Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2025
Adjuvant radiotherapy in patients with pathological high-risk bladder cancer: Acute toxicity results from a randomized multicentre phase II trial (Bladder-ART/GETUG-AFU30).
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Sargos Paul, Pignot Géraldine, Bellera Carine, Pommier Pascal, Martin Etienne, Clavere Pierre, Hennequin Christophe, Hoepffner Jean-Luc, Marcq Gautier, Roumiguié Mathieu, Crouzet Sébastien, Cormier Luc, Schartner Vanessa, Huchet Noémie, Pasquier David, Khalifa Jonathan
Аннотация
BACKGROUND AND PURPOSE: Patients with muscle-invasive bladder cancer (MIBC) treated with radical cystectomy remain at significant risk of pelvic recurrence. We aim to report acute toxicity from a multicentric phase II randomized trial evaluating adjuvant radiotherapy (ART).
MATERIALS AND METHODS: Patients with pathological high-risk urothelial MIBC, defined as pT3a-4b and/or pN1-2 and/or positive surgical margins, were randomized (3:1) between ART (arm A) and observation (arm B). ART consisted of IMRT (50.4 Gy / 28 fractions) to the pelvic lymph nodes ± cystectomy bed. The primary endpoint was pelvic recurrence-free survival. Herein, we report on acute toxicity (< 6 months after treatment) using the NCI CTCAE 4.0.
RESULTS: From May 2018 to December 2023, 80 eligible patients from 19 centres across France were enrolled: 58 in arm A and 22 in arm B. The present safety analysis focuses on 74 patients: 52 patients in arm A who effectively initiated ART and 22 in arm B. The median age was 66 years. Chemotherapy (mostly neoadjuvant) was given in 62.2 %. All the patients in the arm A completed the treatment. The rate of grade ≥ 2 and grade ≥ 3 acute gastro-intestinal adverse events (AEs) was 28.8 % and 3.8 %, respectively in arm A, and 4.5 % and 0 % respectively in arm B. Of the two grade ≥ 3 GI AE observed in arm A, one was attributed to surgical complications and the other to disease progression. The rate of grade ≥ 2 and grade ≥ 3 acute urinary AEs was 5.8 % and 0 %, respectively in arm A, and 9.1 % and 4.5 % respectively in arm B. As exploratory analyses, when focusing on AE of grade ≥ 2, these proportions were greater for Arm A (28.8 % [n = 15] vs. 4.5 % [n = 1]; p = 0.028, Fisher's exact test). Overall, no radiotherapy-related grade ≥ 3 AE was observed.
CONCLUSION: From a randomized multicentric phase II trial, despite a logical higher rate of radiotherapy-related AE in the experimental arm, low rates of moderate to severe acute toxicity suggest the safety of ART for pathological high-risk MIBC. Efficacy end-points results are awaited.
MATERIALS AND METHODS: Patients with pathological high-risk urothelial MIBC, defined as pT3a-4b and/or pN1-2 and/or positive surgical margins, were randomized (3:1) between ART (arm A) and observation (arm B). ART consisted of IMRT (50.4 Gy / 28 fractions) to the pelvic lymph nodes ± cystectomy bed. The primary endpoint was pelvic recurrence-free survival. Herein, we report on acute toxicity (< 6 months after treatment) using the NCI CTCAE 4.0.
RESULTS: From May 2018 to December 2023, 80 eligible patients from 19 centres across France were enrolled: 58 in arm A and 22 in arm B. The present safety analysis focuses on 74 patients: 52 patients in arm A who effectively initiated ART and 22 in arm B. The median age was 66 years. Chemotherapy (mostly neoadjuvant) was given in 62.2 %. All the patients in the arm A completed the treatment. The rate of grade ≥ 2 and grade ≥ 3 acute gastro-intestinal adverse events (AEs) was 28.8 % and 3.8 %, respectively in arm A, and 4.5 % and 0 % respectively in arm B. Of the two grade ≥ 3 GI AE observed in arm A, one was attributed to surgical complications and the other to disease progression. The rate of grade ≥ 2 and grade ≥ 3 acute urinary AEs was 5.8 % and 0 %, respectively in arm A, and 9.1 % and 4.5 % respectively in arm B. As exploratory analyses, when focusing on AE of grade ≥ 2, these proportions were greater for Arm A (28.8 % [n = 15] vs. 4.5 % [n = 1]; p = 0.028, Fisher's exact test). Overall, no radiotherapy-related grade ≥ 3 AE was observed.
CONCLUSION: From a randomized multicentric phase II trial, despite a logical higher rate of radiotherapy-related AE in the experimental arm, low rates of moderate to severe acute toxicity suggest the safety of ART for pathological high-risk MIBC. Efficacy end-points results are awaited.