1 Low cells.Therefore,by exchanging the dosing sequence of Nab and Tras,and by adding Lova at appropriate time points,the precise three-drug-sequential regimen(PTDS,Nab(D1)-Lova(D2)-Lova&Tras(D2+12 h))was established.Compared with the concurrent regimen,the PTDS regimen exhibited a higher in vitro cytotoxicity and a stronger tumor growth inhibition in HER2+Cav-1 High tumors,which might be a promising combination regimen for these patients in clinics.

Adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine alone for resected pancreatic ductal adenocarcinoma: A single center experience in China

BACKGROUND Nab-paclitaxel plus gemcitabine(AG)has resulted in higher tumor response and survival rates for metastatic or advanced pancreatic ductal adenocarcinoma(PDAC)compared with gemcitabine(GEM)alone.AIM To examine the feasibility and safety of AG adjuvant chemotherapy of resectable PDAC.METHODS We retrospectively analyzed patients with resected PDAC who received AG or GEM as postoperative adjuvant treatment between January 2013 and December 2016 at the Chinese People’s Liberation Army General Hospital,Beijing,China.The patients adopted combined nab-paclitaxel(125 mg/m^2)and GEM(1 g/m^2)or GEM(1 g/m^2)alone treatment,on days 1 and 8 every 3 wk for six cycles,unless intolerable adverse events or disease progression occurred.The disease-free survival,overall survival(OS)and adverse events of the two groups were statistically analyzed.RESULTS Compared with GEM,median disease-free survival(12.2 mo vs 15.8 mo,P=0.039)and OS(20.6 mo vs 28.3 mo,P=0.028)were significantly improved in the AG group.The 2-year OS rates were 63.3%and 43.3%in the AG and GEM groups,respectively.However,the incidence of sensory neuropathy was increased significantly in the AG than the GEM group(53.3%vs 23.3%,P<0.001).CONCLUSION In our initial experience,AG significantly improved disease-free survival and OS of patients with resected PDAC.AG may be a potential option for postoperative adjuvant chemotherapy of resectable PDAC.

Meta-analysis of gemcitabine plus nab-paclitaxel combined with targeted agents in the treatment of metastatic pancreatic cancer

BACKGROUND Gemcitabine plus nab-paclitaxel(GA) is a commonly used first-line treatment regimen for metastatic pancreatic cancer,and many studies will add a novel targeted agent to this regimen for improving patient survival rate.However,the clinical effectiveness of GA is the most controversial issue.AIM To compare the efficacy and safety of GA regimen with a targeted agent and GA regimen.METHODS Up to 1 December 2021,the eligible randomized controlled trials(RCTs) relating to GA and GA with a targeted agent were searched on Pub Med,EMBASE and Cochrane Library for eligible data.We screened out appropriate studies for overall survival(OS),progression-free survival(PFS),objective response rate(ORR),and toxicity,which had been pooled and finally analyzed by using Stata version 15.1.In addition,we use Reference Citation Analysis(https://www.referencecitationanalysis.com/) to collect the latest related literature to improve the latest cutting-edge research results.RESULTS Seven RCTs involving 1544 patients(848 men and 696 women) were included.There were no significant differences between GA with a targeted agent and GA in PFS [hazard ratio(HR):1.18 95% confidence interval(CI):0.91-1.53],OS(HR:1.12 95%CI:0.99-1.27),and ORR(HR:0.96 95%CI:0.71-1.29).There was no notable difference in the two groups in grade 3/4 toxicity(fatigue,anemia,vomiting and neutropenia),whereas the incidence of grade 3/4 diarrhea considerably increased in GA with a targeted drug.CONCLUSION Adding a novel targeted agent to the GA regimen did not improve survival rate of patients with metastatic pancreatic cancer.

Impressive Objective Response to Nab-Paclitaxel plus Trastuzumab as Fifth Line Therapy in an Elderly HER-2 Positive Breast Cancer Patient

Background: Agent targeting HER-2 pathway plus chemotherapy has represented a major progress in the management of patients with breast cancer. However, the role of late-line treatment in heavily pretreated patients is still largely unclear. In the last decade, nab-paclitaxel has shown significant activity and good toxicity profile in metastatic breast cancer. Case Presentation: We report the case of a 76-year-old Caucasian woman with metastatic HER-2 positive ductal infiltrating breast carcinoma treated with a combination of weekly nab-paclitaxel and trastuzumab as fifth-line therapy. She had previously received first-line paclitaxel and trastuzumab, second-line vinorelbine and trastuzumab, third-line TDM1 and fourth-line oral capecitabine and lapatinib. Clinical and radiological staging showed progression at bone, skin and soft-tissue. The patient received weekly nab-paclitaxel plus trastuzumab. Massive objective response was clinically and PET documented which lasted 8 months. Tolerance to treatment was fairly good as well as cardiac safety. Conclusion: To the best of our knowledge, this is the first reported case of efficacy of nab-paclitaxel in combination with trastuzumab as fifth-line of treatment in a patient with metastatic HER-2 positive breast cancer.

Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial

Background:This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule(S-1)for patients with advanced biliary tract carcinoma(BTC).Methods:Patients were treated with nab-paclitaxel at a dose of 125 mg/m2 on day 1 and 8,and S-1,80 to 120 mg/day on days 1-14 of a 21-day cycle.Treatments were repeated until disease progression or unacceptable toxicity occurred.The primary endpoint was objective response rate(ORR).The secondary endpoints were median progression-free survival(PFS),overall survival(OS),and adverse events(AEs).Results:The number of patients enrolled were 54,and 51 patients were evaluated for efficacy.A total of 14 patients achieved partial response(PR)with an ORR of 27.5%.The ORR varied by sites,with 53.8%(7/13)for gallbladder carcinoma,18.4%(7/38)for cholangiocarcinoma.The most common grade 3 or 4 toxicities were neutropenia and stomatitis.The median PFS and OS were 6.0 and 13.2 months,respectively.Conclusions:The combination of nab-paclitaxel with S-1 showed explicit antitumor activities and favorable safety profile in advanced BTC and could serve as a potential non-platinum and-gemcitabine-based regimen.

白蛋白结合型紫杉醇或多西他赛联合卡铂新辅助治疗HER2阳性乳腺癌疗效比较

目的比较在真实世界临床实践中曲妥珠单抗和帕妥珠单抗(HP)分别配伍白蛋白结合型紫杉醇加卡铂方案与多西他赛加卡铂方案新辅助治疗HER2阳性乳腺癌的疗效。方法回顾性收集2019年6月至2021年12月在河北省共11家三级甲等医院接受HP分别配伍白蛋白结合型紫杉醇加卡铂方案与多西他赛加卡铂方案新辅助治疗并完成后续手术的HER2阳性乳腺癌患者的临床资料,比较两组患者的总体病理完全缓解(tpCR)率。结果共纳入76例患者,其中白蛋白结合型紫杉醇组47例,多西他赛组29例。白蛋白结合型紫杉醇组tpCR率显著高于多西他赛组(72.3%vs.48.3%,χ^(2)=4.463,P=0.035)。亚组分析表明,年龄大于40岁、cN2-3、cTNMⅢ期、激素受体(+)、Ki67>30%患者中,白蛋白结合型紫杉醇组tpCR率高于多西他赛组,差异有统计学意义(P<0.05)。结论在真实世界临床实践中,HP配伍白蛋白结合型紫杉醇加卡铂方案新辅助治疗HER2阳性乳腺癌的疗效优于HP配伍多西他赛加卡铂方案。

基于Markov模型的三种方案治疗胰腺癌的药物经济学分析

目的通过建立Markov模型,对三种治疗胰腺癌的方案进行药物经济学评价,为临床用药提供循证依据。方法参考药品价格、治疗成本、健康效用值、状态转移概率建立马尔可夫(Markov)模型,对兰州大学第一医院2017年6月~2022年5月三种方案的有效性和经济性进行评价,并进行敏感性分析。结果Markov模型模拟回乘分析结果显示60个周期(5年)后,吉西他滨联合白蛋白结合型紫杉醇方案组(AG方案)的成本-效果比为437903.43元/11.80质量调整生命月(QALMs);吉西他滨联合卡培他滨方案组(GX方案)的成本-效果比为162234.52元/6.58 QALMs;吉西他滨联合替吉奥方案组(GS方案)的成本-效果比为429029.92元/15.64 QALMs。与GX方案相比较,AG方案的成本高出275668.91元,效果高出5.22 QALMs,ICER却为负值,处于绝对劣势;GS方案比GX方案效果高出9.06 QALMs,ICER为正值。结论从成本-效果的角度来看,方案AG的成本最高,治疗效果也相对较差,处于绝对劣势;GS方案比GX方案效果高,ICER也为正值,但成本较高,GX方案为优选方案。从药物经济学的角度来看,GS方案和GX方案相对于AG方案具有更高的性价比,患者在接受治疗后能够获得更长的生存期和更好的生活质量,从而提高整体的经济效果。在实际应用中,需要结合患者的具体情况和医生的专业建议来制定最佳治疗方案。

吉西他滨联合白蛋白结合型紫杉醇经导管动脉灌注治疗晚期胰腺癌的疗效及安全性

目的评价吉西他滨联合白蛋白结合型紫杉醇(GN)经导管动脉灌注治疗晚期胰腺癌的疗效及安全性。方法收集浙江省肿瘤医院2016年1月至2020年12月采用GN方案经导管动脉灌注治疗晚期胰腺癌患者50例,分析其客观有效率(ORR),无进展生存期(PFS),总生存期(OS)及治疗相关的毒性反应。结果50例胰腺癌患者共行动脉灌注化疗236次,平均灌注4.72次,其中完全缓解(CR)0例,部分缓解(PR)16例,疾病稳定(SD)21例,ORR为32%,中位PFS为5.1个月,OS为9.8个月,不良事件主要包括中性粒细胞减少、血小板减少、呕吐、恶心和乏力等。结论采用GN方案经导管动脉灌注治疗晚期胰腺癌有较好的近期疗效,且安全,可一定程度提升患者的PFS和OS。

替雷利珠单抗联合白蛋白结合型紫杉醇/奈达铂治疗晚期肺鳞癌病人的近期疗效分析

目的:探讨替雷利珠单抗联合白蛋白结合型紫杉醇/奈达铂治疗晚期肺鳞癌的近期疗效及不良反应。方法:选取驱动基因表皮生长因子受体、间变性淋巴瘤激酶、C-ROS原癌基因阴性的晚期肺鳞癌病人80例,随机分为单纯化疗组和免疫联合化疗组,各40例,分别给予白蛋白结合型紫杉醇/奈达铂和替雷利珠单抗联合白蛋白结合型紫杉醇/奈达铂治疗4周期,比较2组病人的近期疗效及主要不良反应。结果:免疫联合化疗组完全缓解(CR)1例,部分缓解(PR)28例,稳定(SD)9例,进展(PD)2例,客观缓解率(ORR)72.5%(29/40);疾病控制率(DCR)95%(38/40)。单纯化疗组CR 0例,PR 13例,SD 22例,PD 5例,ORR 37.5%(13/40),DCR 87.5%(35/40)。免疫联合化疗组ORR明显高于单纯化疗组(P<0.01),2组DCR差异无统计学意义(P>0.05)。2组病人白细胞计数减少、中性粒细胞计数减少、血小板计数减少、贫血、低蛋白血症、转氨酶升高、乏力、脱发、恶心、四肢疼痛等不良反应发生率差异均无统计学意义(P>0.05)。结论:雷利珠单抗联合白蛋白结合型紫杉醇/奈达铂治疗晚期肺鳞癌较单纯化疗具有更佳的近期疗效,不会增加病人治疗期间的不良反应,安全性好,可以作为驱动基因阴性的晚期肺鳞癌病人的一线治疗方案。

贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌的近期疗效和安全性

目的:分析贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌的近期疗效和安全性。方法:选取2022年10月至2023年7月北京市朝阳区三环肿瘤医院收治的Ⅳ期胆道腺癌患者22例,进行单中心、单臂、前瞻性Ⅱ期临床研究。治疗方案为贝伐珠单抗5 mg/kg静脉滴注第1天,白蛋白紫杉醇150 mg/m^(2)静脉滴注第1天,替吉奥40~60 mg口服第1~10天,2次/d,每14天为1个周期,直到疾病进展或出现不能耐受的毒性。主要研究终点为客观缓解率(objective response rate,ORR),次要终点为疾病控制率(disease control rate,DCR)、无进展生存期、安全性。结果:22例患者可评价疗效21例,中位治疗6个周期,中位治疗线数二线,ORR为42.9%(9/21),DCR为85.7%(18/21),疾病进展3例(14.3%,3/21)。中位无进展生存期为8个月[95%置信区间(95%confidence interval,95%CI:4.5~11.5]。22例患者3级不良反应发生率为68.2%(15/22),主要为中性粒细胞减少4例(18.1%),血小板减少2例(9.1%),胃肠道反应2例(9.1%),总胆红素(total bilirubin,TBIL)/直接胆红素(direct bilirubin,DBIL)升高1例(4.5%),贫血1例(4.5%)。其他不良反应包括神经毒性、转氨酶升高、出血、腹泻、乏力、血压升高、蛋白尿等,均为1、2级。4例(18.1%)患者治疗过程中合并感染。3例患者因不良反应停止治疗。无治疗相关性死亡。结论:贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌显示了良好的抗肿瘤活性和安全性,具有较好的临床应用价值。

Efficacy and toxicity comparison of nab-paclitaxel plus S-1 and nab-paclitaxel plus gemcitabine as first-line chemotherapy for metastatic pancreatic cancer

To compare efficacy and safety of nab-paclitaxel plus gemcitabine(AG)with nab-paclitaxel plus S-1(AS)as first-line treatment for metastatic pancreatic cancer,we conducted a retrospective analysis by reviewing medical records of 53 metastatic pancreatic cancer patients in our institution.They received either AG(nab-paclitaxel 125 mg/m 2 on days 1,8 and gemcitabine 1000 mg/m 2 on days 1,8)or AS(nab-paclitaxel 125 mg/m 2 on days 1,8 and S-180-120 mg on days 1-14)chemotherapy.We found that AS had higher objective response rate(36%vs 21.4%),better disease control rate(84%vs 75%),prolonged time to progression(TTP,7.1 vs 5 months),and improved overall survival(OS,15.3 vs 12 months)when compared with AG.In Cox proportional hazards model,sex was significantly associated with TTP(P value=.031)and metastatic sites plus treatment after progression were significantly associated with OS(P value=.028 and.01,respectively).The incidence rate of chemotherapy-related adverse events was similar in both groups.Neutropenia(50%and 60%,all grade;21.4%and 36%,grade 3 or 4,in AG and AS group)and sensory neuropathy(21.4%and 24%,all grade;3.6%and 4%,grade 3 or 4,in AG and AS group)were the most common hematologic and non-hematologic toxicity.Thus,we believed that AS is a reasonable and convenient alternative for patients treated with AG as first-line chemotherapy for metastatic pancreatic cancer.

信迪利单抗一线治疗晚期胃癌或胃食管结合部腺癌的疗效分析

目的回顾性分析信迪利单抗联合化疗一线治疗晚期胃癌或胃食管结合部腺癌的疗效。方法收集2019-01至2022-10解放军总医院第一医学中心收治的信迪利单抗联合化疗一线治疗晚期胃癌或胃食管结合部腺癌患者临床资料,分析入组患者中位无进展生存期(mPFS)、客观缓解率(ORR)及疾病控制率(DCR)。结果共纳入71例患者,中位年龄60岁,男53例,女18例,其中45例给予信迪利联合以奥沙利铂为基础方案的治疗,26例给予信迪利联合以紫杉醇(白蛋白结合型)为基础方案的治疗。全组患者的ORR为67.6%,DCR为97.2%,mPFS为11.2个月(95%CI 9.7~12.8)。联合奥沙利铂为基础方案组的ORR为73.3%,DCR为97.8%,mPFS为11.3个月(95%CI 5.5~17.2)。联合紫杉醇(白蛋白结合型)为基础方案组的ORR为57.7%,DCR为96.2%,mPFS为10.9个月(95%CI 9.0~12.9),两组ORR及mPFS差异无统计学意义。结论在晚期胃癌或胃食管结合部腺癌中,一线应用信迪利单抗联合化疗,患者无进展生存期明显获益。信迪利单抗联合以紫杉醇(白蛋白结合型)为基础的治疗组疗效与联合以奥沙利铂为基础治疗组相当。

白蛋白紫杉醇联合卡培他滨方案二线治疗晚期胆系恶性肿瘤的回顾性研究

目的观察AX方案(白蛋白紫杉醇联合卡培他滨)二线治疗转移性/不可手术的晚期胆系恶性肿瘤(advanced biliary tract cancer,aBTC)患者的有效性和安全性。方法选取2020年4月至2022年4月在浙江大学医学院附属第一医院肿瘤内科使用AX方案二线治疗的aBTC患者52例。回顾性分析其生存情况和不良反应,并采用单因素和多因素Cox回归分析研究影响患者预后的相关临床特征。结果52例aBTC患者经AX方案二线治疗后,完全缓解1例,部分缓解9例,客观缓解率为19.2%,疾病控制率为63.5%,中位无进展生存期为4.3个月(95%CI:2.2~6.4个月),中位总生存期为8.8个月(95%CI:7.2~10.4个月)。发生率>10%的治疗相关3~4级不良反应包括白细胞细胞减少(15.4%)和外周神经毒性(21.2%)。多因素分析表明,血清白蛋白和糖类抗原19-9水平均是aBTC患者AX方案二线治疗后无进展生存期和总生存期的独立危险因素(均P<0.05)。结论AX方案作为aBTC的二线治疗方案具有较好的疗效和安全性,血清白蛋白和糖类抗原19-9水平具有一定的预后价值。

行前哨淋巴结活检的保乳术联合白蛋白结合型紫杉醇治疗乳腺癌效果及对HCCR-1影响

目的探讨行前哨淋巴结活检的保乳术联合白蛋白结合型紫杉醇治疗乳腺癌效果及对人宫颈癌基因(HCCR)-1影响。方法以开展行前哨淋巴结活检的保乳术联合白蛋白结合型紫杉醇治疗时间为截点,选取2018年11月—2020年11月收治的乳腺癌55例作为对照组(行前哨淋巴结活检的保乳术治疗),2020年12月—2021年12月收治的乳腺癌55例作为观察组(行前哨淋巴结活检的保乳术联合白蛋白结合型紫杉醇治疗)。比较2组入院时及治疗后2、3个月HCCR-1阳性检出率,入院时及治疗后2个月T淋巴细胞水平,治疗后6个月的临床效果,以及观察组治疗期间毒副作用。结果治疗后2和3个月,乳腺癌病灶和周围组织HCCR-1阳性检出率2组均低于入院时,观察组均低于对照组(P<0.05)。治疗后2个月,CD3+、CD4+和CD4+/CD8+2组均较治疗前升高,且观察组高于对照组(P<0.05)。治疗后6个月,观察组完全缓解率74.55%(41/55)高于对照组52.73%(29/55)(P<0.05)。治疗期间,观察组出现恶心呕吐11例,皮肤潮红2例,骨髓抑制1例,给予对症治疗均在2周内恢复正常。结论行前哨淋巴结活检的保乳术联合白蛋白结合型紫杉醇治疗乳腺癌可降低HCCR-1水平,促进免疫指标恢复,改善近期疗效,且毒副作用较小。

白蛋白结合型紫杉醇三周疗和剂量密集疗治疗晚期胰腺癌的疗效观察

目的:探索白蛋白结合型紫杉醇传统三周疗和剂量密集化疗在一线治疗不可切除胰腺癌中的临床疗效和安全性。方法:回顾性收集2016年1月至2021年12月期间于我院接受白蛋白结合型紫杉醇传统三周疗的联合化疗(传统治疗组)与白蛋白结合型紫杉醇剂量密集化疗的联合化疗(剂量密集组)不可切除胰腺癌患者的病历资料,比较患者生存获益情况。主要研究终点是无进展生存期(progression-free survival,PFS)及总生存期(overall survival,OS)。次要研究终点是客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)及安全性。结果:一共有136名患者被纳入研究,40名患者接受白蛋白结合型紫杉醇传统三周疗,96名患者接受白蛋白结合型紫杉醇剂量密集化疗。传统治疗组中位PFS时间为5.5个月[95%置信区间(confidence interval,CI):4.6~7.7],剂量密集组中位PFS时间为5.9个月(95%CI:4.4~6.8)[风险比(hazard ratio,HR)=0.95,95%CI:0.63~1.41,P=0.77]。传统治疗组的中位OS时间为8.6个月(95%CI:7.2~12.6),剂量密集组中位OS时间为8.9个月(95%CI:7.3~10.8)(HR=0.99,95%CI:0.65~1.50,P=0.95),两组患者的PFS和OS均未有明显差异。传统治疗组和剂量密集组的客观缓解率分别为32.5%和27.1%(P=0.52),两组疾病控制率分别为62.5%和66.7%(P=0.64),没有达到统计学差异。安全性方面,传统治疗组和剂量密集组的3/4级血液学不良事件主要包括中性粒细胞减少(5.0%vs 27.1%)、白细胞减少(5.0%vs 18.8%)和贫血(10.0%vs 15.6%)。结论:白蛋白结合型紫杉醇传统三周疗和剂量密集化疗在一线治疗不可切除胰腺癌的临床疗效相当,但传统三周疗组具有更好便捷性,并且毒副反应更加可控、可预防,安全性更高。

白蛋白结合型紫杉醇致黄斑囊样水肿一例

眼黄斑囊样水肿(cystoid macular edema,CME)是白蛋白结合型紫杉醇的罕见并发症。该文报告了一例60岁女性患者,在右侧乳腺癌根治术后进行为期7周的白蛋白结合型紫杉醇化学治疗,治疗过程中出现双眼视力下降,经眼科检查诊断为由白蛋白结合型紫杉醇引起的双眼CME。确诊后即刻停用白蛋白结合型紫杉醇,并采用口服乙酰唑胺治疗。经随访,患者停药20个月时双眼CME基本消失,同时双眼矫正视力恢复至1.0。该病例为化学治疗药物引起的CME,机制可能与紫杉烷类药物对Müller细胞和视网膜色素上皮层产生毒性作用有关。值得注意的是,其典型的特征表现为荧光素眼底血管造影未见明显的荧光渗漏。文章回顾了该病例的病程发展,并对其他文献中报道的白蛋白结合型紫杉醇诱导的CME病例的临床特点及诊疗进行了总结。同时,对白蛋白结合型紫杉醇诱导CME的潜在发病机制进行了讨论,旨在为眼科医生提供早期诊断和治疗此类疾病的思路。