Department of Hepatobiliary and Pancreatic Oncology, c/o Kanagawa Cancer Center, 1-1-2, Nakao, Asahi-ku Yokohama-shi, Kanagawa 241-0815, Japan.
Jpn J Clin Oncol. 2013 Jun;43(6):636-40. doi: 10.1093/jjco/hyt059. Epub 2013 Apr 25.
Before the ABC-02 trial, because there was no standard chemotherapy for patients with advanced biliary tract cancer, we treated them with gemcitabine alone. However, recently cisplatin plus gemcitabine became the standard first-line chemotherapy. We assessed the benefits of gemcitabine plus cisplatin chemotherapy after failed gemcitabine monotherapy.
We retrospectively examined patients with advanced biliary tract cancer who were treated with gemcitabine plus cisplatin chemotherapy after failed gemcitabine monotherapy. They had adequate organ function, including renal function and Eastern Cooperative Oncology Group performance status 0-1. The treatment consisted of cisplatin (25 mg/m(2) of body surface area) plus gemcitabine (1000 mg/m(2)) on Days 1 and 8 for every 3 weeks.
Between December 2010 and January 2013, 20 patients were treated. The median age was 63 years. There were 15 males and 5 females. The ratio of intrahepatic bile duct, gall bladder and extrahepatic bile duct was 9:6:5. The ratio of locally advanced and metastatic disease was 2:18, and the ratio of PS0 and PS1 was 5:15. The objective response rate was 15.0%, and the tumour control rate was 60.0%. The median progression-free survival was 6.5 months (95% confidence interval, 2.1-6.9 months). The median overall survival was 13.7 months (95% confidence interval, 8.3-19.7 months). Grade 3-4 toxic events included neutropenia (30%), anaemia (20%) and thrombocytopenia (5%).
Cisplatin plus gemcitabine could be an optional therapy for unresectable or recurrent biliary tract cancer after failed gemcitabine monotherapy.
在 ABC-02 试验之前，由于晚期胆道癌患者没有标准的化疗方案，我们单独使用吉西他滨进行治疗。然而，最近顺铂联合吉西他滨成为了标准的一线化疗方案。我们评估了吉西他滨单药治疗失败后接受吉西他滨联合顺铂化疗的疗效。
我们回顾性分析了晚期胆道癌患者，这些患者在吉西他滨单药治疗失败后接受了吉西他滨联合顺铂化疗。这些患者的器官功能充足，包括肾功能和东部肿瘤协作组体能状态 0-1 级。治疗方案为顺铂（25mg/m2 体表面积）联合吉西他滨（1000mg/m2），第 1 天和第 8 天给药，每 3 周 1 个周期。
2010 年 12 月至 2013 年 1 月，共有 20 例患者接受了治疗。中位年龄为 63 岁，其中男性 15 例，女性 5 例。肝内胆管癌、胆囊癌和肝外胆管癌的比例分别为 9:6:5。局部晚期和转移性疾病的比例为 2:18，PS0 和 PS1 的比例为 5:15。客观缓解率为 15.0%，肿瘤控制率为 60.0%。中位无进展生存期为 6.5 个月（95%置信区间，2.1-6.9 个月）。中位总生存期为 13.7 个月（95%置信区间，8.3-19.7 个月）。3-4 级毒性事件包括中性粒细胞减少症（30%）、贫血症（20%）和血小板减少症（5%）。
吉西他滨联合顺铂可能是吉西他滨单药治疗失败后无法切除或复发性胆道癌的一种可选治疗方案。
