A phase II trial of preoperative chemotherapy with epirubicin, cisplatin and capecitabine for patients with localised gastro-oesophageal junctional adenocarcinoma

被引：21

作者：

Starling, N. ^{[1
,2
]}

Okines, A. ^{[1
,2
]}

Cunningham, D. ^{[1
,2
]}

Allum, W. ^{[3
,4
]}

Wotherspoon, A. ^{[5
,6
]}

Benson, M. ^{[1
,2
]}

Thompson, J. ^{[3
,4
]}

Thomas, J. ^{[1
,2
]}

Brown, G. ^{[7
,8
]}

Riddell, A. ^{[7
,8
]}

Stavridi, F. ^{[1
,2
]}

Ashley, S. ^{[9
,10
]}

Oates, J. ^{[1
,2
]}

Chau, I. ^{[1
,2
]}

机构：

[1] Royal Marsden Hosp, Dept Med, NHS Fdn Trust, Sutton SM2 5PT, Surrey, England

[2] Royal Marsden Hosp, Dept Med, NHS Fdn Trust, London, England

[3] Royal Marsden Hosp, Dept Surg, NHS Fdn Trust, Surrey, England

[4] Royal Marsden Hosp, Dept Surg, NHS Fdn Trust, London, England

[5] Royal Marsden Hosp, Dept Histopathol, NHS Fdn Trust, London, England

[6] Royal Marsden Hosp, Dept Histopathol, NHS Fdn Trust, Surrey, England

[7] Royal Marsden Hosp, Dept Radiol, NHS Fdn Trust, Surrey, England

[8] Royal Marsden Hosp, Dept Radiol, NHS Fdn Trust, London, England

[9] Royal Marsden Hosp, Dept Comp & Stat, NHS Fdn Trust, London, England

[10] Royal Marsden Hosp, Dept Comp & Stat, NHS Fdn Trust, Surrey, England

来源：

BRITISH JOURNAL OF CANCER | 2009年 / 100卷 / 11期

关键词：

oesophageal adenocarcinoma; preoperative chemotherapy; pathological complete response; ADVANCED ESOPHAGOGASTRIC CANCER; ESOPHAGEAL CANCER; NEOADJUVANT THERAPY; COMPLETE RESPONSE; RANDOMIZED-TRIAL; CARCINOMA; SURGERY; CHEMORADIOTHERAPY; FLUOROURACIL; SURVIVAL;

D O I：

10.1038/sj.bjc.6605070

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Preoperative cisplatin/fluorouracil is used for the treatment of localised oesophageal carcinoma. This phase II study aimed to assess the efficacy and safety of administering preoperative epirubicin/cisplatin/capecitabine (ECX). Patients with stage II or III oesophageal/gastro-oesophageal junctional adenocarcinoma from one institution received 4 cycles of ECX (epirubicin 50 mg m(-2) day 1, cisplatin 60 mg m(-2) day 1, capecitabine 625 mg m(-2) b.i.d. daily) followed by surgery. The primary end point was the pathological complete response (pCR) rate based on a Simon two-stage design. Secondary end points included overall and progression-free survival (OS/PFS). Thirty-four patients were recruited: median age 60 years (range 41-81), 91% male, 97% PS 0/1, 80% T3, 68% N1. Thirty-one patients completed four ECX cycles. Grade 3/4 toxicities >= 5% included neutropenia (62%), hand-foot syndrome (15%) and nausea/vomiting (9%). Thirteen out of 28 (46%) evaluable patients responded to chemotherapy by EUS (>= 30% reduction in maximal tumour thickness). Twenty-six out of 34 (76%) patients underwent resection (R0 = 73%, R1 = 27%). Post-operatively, two patients died within 60 days of surgery. The pCR rate was 5.9% (95% CI 0-14%) in the intent-to-treat population. According to the statistical design, this prompted early study termination. However, with a median follow-up of 34 months the median OS and 1- and 2-year survival rates were 17 months, 67 and 39% respectively. Median PFS was 13 months. Of the 14 relapsed patients, 10 presented with distant metastases. Preoperative ECX is feasible and well tolerated. Although associated with a low pCR rate, survival with ECX was comparable with published studies suggesting that pCR may not correlate with satisfactory outcome from preoperative chemotherapy for localised oesophageal adenocarcinoma. British Journal of Cancer (2009) 100, 1725-1730. doi: 10.1038/sj.bjc.6605070 www.bjcancer.com Published online 12 May 2009 (C) 2009 Cancer Research UK

引用

页码：1725 / 1730

页数：6

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