Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone:: A randomized multicenter phase III clinical trial -: SAKK 44/00-CECOG/PAN.1.3.001
Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone:: A randomized multicenter phase III clinical trial -: SAKK 44/00-CECOG/PAN.1.3.001
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DOI：
10.1200/jco.2007.15.6240
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发表时间：
2008-08-01
影响因子：
45.3
通讯作者：
Herrmann, Richard
中科院分区：
文献类型：
--
作者：
Bernhard, Juerg;Dietrich, Daniel;Herrmann, Richard
目的比较吉西他滨(Gem)联合卡培他滨(Capecitabine，Cap)与单药吉西他滨(Gem)治疗晚期/转移性胰腺癌患者的临床受益反应(CBR)和生活质量(QOL)。患者和方法患者随机分为两组，GemCap每日两次，第1~14天口服650 mg/m(2)，Gem 1000 mg/m(2)，每3周第1、8天30分钟静脉滴注；Gem(1000 mg/m2，每周30分钟输注，共7周)，然后休息1周。然后每周3周，每4周)，持续24周或直到病情进展。在此期间评估CBR标准和生活质量指标。CBR被定义为连续4周疼痛(疼痛强度或止痛剂用量)和Karnofsky功能状态的改善，一个稳定但另一个改善，或疼痛和性能状态稳定但体重改善。结果在319名患者中，接受GemCap治疗的19%和接受Gem治疗的20%经历了CBR，中位持续时间分别为9.5周和6.5周(P<；02)；接受GemCap治疗的患者和接受Gem治疗的60%的患者没有CBR(其余患者无法评估)。治疗前后生活质量无明显差异(n=311)。化疗后患者的生活质量指标明显改善(P<；0.05)。这些变化因失败的时间不同而不同，在治疗失败前1至2个月恶化(均为P<；0.05)。结论GemCap和Gem在CBR或QOL方面没有迹象表明存在差异。不管他们的初始情况如何，一些患者在化疗后生活质量会有所改善，然后在治疗失败之前会恶化。
Purpose To compare clinical benefit response (CBR) and quality of life (QOL) in patients receiving gemcitabine (Gem) plus capecitabine (Cap) versus single-agent Gem for advanced/metastatic pancreatic cancer.Patients and Methods Patients were randomly assigned to receive GemCap (oral Cap 650 mg/m(2) twice daily on days 1 through 14 plus Gem 1,000 mg/m(2) in a 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2 in a 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks) for 24 weeks or until progression. CBR criteria and QOL indicators were assessed over this period. CBR was defined as improvement from baseline for >= 4 consecutive weeks in pain (pain intensity or analgesic consumption) and Karnofsky performance status, stability in one but improvement in the other, or stability in pain and performance status but improvement in weight.Results Of 319 patients, 19% treated with GemCap and 20% treated with Gem experienced a CBR, with a median duration of 9.5 and 6.5 weeks, respectively (P < .02); 54% of patients treated with GemCap and 60% treated with Gem had no CBR (remaining patients were not assessable). There was no treatment difference in QOL (n = 311). QOL indicators were improving under chemotherapy (P < .05). These changes differed by the time to failure, with a worsening 1 to 2 months before treatment failure (all P < .05).Conclusion There is no indication of a difference in CBR or QOL between GemCap and Gem. Regardless of their initial condition, some patients experience an improvement in QOL on chemotherapy, followed by a worsening before treatment failure.