First Line Gemcitabine/Pazopanib in Locally Advanced and/or Metastatic Biliary Tract Carcinoma. A Hellenic Cooperative Oncology Group Phase II Study

Sgouros Joseph; Aravantinos Gerasimos; Koliou Georgia-Angeliki; Pentheroudakis George; Zagouri Flora; Psyrri Amanda; Lampropoulou Dimitra Ioanna; Demiri Stamatina; Pectasides Dimitrios; Razis Evangelia; Fountzilas George; Samantas Epaminontas

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First Line Gemcitabine/Pazopanib in Locally Advanced and/or Metastatic Biliary Tract Carcinoma. A Hellenic Cooperative Oncology Group Phase II Study

机译：第一线吉西他滨/ Pazopanib在局部晚期和/或转移性胆道癌。 Hellenic合作肿瘤组阶段II研究

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Background/Aim: The efficacy of gemcitabine-based chemotherapy in locally advanced/metastatic biliary tract carcinoma is limited. The aim of this trial was to assess the activity of a novel gemcitabine-pazopanib combination in such patients. Patients and Methods: In this phase II, multicenter trial, patients with histologically/cytologically confirmed biliary tract carcinoma, previously untreated for advanced disease, received 1000 mg/m(2) of gemcitabine on days 1 and 8 every 21 days and 800 mg of pazopanib once daily continuously for 8 cycles, followed by pazopanib maintenance. The primary endpoint was objective response rate (ORR). Results: A total of 29 patients (median age; 69 years) were enrolled between June 2013 and March 2018. The ORR was 13.8% in the intent-to-treat and 19.1% in the per protocol population. The median progression-free and overall survival were 6.3 and 10.4 months, respectively. Conclusion: The low response rate precludes further testing of the combination in patients with biliary tract carcinoma.

机译：背景/目的：吉西他滨的化疗在局部晚期/转移性胆道癌中的疗效受到限制。该试验的目的是评估该等患者在此类患者中的新型吉西他滨 - Pazopanib组合的活性。患者和方法：在本II期，多中心试验，组织学/细胞学证实胆道癌患者，以前未经治疗的晚期疾病，每21天接受1000mg / m（2）颗吉西他滨每21天和800毫克Pazopanib每天一次连续8个循环，然后是Pazopanib维护。主要端点是客观响应率（ORR）。结果：2013年6月和2018年3月，共有29名患者（中位数年龄; 69岁）。orr在意图治疗中为13.8％，每议定书均为19.1％。中位进展和整体生存率分别为6.3和10.4个月。结论：低应答速率排除了对胆道癌患者的进一步测试。

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来源
《Anticancer Research: International Journal of Cancer Research and Treatment》 |2020年第2期|共10页
作者
Sgouros Joseph; Aravantinos Gerasimos; Koliou Georgia-Angeliki; Pentheroudakis George; Zagouri Flora; Psyrri Amanda; Lampropoulou Dimitra Ioanna; Demiri Stamatina; Pectasides Dimitrios; Razis Evangelia; Fountzilas George; Samantas Epaminontas;
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作者单位

Agii Anargiri Canc Hosp Dept Med Oncol 3 Athens 14564 Greece;

Agii Anargiri Canc Hosp Dept Med Oncol 2 Athens Greece;

Data Off Hellen Cooperat Oncol Grp Sect Biostat Athens Greece;

Univ Ioannina Med Sch Dept Med Oncol Ioannina Greece;

Natl &

Kapodistrian Univ Athens Sch Med Alexandra Hosp Dept Clin Therapeut Athens Greece;

Natl &

Kapodistrian Univ Athens Sch Med Attikon Univ Hosp Sect Med Oncol Dept Internal Med Fac;

Agii Anargiri Canc Hosp Dept Med Oncol 2 Athens Greece;

Agios Savvas Canc Hosp Dept Internal Med 2 Athens Greece;

Hippokrateion Hosp Oncol Sect Dept Internal Med 2 Athens Greece;

Hygeia Hosp Dept Med Oncol 3 Athens Greece;

Aristotle Univ Thessaloniki Hellen Fdn Canc Res Lab Mol Oncol Thessaloniki Greece;

Agii Anargiri Canc Hosp Dept Med Oncol 3 Athens 14564 Greece;

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原文格式 PDF
正文语种 eng
中图分类肿瘤学;
关键词
Biliary tract carcinoma; gemcitabine; pazopanib; phase II study;

机译：胆道癌;吉西他滨;Pazopanib;II期研究;

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First Line Gemcitabine/Pazopanib in Locally Advanced and/or Metastatic Biliary Tract Carcinoma. A Hellenic Cooperative Oncology Group Phase II Study

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