Posted: Thursday, June 15, 2023
Data are limited regarding the oncologic value of consolidation chemoradiation therapy in patients with unresectable, advanced gallbladder cancer who responded to first-line chemotherapy. The results of the RACE-GB study, which were presented by Sushma Agrawal, MD, of the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, and colleagues during the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 4016), revealed both prolonged overall survival and an association with adverse events. This is reportedly the first randomized trial to evaluate the role of consolidation chemoradiation therapy in this patient population.
Patients who achieved a partial response or stable disease after receiving four cycles of standard-of-care gemcitabine plus cisplatin were randomly assigned to undergo consolidation chemoradiation therapy (n = 68) or observation (n = 67). Those in the experimental arm were irradiated via a three-dimensional conformal method (45 Gy in 25 fractions to the tumor and lymphatics, followed by a boost of 9 Gy in 5 fractions to the tumor) and concurrently treated with 1,250 mg/m2 of capecitabine.
The median duration of overall survival was prolonged with consolidation chemoradiation therapy versus observation (10 vs. 4 months; hazard ratio = 0.47; P = .001). The trial is designed to detect an improvement in 2-year overall survival from 8% in the control arm to 25% in the study arm, with 80% power at a 0.05 significant level. Consolidation chemoradiation therapy–associated adverse events of grade 3 or higher included hepatotoxicity (13%), anemia (9%), gastrointestinal bleeding (6%), and nausea (3%).
Disclosure: The study authors reported no conflicts of interest.