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Toxicity profile and Patient-Reported outcomes following salvage Stereotactic Ablative Radiation Therapy to the prostate Bed: The POPART multicentric prospective study.
Ferrario, Federica; Franzese, Ciro; Faccenda, Valeria; Vukcaj, Suela; Belmonte, Maria; Lucchini, Raffaella; Baldaccini, Davide; Badalamenti, Marco; Andreoli, Stefano; Panizza, Denis; Magli, Alessandro; Scorsetti, Marta; Arcangeli, Stefano.
Afiliación
  • Ferrario F; School of Medicine and Surgery, University of Milan Bicocca, 20126 Milan, Italy.
  • Franzese C; Department of Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy.
  • Faccenda V; Department of Biomedical Sciences, Humanitas University, 20090 Pieve Emanuele (MI), Italy.
  • Vukcaj S; Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, 20089 Rozzano (MI), Italy.
  • Belmonte M; Department of Medical Physics, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy.
  • Lucchini R; Department of Radiation Oncology, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy.
  • Baldaccini D; School of Medicine and Surgery, University of Milan Bicocca, 20126 Milan, Italy.
  • Badalamenti M; Department of Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy.
  • Andreoli S; School of Medicine and Surgery, University of Milan Bicocca, 20126 Milan, Italy.
  • Panizza D; Department of Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy.
  • Magli A; Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, 20089 Rozzano (MI), Italy.
  • Scorsetti M; Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, 20089 Rozzano (MI), Italy.
  • Arcangeli S; Department of Medical Physics, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy.
Clin Transl Radiat Oncol ; 44: 100704, 2024 Jan.
Article en En | MEDLINE | ID: mdl-38111610
ABSTRACT

Background:

While SBRT to the prostate has become a valuable option as a radical treatment, limited data support its use in the postoperative setting. Here, we report the updated results of the multicentric Post-Prostatectomy Ablative Radiation Therapy (POPART) trial, investigating possible predictors of toxicities and patient-reported outcomes.

Methods:

Patients with PSA levels between 0.1-2.0 ng/mL after radical prostatectomy received Linac-based SBRT to the prostate bed in five fractions every other day for a total dose of 32.5 Gy (EQD21.5 = 74.3 Gy). Late toxicity was assessed using CTCAE v.5 scale, while EPIC-CP, ICIQ-SF, IIEF 5 questionnaires and PSA levels measured quality of life and biochemical control. Pre- and post-treatment scores were compared using a paired t-test, with MID established at > 0.5 pooled SD from the baseline. A logistic regression analysis was performed to evaluate potential associations between specific patient/tumor/treatment factors and outcome deterioration.

Results:

From April 2021 to April 2023 a total of 50 pts were enrolled and treated. Median follow-up was 12.2 (3-27) months. No late ≥ G2 GI or GU toxicity was registered. Late G1 urinary and rectal toxicities occurred in 46 % and 4 % of patients, respectively. Among 47 patients completing all EPIC-CP domains, four (9 %) showed worsened QoL, and eleven (26 %) developed erectile dysfunction correlating with PTV D2% (P = 0.032). At Multivariate analysis bladder wall D10cc independently correlated with late G1 GU toxicity (P = 0.034). Median post-treatment PSA nadir was 0.04 ng/mL (0.00 - 0.84). At the last follow-up, six patients presented with biochemical failure, including two nodal relapses.

Conclusions:

Our findings show that post-prostatectomy SBRT did not result in increased toxicity nor a significant decline in QoL measures, thus showing that it can be safely extended to the postoperative setting. Long-term follow-up and randomized comparisons with different RT schedules are needed to validate this approach.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Transl Radiat Oncol Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Irlanda

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Transl Radiat Oncol Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Irlanda