Pilot study of intraoperative chemotherapy with cisplatin and 5-fluorouracil in patients with advanced squamous cell carcinoma of the head and neck

Background. Intraoperative manipulation of the tumor during cancer surgery has long been recognized as a source of metastasis and contamination of the surgical wound during tumor removal. We explored the use of intraoperative chemotherapy to minimize the risk of tumor cell implantation and metastasis during head and neck cancer surgery and conducted a dose escalating intraoperative chemotherapy clinical trial designed to assess the feasibility of this approach and associated toxicities in patients with advanced squamous cell carcinoma of the head and neck. Methods. Fourteen patients were treated with 5‐fluorouracil at a dose of 1000 mg/m2 administered intravenously over an 8‐hour period during the surgery with simultaneous cisplatin. The cisplatin dose was escalated and toxicity observed. Cisplatin at 75 mg/m2 was chosen as the maximum tolerated dose level. Results. One patient experienced a grade 3 nephrotoxicity, 1 patient a grade 1 neuropathy, and 5 patients grade 2 nausea (36%). There were no grade 4 toxicities. Conclusion. Intraoperative chemotherapy is feasible, and the combination of cisplatin at 75 mg/m2 and 5‐fluorouracil at 1000 mg/m2 can be administered during surgery without significant toxicity. © 2006 Wiley Periodicals, Inc. Head Neck, 2007.