Induction cisplatin and paclitaxel followed by combination chemoradiotherapy with 5-fluorouracil, cisplatin, and paclitaxel before resection in localized esophageal cancer: a phase II report.

Abstract

BACKGROUND:

Multimodality therapy for esophageal cancer holds promise for improving outcome in this lethal disease. On the basis of encouraging data from a phase I trial, we conducted a phase II study of preoperative chemotherapy, followed by concurrent chemoradiotherapy and surgery.

METHODS:

Patients with clinically staged resectable esophageal cancer were treated with induction cisplatin and paclitaxel, followed by 45 Gy of external beam radiation with concurrent infusional 5-fluorouracil and weekly cisplatin and paclitaxel. Four to eight weeks after multimodality induction, esophagectomy was performed in suitable patients. Study end points were survival, pathologic complete response, and toxicity.

RESULTS:

Twenty-one patients were enrolled with a median age of 58 years, and all patients were clinically staged II or III. Sixteen (76.2%) patients completed the trial, of whom four (25%) had a pathologic complete response. One patient died from postoperative complications. Grade 3 or 4 toxicity was observed in 76% of patients, and dose-limiting toxicity was seen in 6 of the first 14 patients, thus necessitating a planned dose reduction of paclitaxel. At a median follow-up of 30 months, 13 patients remain alive. The 2-year disease-specific survival for the study population was 78%.

CONCLUSIONS:

This regimen of multimodality therapy before resection resulted in an encouraging 2-year survival rate but a disappointing rate of pathologic complete response and was toxic, necessitating a predetermined paclitaxel dose reduction. The incorporation of taxanes into induction strategies for esophageal cancer seems promising, but the optimal schedule remains undefined.

• Authors: Leonard R Henry, Melvyn Goldberg, Walter Scott, Andre Konski, Neal J Meropol, Gary Freedman, Louis M Weiner, Perry Watts, Mary Beard, Susan McLaughlin, Jonathan D Cheng
• Journal: Annals of surgical oncology (Ann Surg Oncol) Vol. 13 Issue 2 Pg. 214-20 (Feb 2006) ISSN: 1068-9265 [Print] United States
• PMID: 16418887 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Paclitaxel
• Cisplatin
• Fluorouracil

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Cisplatin (administration & dosage)
• Drug Administration Schedule
• Esophageal Neoplasms (mortality, pathology, therapy)
• Esophagectomy
• Female
• Fluorouracil (administration & dosage)
• Humans
• Male
• Middle Aged
• Neoadjuvant Therapy (adverse effects, methods)
• Paclitaxel (administration & dosage)
• Postoperative Complications
• Radiotherapy Dosage
• Remission Induction
• Survival Rate