ArticleAmerican journal of cancer research2026
Survival outcomes and safety of adding high-dose-rate intraluminal brachytherapy (HDR-ILBT) utilizing the novel balloon applicator (BRAXX) following concurrent chemoradiotherapy (CCRT) for non-surgical esophageal cancer: a prospective pilot and real-world comparative study.
Article in American journal of cancer research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
To investigate the local control and safety of adding high-dose-rate intraluminal brachytherapy (HDR-ILBT) with novel balloon applicator (BRAXX) after concurrent chemoradiation (CCRT) for non-surgery patients with esophageal cancer. The study enrolled 178 patients with esophageal cancer. A total of 13 patients were prospectively recruited to receive HDR-ILBT after CCRT and compared with two standard-of-care cohorts treated between 2022 and 2024. Brachytherapy was delivered via the BRAXX balloon applicator (Taiwan Food and Drug Administration approval No. 006603) using an Iridium-192 Nucletron remote afterloading system (Elekta, Stockholm, Sweden). The primary endpoint was freedom from local tumor recurrence (FFLTR). Secondary endpoints included overall survival (OS), disease progression-free survival (DPFS), and toxicities. Sankey diagrams and swimmer plot were utilized to visualize the longitudinal tumor response dynamics and individual survival trajectories. The median follow-up was 25.2 months. The 1-year and 2-year FFLTR rates were 93.3% and 81.2% (nCCRT + surgery), 84.6% and 67.7% (CCRT + ILBT), and 62.5% and 52.9% (dCCRT alone), respectively (P < 0.001). Consistent survival improvements were observed in both OS and DPFS in CCRT + ILBT cohort. Sankey diagrams demonstrated a favorable dynamic evolution in treatment response within the CCRT + ILBT cohort, achieving a clinical complete response (cCR) rate of 61.5% and overall response rate (ORR) of 69.2% at the end of per-protocol 1-year follow-up. Swimmer plot illustrated that response conversion and consolidation translated into long-term survival. The addition of HDR-ILBT did not exacerbate treatment-related esophageal strictures or fistula formations necessitating intervention. The addition of HDR-ILBT utilizing BRAXX applicator following CCRT is a feasible and promising strategy to enhance local control and prolong survival for non-surgical patients with esophageal cancer. By leveraging its distinct dosimetric advantages and streamlined workflow, ILBT holds the potential to consolidate disease-free status and eradicate residual disease. Further validation through large-scale, prospective clinical trials is still warranted to confirm its clinical benefit and long-term safety. If further validated, this strategy could offer a meaningful addition to the current treatment paradigm.
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