Use of Proktis-M suppositories in patients undergoing neoadjuvant radiochemotherapy for adenocarcinoma of the rectum

Generally speaking, the negative side of radiation treatment of the pelvic district is the toxicity that may compromise the patient's quality of life and lead to temporary suspension of treatment with possible negative effects on its effectiveness. In neoadjuvant radiochemotherapy for locally advanced rectal cancer (LARC), the toxicity that is most frequently observed is proctitis, usually treated with topical corticosteroids or mesalazine. Hyaluronic acid's function is to restore the regular trophism and elasticity of the connective tissues leading to faster repair of the damage, and this could represent a viable option for the control of actinic proctitis.

Since March 2012, a neoadjuvant radiochemotherapy protocol has been active at the Pisa Universitary Hospital for patients with LARC; 23 patients have been enrolled up to the present. Treatment involves an induction chemotherapy phase according to the FOLFOXIRI + Bevacizumab regimen for 6 cycles, followed by chemotherapy (capecitabina + Bevacizumab) concomitant with radiotherapy (5040 cGy in 28 fractions). Surgery is scheduled 6-8 weeks after the end of RTCT. During the course of associated treatment (RTCT), 12/23 patients received topical therapy with hyaluronic acid (Proktis-M suppositories) for the prevention of proctitis.

All 23 patients enrolled in the study completed the induction chemotherapy phase. In the first 11 enrolled patients who did not receive prior Proktis-M suppositories, intense rectal toxicity was observed. Proctalgia of grade G1-2 and G3-4 presented respectively in 64% and 36% of cases, with consequent interruption of treatment which, in 45% of patients, lasted longer than 10 days. In the remaining 12 patients who underwent prior treatment with Proktis-M suppositories, the percentage of rectal toxicity was lower. In those cases where it did present, onset was later and its intensity and duration lower. 25% of patients did not develop proctalgia, 33% developed proctalgia of grade G1 and 42% proctalgia of grade G2. In none of these was it found necessary to interrupt radiochemotherapy.

Prior topical treatment with Proktis-M suppositories in patients undergoing preoperative RTCT for LARC, enabled us to carry out radiochemotherapy at scheduled times, so protecting the treatment's effectiveness on the down-staging of the disease and preserving the patient's quality of life.