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Annals of Oncology 15:947-954, 2004
© 2004 European Society for Medical Oncology

Original Paper

A single institutional phase III trial of preoperative chemotherapy with hyperfractionation radiotherapy plus surgery versus surgery alone for resectable esophageal squamous cell carcinoma

Received 11 October 2003; revised 2 February 2004; accepted 2 February 2004

Background:

We conducted a prospective randomized controlled trial comparing surgery alone (S) with concurrent chemoradiotherapy followed by surgery (CRT-S) for resectable esophageal squamous cell carcinoma (SCC) based on our previous report.

Patients and methods:

One hundred and one patients with stage II/III esophageal SCC were randomized to receive either S (50 patients) or CRT-S (51 patients). The chemoradiotherapy (CRT) consisted of cisplatin 60 mg/m2 intravenously (i.v.) on day 1, 5-fluorouracil (5-FU) 1000 mg/m2 i.v. on days 2–5, cisplatin 60 mg/m2 i.v. on day 22 combined with radiation therapy (45.6 Gy, 1.2 Gy b.i.d. on days 1–28). Surgery was performed 3–4 weeks after radiotherapy was completed. For patients with disease that was stable or responsive to CRT, three additional cycles of chemotherapy (cisplatin 60 mg/m2 i.v. on day 1, 5-FU 1000 mg/m2 on days 2–5 every 4 weeks) were given after surgical resection.

Results:

The median age was 62 years. The toxicity of CRT was acceptable and did not affect the post-operative morbidity and the duration of hospital stay. Clinical response was 86% including 21% of complete response (CR) rate. Pathological CR was achieved in 43% [95% confidence interval (CI) 27–59] of the patients who underwent surgery after CRT. At a median follow-up of 25 months, median overall survival (OS) was 27.3 months in S and 28.2 months in CRT-S (P = 0.69). Event-free survival (EFS) at 2 years was 51% in S and 49% in CRT-S (P = 0.93). This trial, which was statistically powered to detect a relatively large difference in 2-year survival rate from 30% to 50% with 80% power, was discontinued at interim analysis because of the unexpectedly high drop-out rate for esophagectomy (31%) and resultant excessive locoregional failure rate in CRT-S arm (22% versus 12%, P = 0.31), though it was not statistically significant.

Conclusion:

Although preoperative CRT induced high clinical and pathological response, there was no statistically significant benefit in OS and EFS.

J.-L. Lee1,6, S. I. Park2, S.-B. Kim1,*, H.-Y. Jung1, G. H. Lee1, J.-H. Kim3, H.-Y. Song4, K.-J. Cho5, W.-K. Kim1, J.-S. Lee1, S.-H. Kim1 and Y.-I. Min1

Departments of 1 Medicine, 2 Thoracic and Cardiovascular Surgery, 3 Radiation Oncology, 4 Diagnostic Radiology, and 5 Pathology, ECSG (Esophageal Cancer Study Group), Asan Medical Center, University of Ulsan College of Medicine, Seoul; 6 Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea

Key words: combined modality therapy, esophageal cancer, neoadjuvant therapy, randomized controlled trial, squamous cell carcinoma


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