Treatment of Patients with Advanced Biliary Tract Cancer with Either Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine-A Randomized Phase II Trial
Treatment of Patients with Advanced Biliary Tract Cancer with Either Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine-A Randomized Phase II Trial
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DOI：
10.3390/cancers12071975
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发表时间：
2020-07-01
期刊：
影响因子：
5.2
通讯作者：
Larsen, Finn Ole
中科院分区：
文献类型：
--
作者：
Markussen, Alice;Jensen, Lars Henrik;Larsen, Finn Ole
这项研究是一项由研究人员发起的随机第二阶段试验，重点是奥沙利铂50 mg/m(2)和吉西他滨1000 mg/m(2)在两周周期的第一天与卡培他滨650 mg/m(2)每日连续两次或顺铂25 mg/m(2)和吉西他滨1000 mg/m(2)在第一天和第八天的三周周期中治疗晚期胆道癌。研究对象包括100名患者。47例患者接受奥沙利铂、吉西他滨和卡培他滨治疗，中位无进展生存期(MPFS)为5.7个月(95%可信区间3.0~7.8)，中位总生存期(MOS)为8.7个月(95%可信区间6.5~11.2)。49例患者接受顺铂和吉西他滨治疗，平均生存时间为7.3个月(95%可信区间为6.0~8.7)，最小生存时间为12.0个月(95%可信区间为8.3~16.7)。这项试验证实了顺铂和吉西他滨的最低月龄为12个月，这是在早期试验中发现的。顺铂和吉西他滨的肿瘤控制率分别为79%和60%(P=0.045)，MPFS相差1.6个月(HR=0.721，P=0.1)，MOS相差3.3个月(HR=0.731，P=0.1)，顺铂和吉西他滨仍应被视为晚期胆道癌的标准一线治疗方案。
This study is an investigator-initiated randomized phase II trial focusing on the treatment of advanced biliary tract cancer with either oxaliplatin 50 mg/m(2)and gemcitabine 1000 mg/m(2)on day 1 in a two-week cycle with capecitabine 650 mg/m(2)twice-daily continuously or cisplatin 25 mg/m(2)and gemcitabine 1000 mg/m(2)on day 1 and day 8 in a three-week cycle. One-hundred patients were included. Forty-seven patients received oxaliplatin, gemcitabine, and capecitabine with a median progression-free survival (mPFS) of 5.7 months (95% CI 3.0-7.8) and a median overall survival (mOS) of 8.7 months (95% CI 6.5-11.2). Forty-nine patients received cisplatin and gemcitabine with a mPFS of 7.3 months (95% CI 6.0-8.7) and a mOS of 12.0 months (95% CI 8.3-16.7). This trial confirms a mOS of 12 months with cisplatin and gemcitabine, as found in earlier trials. With a superior tumor control rate of 79% vs. 60% (p= 0.045), a difference in the mPFS of 1.6 months (HR = 0.721,p= 0.1), and a difference in the mOS of 3.3 months (HR = 0.731,p= 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.