title: Immunological and side effects of low sc recombinant interleukin-2 dose in addition to conventional treatment in relapsed breast and colorectal cancer patients.
abstract: Thirteen relapsed cancer patients, four of them operated for colorectal and the nine remaining for breast cancer, were cyclically given low subcutaneous (sc) recombinant interleukin-2 (rIL-2) doses in addition to chemo- or hormone therapy. Cycle intervals were 2 or 6 weeks in length, and the number of cycles ranged from one to 14 and from one to six respectively. Tolerance assessed by clinical and laboratory data, eosinophils, lymphocytes (total number), T subpopulations, B lymphocytes and NK cells were the evaluated parameters. One (7.6%) of the 13 studied patients interrupted the first low dose sc rIL-2 cycle due to a hypersensitive reaction. This case showed relapse from breast cancer. During further cycles, three patients (25%), one operated on for colorectal and two others for breast cancer of the 12 remaining cases who completed all rIL-2 cycles showed an increase in glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), gamma-gt, and creatininemia without any clinical symptoms. A slight influenza-like syndrome and 10-20 mmHg decrease in blood pressure sporadically occurred in all patients under rIL-2 therapy. In both cancer types, a significant (P < 0.05 - P < 0.001) increase in lymphocytes, eosinophils. T4 and T3 subpopulations but not in T8 subpopulations and NK cells occurred at the end of the rIL-2 cycles. In 11 of the 13 patients responsive to conventional therapy, a highly significant increase (P < 0.001) in all parameters apart from B lymphocytes and T4/T8 ratio was observed, while in three cases which were no longer responsive and in another case which had never been responsive to conventional therapy, a slightly significant increase in eosinophils only occurred (P < 0.05). Three colorectal cancer patients showed a partial response and the last a complete response to conventional therapy. In these four patients, time to progression during rIL-2 cycles ranged from 2.5-5 months and the duration of response ranged from 8-19 months. In seven of the eight breast cancer patients who completed all rIL-2 cycles, the response ranged from 3-51+ months and in the last case, which was not responsive to conventional therapy, the disease progressed in spite of the addition of rIL-2. These data suggest that: a) rIL-2 is likely to constitute a well-tolerated and suitable home therapy even when cyclically given for a prolonged period; b) following rIL-2 administration, eosinophils and lymphocytes increase in addition to the T subpopulations.
authors.affiliation: Institute of Clinical Medicine University of Pisa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Nicolini
authors.forename: P A
authors.initials: PA
authors.lastname: Mancini
authors.forename: P
authors.initials: P
authors.lastname: Ferrari
authors.forename: L
authors.initials: L
authors.lastname: Anselmi
authors.forename: A
authors.initials: A
authors.lastname: Sagripanti
authors.forename: A
authors.initials: A
authors.lastname: Carpi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000601:surgery; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011182:Postoperative Care; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins