Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom.
UCL Cancer Institute, London, United Kingdom.
Eur J Cancer. 2015 Sep;51(13):1694-703. doi: 10.1016/j.ejca.2015.05.018. Epub 2015 Jun 8.
The advanced biliary tract cancer (ABC)-02 study established cisplatin and gemcitabine (CisGem) as a reference 1(st)-line regimen for patients with advanced/metastatic biliary tract cancer; patients with bilirubin ⩾ 1.5 × upper limit of normal (ULN) were excluded and there are few extant data for systemic treatment in the context of elevated bilirubin.
Patients with ABC, receiving CisGem with a baseline bilirubin of ⩾ 1.5 × ULN were eligible for this retrospective analysis; response, toxicity and survival data were collected.
Thirty-three patients of 545 screened; median age 59 years, range 23-79; 58% male, 58% with metastases (79% in the liver) of performance status (PS) 0 (33%), 1 (64%) or 2 (3%) were eligible. The median baseline bilirubin was 55 μmol/L (range 32-286); due to biliary tract obstruction (BTO, 76%) or liver metastases (LM, 24%). Toxicity was comparable to the ABC-02 study; bilirubin normalised in 64% during chemotherapy/follow-up. The median progression-free survival (PFS) was 6.9 months (95% confidence interval (CI): 4.4-9.0) and median overall survival (OS) 9.5 months (95% CI: 5.7-12.8). Patients with BTO had a longer PFS and OS than those with LM (7.0 versus 2.6 months; p = 0.1633 and 9.8 versus 4.4 months, hazard ratio (HR) 0.74; p = 0.465, respectively); not statistically significant (due to small sample size). Normalisation of bilirubin and completion of eight CisGem cycles were associated with longer OS (11.4 versus 2.9 months, HR 0.49; p = 0.08 and 15.2 versus 5.4 months, HR 0.12 p < 0.001, respectively). No difference in OS was shown between the bilirubin percentiles (for either PFS or OS).
For PS 0-1 patients with ABC and high bilirubin due to luminal disease despite optimal stenting CisGem can be used safely with results similar to those in patients with normal bilirubin.
ABC-02 研究确立顺铂和吉西他滨（CisGem）为晚期/转移性胆道癌患者的一线治疗参考方案；排除了胆红素 ⩾ 1.5 ×正常值上限（ULN）的患者，并且在胆红素升高的情况下，系统治疗的现有数据很少。
本回顾性分析纳入了基线胆红素 ⩾ 1.5 × ULN 且接受 CisGem 治疗的 ABC 患者；收集了反应、毒性和生存数据。
在 545 例筛选患者中，有 33 例符合条件；中位年龄 59 岁，范围 23-79 岁；58%为男性，58%有转移（79%在肝脏），ECOG 体能状态（PS）为 0（33%）、1（64%）或 2（3%）。中位基线胆红素为 55 μmol/L（范围 32-286）；由于胆道梗阻（BTO，76%）或肝转移（LM，24%）。毒性与 ABC-02 研究相当；64%的患者在化疗/随访期间胆红素恢复正常。中位无进展生存期（PFS）为 6.9 个月（95%置信区间（CI）：4.4-9.0），中位总生存期（OS）为 9.5 个月（95%CI：5.7-12.8）。BTO 患者的 PFS 和 OS 长于 LM 患者（7.0 个月与 2.6 个月；p = 0.1633 和 9.8 个月与 4.4 个月，风险比（HR）为 0.74；p = 0.465，分别）；无统计学意义（由于样本量小）。胆红素正常化和完成 8 个 CisGem 周期与较长的 OS 相关（11.4 个月与 2.9 个月，HR 为 0.49；p = 0.08 和 15.2 个月与 5.4 个月，HR 为 0.12 p < 0.001，分别）。在 OS 方面，不同胆红素百分位数之间无差异（无论是 PFS 还是 OS）。
对于 PS 0-1 且由于管腔内疾病而胆红素升高的 ABC 患者，尽管进行了最佳支架置入，CisGem 仍可安全使用，且结果与胆红素正常的患者相似。
