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.

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.

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.

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.

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.

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。

白蛋白结合型紫杉醇的作用机制和其给药系统的研究进展

紫杉烷类药物是被批准用于临床治疗肿瘤的重要新型药物,主要用于转移性乳腺癌、卵巢癌和非小细胞肺癌的治疗。然而,目前市售的溶剂型紫杉醇尽管采用适当的术前用药,仍然具有与溶剂相关的严重副作用和过敏反应。白蛋白结合型紫杉醇(nab-paclitaxel)是一种新型的无溶剂紫杉醇,它不需要合成的溶剂作为载体,不需要皮质类固醇或抗组胺药物等预处理,静脉滴注时间短(30min)。其利用了白蛋白的自然生物特性,通过gp-60(糖基化囊膜蛋白)介导的内皮细胞跨膜转运和一种与白蛋白结合的蛋白SPARC(一种酸性的富含半胱氨酸的分泌蛋白)的相互作用而增加肿瘤组织对紫杉醇的摄取和蓄积。临床前模型研究证实白蛋白结合型紫杉醇与溶剂型紫杉醇相比,抗肿瘤活性明显增强。以此为基础,近年国内外进行了一系列白蛋白结合型紫杉醇应用于各种恶性肿瘤化疗的临床研究,取得了令人鼓舞的效果。本文对白蛋白结合型紫杉醇的抗癌机制、体内运输机制和临床研究进行综述。

白蛋白结合型紫杉醇一线治疗40例晚期肺鳞癌的观察

目的:观察白蛋白结合型紫杉醇(NAB-P)一线治疗老年晚期肺鳞癌患者的疗效、不良反应及预后因素。方法:前瞻性设计收集2012年12月至2015年12月福建医科大学附属第二医院入组40例老年晚期肺鳞癌患者,给予注射用NAB-P方案一线化疗,具体化疗方案为:NAB-P 260 mg/m^2,静滴d1,3周为1个疗程,每2个周期后评价疗效。结果:40例患者均可评价疗效及获得随访,其中完全缓解(complete response,CR)2例,部分缓解(partial response,PR)13例,稳定(stable disease,SD)13例,进展(progression disease,PD)12例,客观缓解率(objective response rate,ORR)为37.5%,疾病控制率(disease control rate,DCR)为70.0%;无进展生存期(progression-free survival,PFS)为6.3个月、总生存期(overall survival,OS)为12.6个月、1年生存率为62.5%;血液毒性方面中性粒细胞减少及贫血较为常见,非血液毒性主要为乏力、便秘、恶心、呕吐、肌肉酸痛、脱发,大部分患者均能耐受上述不良反应;肿瘤分期、体力状况评分(ECOG)、有效率和PFS是影响老年患者生存的独立预后因素(P<0.05),而年龄与患者的预后无关(P>0.05)。结论:NAB-P单药一线治疗老年晚期肺鳞癌有较好的疗效和安全性。

白蛋白结合型紫杉醇联合铂类治疗中国晚期黑色素瘤患者的疗效与安全性评价

【目的】评价白蛋白结合型紫杉醇联合铂类方案治疗中国晚期黑色素瘤患者的疗效与安全性。【方法】38例晚期恶性黑色素瘤患者接受白蛋白结合型紫杉醇[100 mg/（m2·d）,第1天、第8天,每21天为一个周期]联合铂类药物方案化疗,至少2个周期后评价疗效。【结果】38例患者平均接受3.3（1-20）个周期治疗,客观有效率为13.8%（初治与复治患者分别为20.0%和7.1%）,疾病控制率为75.9%,中位无进展生存期（PFS）为4.0（1.0-25.0）月,总生存期（OS）是9.0（1.0-27.0）月。初治与复治患者PFS、OS无显著性差异。常见的不良反应是骨髓抑制（57.9%）、胃肠道反应（44.7%）及脱发（100.0%）。3/4度不良反应为骨髓抑制（21.1%）及胃肠道反应（2.6%）。【结论】白蛋白结合型紫杉醇联合铂类药物治疗晚期黑色素瘤疗效确切,耐受性良好。

白蛋白结合型紫杉醇治疗晚期恶性肿瘤的疗效与安全性研究

目的:观察白蛋白结合型紫杉醇治疗晚期恶性肿瘤的疗效和安全性。方法:25例晚期恶性肿瘤患者接受含白蛋白结合型紫杉醇方案(白蛋白结合型紫杉醇130 mg/m^2,第1天、第8天)每21 d为1周期,至少2个周期后评价疗效。结果:25例患者中总有效率56%(14/25),临床受益率76%(19/25),中位TTP5.6(2.1～11.6)个月。不良反应主要为中性粒细胞减少(12%),外周神经损害(8%)和肌肉酸痛乏力(12%)。结论:白蛋白结合型紫杉醇方案治疗晚期恶性肿瘤疗效确切,安全性良好。

白蛋白结合型紫杉醇治疗吉西他滨一线化疗失败后晚期胰腺癌的临床观察

目的观察和评价白蛋白结合型紫杉醇（Nab-P）治疗吉西他滨一线化疗失败后晚期胰腺癌的疗效和安全性。方法回顾分析2012年5月至2015年5月接受Nab-P单药或联合方案（Nab-P 110 mg/m^2静滴,第1、8天,21天为1周期）作为二线或二线以上治疗的晚期胰腺癌患者。分别采用RECIST 1.1版与NCI-CTC 4.0版标准评价近期疗效和毒副反应。采用Kaplan-Meier法进行生存分析。结果共纳入13例患者,其中9例可评价疗效和毒副反应。9例患者平均年龄为56.1岁,Nab-P平均治疗2.27个周期。9例患者的疾病控制率（DCR）为55.6%,其中2例获PR,3例SD,4例PD;CA199较基线下降50%者4例（44.4%）;中位疾病进展时间（TTP）为3.3个月（95%CI：2.4~4.2个月）,中位生存时间（OS）为14.2个月（95%CI：2.8~25.6个月）;3个月及6个月生存率分为88.9%和77.8%。常见毒副反应多为1~2级,主要为白细胞减少、中性粒细胞减少、乏力、恶心、呕吐等。结论 Nab-P对国人吉西他滨一线治疗失败后的晚期胰腺癌具有较好的疗效,且耐受性良好。