Effects of a preoperative course of interleukin-2 on surgical and immunobiological variables in patients with colorectal cancer: a phase 2 study.
OBJECTIVE
A phase 2 study to evaluate the effects of a short preoperative course of interleukin-2 (IL-2) on the postoperative course of patients with cancer.


METHODS
Open study.


METHODS
San Gerardo Hospital, Monza, Italy.


METHODS
16 Consecutive patients with locally advanced colorectal cancer, with or without metastases.


METHODS
IL-2 in a dose of 9 x 10(6) IU/m2 twice daily for three days; patients were operated on within 36 hours of the cessation of IL-2 treatment.


METHODS
Morbidity, mortality, and changes in numbers of lymphocytes, T lymphocytes, natural killer (NK) cells, and CD25 (cluster of determination) positive cells.


RESULTS
There was no morbidity or mortality--in particular, there were no infections even in the patients who were at highest risk. The mean numbers of lymphocytes, T lymphocytes, NK cells, and CD25 positive cells increased significantly during the postoperative period. All patients showed evidence of infiltration of lymphocytes or eosinophils (or both) into the tumour tissue.


CONCLUSIONS
The results suggest that a three day course of IL-2 preoperatively is well tolerated, stimulates would repair, neutralizes the lymphocytopenia induced by major operation, and induces immune cells to infiltrate the tumour. Randomised studies are needed to confirm these results.
Brivio
F
F
Second Division of Surgery, San Gerardo Hospital, Monza, Milano, Italy.
Lissoni
P
P
Barni
S
S
Tancini
G
G
Ardizzoia
A
A
Erba
L
L
Alderi
G
G
Nociti
V
V
D000328:Adult; D000368:Aged; D002277:Carcinoma / Q000276:immunology / Q000601:surgery* / Q000628:therapy*; D003110:Colonic Neoplasms / Q000276:immunology / Q000601:surgery* / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D007694:Killer Cells, Natural / Q000473:pathology; D007958:Leukocyte Count; D008213:Lymphocyte Activation; D008214:Lymphocytes / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D011292:Premedication; D012004:Rectal Neoplasms / Q000276:immunology / Q000601:surgery* / Q000628:therapy*; D013601:T-Lymphocytes / Q000473:pathology; D014945:Wound Healing
D007376:Interleukin-2