Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Sciences Centre, Manchester.
MAHSC Clinical Trials Unit, The Christie NHS Foundation Trust, Manchester, UK.
Ann Oncol. 2014 Dec;25(12):2328-2338. doi: 10.1093/annonc/mdu162. Epub 2014 Apr 25.
The randomized NCRN phase III ABC-02 trial provided level-A evidence for first-line chemotherapy with cisplatin and gemcitabine combination in advanced biliary cancer (ABC). This systematic literature review aims to evaluate the level of evidence for the use of second-line chemotherapy for patients with ABC in terms of overall survival (OS), response, toxicity and quality of life. Eligible studies were identified using Medline, ASCO, ESMO and the World Gastrointestinal Congress databases. Searches were last updated on 15 December 2013. Eligible studies reported survival and/or response data for patients with ABC receiving second-line systemic chemotherapy. This systematic review was registered in the PROSPERO database (No. CRD42013004205). Five hundred and fifty-eight studies were identified from the searches in Medline (n = 342), ASCO (n = 160), ESMO (n = 27) and World Gastrointestinal Congress (n = 29). Twenty-five studies were eligible: 14 phase II clinical trials, 9 retrospective analyses and 2 case reports. In total, data from 761 patients were reported with median number of patients included in each study of 22 (range 9-96). The mean OS was 7.2 months [95% confidence interval (CI) 6.2-8.2] [phase II: 6.6 (95% CI 5.1-8.1); retrospective analysis: 7.7 (95% CI 6.5-8.9)]. The mean progression-free survival (PFS), response rate (RR) and disease control rate were 3.2 months (95% CI 2.7-3.7), 7.7% (95% CI 4.6-10.9) and 49.5% (95% CI 41.4-57.7), respectively. The best correlations were between OS and PFS for all studies (r = 0.54; P = 0.01) and between OS and PFS (r = 0.61; P = 0.04) and OS and RR (r = 0.62; P = 0.03) for phase II studies, respectively. Biliary tract cancer is known to be a chemo-responsive disease. There is insufficient evidence (level C) to recommend a second-line chemotherapy schedule in ABC, although the available data suggest that a cohort of patients may benefit. Further prospective and randomized studies are needed to clarify the relative value of second-line chemotherapy in this setting.
ABC-02 是一项随机、NCRN 开展的 III 期临床试验，该试验提供了高级别循证医学证据，表明顺铂联合吉西他滨方案可作为晚期胆道癌（ABC）的一线化疗方案。本系统文献复习旨在评估二线化疗在 ABC 患者中的生存（OS）、反应、毒性和生活质量方面的证据水平。通过 Medline、ASCO、ESMO 和世界胃肠癌大会数据库进行检索，纳入符合条件的研究。检索最后一次更新日期为 2013 年 12 月 15 日。纳入标准为：报告 ABC 患者接受二线全身化疗的生存和/或反应数据的研究。本系统评价已在 PROSPERO 数据库（注册号：CRD42013004205）中注册。从 Medline（n = 342）、ASCO（n = 160）、ESMO（n = 27）和世界胃肠癌大会（n = 29）的检索中，共确定了 558 项研究。25 项研究符合纳入标准：14 项为 II 期临床试验，9 项为回顾性分析，2 项为病例报告。共纳入了 761 例患者的数据，每项研究纳入患者的中位数为 22 例（范围 9-96 例）。中位 OS 为 7.2 个月[95%置信区间（CI）6.2-8.2]（II 期：6.6[95%CI 5.1-8.1]；回顾性分析：7.7[95%CI 6.5-8.9]）。中位无进展生存期（PFS）、反应率（RR）和疾病控制率分别为 3.2 个月（95%CI 2.7-3.7）、7.7%（95%CI 4.6-10.9）和 49.5%（95%CI 41.4-57.7）。所有研究中，OS 与 PFS 之间的相关性最好（r = 0.54；P = 0.01），II 期研究中 OS 与 PFS（r = 0.61；P = 0.04）和 OS 与 RR（r = 0.62；P = 0.03）之间的相关性最好。胆道癌被认为是一种化疗敏感的疾病。尽管现有数据表明，可能有一部分患者从中获益，但尚无足够的证据（C 级）推荐 ABC 二线化疗方案。需要进一步开展前瞻性、随机研究，以明确二线化疗在该治疗环境中的相对价值。
