1. A highly active and tolerable neoadjuvant regimen combining paclitaxel, carboplatin, 5-FU, and radiation therapy in patients with stage II and III esophageal cancer.
- Author
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van de Schoot L, Romme EA, van der Sangen MJ, Creemers GJ, van Lijnschoten G, van Driel OJ, Rutten HJ, and Nieuwenhuijzen GA
- Subjects
- Adenocarcinoma drug therapy, Adenocarcinoma pathology, Adenocarcinoma radiotherapy, Adult, Aged, Carboplatin administration & dosage, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell radiotherapy, Combined Modality Therapy, Disease-Free Survival, Esophageal Neoplasms drug therapy, Esophageal Neoplasms pathology, Esophageal Neoplasms radiotherapy, Feasibility Studies, Female, Fluorouracil administration & dosage, Humans, Male, Middle Aged, Neoadjuvant Therapy, Neoplasm Staging, Paclitaxel administration & dosage, Prospective Studies, Remission Induction, Survival Rate, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Esophageal Neoplasms therapy
- 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., 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.
- Published
- 2008
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