Kim Mi-Jung, Oh Do-Youn, Lee Se-Hoon, Kim Dong-Wan, Im Seock-Ah, Kim Tae-You, Heo Dae Seog, Bang Yung-Jue
Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
BMC Cancer. 2008 Dec 18;8:374. doi: 10.1186/1471-2407-8-374.
There is no standard palliative chemotherapy regimen in biliary tract cancers (BTC). Fluoropyrimidine or gemcitabine, with or without platinum, are most frequently used. We conducted this study to clarify the efficacy of palliative chemotherapy in BTC.
Patients with unresectable BTC treated with palliative chemotherapy between Oct 2001 and Aug 2006 at Seoul National University Hospital were reviewed retrospectively. Histologically confirmed cases of intrahepatic cholangiocarcinoma, gallbladder cancer, extrahepatic bile duct cancer, and ampulla of Vater carcinoma were enrolled. We analyzed the efficacy of regimens: gemcitabine (G) versus fluoropyrimidine (F) and with or without platinum (P).
A total of 243 patients were enrolled. 159 patients (65%) were male and the median age of the patients was 60 years (range 26-81). Intrahepatic cholangiocarcinoma, gallbladder cancer, extrahepatic bile duct cancer, and ampulla of Vater carcinoma were 92, 72, 58, and 21 cases, respectively. The median progression free survival (PFS) was 4.3 months (95% CI, 3.7-4.9) and median overall survival (OS) was 8.7 months (95% CI, 7.4-10.0). Ninety-nine patients received G-based chemotherapy (94 GP, 5 G alone), and 144 patients received F-based chemotherapy (83 FP, 61 F alone). The response rate (RR), disease control rate (DCR), PFS and OS of G-based chemotherapy versus F-based chemotherapy were 16.7% vs. 19.5% (P=0.591), 52.8% vs. 58.9% (P=0.372), 4.0 months vs. 4.3 months (P=0.816), and 7.8 months vs. 9.1 months (P=0.848), respectively. Sixty-six patients received F or G without P, and 177 patients received F or G with P. The RR, DCR, PFS and OS of chemotherapy without P versus chemotherapy including P were 12.7% vs. 20.6% (P=0.169), 46.0% vs. 60.6% (P=0.049), 3.3 months vs. 4.4 months (P=0.887), and 10.6 months vs. 8.1 months (P=0.257), respectively.
In unresectable BTC, F-based and G-based chemotherapy showed similar efficacy in terms of RR, DCR, PFS and OS. The benefit of adding P to F or G was not significant except for DCR. Further prospective studies which define the efficacy of various chemotherapeutic regimens in BTC are warranted.
胆道癌（BTC）尚无标准的姑息化疗方案。氟嘧啶或吉西他滨，无论是否联合铂类，是最常用的药物。我们开展本研究以阐明姑息化疗在BTC中的疗效。
回顾性分析2001年10月至2006年8月在首尔国立大学医院接受姑息化疗的不可切除BTC患者。纳入经组织学确诊的肝内胆管癌、胆囊癌、肝外胆管癌和壶腹癌病例。我们分析了不同方案的疗效：吉西他滨（G）对比氟嘧啶（F），以及是否联合铂类（P）。
共纳入2,43例患者。159例（65%）为男性，患者中位年龄为60岁（范围26 - 81岁）。肝内胆管癌、胆囊癌、肝外胆管癌和壶腹癌分别为92例、72例、58例和21例。中位无进展生存期（PFS）为4.3个月（95%CI，3.7 - 4.9），中位总生存期（OS）为8.7个月（95%CI，7.4 - 10.0）。99例患者接受以G为基础的化疗（94例GP，5例单纯G），144例患者接受以F为基础的化疗（83例FP，61例单纯F）。以G为基础的化疗与以F为基础的化疗的缓解率（RR）、疾病控制率（DCR）、PFS和OS分别为16.7%对19.5%（P = 0.591）、52.8%对58.9%（P = 0.372）、4.0个月对4.3个月（P = 0.816）和7.8个月对9.1个月（P = 0.848）。66例患者接受不含P的F或G治疗，177例患者接受含P的F或G治疗。不含P的化疗与含P的化疗的RR、DCR、PFS和OS分别为12.7%对20.6%（P = 0.169）、46.0%对60.6%（P = 0.049）、3.3个月对4.4个月（P = 0.887）和10.6个月对8.1个月（P = 0.257）。
在不可切除的BTC中，以F为基础和以G为基础的化疗在RR、DCR、PFS和OS方面显示出相似的疗效。除DCR外，F或G联合P的获益并不显著。有必要开展进一步的前瞻性研究以明确各种化疗方案在BTC中的疗效。
