title: Thymopentin and interleukin-2 in combination with 5-fluorouracil and leucovorin in metastatic colorectal adenocarcinoma: preliminary results.
abstract: Thymic hormones have been shown to exhibit immunorestorative effects in vivo and in vitro, and to enhance the expression of high affinity interleukin-2 (IL-2) receptors on normal human lymphocytes stimulated with phytohemagglutinin. Based on these data, a clinical trial was initiated to determine the effects of the combination of 5-fluorouracil (5-FU) and folinic acid (FA) with thymopentin (TP-5) and interleukin-2 (IL-2) in patients with advanced colorectal carcinoma. Fifteen patients were treated with FA, 200 mg/m2/day by IV bolus, and 5-FU, 400 mg/m2/day as a 30-minute infusion, both given for 5 consecutive days every 28 days. TP-5, 50 mg/day, was administered subcutaneously on days 8-11, and IL-2, 9 million IU/m2 twice daily, was given subcutaneously on days 12-16. Of 8 patients evaluable for response, 4 achieved a response. Two patients had stable disease, and two progressed during treatment. There were no instances of life-threatening toxicity. Two patients developed grade III stomatitis and diarrhea followed by leukopenia and fever, requiring hospitalization. Other toxicities were moderate. These results are only preliminary, and a larger number of patients and longer follow-up are needed to draw meaningful conclusions about the merits of this new approach in cancer treatment.
authors.affiliation: Department of Medical Oncology II, Regina Elena Institute for Cancer Research, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Lopez
authors.forename: L
authors.initials: L
authors.lastname: Di Lauro
authors.forename: T
authors.initials: T
authors.lastname: Gionfra
authors.forename: G
authors.initials: G
authors.lastname: Gandolfo
authors.forename: F
authors.initials: F
authors.lastname: Ameglio
authors.forename: G
authors.initials: G
authors.lastname: Paoletti
mesh_terms: D000230:Adenocarcinoma / Q000556:secondary / Q000628:therapy*; D015179:Colorectal Neoplasms / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D002955:Leucovorin / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D016305:Thymopentin / Q000627:therapeutic use*
chemical_list: D007376:Interleukin-2; D016305:Thymopentin; D002955:Leucovorin; D005472:Fluorouracil