Background:?Treatment of frail elderly patients with pancreatic cancer is still a major problem due to intolerance to standard chemotherapy doses. Aim:?This study aims to compare the low-dose gemcitabine over 6 hours ...Background:?Treatment of frail elderly patients with pancreatic cancer is still a major problem due to intolerance to standard chemotherapy doses. Aim:?This study aims to compare the low-dose gemcitabine over 6 hours (LD6H) to the standard gemcitabine protocol in terms of clinical benefit, survival, and safety in the frail elderly patients with advanced pancreatic adenocarcinoma. Methods:?Patients enrolled in this trial were randomly assigned by in a 1:1 fashion via closed envelope method to either receive gemcitabine of 1000 mg/m2?over 30-minute infusion on days 1, 8, and 15 of every 4-week cycle (standard protocol arm) or gemcitabine as a weekly low-dose (250 mg/m2) over 6-hour infusion (LD6H arm). Results:?We enrolled eighty-two eligible frail elderly patients with advanced pancreatic cancer. The patients were randomly assigned to receive either standard gemcitabine protocol (40 patients) or low-dose (250 mg/m2) gemcitabine over 6-hour infusion, given weekly (42 patients). There was no significant difference between the standard group and low-dose group as regard of the overall response rate (p = 0.654), the disease control rate (DCR) (p = 0.845), the median progression-free survival (PFS) (p = 0.908) and the overall survival (OS) (p = 0.331). The low-dose regimen had a significantly lower incidence of adverse effects grades 3 or 4 when compared to the standard regimen: (p = 0.024 for fatigue, p = 0.027 for hypotension, p = 0.012 for each anemia as well as thrombocytopenia, and p = 0.006 for neutropenia). Conclusion:?Low-dose gemcitabine over 6-hour infusion is equally effective and less toxic when compared to standard gemcitabine protocol in frail elderly patients with advanced pancreatic adenocarcinoma. So, we recommend the low-dose gemcitabine for frail elderly patients with advanced pancreatic cancer.展开更多
BACKGROUND Occult hepatitis C virus(HCV) infection(OCI) may be associated with extrahepatic diseases and it is known that the patients with chronic kidney disease(CKD) who are on hemodialysis(HD) present a higher prev...BACKGROUND Occult hepatitis C virus(HCV) infection(OCI) may be associated with extrahepatic diseases and it is known that the patients with chronic kidney disease(CKD) who are on hemodialysis(HD) present a higher prevalence of this type of infection than the general population, with a worse clinical outcome.However, there are no data in the literature to assess the presence of OCI in patients prior to the initiation of renal replacement therapy(RRT). Therefore, this study aimed to evaluate the occurrence and epidemiological aspects of OCI in patients with Predialysis CKD. We hypothesize that this infection could occur before RRT initiation.AIM To research the status in predialysis patients when HD patients have high prevalence of OCI.METHODS A cross-sectional study was conducted between 2015 and 2017. Adults with creatinine clearance < 60 mL/min·1.73 m^2(predialysis patients) were recruited to the study. Pregnant and postpartum women, patients with glomerulopathies,and patients showing positivity for serological markers of hepatitis B virus(HBV), HCV or human immunodeficiency virus infection were excluded. Patients were diagnosed with OCI according to test results of anti-HCV antibody negativity and HCV RNA positivity in either ultracentrifuged serum or, if serumnegative, in peripheral blood mononuclear cells.RESULTS Among the 91 total patients included in the study, the prevalence of OCI was 16.5%. Among these 15 total OCI patients, 1 was diagnosed by 14 ultracentrifuged serum results and 14 were diagnosed by peripheral blood mononuclear cell results. Compared to the non-OCI group, the OCI patients presented higher frequency of older age(P = 0.002), patients with CKD of mixed etiology(P = 0.019), and patients with markers of previous HBV infection(i.e.,combined positivity for anti-hepatitis B core protein antibody and anti-hepatitis B surface protein antibody)(P = 0.001).CONCLUSION Among predialysis patients, OCI involved the elderly, patients with CKD of mixed etiology, and patients with previous HBV infection展开更多
文摘Background:?Treatment of frail elderly patients with pancreatic cancer is still a major problem due to intolerance to standard chemotherapy doses. Aim:?This study aims to compare the low-dose gemcitabine over 6 hours (LD6H) to the standard gemcitabine protocol in terms of clinical benefit, survival, and safety in the frail elderly patients with advanced pancreatic adenocarcinoma. Methods:?Patients enrolled in this trial were randomly assigned by in a 1:1 fashion via closed envelope method to either receive gemcitabine of 1000 mg/m2?over 30-minute infusion on days 1, 8, and 15 of every 4-week cycle (standard protocol arm) or gemcitabine as a weekly low-dose (250 mg/m2) over 6-hour infusion (LD6H arm). Results:?We enrolled eighty-two eligible frail elderly patients with advanced pancreatic cancer. The patients were randomly assigned to receive either standard gemcitabine protocol (40 patients) or low-dose (250 mg/m2) gemcitabine over 6-hour infusion, given weekly (42 patients). There was no significant difference between the standard group and low-dose group as regard of the overall response rate (p = 0.654), the disease control rate (DCR) (p = 0.845), the median progression-free survival (PFS) (p = 0.908) and the overall survival (OS) (p = 0.331). The low-dose regimen had a significantly lower incidence of adverse effects grades 3 or 4 when compared to the standard regimen: (p = 0.024 for fatigue, p = 0.027 for hypotension, p = 0.012 for each anemia as well as thrombocytopenia, and p = 0.006 for neutropenia). Conclusion:?Low-dose gemcitabine over 6-hour infusion is equally effective and less toxic when compared to standard gemcitabine protocol in frail elderly patients with advanced pancreatic adenocarcinoma. So, we recommend the low-dose gemcitabine for frail elderly patients with advanced pancreatic cancer.
基金Supported by the National Council for Scientific and Technological Development(CNPq),No.429736-2016/9
文摘BACKGROUND Occult hepatitis C virus(HCV) infection(OCI) may be associated with extrahepatic diseases and it is known that the patients with chronic kidney disease(CKD) who are on hemodialysis(HD) present a higher prevalence of this type of infection than the general population, with a worse clinical outcome.However, there are no data in the literature to assess the presence of OCI in patients prior to the initiation of renal replacement therapy(RRT). Therefore, this study aimed to evaluate the occurrence and epidemiological aspects of OCI in patients with Predialysis CKD. We hypothesize that this infection could occur before RRT initiation.AIM To research the status in predialysis patients when HD patients have high prevalence of OCI.METHODS A cross-sectional study was conducted between 2015 and 2017. Adults with creatinine clearance < 60 mL/min·1.73 m^2(predialysis patients) were recruited to the study. Pregnant and postpartum women, patients with glomerulopathies,and patients showing positivity for serological markers of hepatitis B virus(HBV), HCV or human immunodeficiency virus infection were excluded. Patients were diagnosed with OCI according to test results of anti-HCV antibody negativity and HCV RNA positivity in either ultracentrifuged serum or, if serumnegative, in peripheral blood mononuclear cells.RESULTS Among the 91 total patients included in the study, the prevalence of OCI was 16.5%. Among these 15 total OCI patients, 1 was diagnosed by 14 ultracentrifuged serum results and 14 were diagnosed by peripheral blood mononuclear cell results. Compared to the non-OCI group, the OCI patients presented higher frequency of older age(P = 0.002), patients with CKD of mixed etiology(P = 0.019), and patients with markers of previous HBV infection(i.e.,combined positivity for anti-hepatitis B core protein antibody and anti-hepatitis B surface protein antibody)(P = 0.001).CONCLUSION Among predialysis patients, OCI involved the elderly, patients with CKD of mixed etiology, and patients with previous HBV infection
