At the 2024 CCA Summit, Maria A. Hawkins, MD, FRCR, MRCP, and Jordan Berlin, MD, debated on the role for consolidative radiotherapy in patients with locally advanced cholangiocarcinoma (CCA). Dr Hawkins debated that there is no role for consolidative radiotherapy in locally advanced CCA. In her opening remarks, she pointed out that 70% of patients with unresectable disease ultimately die from liver failure associated with tumors, a consequence of inadequate local control that leads to the obstruction or invasion of adjacent biliary or vascular systems.1
The phase 2 ABC-07 study aimed to investigate the efficacy and safety of the addition of stereotactic body radiation therapy (SBRT) to gemcitabine-cisplatin (Gem-Cis) in patients with locally inoperable CCA.1 The primary endpoint was progression-free survival (PFS). Patients were randomized to receive either 6 cycles of Gem-Cis plus SBRT (n=45) or 8 cycles of Gem-Cis alone (n=24). The study found that there was no difference in PFS or overall survival (OS) between the 2 arms. In the Gem-Cis group there were 5 patients who died because of failure to thrive (2 liver failure, 1 ascites, 1 cirrhosis of the liver, and 1 biliary obstruction) compared with 0 patients in the Gem-Cis plus SBRT group.1
Based on the results of this trial, Dr Hawkins concluded that the role of radiotherapy in patients with locally advanced CCA is not clear.1 The use of radiotherapy is increasing, but she argued that recognizing how to properly select patients for radiotherapy is not always understood. There needs to be more high-level evidence of the benefits of radiotherapy before it is recommended to all patients.1
Dr Berlin then debated that there is a role for radiation therapy in patients with localized CCA using SBRT.2 Dr Berlin stated that SBRT is more precise and quicker than external beam radiation and is ideal for smaller localized tumors.2 Although the results of ABC-07 were not statistically significant, he argued that the tumors were fairly small but were not miniscule, and that imaging in the study was limited in areas where some of the tumors may not have been completely visible on the scans. He also noted that the study sample size was small and there were apparent differences in the site of disease.
Dr Berlin finished by noting that the biggest flaw of radiation trials in gastrointestinal cancers, in general, is that OS and PFS may not be the correct endpoints. He argued that these are systemic diseases, and that local therapy should produce local effects. Local recurrence may not be clinically relevant, but time off of chemotherapy and prevention of clinical deterioration may be more effective. He concluded that the relevant clinical benefit of radiation needs to be determined, and a study should be done to assess that benefit.2
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