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Efficacy of treatment with AM3 (inmunoferon) in the prevention of proctitis in patients with prostate carcinoma treated with radiotherapy.

4741 Background: Proctitis and cystitis are known complications of radiotherapy of pelvic malignancies. Radiation-induced mucosal lesions increase the risk of infectious complications and reduce patient quality of life. Furthermore, cystitis and/or proctitis often interfere with therapeutic radiation schedule reducing its potential benefits. AM3 (Inmunoferon) is a protein-associated polysaccharide with proven immunomodularoty effects. Oral AM3 treatment promotes: (a) enhancement of the innate and acquired immune responses against infectious agents (b) reduced production of proinflamatory cytokines, and (c) increased secretion of regulatory cytokines such as granulocyte-monocyte colony stimulation factor. Herein, we have investigated the potential effects of AM3 on the prevention of radiotherapy-induced proctitis and cystitis.


METHODS
24 consecutive patients with histologically-proven diagnosis of prostate carcinoma were treated with prostate tridimensional radiation. 15 patients received adjuvant treatment with oral AM3 at a dose of 3 g per day from the first day of radiation treatment (180 cGy/fraction, total dose 7032±284 cGy). Daily AM3 was mainteined for 30 days after completion of radiotherapy. 9 patients did not receive AM3 (control group, total dose 6702 ± 391 cGy). Patients follow-up was performed for 90 days after radiotherpy.


RESULTS
The incidence of radiation induced proctitis was significantly lower in the AM3 arm (40%) than in controls (89% ) (p=0.033). The mean time for the appearance of proctitis was significantly delayed in AM3 arm (44 days) with respect to control group (22 days) (p=0.005). The clinical intensity of cystitis was lower in the AM3 arm than in controls(47% and 67% of grade II, respectively). Serum levels of proinflammatory cytokines (TNFalpha, IL-1 and 6) remained stable along the follow up in the AM3 arm.


CONCLUSIONS
In this prospective controlled pilot study, treatment with the AM3 immunomodulator significantly reduces the incidence of radiation-induced proctitis in prostate carcinoma patients. No significant financial relationships to disclose.