, Volume 15, Issue 1, pp 88-95,
Open Access This content is freely available online to anyone, anywhere at any time.
Date: 26 Sep 2007

A Highly Active and Tolerable Neoadjuvant Regimen Combining Paclitaxel, Carboplatin, 5-FU, and Radiation Therapy in Patients with Stage II and III Esophageal Cancer

Abstract

Background

The present phase II study aimed to assess the feasibility and efficacy of a new paclitaxel-based neoadjuvant chemoradiation regimen followed by surgery in patients with stage II–III esophageal cancer.

Methods

From January 2002 to November 2004, 50 patients with a potentially resectable stage II–III esophageal cancer received chemotherapy with paclitaxel, carboplatin, and 5-FU in combination with radiotherapy 45 Gy in 25 fractions. Surgery followed 6–8 weeks after completion of neoadjuvant treatment.

Results

Patient characteristics: male/female: 44/6, median age 60 years (34–75), median WHO 1 (0–2), adenocarcinoma (n = 42), squamous cell carcinoma (n = 8). Toxicity was mild, and 84 % of the patients completed the whole regimen. Forty-seven patients underwent surgery with a curative intention (transhiatal n = 44, transthoracic n = 3).

Pathologic complete tumor regression was achieved in 18 of 47 operated patients (38%). R0 resection was achieved in 45 of 47 operated patients (96%). There were four postoperative deaths (8.5). Postoperative complications were comparable with other studies. After a median follow-up of 41.5 months (21–59) estimated 3- and 5-year survival on an intention-to-treat basis was 56 and 48%. Estimated 3-year survival in responders was 61%, in nonresponders 33%.

Conclusion

This novel neoadjuvant chemoradiation regimen for treatment of patients with stage II–III esophageal cancer is feasible. Results are encouraging with a high pathologic complete tumor regression and R0 resection rate and an acceptable morbidity and mortality. Preliminary survival data are very promising.

On behalf of the hospitals affiliated to the Comprehensive Cancer Center South, The Netherlands