title: Perinodular injection of thymopentin (TP5) in cutaneous and subcutaneous metastases of melanoma.
abstract: The potential therapeutic efficacy of TP5 in patients with cutaneous and subcutaneous metastases of melanoma was tested in a double-blind study comparing the drug and placebo injected perinodularly. Of the 47 nodules present in the 16 patients treated with TP5, 24 showed a measurable response, whereas only one out of 15 nodules in patients treated with a placebo showed a minor response (P = 0.02). In two patients treated with TP5 a response of two nodules not perinodularly injected was also observed. Sclerosis, CD45RO+ cells and MIB 1- cells were more frequently observed in nodules treated with TP5 than with placebo. (P = 8 x 10(-4); 0.03 and 0.01, respectively). Evaluating the trends of these findings in nodules treated with placebo; with TP5-treated, non-responding nodules; or with TP5-treated, responding, a positive trend was observed for sclerosis and CD45RO+ cells (P = 5 x 10(-4) and 2 x 10(-3), respectively) and a negative one for MIB 1 cells (P = 2 x 10(-3)). These preliminary data suggest that lymphoid cells associated with nodules regression are activated large lymphocytes (CD45RO+ and CD3-). Sclerosis might be interpreted as the final morphologic event, and reduction of proliferative activity (MIB 1- cells) as the consequence of cytolytic action.
authors.affiliation: Division of Surgical Oncology B, National Cancer Institute, Milan, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Cascinelli
authors.forename: C
authors.initials: C
authors.lastname: Clemente
authors.forename: R
authors.initials: R
authors.lastname: Bufalino
authors.forename: M
authors.initials: M
authors.lastname: Baldini
authors.forename: L
authors.initials: L
authors.lastname: Mascheroni
authors.forename: S
authors.initials: S
authors.lastname: Zurrida
authors.forename: M C
authors.initials: MC
authors.lastname: Mihm
mesh_terms: D017252:CD3 Complex / Q000032:analysis; D004311:Double-Blind Method; D006801:Humans; D007267:Injections; D017493:Leukocyte Common Antigens / Q000032:analysis; D016131:Lymphocyte Subsets / Q000276:immunology; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D012598:Sclerosis; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D016305:Thymopentin / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D017252:CD3 Complex; D017493:Leukocyte Common Antigens; D016305:Thymopentin