Early adverse events and patient-reported outcomes after salvage radiotherapy following prostatectomy according to fractionation schedule: Interim analysis of the phase III URONCOR 06-24 trial.
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Couñago Felipe, González Carmen, Gómez-Iturriaga Alfonso, Álvarez Ana, Santos Marina, Boladeras Ana, García Nagore, Fernández Sandra, Guardado Sandra, Ocanto Abrahams, Gonsalves Daniela, Glaría Luis, Castaño Ana, Martín Patricia, Montezuma Laura, Mera Arantxa, Mases Joel, Meca Gerard, Duque-Santana Víctor, Olivera Jesús, Pérez Sara, Henriquez Ivan, Malavé Bárbara, Rodríguez Aurora, García Rafael, Büchser David, Garre Josep, Altabas Manuel, Valero Jeannette, García-Gómez Raquel, Berenguer Miguel, Calvo Ángel, Ordoñez Rafael, Willisch Patricia, Candal Aldara, Aymar Neus, Mayrata Esther, López-Campos Fernando
Аннотация
MATERIALS AND METHODS: This prespecified interim analysis included the first 250 patients enrolled in the URONCOR 06-24 randomized trial (NCT05781217). SRT was delivered using moderate hypofractionation (n = 175), most commonly 62.5 Gy in 25 fractions (80.5%), followed by 65.25 Gy in 29 fractions (7.5%), 60 Gy in 24 fractions (4.6%), and 52.5 Gy in 20 fractions (2.9%), corresponding to a biologically equivalent dose (EQ.D2) of approximately 65-71 Gy (α/β = 1.5), or conventional fractionation (n = 75; 66-70 Gy in 33-35 fractions). Adverse events were assessed using CTCAE v5.0. PROs were evaluated using EPIC-26 and EORTC QLQ-C30 at baseline, 3, and 6 months.
RESULTS: With a median follow-up of 12.7 months, grade ≥ 2 genitourinary (GU) adverse events occurred in 21.7% of patients treated with hypofractionation versus 17.3% with conventional fractionation (p = 0.431). Grade ≥ 2 gastrointestinal (GI) adverse events occurred in 10.8% and 4.0%, respectively (p = 0.079). Pelvic nodal irradiation was more frequent in the hypofractionation group (39.4% vs 13.3%, p = 0.001). On multivariable analysis, age was associated with increased risk of GU ≥2 adverse events, while pelvic nodal irradiation was associated with increased risk of GI ≥2 adverse events. No clinically meaningful differences were observed in PROs.
CONCLUSION: Early adverse events after SRT were low and comparable between fractionation schedules, and moderate hypofractionation showed a similar safety profile despite more frequent pelvic irradiation. However, given the non-randomized nature of the fractionation schedules, longer follow-up and robust adjustment for treatment-selection biases are needed before drawing definitive conclusions regarding comparative safety.