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J Thorac Cardiovasc Surg 2003;126:1168-1173
© 2003 The American Association for Thoracic Surgery

General thoracic surgery

Survival following intensive preoperative combined modality therapy with paclitaxel, cisplatin, 5-fluorouracil, and radiation in resectable esophageal carcinoma: A phase I report

^a Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pa, USA
^b Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pa, USA
^c Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pa, USA
^d Department of Gastroenterology, Fox Chase Cancer Center, Philadelphia, Pa, USA

Received for publication August 20, 2002; revisions received October 8, 2002; revisions received January 8, 2003; accepted for publication March 25, 2003.

^* Address for reprints: Dr M. Goldberg, Fox Chase Cancer Center, Division of Thoracic Surgical Oncology, 7701 Burholme Ave, Philadelphia, PA 19111, USA
M_Goldberg{at}fccc.edu

PURPOSE: To assess the benefits of aggressive chemoradiation therapy followed by surgery in resectable esophageal carcinoma.

METHOD: Twenty-nine patients with resectable carcinoma were treated with 60 Gy of radiation (2 Gy daily for 6 weeks) and concurrent chemotherapy consisting of continuous infusion of 5-fluorouracil (200-225 mg/m²/d), paclitaxel (25, 40, 50, or 60 mg/m²) weekly over 1 hour, and cisplatin (25 mg/m²) weekly immediately following paclitaxel throughout radiation. Patients received either 4 cycles of postoperative paclitaxel 175 mg/m² over 3 hours and cisplatin 75 mg/m² every 3 weeks or paclitaxel 175 mg/m² over 3 hours and cisplatin 75 mg/m² every 3 weeks prior to the initiation of chemoradiation. After induction therapy and restaging, esophagectomy was performed 4 to 6 weeks later.

RESULTS: Twenty-seven patients were eligible for study (26 men, 23 with adenocarcinoma). Median age was 58 years (range 30-73). The maximum tolerated dose combination was paclitaxel 50 mg/m² over 1 hour weekly, cisplatin 25 mg/m² over 1 hour weekly, 5-fluorouracil 200 mg/m²/d by continuous infusion throughout radiotherapy and radiation to 60 Gy. Twenty-two patients completed therapy and underwent surgical resection. Four patients had complete pathological responses and 18 had partial responses with no mortality. The commonest dose-limiting toxicity was mucositis and esophagitis (n = 7). Median follow-up of 27 patients was 150 weeks (range 7-303). At 2-year follow-up 16/27 (59%) were alive and 15/27 (56%) were free of disease. At 4-year follow-up 12/27 (44%) were alive and free of disease. Median follow-up of 22 patients undergoing esophagectomy was 205 weeks (range 26-303). At 4-year follow-up 10/22 (45%) were alive and free of disease. For the 18 patients treated at or above the maximum tolerated dose, median follow-up was 151 weeks (range 35-206) and at 3-year follow-up 9/18 (50%) were alive and free of disease.

CONCLUSION: Aggressive combined modality therapy of esophageal carcinoma was associated with excellent long-term survival in this phase I trial.

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				A. C. Berger, J. Farma, W. J. Scott, G. Freedman, L. Weiner, J. D. Cheng, H. Wang, and M. Goldberg Complete Response to Neoadjuvant Chemoradiotherapy in Esophageal Carcinoma Is Associated With Significantly Improved Survival J. Clin. Oncol., July 1, 2005; 23(19): 4330 - 4337. [Abstract] [Full Text] [PDF]