Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial
Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial
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DOI：
10.1200/jco.1997.15.6.2403
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发表时间：
1997-06-01
影响因子：
45.3
通讯作者：
VanHoff, DD
中科院分区：
文献类型：
--
作者：
Burris, HA;Moore, MJ;VanHoff, DD
目的：大多数晚期胰腺癌患者都会经历疼痛，并且由于肿瘤相关症状而必须限制他们的日常活动，迄今为止，没有治疗对这种疾病产生重大影响。在吉西他滨的早期研究中，胰腺癌患者的疾病相关症状得到改善。基于这些发现，进行了一项明确的试验，以评估吉西他滨在新诊断的晚期胰腺癌患者中的有效性。126例晚期症状性胰腺癌患者完成了一个描述和稳定疼痛的导入期，并随机接受吉西他滨1,000 mg/m2每周一次× 7，随后休息1周，然后每周一次，此后每4周3次（63例患者），或氟尿嘧啶（5-FU）600 mg/m（2）每周一次（63例患者）。主要疗效指标为临床获益反应，其为疼痛（镇痛剂用量和疼痛强度）、Karnofsky体力状态和体重测量结果的复合指标。临床获益要求至少一个参数持续（≥ 4周）改善，而其他任何参数均未恶化。其他疗效指标包括缓解率、疾病进展时间和生存率，结果：吉西他滨治疗组23.8%的患者出现临床获益反应，而5-FU治疗组4.8%的患者出现临床获益反应吉西他滨组和5-FU组的中位生存期分别为5.65和4.41个月，（P = 0.0025），吉西他滨组12个月生存率为18%，5-FU组为2%，Treatment wets well tolerant.Conclusion：本研究表明吉西他滨在缓解晚期胰腺癌患者的某些疾病相关症状方面比5-FU更有效。吉西他滨也比5-FU治疗具有一定的生存优势，（C）1997年美国临床肿瘤学会。
Purpose: Most patients with advanced pancreas cancer experience pain and must limit their daily activities because of tumor-related symptoms, To date, no treatment has had a significant impact on the disease. In early studies with gemcitabine, patients with pancreas cancer experienced an improvement in disease-related symptoms. Based on those findings, a definitive trial was performed to assess the effectiveness of gemcitabine in patients with newly diagnosed advanced pancreas cancer.Patients and Methods: One hundred twenty-six patients with advanced symptomatic pancreas cancer completed a lead-in period to characterize and stabilize pain and were randomized to receive either gemcitabine 1,000 mg/m(2) weekly x 7 followed by 1 week of rest, then weekly x 3 every 4 weeks thereafter (63 patients), or to fluorouracil (5-FU) 600 mg/m(2) once weekly (63 patients). The primary efficacy measure was clinical benefit response, which was a composite of measurements of pain (analgesic consumption and pain intensity), Karnofsky performance status, and weight, Clinical benefit required a sustained (greater than or equal to 4 weeks) improvement in at least one parameter without worsening in any others. Other measures of efficacy included response rate, time to progressive disease, and survival,Results: Clinical benefit response was experienced by 23.8% of gemcitabine-treated patients compared with 4.8% of 5-FU-treated patients (P = .0022), The median survival durations were 5.65 and 4,41 months for gemcitabine-treated and 5-FU-treated patients, respectively (P = .0025), The survival rate at 12 months was 18% for gemcitabine patients and 2% for 5-FU patients, Treatment wets well tolerated.Conclusion: This study demonstrates that gemcitabine is more effective than 5-FU in alleviation of some disease-related symptoms in patients with advanced, symptomatic pancreas cancer. Gemcitabine also confers a modest survival advantage over treatment with 5-FU, (C) 1997 by American Society of Clinical Oncology.