Autores: Zapatero, A. (Autor de correspondencia); Guerrero, A.; Maldonado, X. ; Alvarez, A. ; Segundo, C. G. S.; Rodriguez, M. A. C.; Macias, V.; Olive, A. P. ; Casas, F.; Boladeras, A.; de Vidales, C. M.; de la Torre, M. L. V.;
Calvo Manuel, Felipe
Resumen:
Purpose: To present data on the late toxicity endpoints of a randomized trial (DART 01/05) conducted to determine whether long-term androgen deprivation (LTAD) was superior to short-term AD (STAD) when combined with high-dose radiation therapy (HDRT) in patients with prostate cancer (PCa). Patients and Methods: Between November 2005 and December 2010, 355 eligible men with cT1c-T3aN0M0 PCa and intermediate-risk and high-risk factors (2005 National Comprehensive Cancer Network criteria) were randomized to 4 months of AD combined with HDRT (median dose, 78 Gy) (STAD) or the same treatment followed by 24 months of AD (LTAD). Treatment-related complications were assessed using European Organization for Research and Treatment of CancereRadiation Therapy Oncology Group and Common Terminology Criteria for Adverse Events v3.0 scoring schemes. Multivariate analyses for late toxicity were done using the Fine-Gray method. Results: The 5-year incidence of grade >= 2 rectal and urinary toxicity was 11.1% and 8.2% for LTAD and 7.6% and 7.3% for STAD, respectively. Compared with STAD, LTAD was not significantly associated with a higher risk of late grade >= 2 rectal toxicity (hazard ratio [HR] 1.360, 95% confidence interval [CI] 0.660-2.790, P=. 410) or urinary toxicity (HR 1.028, 95% CI 0.495-2.130, P=. 940). The multivariate analysis showed that a baseline history of intestinal comorbidity (HR 3.510, 95% CI 1.560-7.930, P=. 025) and the rectal volume receiving > 60 Gy (Vr60) (HR 1.030, 95% CI 1.001-1.060, P=. 043) were the only factors significantly correlated with the risk of late grade >= 2 rectal complications. A history of previous surgical prostate manipulations was significantly associated with a higher risk of grade >= 2 urinary complications (HR 2.427, 95% CI 1.051-5.600, P=. 038). Long-term AD (HR 2.090; 95% CI 1.170-3.720, P=. 012) and a history of myocardial infarction (HR 2.080; 95% CI 1.130-3.810, P=. 018) were significantly correlated with a higher probability of cardiovascular events. Conclusion: Long-term AD did not significantly impact urinary or rectal radiationinduced toxicity, although it was associated with a higher risk of cardiovascular events. Longer follow-up is needed to measure the impact of AD on late morbidity and nonPCa mortality. (C) 2016 Elsevier Inc. All rights reserved.
