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In Frail Elderly Patients, Low-Dose Gemcitabine over 6-Hour Infusion Is Equally Effective and Less Toxic Than the Standard Gemcitabine Protocol for Advanced Pancreatic Adenocarcinoma: A Randomized Phase II Trial 被引量:1

In Frail Elderly Patients, Low-Dose Gemcitabine over 6-Hour Infusion Is Equally Effective and Less Toxic Than the Standard Gemcitabine Protocol for Advanced Pancreatic Adenocarcinoma: A Randomized Phase II Trial
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摘要 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. 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.
出处 《Journal of Cancer Therapy》 2020年第3期124-141,共18页 癌症治疗(英文)
关键词 Continuous INFUSION Elderly FRAIL Low Dose GEMCITABINE PANCREATIC Cancer Continuous Infusion Elderly Frail Low Dose Gemcitabine Pancreatic Cancer
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