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...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.展开更多
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 significan...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.展开更多
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 an...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.展开更多
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 ...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.展开更多
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...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.展开更多
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 examin...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.展开更多
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 su...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.展开更多
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...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.展开更多
Pancreatic ductal adenocarcinoma is an infrequent cancer with a high disease related mortality rate, even in the context of early stage disease. Until recently, the rate of death from pancreatic cancer has remained la...Pancreatic ductal adenocarcinoma is an infrequent cancer with a high disease related mortality rate, even in the context of early stage disease. Until recently, the rate of death from pancreatic cancer has remained largely similar whereby gemcitabine monotherapy was the mainstay of systemic treatment for most stages of disease. With the discovery of active multiagent chemotherapy regimens, namely FOLFIRINOX and gemcitabine plus nab-paclitaxel, the treatment landscape of pancreatic cancer is slowly evolving. FOLFIRINOX and gemcitabine plus nab-paclitaxel are now considered standard first line treatment options in metastatic pancreatic cancer. Studies are ongoing to investigate the utility of these same regimens in the adjuvant setting. The potential of these treatments to downstage disease is also being actively examined in the locally advanced context since neoadjuvant approaches may improve resection rates and surgical outcomes. As more emerging data become available, the management of pancreatic cancer is anticipated to change significantly in the coming years.展开更多
This report describes a patient with metastatic epithelioid hemangioendothelioma treated with bevacizumab and nanoparticle albumin-bound paclitaxel.The treatment was well tolerated and led to the stabilization of an a...This report describes a patient with metastatic epithelioid hemangioendothelioma treated with bevacizumab and nanoparticle albumin-bound paclitaxel.The treatment was well tolerated and led to the stabilization of an aggressive variant of the disease. This case report is the first one that describes the activity of the combination of chemotherapy and bevacizumab in epithelioid hemangioendothelioma.Literature describing the activity of bevacizumab and other agents(thalidomide,lenalidomide,and interferon) believed to possess anti-angiogenic activities is also reviewed.展开更多
Pancreatic cancer is the fourth leading cause of cancerrelated death worldwide.Extensive research has yielded advances in first-line treatment strategies,but there is no standardized second-line therapy.In this review...Pancreatic cancer is the fourth leading cause of cancerrelated death worldwide.Extensive research has yielded advances in first-line treatment strategies,but there is no standardized second-line therapy.In this review,we examine the literature trying to establish a possible therapeutic algorithm.展开更多
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).Meth...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.展开更多
Pancreatic cancer is one of the deadliest cancers,ranking fourth among cancer-related deaths. Despite all the major molecular advances and treatment breakthroughs, mainly targeted therapies, the cornerstone treatment ...Pancreatic cancer is one of the deadliest cancers,ranking fourth among cancer-related deaths. Despite all the major molecular advances and treatment breakthroughs, mainly targeted therapies, the cornerstone treatment of metastatic pancreatic cancer(m PC) remains cytotoxic chemotherapy. In 2016, more than 40 years after the introduction of gemcitabine in the management of m PC, the best choice for first-line treatment has not yet been fully elucidated. Two main strategies have been adopted to enhance treatment efficacy. The first strategy is based on combining non-cross resistant drugs, while the second option includes the development of newer generations of chemotherapy. More recently, two new regimens, FOLFIRINOX and gemcitabine/nab-paclitaxel(GNP), have both been shown to improve overall survival in comparison with gemcitabine alone, at the cost of increased toxicity. Therefore, the best choice for first line therapy is a matter of debate. For some authors, FOLFIRINOX should be the first choice in patients with an Eastern Cooperative Oncology Group score(0-1) given its lower hazard ratio. However, others do not share this opinion. In this paper, we review the main comparison points between FOLFIRINOX and GNP. We analyze the two pivotal trials to determine the similarities and differences in study design. In addition, we compare the toxicity profile of the two regimens as well as the impact on quality of life. Finally, we present studies revealing real life experiences and review the advantages and disadvantages of possible second-line therapies including their cost effectiveness.展开更多
BACKGROUND Squamous cell carcinoma (SCC) is one the most common subtypes of non-small cell lung cancer, yet the treatment options for it remain limited. Here, we report a case of advanced SCC and review the related li...BACKGROUND Squamous cell carcinoma (SCC) is one the most common subtypes of non-small cell lung cancer, yet the treatment options for it remain limited. Here, we report a case of advanced SCC and review the related literature focusing on the multiline therapy method. CASE SUMMARY We report the case of a 45-year-old man with advanced SCC who was deemed inoperable at the time of advanced SCC diagnosis. The patient had been referred to our hospital in April 2013 with complaints of a stuffy feeling in the chest, dyspnea, and pain in the right shoulder lasting for 1 mo. Physical examination found no obvious abnormalities, except for lower breath sound in the right lower lung. Laboratory data were within normal limits. Immunohistochemistry analysis of the tumor tissue showed CK5/6 (+), p63 (+), CD56 (+), and Ki-67 (+, approximately 30%), and genetic testing detected no EGFR mutation. He received a multiline treatment that included chemotherapy, radiotherapy, targeted therapy, and antiangiogenic therapy. After more than 5-year comprehensive treatment, the patient remains alive. CONCLUSION This typical case highlights the importance of appropriate multiline therapy for those patients with advanced SCC.展开更多
Background: Locally advanced or metastatic pancreatic cancer patients have a poor prognosis with median survival less than 12 months. Nanoparticle albumin bound (nab)-paclitaxel is a novel agent that has demonstrated ...Background: Locally advanced or metastatic pancreatic cancer patients have a poor prognosis with median survival less than 12 months. Nanoparticle albumin bound (nab)-paclitaxel is a novel agent that has demonstrated antitumor effects in cancers that overexpress the albumin binding protein SPARC (secreted protein acidic and rich in cysteine), which includes pancreatic cancer. A recent phase III trial comparing nab-paclitaxel and gemcitabine to gemcitabine alone demonstrated a survival advantage in patients with previously untreated metastatic pancreatic cancer. Here we present our local experience with this drug in patients with gastrointestinal malignancies. Methods: Patients treated with nab-paclitaxel for gastrointestinal malignancies at the Cross Cancer Institute in Edmonton, Alberta, Canada were identified and these patient’s medical records were interrogated for data. Results: Three patients with pancreatic cancer and two with cholangiocarcinoma have been treated with nab-paclitaxel at the Cross Cancer Institute. Three patients achieved stable disease, while one had a partial response, and one had progressive disease after the first assessment. Median time to progression was 3.7 months. Median overall survival (OS) was 32.5 months. Median OS from initiation of nab-paclitaxel was 7.2 months. Patients tolerated treatment with nab-paclitaxel well with only one patient requiring treatment modification due to neutropenia. Conclusion: The experience at this single center supports published evidence that nab-paclitaxel is a safe and effective therapy in pancreatic cancer, but also suggests that it may have activity in cholangiocarcinoma, which to our knowledge is the first published evidence of this in humans.展开更多
Pancreatic ductal adenocarcinoma(PDA) is one of the major causes for cancer death worldwide. Treatment of metastatic disease remains challenging as only certain patients benefit from advances made with the intensified...Pancreatic ductal adenocarcinoma(PDA) is one of the major causes for cancer death worldwide. Treatment of metastatic disease remains challenging as only certain patients benefit from advances made with the intensified chemotherapy regimen folinic acid, irinotecan and oxaliplatin, the epidermal growth factor receptor inhibitor erlotinib or the recently FDA-approved nab-paclitaxel. Up to date, no established approach for prediction of treatment response or specific treatment allocation exists. Translational research was able to identify a number of potential biomarkers that might help to improve the dismal prognosis of PDA by facilitating upfront treatment allocation. This topic highlight is focused on current evidence on potential biomarkers for tumor biology, prognosis and prediction of treatment efficacy.展开更多
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 ...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.展开更多
文摘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.
基金Supported by The Department of Science and Technology of Qinghai Province,No.2018-SF-113"Kunlun Talents-Plateau Famous Doctors"Project in Qinghai Province.
文摘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.
文摘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.
基金by the National Natural Science Foundation of China(Nos.81872809,82073786)the Beijing Natural Science Foundation(L212013).
文摘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.
基金supported by grants from National High Level Hospital Clinical Research Funding(Grant Nos.2022-PUMCH-D-001 and 2022-PUMCH-A-213)。
文摘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.
基金Supported by the China Postdoctoral Science Foundation,No.2015M582853.
文摘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.
文摘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.
文摘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.
文摘Pancreatic ductal adenocarcinoma is an infrequent cancer with a high disease related mortality rate, even in the context of early stage disease. Until recently, the rate of death from pancreatic cancer has remained largely similar whereby gemcitabine monotherapy was the mainstay of systemic treatment for most stages of disease. With the discovery of active multiagent chemotherapy regimens, namely FOLFIRINOX and gemcitabine plus nab-paclitaxel, the treatment landscape of pancreatic cancer is slowly evolving. FOLFIRINOX and gemcitabine plus nab-paclitaxel are now considered standard first line treatment options in metastatic pancreatic cancer. Studies are ongoing to investigate the utility of these same regimens in the adjuvant setting. The potential of these treatments to downstage disease is also being actively examined in the locally advanced context since neoadjuvant approaches may improve resection rates and surgical outcomes. As more emerging data become available, the management of pancreatic cancer is anticipated to change significantly in the coming years.
文摘This report describes a patient with metastatic epithelioid hemangioendothelioma treated with bevacizumab and nanoparticle albumin-bound paclitaxel.The treatment was well tolerated and led to the stabilization of an aggressive variant of the disease. This case report is the first one that describes the activity of the combination of chemotherapy and bevacizumab in epithelioid hemangioendothelioma.Literature describing the activity of bevacizumab and other agents(thalidomide,lenalidomide,and interferon) believed to possess anti-angiogenic activities is also reviewed.
文摘Pancreatic cancer is the fourth leading cause of cancerrelated death worldwide.Extensive research has yielded advances in first-line treatment strategies,but there is no standardized second-line therapy.In this review,we examine the literature trying to establish a possible therapeutic algorithm.
文摘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.
文摘Pancreatic cancer is one of the deadliest cancers,ranking fourth among cancer-related deaths. Despite all the major molecular advances and treatment breakthroughs, mainly targeted therapies, the cornerstone treatment of metastatic pancreatic cancer(m PC) remains cytotoxic chemotherapy. In 2016, more than 40 years after the introduction of gemcitabine in the management of m PC, the best choice for first-line treatment has not yet been fully elucidated. Two main strategies have been adopted to enhance treatment efficacy. The first strategy is based on combining non-cross resistant drugs, while the second option includes the development of newer generations of chemotherapy. More recently, two new regimens, FOLFIRINOX and gemcitabine/nab-paclitaxel(GNP), have both been shown to improve overall survival in comparison with gemcitabine alone, at the cost of increased toxicity. Therefore, the best choice for first line therapy is a matter of debate. For some authors, FOLFIRINOX should be the first choice in patients with an Eastern Cooperative Oncology Group score(0-1) given its lower hazard ratio. However, others do not share this opinion. In this paper, we review the main comparison points between FOLFIRINOX and GNP. We analyze the two pivotal trials to determine the similarities and differences in study design. In addition, we compare the toxicity profile of the two regimens as well as the impact on quality of life. Finally, we present studies revealing real life experiences and review the advantages and disadvantages of possible second-line therapies including their cost effectiveness.
文摘BACKGROUND Squamous cell carcinoma (SCC) is one the most common subtypes of non-small cell lung cancer, yet the treatment options for it remain limited. Here, we report a case of advanced SCC and review the related literature focusing on the multiline therapy method. CASE SUMMARY We report the case of a 45-year-old man with advanced SCC who was deemed inoperable at the time of advanced SCC diagnosis. The patient had been referred to our hospital in April 2013 with complaints of a stuffy feeling in the chest, dyspnea, and pain in the right shoulder lasting for 1 mo. Physical examination found no obvious abnormalities, except for lower breath sound in the right lower lung. Laboratory data were within normal limits. Immunohistochemistry analysis of the tumor tissue showed CK5/6 (+), p63 (+), CD56 (+), and Ki-67 (+, approximately 30%), and genetic testing detected no EGFR mutation. He received a multiline treatment that included chemotherapy, radiotherapy, targeted therapy, and antiangiogenic therapy. After more than 5-year comprehensive treatment, the patient remains alive. CONCLUSION This typical case highlights the importance of appropriate multiline therapy for those patients with advanced SCC.
文摘Background: Locally advanced or metastatic pancreatic cancer patients have a poor prognosis with median survival less than 12 months. Nanoparticle albumin bound (nab)-paclitaxel is a novel agent that has demonstrated antitumor effects in cancers that overexpress the albumin binding protein SPARC (secreted protein acidic and rich in cysteine), which includes pancreatic cancer. A recent phase III trial comparing nab-paclitaxel and gemcitabine to gemcitabine alone demonstrated a survival advantage in patients with previously untreated metastatic pancreatic cancer. Here we present our local experience with this drug in patients with gastrointestinal malignancies. Methods: Patients treated with nab-paclitaxel for gastrointestinal malignancies at the Cross Cancer Institute in Edmonton, Alberta, Canada were identified and these patient’s medical records were interrogated for data. Results: Three patients with pancreatic cancer and two with cholangiocarcinoma have been treated with nab-paclitaxel at the Cross Cancer Institute. Three patients achieved stable disease, while one had a partial response, and one had progressive disease after the first assessment. Median time to progression was 3.7 months. Median overall survival (OS) was 32.5 months. Median OS from initiation of nab-paclitaxel was 7.2 months. Patients tolerated treatment with nab-paclitaxel well with only one patient requiring treatment modification due to neutropenia. Conclusion: The experience at this single center supports published evidence that nab-paclitaxel is a safe and effective therapy in pancreatic cancer, but also suggests that it may have activity in cholangiocarcinoma, which to our knowledge is the first published evidence of this in humans.
文摘Pancreatic ductal adenocarcinoma(PDA) is one of the major causes for cancer death worldwide. Treatment of metastatic disease remains challenging as only certain patients benefit from advances made with the intensified chemotherapy regimen folinic acid, irinotecan and oxaliplatin, the epidermal growth factor receptor inhibitor erlotinib or the recently FDA-approved nab-paclitaxel. Up to date, no established approach for prediction of treatment response or specific treatment allocation exists. Translational research was able to identify a number of potential biomarkers that might help to improve the dismal prognosis of PDA by facilitating upfront treatment allocation. This topic highlight is focused on current evidence on potential biomarkers for tumor biology, prognosis and prediction of treatment efficacy.
基金This study was supported by Shanghai Hospital Development Center(SHDC12017X04).
文摘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.