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Preoperative chemoradiotherapy for esophageal or junctional cancer.

Authors :
van Hagen P
Hulshof MC
van Lanschot JJ
Steyerberg EW
van Berge Henegouwen MI
Wijnhoven BP
Richel DJ
Nieuwenhuijzen GA
Hospers GA
Bonenkamp JJ
Cuesta MA
Blaisse RJ
Busch OR
ten Kate FJ
Creemers GJ
Punt CJ
Plukker JT
Verheul HM
Spillenaar Bilgen EJ
van Dekken H
van der Sangen MJ
Rozema T
Biermann K
Beukema JC
Piet AH
van Rij CM
Reinders JG
Tilanus HW
van der Gaast A
Source :
The New England journal of medicine [N Engl J Med] 2012 May 31; Vol. 366 (22), pp. 2074-84.
Publication Year :
2012

Abstract

Background: The role of neoadjuvant chemoradiotherapy in the treatment of patients with esophageal or esophagogastric-junction cancer is not well established. We compared chemoradiotherapy followed by surgery with surgery alone in this patient population.<br />Methods: We randomly assigned patients with resectable tumors to receive surgery alone or weekly administration of carboplatin (doses titrated to achieve an area under the curve of 2 mg per milliliter per minute) and paclitaxel (50 mg per square meter of body-surface area) for 5 weeks and concurrent radiotherapy (41.4 Gy in 23 fractions, 5 days per week), followed by surgery.<br />Results: From March 2004 through December 2008, we enrolled 368 patients, 366 of whom were included in the analysis: 275 (75%) had adenocarcinoma, 84 (23%) had squamous-cell carcinoma, and 7 (2%) had large-cell undifferentiated carcinoma. Of the 366 patients, 178 were randomly assigned to chemoradiotherapy followed by surgery, and 188 to surgery alone. The most common major hematologic toxic effects in the chemoradiotherapy-surgery group were leukopenia (6%) and neutropenia (2%); the most common major nonhematologic toxic effects were anorexia (5%) and fatigue (3%). Complete resection with no tumor within 1 mm of the resection margins (R0) was achieved in 92% of patients in the chemoradiotherapy-surgery group versus 69% in the surgery group (P<0.001). A pathological complete response was achieved in 47 of 161 patients (29%) who underwent resection after chemoradiotherapy. Postoperative complications were similar in the two treatment groups, and in-hospital mortality was 4% in both. Median overall survival was 49.4 months in the chemoradiotherapy-surgery group versus 24.0 months in the surgery group. Overall survival was significantly better in the chemoradiotherapy-surgery group (hazard ratio, 0.657; 95% confidence interval, 0.495 to 0.871; P=0.003).<br />Conclusions: Preoperative chemoradiotherapy improved survival among patients with potentially curable esophageal or esophagogastric-junction cancer. The regimen was associated with acceptable adverse-event rates. (Funded by the Dutch Cancer Foundation [KWF Kankerbestrijding]; Netherlands Trial Register number, NTR487.).

Details

Language :
English
ISSN :
1533-4406
Volume :
366
Issue :
22
Database :
MEDLINE
Journal :
The New England journal of medicine
Publication Type :
Academic Journal
Accession number :
22646630
Full Text :
https://doi.org/10.1056/NEJMoa1112088