Macroscopic Hematuria after Conventional or Hypofractionated Radiotherapy: Results from a Prospective Phase III Study

Publication date: Available online 25 May 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Giuseppe Sanguineti, Fabio Arcidiacono, Valeria Landoni, Bianca Maria Saracino, Alessia Farneti, Stefano Arcangeli, Maria Grazia Petrongari, Sara Gomellini, Lidia Strigari, Giorgio Arcangeli
PurposeTo assess macroscopic hematuria rates within a single institution randomized phase III trial comparing dose escalated, conventionally fractionated radiotherapy (CFRT) vs moderately hypofractionated RT (MHRT) for localized prostate cancer.Methods and MaterialsPatients with intermediate to high risk localized prostate cancer were treated with conformal radiotherapy and short-course androgen deprivation. Both the prostate and the entire seminal vesicles were treated to 80 Gy in 40 fractions over 8 weeks (CFRT) or 62 Gy in 20 fractions over 5 weeks (MHRT). The endpoint of this study is the development of any episode/grade of macroscopic hematuria. Median follow-up is 93 months (range: 6-143 months).ResultsMacroscopic hematuria was reported by 25/168 (14.9%) patients. The actuarial estimate of hematuria at 8 yrs is 17.0% (95%CI: 10.7%-23.3%). The number of patients with hematuria was 6 vs 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-yr estimate of 9.7% and 24.3% (HR: 3.468, 95%CI: 1.385-8.684, p=0.008). Overall, 8/25 patients were found to have a biopsy-proven urothelial carcinoma (CFRT: 3 pts; MHRT: 5 pts, p=0.27). Nevertheless, the 8-yr actuarial incidence of macroscopic hematuria (after censoring urothelial cancer-related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (HR: 4.961, 95%CI: 1.426-17.263, p=0.012). The results were confirmed at multivariate analysis after taking into account several patient, treatment and tumor related covariates.ConclusionMHRT is associated with a statistically significant increased risk of macroscopic hematuria over CFRT.

Teaser

Despite favorable radiobiologic expectations, the present study shows that moderate hypofractionation was associated with a significantly higher incidence of macroscopic hematuria than conventionally fractionated radiotherapy for localized prostate cancer within a prospective randomized trial.


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