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首页> 外文期刊>Journal of Cancer Therapy >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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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

机译：在勒克老年患者中，低剂量吉西滨过度输注超过6小时的输注同等效果和毒性少于胰腺癌腺癌的标准吉西他滨协议：随机期II试验

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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/m ~( 2 ) ?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/m ~( 2 ) ) 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/m ~( 2 ) ) 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.
机译：背景：？脆弱性胰腺癌的治疗患者仍然是由于标准化疗剂量不耐受的主要问题。 目的：本研究旨在将低剂量吉西他滨在6小时内（LD6H）与临床益处，生存和安全性患者晚期胰腺癌患者的临床效益，存活和安全性。 方法：？通过闭合的包络方法在1：1时，通过闭合的包络方法随机分配患者，以接受1000mg / m〜（2）的吉西他滨（2）？在第1天，8天内输注超过30分钟的输注。每4周周期（标准协议臂）或吉西他滨15个每周一次低剂量（250mg / m〜（2）），超过6小时输注（LD6H臂）。 结果：？我们注册了八十二个符合条件的勒布老年患者先进的胰腺癌。患者被随机分配接受每周（42名患者）的6小时输注超过6小时的吉西他滨（450mg / m〜（2））或低剂量（250mg / m〜（2））。标准组和低剂量组在整体反应率（P = 0.654），疾病控制率（DCR）（P = 0.845），中位进展存活（PFS）之间没有显着差异（PFS）（ P = 0.908）和总存活（OS）（P = 0.331）。与标准方案相比，低剂量方案具有显着较低的不良反应成绩3或4级的发生率：（对于疲劳，P = 0.024，P = 0.027用于低血压，每个贫血和血小板减少症和P中性粒细胞减少率= 0.006）。 结论：ω少剂吉西他滨在6小时内输注同样有效且毒性较低，与脆弱性胰腺癌患者的标准吉西他滨协议相比。因此，我们推荐低剂量吉西他滨用于脆弱的胰腺癌患者。

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