Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy

Results From a Prospective Phase 3 Study

Giuseppe Sanguineti, Fabio Arcidiacono, Valeria Landoni, Bianca Maria Saracino, Alessia Farneti, Stefano Arcangeli, Maria Grazia Petrongari, Sara Gomellini, Lidia Strigari, Giorgio Arcangeli

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT 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 the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.

Original languageEnglish
Pages (from-to)304-312
Number of pages9
JournalInternational Journal of Radiation Oncology Biology Physics
Volume96
Issue number2
DOIs
Publication statusPublished - Oct 1 2016

Fingerprint

hematuria
Hematuria
radiation therapy
Radiotherapy
confidence
cancer
Confidence Intervals
intervals
hazards
Prostatic Neoplasms
deprivation
Seminal Vesicles
estimates

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy : Results From a Prospective Phase 3 Study. / Sanguineti, Giuseppe; Arcidiacono, Fabio; Landoni, Valeria; Saracino, Bianca Maria; Farneti, Alessia; Arcangeli, Stefano; Petrongari, Maria Grazia; Gomellini, Sara; Strigari, Lidia; Arcangeli, Giorgio.

In: International Journal of Radiation Oncology Biology Physics, Vol. 96, No. 2, 01.10.2016, p. 304-312.

Research output: Contribution to journalArticle

Sanguineti, Giuseppe ; Arcidiacono, Fabio ; Landoni, Valeria ; Saracino, Bianca Maria ; Farneti, Alessia ; Arcangeli, Stefano ; Petrongari, Maria Grazia ; Gomellini, Sara ; Strigari, Lidia ; Arcangeli, Giorgio. / Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy : Results From a Prospective Phase 3 Study. In: International Journal of Radiation Oncology Biology Physics. 2016 ; Vol. 96, No. 2. pp. 304-312.
@article{7900547d24a04b5c810540a887be2ca2,
title = "Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy: Results From a Prospective Phase 3 Study",
abstract = "Purpose To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT 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 the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results Macroscopic hematuria was reported by 25 of 168 patients (14.9{\%}). The actuarial estimate of hematuria at 8 years was 17.0{\%} (95{\%} confidence interval [CI] 10.7{\%}-23.3{\%}). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7{\%} and 24.3{\%}, respectively (hazard ratio 3.468, 95{\%} CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1{\%} and 18.2{\%} after CFRT and MHRT, respectively (hazard ratio 4.961, 95{\%} CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.",
author = "Giuseppe Sanguineti and Fabio Arcidiacono and Valeria Landoni and Saracino, {Bianca Maria} and Alessia Farneti and Stefano Arcangeli and Petrongari, {Maria Grazia} and Sara Gomellini and Lidia Strigari and Giorgio Arcangeli",
year = "2016",
month = "10",
day = "1",
doi = "10.1016/j.ijrobp.2016.05.017",
language = "English",
volume = "96",
pages = "304--312",
journal = "International Journal of Radiation Oncology Biology Physics",
issn = "0360-3016",
publisher = "Elsevier Inc.",
number = "2",

}

TY - JOUR

T1 - Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy

T2 - Results From a Prospective Phase 3 Study

AU - Sanguineti, Giuseppe

AU - Arcidiacono, Fabio

AU - Landoni, Valeria

AU - Saracino, Bianca Maria

AU - Farneti, Alessia

AU - Arcangeli, Stefano

AU - Petrongari, Maria Grazia

AU - Gomellini, Sara

AU - Strigari, Lidia

AU - Arcangeli, Giorgio

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Purpose To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT 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 the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.

AB - Purpose To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT 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 the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.

UR - http://www.scopus.com/inward/record.url?scp=84994507743&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84994507743&partnerID=8YFLogxK

U2 - 10.1016/j.ijrobp.2016.05.017

DO - 10.1016/j.ijrobp.2016.05.017

M3 - Article

VL - 96

SP - 304

EP - 312

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

SN - 0360-3016

IS - 2

ER -