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Lattanzi JP , Coia LR , Scher RM , Engstrom PF , Hoffman JP , Eisenberg BF , Sigursdson ER , Epstein BE , Weiner LM
A prospective phase I/II study of intra-arterial chemotherapy and escalating doses of radiation therapy for surgically unresectable carcinoma confined to the liver
Gi Cancer. 1997 ;2(2) :111-117
PMID: ISI:000072187300004   
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Purpose: At Fox Chase Cancer Center intra-arterial 5- fluorouracil (5-FU), adriamycin and cisplatin and concurrent hepatic irradiation were studied in a prospective Phase I/II study in patients with biopsy proven inoperable invasive cancer confined to the liver. The purpose of this trial was to employ an escalating dose schedule of radiation to determine the feasibility, toxicity and efficacy of combination intra- arterial chemotherapy and external beam radiation from 0 to 21 Gy. Methods and Materials: Patients received hepatic intra- arterial chemotherapy consisting of 5-FU 1000 mg/m(2)/day, 96 hour infusion, adriamycin 5 mg/m(2)/day bolus for four days and cisplatin 75 mg/m(2) day 1 concomitant with involved field radiation at 300 cGy/day, Total radiation dose ranged from 0 - 2100 cGy as determined by a dose escalation schema of 0, 1200, 1500, 2100 cGy with a minimum of three patients per dose group. The chemotherapy regime was cycled every 28 days. Patients were required to have an ECOG performance status of less than or equal to 2 and measurable disease. Results: Between 2/91 and 11/94, 17 patients were entered. All patients had > 75% of the whole liver irradiated and 6 (35%) had the entire liver treated. Only one patient, treated to 1800 cGy had greater than or equal to Grade 3 hepatic toxicity (Grade 3, elevated SGOT), Hematologic toxicity (greater than or equal to Grade 3) was observed as leukopenia in 12 patients (71%), granulocytopenia in 8 patients (47%), thrombocytopenia in 5 patients (29%), and anemia in 3 patients (18%). There were no treatment-related deaths, No significant diarrhea or nausea/vomiting was observed. Thirteen patients were evaluable for response. Four of 13 (31%) evaluable patients experienced partial response as defined by a greater than or equal to 50% reduction in CT scan measured tumor volume. Six patients (46%) achieved disease stabilization while only 3 patients progressed on treatment. Due to the study design, the trial was terminated prior to determining the maximum tolerated radiation dose, Conclusion: At least 75% of the liver can be irradiated to 2100 cGy with concomitant hepatic intra-arterial infusion of 5-FU, adriamycin and cisplatin without significant hepatic toxicity, and suggests that dose intensification with colony stimulating factor support may provide avenues for effective therapies in patients with unresectable cancers confined to the liver.
Times Cited: 0 English Article YY806 GI CANCER