A phase II trial of preoperative chemotherapy with epirubicin, cisplatin and capecitabine for patients with localised gastro-oesophageal junctional adenocarcinoma
Author(s)
Type
Journal Article
Abstract
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 greater than or equal to5% included neutropenia (62%), hand–foot syndrome (15%) and nausea/vomiting (9%). Thirteen out of 28 (46%) evaluable patients responded to chemotherapy by EUS (greater than or equal to30% 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.
Date Issued
2009-05-26
Date Acceptance
2009-04-06
Citation
British Journal of Cancer, 2009, 100 (11), pp.1725-1730
ISSN
1532-1827
Publisher
Cancer Research UK
Start Page
1725
End Page
1730
Journal / Book Title
British Journal of Cancer
Volume
100
Issue
11
Copyright Statement
From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License.
To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/
To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/
Subjects
Science & Technology
Life Sciences & Biomedicine
Oncology
ONCOLOGY
oesophageal adenocarcinoma
preoperative chemotherapy
pathological complete response
ADVANCED ESOPHAGOGASTRIC CANCER
ESOPHAGEAL CANCER
NEOADJUVANT THERAPY
COMPLETE RESPONSE
RANDOMIZED-TRIAL
CARCINOMA
SURGERY
CHEMORADIOTHERAPY
FLUOROURACIL
SURVIVAL
Publication Status
Published