Yamanaka Kenya, Hatano Etsuro, Kanai Masashi, Tanaka Shiro, Yamamoto Keiichi, Narita Masato, Nagata Hiromitsu, Ishii Takamichi, Machimoto Takahumi, Taura Kojiro, Uemoto Shinji
Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.
Int J Clin Oncol. 2014;19(3):485-9. doi: 10.1007/s10147-013-0578-x. Epub 2013 Jun 14.
Surgical resection is the only curative treatment of biliary tract cancer (BTC). However, the prognosis of BTC remains unsatisfactory. The aim of this study is to evaluate the benefits of adjuvant gemcitabine chemotherapy for BTC.
We performed a historical cohort study that involved 198 patients who underwent R0 surgical resection. Patients who underwent major hepatectomy were administered biweekly intravenous gemcitabine at a dose of 800 mg/m(2). Otherwise, patients were administered intravenous gemcitabine at a dose of 1,000 mg/m(2) in 3 weekly infusions, which were followed by a 1-week pause. The primary outcome was overall survival. The hazard ratio (HR) of adjuvant chemotherapy was estimated by propensity score-stratified Cox regression that was adjusted for confounders.
Forty patients received adjuvant chemotherapy. The HR of adjuvant chemotherapy was 0.47 [95 % confidence interval (CI) 0.28-0.95; P = 0.03]. Subgroup analysis showed that the survival benefits were possibly modified by lymph node positivity (HR 0.19; 95 % CI 0.07-0.58; interaction, P = 0.22), stage III (HR 0.11; 95 % CI 0.02-0.50; interaction, P < 0.01), intrahepatic cholangiocarcinoma (ICC) (HR 0.09; 95 % CI 0.01-0.67; interaction, P = 0.05), and poorly differentiated tumor (HR 0.16; 95 % CI 0.03-0.85; interaction, P = 0.13).
Adjuvant gemcitabine chemotherapy for BTC may be effective, particularly for patients with stage III and ICC.
手术切除是胆管癌(BTC)唯一的根治性治疗方法。然而,BTC的预后仍然不尽人意。本研究的目的是评估辅助吉西他滨化疗对BTC的益处。
我们进行了一项历史性队列研究,纳入了198例行R0手术切除的患者。接受大范围肝切除术的患者每两周静脉注射一次吉西他滨,剂量为800mg/m²。否则,患者每3周静脉输注一次吉西他滨,剂量为1000mg/m²,随后休息1周。主要结局是总生存期。辅助化疗的风险比(HR)通过倾向评分分层的Cox回归进行估计,并对混杂因素进行了校正。
40例患者接受了辅助化疗。辅助化疗的HR为0.47[95%置信区间(CI)0.28 - 0.95;P = 0.03]。亚组分析表明,生存获益可能因淋巴结阳性(HR 0.19;95%CI 0.07 - 0.58;交互作用,P = 0.22)、Ⅲ期(HR 0.11;95%CI 0.02 - 0.50;交互作用,P < 0.01)、肝内胆管癌(ICC)(HR 0.09;95%CI 0.01 - 0.67;交互作用,P = 0.05)和低分化肿瘤(HR 0.16;95%CI 0.03 - 0.85;交互作用,P = 0.13)而有所改变。
BTC辅助吉西他滨化疗可能有效,特别是对于Ⅲ期和ICC患者。