Destefanis P.(*), Gonella A.(*), Allasia M.(*), Battaglia A.(*), Pisano F.(*), Melloni
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Hyaluronic acid versus standard therapy for the treatment of local side effects in bladder cancer during intravesical therapy: a randomized prospective study
Destefanis P. (*), Gonella A. (*), Allasia M. (*), Battaglia A. (*), Pisano F. (*), Melloni G. (*), Garzino E. (*), Alessandria E. (*),
Bosio A. (*), Gontero P. (*), B. Frea(*) (*)A.O. Città della Salute e della Scienza - Sede Molinette - Dipartimento di Scienze Chirurgiche e Specialistiche - Divisione di Urologia
Introduction and objectives Intravesical chemotherapy (CT) and BCG are the standard treatment for most of the non-muscle invasive bladder cancers (NMIBC). Side effects are common especially for BCG. Many studies report a relationship between intravesical toxicity and glycosaminoglycan (GG) damage on the bladder surface. Hyaluronic acid (HA) is an endogenous GG of extracellular matrix. Some studies suggest that intravesical HA may reduce these symptoms. We started a randomized prospective study to evaluate the efficacy of HA compared to the standard therapy (ST). The primary aim is to evaluate the effectiveness of the HA therapy on symptom relief. The secondary aims are the reduction of inflammation at histopathology findings, the evaluation of the HA toxicity and the possible improvement of cancer intravesical treatment (as a result of a better compliance to the therapy). We present an interim analysis.
Materials and methods NMIBC patients during BCG/CT therapy who experienced local toxicity (WHO grade II or III) were enrolled. Symptoms were evaluated through questionnaires (VAS; IPSS; CPSE-NIH; ICQ- MLUTS; OAB-q SF and BCG symptoms questionnaire). We collect urinalysis, urine culture, abdominal ultrasound, urine cytology and cystoscopy (as follow-up scheme). Enrolled cases were prospectively randomized: GROUP A (GA), HA therapy (instillation of 40mg HA for at least 30 minutes): 1 instillation/week for 6 weeks + 1 instillation/month for 3 months + 1 instillation/every 3 months as maintenance; GROUP B (GB), ST: oxybutynin hydrochloride (2,5 mg/8 hours until symptom relief) + ofloxacin (200mg/12 hours for 10 days). The evaluation steps were fixed at 6 weeks, 3 and 6 months and after 1 year.
Results From December 2011 to March 2014, 17 patients were enrolled (10 GA and 7 GB). In GA none experienced HA side effects and almost all patients referred a decrease in voiding symptoms. Two patients dropped out for tumor progression. In GB 3 patients exited the protocol for the oxybutynin toxicity (severe urinary retention), 3 had mild side effects (dry mouth), 1 finished the protocol with complete benefit. On VAS pain scale GA has 0,75 score at one-year versus 1,25 recorded in GB. VAS pain relief scale shows a better improvement during HA than ST (mean scores 8,5 vs 8,1 at 12 months). CPSE-NIH confirmed better results in GA (mean score 6,75) than in GB (8,75). The ICIQ-MLUTS after 1 year shows excellent symptoms control in GA comparing to GB (average ratings 5 vs 6,25). All the differences resulted statistically significant (p< 0,05).
Discussion HA therapy shows excellent results on BCG/CT local toxicity management. Data need to be confirmed by increasing patients. HA appears useful to treat local symptoms and may be presented as a standard protocol during BCG/CT therapy, to prevent the toxicity and to improve the intravesical treatment of NMIBC.
Conclusions These preliminary results show that intravesical HA is effective in the treatment of grade II-III BCG/CT toxicity being superior to ST.