title: A randomized prospective trial comparing full dose chemotherapy to 131I antiferritin: an RTOG study.
abstract: A previously reported Phase I/II multimodality program for non-resectable hepatocellular cancer began with external beam-radiation and chemotherapy, followed by administration of 131I antiferritin-specific radioimmunoglobulin and led to a 48% remission (7% complete remission and 41% partial remission). Survival and response depended on alpha fetoprotein status. AFP+ patients had a median survival of 5 months; AFP- patients had a median survival of 10.5 months. No acute effects occurred relative to treatment with radiolabeled antibody. A randomized prospective study was designed to compare full dose chemotherapy consisting of 60 mg/m2, doxorubicin and 500 mg/m2 of 5-fluorouracil administered every 3 weeks, to 131I antiferritin administration every 8 weeks and allowed for crossover treatment if tumor progression occurred. Overall, radiolabeled antibody administration and full dose chemotherapy led to equivalent partial remission rates (22-30% vs 23-25%) and survival rates compared to chemotherapy (6 month median; AFP+ 5 months; AFP- 10 months). The most important new observations were the response in AFP- patients who, following chemotherapy failure, achieved remission using 131I radiolabeled antibody (7/11) and a subset of patients (7%) who were treated with radiolabeled antibody and converted from non-resectable to resectable status followed by surgical excision.
authors.affiliation: Johns Hopkins Oncology Center, Department of Radiation Oncology and Medical Oncology, Baltimore, MD 21205.
authors.forename: S
authors.initials: S
authors.lastname: Order
authors.forename: T
authors.initials: T
authors.lastname: Pajak
authors.forename: S
authors.initials: S
authors.lastname: Leibel
authors.forename: S
authors.initials: S
authors.lastname: Asbell
authors.forename: P
authors.initials: P
authors.lastname: Leichner
authors.forename: D
authors.initials: D
authors.lastname: Ettinger
authors.forename: G
authors.initials: G
authors.lastname: Stillwagon
authors.forename: J
authors.initials: J
authors.lastname: Herpst
authors.forename: T
authors.initials: T
authors.lastname: Haulk
authors.forename: K
authors.initials: K
authors.lastname: Kopher
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy / Q000453:epidemiology / Q000628:therapy*; D003131:Combined Modality Therapy; D004317:Doxorubicin / Q000008:administration & dosage; D005293:Ferritins / Q000276:immunology*; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy / Q000453:epidemiology / Q000628:therapy*; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D015996:Survival Rate
chemical_list: D000911:Antibodies, Monoclonal; D007457:Iodine Radioisotopes; D004317:Doxorubicin; D005293:Ferritins; D005472:Fluorouracil