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J Thorac Cardiovasc Surg 1997;114:811-816
© 1997 Mosby, Inc.

GENERAL THORACIC SURGERY

INDUCTION THERAPY FOR ESOPHAGEAL CANCER WITH PACLITAXEL AND HYPERFRACTIONATED RADIOTHERAPY: A PHASE I AND II STUDY

Received for publication May 12, 1997 revisions requested June 26, 1997; revisions received July 21, 1997 accepted for publication July 21, 1997. Address for reprints: Cameron D. Wright, MD, Thoracic Surgery, Blake 1570, Massachusetts General Hospital, Boston, MA 02114.

Abstract

Objective: Induction chemoradiotherapy followed by surgery may improve survival rates among patients with esophageal carcinoma. We designed a novel intense induction regimen with paclitaxel and high-dose hyperfractionated radiotherapy to maximize complete response rates. Methods: Forty patients with esophageal cancer were treated in a phase I and II trial of induction chemotherapy (cisplatin, 5-fluorouracil, and paclitaxel) at three dosage levels (75, 125, and 100 mg/m²) and concurrent hyperfractionated radiotherapy (45 Gy to the mediastinum, 58.5 Gy to the tumor). The mean age was 62 years, and 32 patients(80%) had adenocarcinoma. Twenty-eight of 40 (70%) patients had locally advanced tumors (T3, or stage IIB or greater). Results: The average hospitalization for induction treatment was 17 days. Toxicity was substantial, with esophagitis necessitating nutritional support the most common complication. The maximum tolerated dose of paclitaxel was 100 mg/m². Two patients died during induction treatment. Thirty-six patients (90%) underwent resection. The median length of stay was 10 days, and two patients died after the operation. Fourteen of 36 patients (39%) had a pathologic complete response. Patients who received all prescribed chemotherapy had a higher pathologic complete response rate (50%) than did patients who required dose reduction (17%; p = 0.076). The 2-year survival rate was 61% (95% CI 35% to 86%) with a median follow-up of 11.9 months. Conclusions: Paclitaxel at a dose of 100 mg/m² appears to have acceptable toxicity. The high pathologic complete response rate in this regimen is encouraging, but it is associated with substantial toxicity. The toxicity of this regimen is not acceptable and will require substantial reduction in the radiation component. Survival data are too short-term to confirm enhanced survival.

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