Bladder Adjuvant RadioTherapy (BART): Acute and Late Toxicity from a Phase III Multicentre Randomized Controlled Trial: Acute and late toxicity in BART RCT.
Abstract
PURPOSE
To report toxicity from the multicentre phase III randomized trial of Bladder Adjuvant Radiotherapy (BART) after radical cystectomy (RC) and chemotherapy in high-risk muscle-invasive bladder cancer (MIBC).
MATERIALS/METHODS
Patients with non-metastatic urothelial MIBC with ≥1 high-risk feature after RC: pT3-4, pN1-3, nodal yield <10, positive margin, or ≥cT3 downstaged with neoadjuvant chemotherapy; were randomized 1:1 to observation (Obs) or adjuvant radiotherapy (RT) at 4 centres, stratified by pN stage (N0, N+) and chemotherapy (neoadjuvant, adjuvant, none). Stoma-sparing IG-IMRT 50.4Gy/28# was prescribed to the cystectomy bed and pelvic nodes. Acute toxicity (≤3 months of RT/randomization) and late toxicity were assessed per protocol using CTCAE v5.0. Patients progressing within 3 or 6 months of randomization were excluded from acute or late toxicity analysis respectively.
RESULTS
BART trial enrolled 153 patients (Obs=76, RT=77). About half (49%) had pN+. Nearly 90% received chemotherapy (70% neoadjuvant; most commonly gemcitabine plus cisplatin). In the RT arm, 63/77 completed radiotherapy per protocol with no toxicity-related RT termination. Of the 134 patients analyzable for acute toxicity, no difference was observed in grade 3 (Obs 4.2% vs RT 1.6%, p=0.34). Grade 2 effects were higher with RT (17.5% vs 1.1%, p<0.001), mainly diarrhea/enteritis or proctitis. Late toxicity was analyzable for 104 patients (Obs=57, RT=47) with median follow up of 27 months. Grade…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 153 participants or records.
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