顺铂、表柔比星、氟尿嘧啶、吉西他滨（PEFG）方案治疗晚期胆道腺癌。

The cisplatin, epirubicin, 5-fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma.

机构信息

Medical Oncology Unit-Department of Oncology, S. Raffaele Scientific Institute, Milan, Italy.

出版信息

Cancer. 2010 May 1;116(9):2208-14. doi: 10.1002/cncr.24970.

DOI:10.1002/cncr.24970

PMID:20187098

Abstract

BACKGROUND

Biliary tract adenocarcinoma (BTA) is an uncommon tumor with a poor prognosis and no standard, systemic chemotherapy. The combined cisplatin, epirubicin, 5-fluorouracil, and gemcitabine (PEFG) regimen is an effective, upfront treatment for advanced pancreatic cancer. In this study, the authors assessed the activity and safety of this combination regimen in patients with advanced BTA.

METHODS

PEFG (cisplatin 40 mg/m(2) and epirubicin 40 mg/m(2) on Day 1; gemcitabine 600 mg/m(2) on Days 1 and 8; and 5-fluorouracil [FU] 200 mg/m(2) daily as a continuous infusion) was administered to chemotherapy-naive patients who had a cytologic or histologic diagnosis of locally advanced or metastatic BTA, aged <or=75 years, and a performance status (PS) >60 either until they had evidence progressive disease or for a maximum of 6 months. Tumor size was assessed every 2 months during treatment.

RESULTS

Between May 1999 and December 2005, 37 patients (62% metastatic) who had a median age of 62 years and a median PS of 90 received the PEFG regimen at the authors' institution. Primary tumor sites were the intrahepatic bile duct in 10 patients (27%), the extrahepatic bile duct in 8 patients (22%), the gallbladder in 12 patients (32%), and the ampulla of Vater in 7 patients (19%). A partial response was observed in 16 patients (43%), and stable disease was observed in 12 patients (32%). The median overall survival (OS) was 12.1 months, and the 1-year OS rate was 52%. The median progression-free survival (PFS) was 7.9 months, and the 6-month PFS rate was 67%. The main grade 3/4 toxicity was neutropenia in 18% of cycles followed by thrombocytopenia in 9% of cycles, nausea/vomiting in 5% of cycles, and febrile neutropenia, fatigue, anemia, and stomatitis in 2% of cycles.

CONCLUSIONS

The current results demonstrated that PEFG was an active regimen with a manageable toxicity profile for patients with advanced BTA.

摘要

背景

胆管腺癌（BTA）是一种罕见的肿瘤，预后较差，目前尚无标准的系统性化疗方案。联合顺铂、表柔比星、氟尿嘧啶和吉西他滨（PEFG）方案是治疗晚期胰腺癌的有效一线治疗方案。在这项研究中，作者评估了该联合方案在晚期 BTA 患者中的疗效和安全性。

方法

PEFG（顺铂 40 mg/m2 和表柔比星 40 mg/m2 于第 1 天；吉西他滨 600 mg/m2 于第 1 和 8 天；5-氟尿嘧啶[FU] 200 mg/m2 每日持续静脉滴注）用于初治的细胞学或组织学诊断为局部晚期或转移性 BTA、年龄<75 岁且 PS>60 的患者，直至出现疾病进展证据或最长 6 个月。在治疗期间每 2 个月评估肿瘤大小。

结果

1999 年 5 月至 2005 年 12 月，作者所在机构共 37 例（62%为转移性）初治、中位年龄 62 岁、中位 PS 90 的患者接受了 PEFG 方案治疗。原发肿瘤部位为肝内胆管 10 例（27%）、肝外胆管 8 例（22%）、胆囊 12 例（32%）和壶腹 7 例（19%）。16 例（43%）患者观察到部分缓解，12 例（32%）患者观察到疾病稳定。中位总生存期（OS）为 12.1 个月，1 年 OS 率为 52%。中位无进展生存期（PFS）为 7.9 个月，6 个月 PFS 率为 67%。主要的 3/4 级毒性为中性粒细胞减少，占周期的 18%，随后血小板减少占周期的 9%，恶心/呕吐占周期的 5%，发热性中性粒细胞减少、乏力、贫血和口腔炎各占周期的 2%。