一项关于个体化 FOLFIRINOX 作为晚期胆道癌一线化疗的回顾性研究。
A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer.
机构信息
Assistance Publique-Hopitaux de Paris, Department of Medical Oncology, Paul Brousse Hospital, 12-14 Avenue Paul Vaillant Couturier, 94800, Villejuif, France.
INSERM U935 Campus CNRS, Villejuif, France.
出版信息
BMC Cancer. 2020 Jun 3;20(1):515. doi: 10.1186/s12885-020-07004-y.
BACKGROUND
FOLFIRINOX is a pillar first-line regimen in the treatment of pancreatic cancer. Historically, biliary tract cancer (BTC) and pancreatic cancer have been treated similarly with gemcitabine alone or combined with a platinum compound. With growing evidence supporting the role of fluoropyrimidines in the treatment of BTC, we aimed at assessing the outcomes of patients (pts) with BTC on frontline FOLFIRINOX.
METHODS
We retrospectively analyzed data of all our consecutive patients with locally advanced (LA) or metastatic (M) BTC who were registered to receive FOLFIRINOX as a first-line therapy between 12/2013 and 11/2017 at Paul Brousse university hospital. The main endpoints were Overall Survival (OS), Time-to-Progression (TTP), best Objective Response Rate (ORR), Disease Control rate (DCR), secondary macroscopically-complete resection (res) and incidence of severe (grade 3-4) toxicity (tox).
RESULTS
There were 17 male (40%) and 25 female (60%) pts. aged 36 to 84 years (median: 67). They had PS of 0 (55%) or 1 (45%), and intrahepatic cholangiocarcinoma (CCA) (21 pts., 50%), gallbladder carcinoma (8 pts., 19%), perihilar CCA (7 pts., 17%), distal CCA (4 pts., 10%) and ampulloma (2 pts., 5%). BTC was LA or M in 10 (24%) and 32 pts. (76%) respectively. Biliary stent was placed in 14 pts. (33%). A median of 10 courses was given with median treatment duration of 6 months. There were no untoward toxicity issues, with no febrile neutropenia, emergency admission for toxicity or toxic death. We observed 12 partial responses (29%) and 19 disease stabilisations (45%). Six patients (14%) underwent secondary R0-R1 resection. Median TTP was 8 months [95%CL, 6-10] and median OS was 15 months [13-17]. Patients undergoing secondary resection displayed a 3-y disease-free rate of 83%.
CONCLUSIONS
First-line FOLFIRINOX offers promising results in patients with LA and M-BTC. It deserves prospective evaluation to further improve outcomes for advanced BTC.
背景
FOLFIRINOX 是治疗胰腺癌的一线基础方案。历史上，胆管癌（BTC）和胰腺癌的治疗方法相似，单独使用吉西他滨或联合使用铂类化合物。随着越来越多的证据支持氟嘧啶类药物在 BTC 治疗中的作用，我们旨在评估接受一线 FOLFIRINOX 治疗的 BTC 患者的结局。
方法
我们回顾性分析了 2013 年 12 月至 2017 年 11 月期间在保罗·布罗塞大学医院接受 FOLFIRINOX 一线治疗的局部晚期（LA）或转移性（M）BTC 连续患者的数据。主要终点是总生存期（OS）、无进展生存期（TTP）、最佳客观缓解率（ORR）、疾病控制率（DCR）、辅助性大体完全切除（res）和严重（3-4 级）毒性（tox）发生率。
结果
共有 17 名男性（40%）和 25 名女性（60%）患者，年龄 36-84 岁（中位数：67 岁）。他们的 PS 为 0（55%）或 1（45%），其中肝内胆管癌（CCA）21 例（50%）、胆囊癌 8 例（21%）、肝门部 CCA 7 例（17%）、远端 CCA 4 例（10%）和壶腹癌 2 例（5%）。BTC 在 10 例（24%）和 32 例（76%）患者中分别为 LA 或 M。14 例（33%）患者放置了胆道支架。中位 10 个疗程，中位治疗时间为 6 个月。无不良毒性问题，无发热性中性粒细胞减少症、因毒性而紧急入院或毒性死亡。我们观察到 12 例部分缓解（29%）和 19 例疾病稳定（45%）。6 例（14%）患者接受了辅助 R0-R1 切除术。中位 TTP 为 8 个月[95%CI：6-10]，中位 OS 为 15 个月[13-17]。接受辅助切除术的患者 3 年无病生存率为 83%。
结论
一线 FOLFIRINOX 为 LA 和 M-BTC 患者提供了有希望的结果。它值得前瞻性评估，以进一步改善晚期 BTC 的结局。
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