Research

Results of a planned interim toxicity analysis with trimodality therapy, including carboplatin AUC = 4, paclitaxel, 5-fluorouracil, amifostine, and radiation for locally advanced esophageal cancer: preliminary analyses and treatment recommendations from the North Central Cancer Treatment Group

Aminah Jatoi¹ , James Martenson¹ , Michelle R Mahoney¹ , Bradley S Lair² , Jeffrey S Brindle³ , Frank Nichols¹ , Normand Caron⁴ , Kendrith Rowland⁵ , Loren Tschetter and Steven Alberts¹

¹  Mayo Clinic, Rochester, Minnesota, USA

²  Iowa Oncology Research Association Cancer Cooperative Oncology Program, Des Moines, Iowa, USA

³  Altru Health Systems, Grand Forks, North Dakota, USA

⁴  Toledo Community Hospital Cancer Cooperative Oncology Program, Toledo, Ohio, USA

⁵  Sioux Community Cancer Consortium, Sioux Falls, South Dakota, USA

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International Seminars in Surgical Oncology 2004, 1:9doi:10.1186/1477-7800-1-9

Published:	8 November 2004

Abstract

Purpose

An aggressive trimodality approach from the Minnie Pearl Cancer Research Network [carboplatin AUC = 6, days 1 and 22; 5-fluorouracil 225 mg/m2 continuous infusion, days 1–42, paclitaxel 200 mg/m2, days 1 and 22; 45 Gy] has resulted in remarkable pathologic response rates but notable toxicity. This trial was designed to mitigate this toxicity by starting with a lower carboplatin dose, AUC = 4, and by adding subcutaneous amifostine.

Methods

This phase II trial included patients with locally advanced, potentially resectable esophageal cancer. All were to receive the above regimen with modifications of carboplatin AUC = 4 and amifostine 500 mg subcutaneously before radiation. All were then to undergo an esophagectomy. A planned interim toxicity analysis after the first 10 patients was to determine whether the carboplatin dose should escalate to AUC = 6.

Results

Ten patients were enrolled, and all required dose reductions/omissions during neoadjuvant therapy. One patient died from paclitaxel anaphylaxis. Six patients manifested a complete pathologic response.

Conclusion

With this regimen, carboplatin AUC = 4 for patients with locally advanced esophageal cancer is appropriate.