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.

• Authors: L van de Schoot, E A P M Romme, M J van der Sangen, G J Creemers, G van Lijnschoten, O J Repelaer van Driel, H J T Rutten, G A P Nieuwenhuijzen
• Journal: Annals of surgical oncology (Ann Surg Oncol) Vol. 15 Issue 1 Pg. 88-95 (Jan 2008) ISSN: 1534-4681 [Electronic] United States
• PMID: 17896144 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Carboplatin
• Paclitaxel
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, pathology, radiotherapy)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carboplatin (administration & dosage)
• Carcinoma, Squamous Cell (drug therapy, pathology, radiotherapy)
• Combined Modality Therapy
• Disease-Free Survival
• Esophageal Neoplasms (drug therapy, pathology, radiotherapy, therapy)
• 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