Sushma Agrawal, MD, SGPGI, Lucknow, India, provides an overview the Phase III RACE-GB (NCT05493956) randomized trial conducted to evaluate the effectiveness of consolidation chemoradiotherapy (CTRT) compared to observation in patients with unresectable advanced gallbladder cancer (GBC) who responded to four cycles of chemotherapy (CT). The primary endpoint was overall survival (OS). The trial aimed to detect an improvement in 2-year OS from 8% in the control arm to 25% in the study arm. A total of 135 responders were randomized, with 67 in the observation arm and 68 in the CTRT arm. The median overall survival in the CTRT arm was 10 months compared to 4 months in the observation arm. Adverse events related to CTRT included nausea, anemia, GI bleed, and hepatotoxicity. The study concludes that CTRT after CT significantly prolonged overall survival but was associated with adverse events.
This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL.
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