Yamashita Yo-ichi, Taketomi Akinobu, Fukuzawa Kengo, Yoshizumi Tomoharu, Uchiyama Hideaki, Simada Mitsuo, Shirabe Ken, Wakasugi Kenzo, Maehara Yoshihiko
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Anticancer Res. 2006 Jan-Feb;26(1B):771-5.
Advanced biliary tree cancers have poor prognosis and chemotherapy has been shown to have little impact. To date, no standard chemotherapy regimens have been established. A pilot study to evaluate gemcitabine/5-Fluorouracil(5-FU)/cisplatin(CDDP) (GFP) chemotherapy in patients with advanced biliary tree cancers was performed.
Eight patients with advanced intrahepatic cholangiocarcinoma and gallbladder carcinoma with no prior chemotherapy were treated with a 4-week cycle GFP chemotherapy consisting of gemcitabine at 1000 mg/m2 on days 1, 8, and 15, and of 5-FU at 250 mg/patient and CDDP at 5 mg/patient on days 1 to 5, 8 to 12 and 22 to 26.
Of these 8 patients, no complete responses (CR) were observed, but 3 patients (37.5%) demonstrated partial responses (PR) with an additional 3 patients (37.5%) having stable diseases (SD), as assessed by RECIST. Two patients with PR and 1 patient with SD were treated by curative operation after GFP chemotherapy and all of them survived with no recurrence. The median overall survival time was 23.5 months, and median time to progression was 14.5 months. Grade 3/4 side-effects, such as leukopenia, thrombocytepenia and anemia were found in 4 patients (50%), but no patients dropped out because of toxicity.
This GFP chemotherapy has promising antitumor activity and is well tolerated in patients with advanced biliary tree cancers. This regimen warrants further evaluation in a phase II study including larger numbers of patients.
晚期胆管癌预后较差，化疗效果甚微。迄今为止，尚未确立标准的化疗方案。开展了一项评估吉西他滨/5-氟尿嘧啶（5-FU）/顺铂（CDDP）（GFP）化疗用于晚期胆管癌患者的试点研究。
8例既往未接受过化疗的晚期肝内胆管癌和胆囊癌患者接受为期4周的GFP化疗周期，具体为第1、8和15天给予吉西他滨1000mg/m²，第1至5天、8至12天以及22至26天给予5-FU 250mg/患者和顺铂5mg/患者。
在这8例患者中，未观察到完全缓解（CR），但根据实体瘤疗效评价标准（RECIST）评估，3例患者（37.5%）显示部分缓解（PR），另有3例患者（37.5%）病情稳定（SD）。2例PR患者和1例SD患者在GFP化疗后接受了根治性手术，且均存活无复发。中位总生存时间为23.5个月，中位疾病进展时间为14.5个月。4例患者（50%）出现3/4级副作用，如白细胞减少、血小板减少和贫血，但无患者因毒性退出研究。
这种GFP化疗具有良好的抗肿瘤活性，晚期胆管癌患者耐受性良好。该方案值得在纳入更多患者的II期研究中进一步评估。
