Top Line: Gallbladder malignancies carry poor prognoses with conventional wisdom prioritizing systemic therapy.
The Study: Here we have a one-of-a-kind prospective randomized study in this space answering a straight-forward question. RACE-GB was conducted at a single center in India where patients who did not progress after an initial four cycles of cisplatin/gemcitabine but were still unresectable were randomized to observation (n=67) versus consolidative chemoradiation (n=68). Note these patients were advanced: 95% had T3-4 disease, 85% had nodal disease, and 10% had liver oligomets. Radiation was a pretty standard 3-D conformal treatment delivering 45 Gy in 25 fractions to the primary tumor including any direct liver involvement or adjacent liver mets as well as gross and elective nodes (periportal, celiac, superior mesenteric, and retroperitoneal extending inferiorly to L2). A sequential boost of 9 Gy was delivered to the primary tumor, and this was all done with concurrent capecitabine. Here we will pause to additionally commend the authors on providing such a detailed description of their planning technique as to allow readers to actually replicate this treatment in their own clinics–see methods for much more. The primary outcome of overall survival from randomization was significantly improved from 4 months with observation to 10 months with the addition of consolidative chemoradiation. Survival at one year was 8% versus 40%, respectively, and at two years a sobering 3% and 5%.
TBL: We have a long way to go in optimizing survival for gallbladder malignancies, but straight-forward consolidative chemoradiation appears to significantly improve outcomes in the first two years. | Agrawal, Int J Radiat Oncol Biol Phys 2025
The Study: Here we have a one-of-a-kind prospective randomized study in this space answering a straight-forward question. RACE-GB was conducted at a single center in India where patients who did not progress after an initial four cycles of cisplatin/gemcitabine but were still unresectable were randomized to observation (n=67) versus consolidative chemoradiation (n=68). Note these patients were advanced: 95% had T3-4 disease, 85% had nodal disease, and 10% had liver oligomets. Radiation was a pretty standard 3-D conformal treatment delivering 45 Gy in 25 fractions to the primary tumor including any direct liver involvement or adjacent liver mets as well as gross and elective nodes (periportal, celiac, superior mesenteric, and retroperitoneal extending inferiorly to L2). A sequential boost of 9 Gy was delivered to the primary tumor, and this was all done with concurrent capecitabine. Here we will pause to additionally commend the authors on providing such a detailed description of their planning technique as to allow readers to actually replicate this treatment in their own clinics–see methods for much more. The primary outcome of overall survival from randomization was significantly improved from 4 months with observation to 10 months with the addition of consolidative chemoradiation. Survival at one year was 8% versus 40%, respectively, and at two years a sobering 3% and 5%.
TBL: We have a long way to go in optimizing survival for gallbladder malignancies, but straight-forward consolidative chemoradiation appears to significantly improve outcomes in the first two years. | Agrawal, Int J Radiat Oncol Biol Phys 2025