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Phase III Trial of Trimodality Therapy With Cisplatin, Fluorouracil, Radiotherapy, and Surgery Compared With Surgery Alone for Esophageal Cancer: CALGB 9781

Joel Tepper, Mark J. Krasna, Donna Niedzwiecki, Donna Hollis, Carolyn E. Reed, Richard Goldberg, Krystyna Kiel, Christopher Willett, David Sugarbaker, Robert Mayer

From the Department of Radiation Oncology, University of North Carolina, Chapel Hill; Cancer and Leukemia Group B Statistical Center, Duke University, Durham, NC; Department of Surgery, Saint Joseph Cancer Institute, Towson, MD; Department of Surgery, Medical University of South Carolina, Charleston, SC; North Central Cancer Treatment Group, Rochester, MN; Department of Medicine, Northwestern University, Chicago, IL; Department of Surgery, Brigham and Women's Hospital; and Department of Medicine, Dana-Farber Cancer Institute, Boston MA

Corresponding author: Joel E. Tepper, MD, CB 7512, Department of Radiation Oncology, University of North Carolina School of Medicine, Chapel Hill, NC 27599-7512; e-mail: tepper{at}med.unc.edu

Purpose The primary treatment modality for patients with carcinoma of the esophagus or gastroesophageal junction has been surgery, although primary radiation therapy with concurrent chemotherapy produces similar results. As both have curative potential, there has been great interest in the use of trimodality therapy. To this end, we compared survival, response, and patterns of failure of trimodality therapy to esophagectomy alone in patients with nonmetastatic esophageal cancer.

Patients and Methods Four hundred seventy-five eligible patients were planned for enrollment. Patients were randomly assigned to either esophagectomy with node dissection alone or cisplatin 100 mg/m² and fluorouracil 1,000 mg/m²/d for 4 days on weeks 1 and 5 concurrent with radiation therapy (50.4 Gy total: 1.8 Gy/fraction over 5.6 weeks) followed by esophagectomy with node dissection.

Results Fifty-six patients were enrolled between October 1997 and March 2000, when the trial was closed due to poor accrual. Thirty patients were randomly assigned to trimodality therapy and 26 were assigned to surgery alone. Patient and tumor characteristics were similar between groups. Treatment was generally well tolerated. Median follow-up was 6 years. An intent-to-treat analysis showed a median survival of 4.48 v 1.79 years in favor of trimodality therapy (exact stratified log-rank, P = .002). Five-year survival was 39% (95% CI, 21% to 57%) v 16% (95% CI, 5% to 33%) in favor of trimodality therapy.

Conclusion The results from this trial reflect a long-term survival advantage with the use of chemoradiotherapy followed by surgery in the treatment of esophageal cancer, and support trimodality therapy as a standard of care for patients with this disease.

Supported by the Cancer and Leukemia Group B, North Central Cancer Treatment Group, Eastern Cooperative Oncology Group, and Radiation Therapy Oncology Group.

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006, Atlanta, GA.

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

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