一项关于PEFG（顺铂、表柔比星、5-氟尿嘧啶、吉西他滨）方案继以胰腺癌根治性手术后放疗的前瞻性试验的最终结果。

Final results of a prospective trial of a PEFG (Cisplatin, Epirubicin, 5-Fluorouracil, Gemcitabine) regimen followed by radiotherapy after curative surgery for pancreatic adenocarcinoma.

作者信息

Reni Michele, Passoni Paolo, Bonetto Elisa, Balzano Gianpaolo, Panucci Maria Grazia, Zerbi Alessandro, Ronzoni Monica, Staudacher Carlo, Villa Eugenio, Di Carlo Valerio

机构信息

Department of Radiochemotherapy, S. Raffaele H. Scientific Institute, Milan, Italy.

出版信息

Oncology. 2005;68(2-3):239-45. doi: 10.1159/000086780. Epub 2005 Jul 7.

DOI:10.1159/000086780

PMID:16015040

Abstract

BACKGROUND

Postoperative management of patients with pancreatic adenocarcinoma (PA) is controversial.

METHODS

The aim of this pilot study was to assess the feasibility of postoperative combination chemotherapy followed by radiotherapy in patients aged 18-70 years with a histological diagnosis of PA, and Karnofsky performance status (KPS) > or =70. Cisplatin and epirubicin 40 mg/m2 on day 1, gemcitabine 600 mg/m2 on day 1 and 8, and 5-fluorouracil 200 mg/m2/day as protracted infusion (PEFG regimen) were delivered every 28 days for 4 cycles. Assuming a minimum one-year disease-free survival (DFS) of interest of 65% and a maximum of low interest of 45% (alpha 0.05; beta 0.10), the target enrollment was 51 patients, and the strategy would be considered to deserve further analysis if more than 29 patients were DF at one-year from surgery.

RESULTS

Fifty-one patients, KPS >80: 29, median tumor size 3.5 cm, stage II/III/IVA: 2/34/13, grade 3-4: 22, positive resection margins: 26, node positive: 46, received 179 cycles of chemotherapy. Main grade 3/4 toxicity consisted of neutropenia (51%), thrombocytopenia (18%), and anemia (4%). One-year DFS was 67 +/- 7%. Two-year overall survival was 53 +/- 7%.

CONCLUSION

Postoperative management of PA with this multimodality strategy was well tolerated and yielded a promising outcome.

摘要

背景

胰腺腺癌（PA）患者的术后管理存在争议。

方法

本初步研究的目的是评估对年龄在18 - 70岁、组织学诊断为PA且卡诺夫斯基体能状态（KPS）≥70的患者术后进行联合化疗继以放疗的可行性。第1天给予顺铂和表柔比星40 mg/m²，第1天和第8天给予吉西他滨600 mg/m²，5-氟尿嘧啶200 mg/m²/天持续输注（PEFG方案），每28天进行1次，共4个周期。假设感兴趣的最小无病生存期（DFS）为65%，最大低兴趣度为45%（α = 0.05；β = 0.10），目标入组人数为51例患者，如果术后1年无病的患者超过29例，则该策略将被认为值得进一步分析。

结果

51例患者，KPS>80：29例，肿瘤中位大小3.5 cm，II/III/IVA期：2/34/13例，3 - 4级：22例，手术切缘阳性：26例，淋巴结阳性：46例，接受了179周期化疗。主要的3/4级毒性反应包括中性粒细胞减少（51%）、血小板减少（18%）和贫血（4%）。1年DFS为67±7%。2年总生存率为53±7%。