2326 - Randomization in Oligoprogressive Disease: Can We Still Run Trials, or Have We Lost Equipoise?
Presenter(s)
E. Boyer1, M. P. Campeau1, E. Filion1, T. T. T. Vu1, D. Roberge2, G. Delouya2, C. Menard2, B. Routy3, D. Taussky1, F. Nguyen1, J. M. Bourque1, L. Hathout4, N. El-Bared5, D. Donath1, M. Barkati1, N. Blais6, and H. Bahig1; 1Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada, 2Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada, 3Centre Hospitalier de l’Université de Montréal (CHUM), Montreal, QC, Canada, 4Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, 5Département de Radio-oncologie, Charles- LeMoyne, longueil, QC, Canada, 6Département d'hémato-oncologie, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada
Purpose/Objective(s): Oligoprogressive disease presents a therapeutic dilemma, with ongoing debate on whether patients should receive stereotactic ablative radiotherapy (SABR) or continue systemic treatment alone. We assess the feasibility of ongoing randomized controlled trials (RCTs) by evaluating patterns of randomization and comparing the baseline clinical characteristics of patients treated within a clinical trial versus those who received SABR off-trial.
Materials/Methods: Two ongoing prospective trials investigate treatment strategies: SUPPRESS-Lung (NCT04405401), focusing on SABR for oligoprogressive lung cancer, and SUPPRESS-General (NCT04989725), including other histologies. A prospective registry was simultaneously established for patients receiving SABR off-trial. This study compares randomization patterns and clinical characteristics between the two cohorts. Baseline characteristics were analyzed descriptively, with paired t-tests for continuous variables, considering p < 0.05 statistically significant.
Results: Between June 2021 and January 2025, 72 patients were randomized within the clinical trials, and 88 received treatment off-trial, for a total of 160 patients. RCT patients represented 40% of the cohort, while 60% were treated off-trial. The distribution of randomized patients by disease site varied: 45% in lung cancer, 56% in breast cancer, 49% in gastrointestinal cancer, 75% in genitourinary cancer, and 50% in head and neck cancer. Randomized patients had a higher metastatic burden, with a mean of 2.4 progressive lesions (range: 1–5) compared to 1.1 (range: 1–3) in registry patients. The total metastatic lesions were 6.4 (range: 1–20) in RCT patients versus 2.4 (range: 0–20) in registry patients. Systemic treatment history was similar, with both groups averaging 1.4 prior treatment lines.
Conclusion: RCT patients had greater disease burden. A significant portion of patients were treated off-trial, especially those with a single oligoprogressive lesion, raising concerns about the feasibility of randomized trials in this setting.