Originally published as JCO Early Release 10.1200/JCO.2008.17.0506 on January 12 2009

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Phase III Comparison of Preoperative Chemotherapy Compared With Chemoradiotherapy in Patients With Locally Advanced Adenocarcinoma of the Esophagogastric Junction

From the Departments of Medical Oncology and Hematology, and Surgery, Kliniken Essen-Mitte; Department of Radiation Oncology, and the Institute for Medical Informatics, Biometry, and Epidemiology, University of Duisburg-Essen Medical School, Essen; Department of Surgery, Klinikum Solingen, Solingen; Departments of Hematology and Oncology, Surgery, and Radiation Oncology, University Clinic, Marburg; and the Department of Gastroenterology, Surgery, and Radiation Oncology, University Clinic, Tübingen, Germany for the German Oesophageal Cancer Study Group.

Corresponding author: Michael Stahl, MD, Department of Medical Oncology and Hematology, Kliniken Essen-Mitte, Henricistr. 92, D-45136 Essen, Germany; e-mail: m.stahl{at}kliniken-essen-mitte.de.

Purpose Preoperative chemotherapy is an accepted standard in the treatment of localized esophagogastric adenocarcinoma. Adding radiation therapy to preoperative chemotherapy appears promising, but its definitive value remains unknown.

Patients and Methods Patients with locally advanced (uT3-4NXM0) adenocarcinoma of the lower esophagus or gastric cardia were randomly allocated to one of two treatment groups: induction chemotherapy (15 weeks) followed by surgery (arm A); or chemotherapy (12 weeks) followed by chemoradiotherapy (3 weeks) followed by surgery (arm B). Primary outcome was overall survival time. A total of 354 patients were needed to detect a 10% increase in 3-year survival from 25% to 35% by addition of radiation therapy. The study was prematurely closed due to low accrual.

Results The median observation time was 46 months. A total of 126 patients were randomly assigned and 119 eligible patients were evaluated. The number of patients undergoing complete tumor resection was not different between treatment groups (69.5% v 71.5%). Patients in arm B had a significant higher probability of showing pathologic complete response (15.6% v 2.0%) or tumor-free lymph nodes (64.4% v 37.7%) at resection. Preoperative radiation therapy improved 3-year survival rate from 27.7% to 47.4% (log-rank P = .07, hazard ratio adjusted for randomization strata variables 0.67, 95% CI, 0.41 to 1.07). Postoperative mortality was nonsignificantly increased in the chemoradiotherapy group (10.2% v 3.8%; P = .26).

Conclusion Although the study was closed early and statistical significance was not achieved, results point to a survival advantage for preoperative chemoradiotherapy compared with preoperative chemotherapy in adenocarcinomas of the esophagogastric junction.

Supported by grants of Ortho-Biotech (Neuss, Germany) and Baxter Deutschland GmbH (Unterschleißheim, Germany).

Presented in part at the 43rd annual meeting of the American Society of Clinical Oncology Chicago, IL, June 1-5, 2007.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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