title: 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.
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.
authors.affiliation: Mayo Clinic, Rochester, Minnesota, USA. jatoi.aminah@mayo.edu.
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: James
authors.initials: J
authors.lastname: Martenson
authors.forename: Michelle R
authors.initials: MR
authors.lastname: Mahoney
authors.forename: Bradley S
authors.initials: BS
authors.lastname: Lair
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Brindle
authors.forename: Frank
authors.initials: F
authors.lastname: Nichols
authors.forename: Normand
authors.initials: N
authors.lastname: Caron
authors.forename: Kendrith
authors.initials: K
authors.lastname: Rowland
authors.forename: Loren
authors.initials: L
authors.lastname: Tschetter
authors.forename: Steven
authors.initials: S
authors.lastname: Alberts