Woodford Rachel, Brungs Daniel, Leighton Carly, Grimison Peter, Sjoquist Katrin M, Becker Therese, Robinson Samuel, Gebski Val, Wilson Kate, Chantrill Lorraine, Aghmesheh Morteza
St George Hospital, Sydney, New South Wales, Australia.
Illawarra Health and Medical Research Institute and School of Medicine, University of Wollongong, Wollongong, New South Wales, Australia.
Asia Pac J Clin Oncol. 2022 Oct;18(5):e220-e226. doi: 10.1111/ajco.13599. Epub 2021 Jun 28.
Advanced biliary tract cancer (ABTC) is a highly aggressive malignancy, with a 5-year overall survival of < 10%. Although preliminary evidence suggests a role of targeted treatments or immunotherapy in a subset of patients, chemotherapy remains the standard second-line treatment in the majority. We conducted a pilot study of second-line chemotherapy with capecitabine and nab-paclitaxel after failure of gemcitabine and platinum.
Eligible patients had histologically proven, unresectable biliary tract cancer, which had progressed on a gemcitabine/platinum doublet. In this single-arm, multicenter trial, all patients received capecitabine (825 mg/m bd PO D1-14 q21d) and nab-paclitaxel (125 mg/m IV D1,8 q21d) until progression or unacceptable toxicity. The primary objective was feasibility of delivering the proposed regimen, with secondary objectives of disease control measures and QOL outcomes.
Ten patients were enrolled between 2015 and 2016 from four cancer centers in NSW. Treatment was generally well tolerated with grade III toxicities in five patients (including infection, cholangitis, obstruction, and intestinal perforation) and no grade IV toxicity. Median treatment duration was 4.3 months, with a disease control rate of 80% (8/10), and median progression-free and overall survival of 5.7 and 12.1 months, respectively. Quality of life data and specimens for translational research have been collected.
Our pilot study demonstrates that combination of capecitabine and nab-paclitaxel is feasible as a second-line treatment in ABTC. Adequate safety and promising early efficacy signals make further assessment of the combination in a formal phase II or III trial reasonable.
ACTRN12615000504516.
晚期胆管癌（ABTC）是一种侵袭性很强的恶性肿瘤，5年总生存率<10%。尽管初步证据表明靶向治疗或免疫疗法在部分患者中发挥作用，但化疗仍是大多数患者的标准二线治疗方法。我们开展了一项关于吉西他滨和铂类治疗失败后使用卡培他滨和纳米白蛋白结合型紫杉醇进行二线化疗的试点研究。
符合条件的患者经组织学证实为不可切除的胆管癌，且在吉西他滨/铂类双药联合治疗后病情进展。在这项单臂多中心试验中，所有患者接受卡培他滨（825 mg/m² 口服，每日两次，第1 - 14天，每21天为一周期）和纳米白蛋白结合型紫杉醇（125 mg/m² 静脉滴注，第1、8天，每21天为一周期），直至病情进展或出现不可接受的毒性反应。主要目标是评估所提议方案的可行性，次要目标为疾病控制措施和生活质量结果。
2015年至2016年期间，新南威尔士州的四个癌症中心招募了10名患者。治疗耐受性总体良好，5名患者出现3级毒性反应（包括感染、胆管炎、梗阻和肠穿孔）但无4级毒性反应。中位治疗持续时间为4.3个月，疾病控制率为80%（8/10），中位无进展生存期和总生存期分别为5.7个月和12.1个月。已经收集了生活质量数据和用于转化研究的标本。
我们的试点研究表明，卡培他滨和纳米白蛋白结合型紫杉醇联合作为ABTC的二线治疗方法是可行的。充分的安全性和有前景的早期疗效信号使得在正式的II期或III期试验中进一步评估该联合方案具有合理性。
ACTRN12615000504516。
