Twenty-two patients with advanced colorectal carcinoma were enrolled in this study. Ten patients had received prior chemotherapy that included the combination of fluorouracil (5-FU) and leucovorin (LV). All patients required subcutaneous port insertion and portable external infusion pumps to allow outpatient treatment. 5-FU (2,600 mg/m2) was administered concurrently with LV (500 mg/m2) over 24 hours of continuous infusion. The mean steady-state plasma concentration of 5-FU was 10 mumol/L (range, 7 to 14 mumol/L). The 5-FU dose was based on our previous phase I study, in which maximum-tolerated dose (MTD) of 5-FU was determined to be 2,600 mg/m2 in combination with a fixed dose of LV at 500 mg/m2. The treatment was repeated weekly. Twenty-two patients received a total of 560 courses of treatment. Eleven instances of grade 2-3 toxicity were observed: diarrhea (five), stomatitis (three), hand/foot syndrome (three). The overall objective response was 45% (10 of 22) and among previously untreated patients was 58%. Three of the responders achieved complete response (CR), with lung and liver as the metastatic sites. The median duration of survival for the previously untreated patients was not reached at 22 months, and was 10 months for the previously treated patients. These results suggest that short-term infusional therapy of 5-FU and LV in patients with advanced metastatic colorectal cancer generates acceptable toxicity, with equivalent or superior survivability in previously treated and untreated patients versus alternative methods of administration of the two agents.

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15541 Management of Stage III or IV Head and Neck (H&N) cancer is debatable. Standard of care is Radical Surgery (Sx) followed by Radiotherapy (XRT). However, cosmetic and functional complications are distressing and result in decreased quality of life. Therefore, organ preservation has become important when deciding best management. The VA larynx study, the EORTC 24891 and the 91–11 US intergroup trial have shown efficacy of organ preserving chemoradiotherapy (Cx+Rx) comparable to Sx and XRT. These studies are limited to laryngeal and hypopharyngeal cancers and whether same principles can be applied to other H&N sites is unknown. We conducted a retrospective study of stage III & IV H&N cancer treated at our Institution between 1996–2004 to evaluate survival, organ preservation and toxicities. 45 males between 47 to 83 years (median 59.6) were studied. 87% were white and 13% black. 82% had history of tobacco and alcohol abuse, 4% tobacco only, 11% alcohol only and 2% never smoked or drank. The sites of disease were: nasopharynx 1 (2%), oropharynx 19 (42%), base of tongue 10 (22%), larynx 6 (13%) and pharynx 9 (20%). 15 patients (33%) where stage III and 30 (67%) stage IV. The treatment was combined Cx+Rx. The mean dose of XRT was 6697 Cgy and mean cycles of chemotherapy (Cx) were 2.2. Of those, 42 patients (93%) received cisplatin and 5FU, 2 (4%) carboplatin and 5FU and 1 (2%) carbo only. 10 patients (22%) received additional Cx and 14 (31%) underwent additional Sx (neck dissection). 19 patients (42%) are alive, 19 (42%) are death and 7 (16%) were lost to f/u. Median survival is 30.6 months. 1 patient was refractory and 6 relapsed in less than a year. Among them, 4 were local relapses, 1 a neck recurrence (no prior dissection) and 1 a distant relapse. The most common acute toxicities were: Anemia 87%, neutropenia 64%, hyperglycemia 82%, transient elevation of BUN 60% and creatinine 36%, hypo/hypernatremia 64%, severe mucositis 71%, weight loss 76%, N/V 47% and severe dysphagia 27%. Cx+Rx appears to be a safe, feasible and comparable alternative to Sx regardless of the anatomical origin in locally advanced H&N cancer, with the advantage of organ preservation. Additional XRT boost, Cx or Sx could decrease relapses. Further studies are warranted to validate these hypotheses. No significant financial relationships to disclose.