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Does Paclitaxel Improve the Chemoradiotherapy of Locoregionally Advanced Esophageal Cancer? A Nonrandomized Comparison With Fluorouracil-Based Therapy

From the Departments of Hematology and Medical Oncology, Thoracic and Cardiovascular Surgery, Biostatistics and Epidemiology, Radiation Oncology, and Gastroenterology, The Cleveland Clinic Foundation, Cleveland, OH.

Address reprint requests to David J. Adelstein, MD, Department of Hematology and Medical Oncology, The Cleveland Clinic Foundation, Desk T40, 9500 Euclid Ave, Cleveland, OH 44195; email adelstd{at}ccf.org

PURPOSE: A phase II trial of accelerated fractionation radiation with concurrent cisplatin and paclitaxel chemotherapy was performed to investigate the role of the paclitaxel, when substituted for fluorouracil (5-FU), in the chemoradiotherapy of esophageal cancer.

PATIENTS AND METHODS: Patients with an esophageal ultrasound stage of T₃ or N₁ or M₁ (nodal) esophageal cancer were treated with two courses of a cisplatin infusion (20 mg/m²/d for 4 days) and paclitaxel (175 mg/m² over 24 hours) concurrent with a split course of accelerated fractionation radiation (1.5 Gy bid to a total dose of 45 Gy). Surgical resection was performed 4 to 6 weeks later followed by a single identical postoperative course of chemoradiotherapy (24 Gy) in patients with significant residual tumor at surgery. Toxicity and results of this treatment were retrospectively compared with our previous 5-FU and cisplatin chemoradiotherapy experience.

RESULTS: Between September 1995 and July 1997, 40 patients were entered onto this study. Although dysphagia proved worse in our 5-FU–treated patients, profound leukopenia and a need for unplanned hospitalization were significantly more common in the paclitaxel group. Thirty-seven patients (93%) proved resectable for cure. The 3-year projected overall survival is 30%, locoregional control is 81%, and distant metastatic disease control is 44%. When compared with a similarly staged cohort of 5-FU–treated patients, there was no advantage for any survival function studied.

CONCLUSION: This paclitaxel-based treatment regimen for locoregionally advanced esophageal cancer produced increased toxicity with no improvement in results when compared with our previous 5-FU experience. Paclitaxel-based treatments must be carefully and prospectively studied before their incorporation into the standard management of esophageal cancer.

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