Emergency use of uridine triacetate for the prevention and treatment of life-threatening 5-fluorouracil and capecitabine toxicity
The combined report of the Vistogard studies: 96 percent of patients treated with oral uridine triacetate after a fluorouracil or capecitabine overdose survived, where 84 percent of an earlier supportive-care group had died.
Overview
Report of two open-label clinical studies in which patients who presented with a 5-fluorouracil or capecitabine overdose or an early onset of severe toxicities were treated with uridine triacetate as soon as possible, most within 96 hours of the chemotherapy. Outcomes included survival, resumption of chemotherapy and safety, and survival was compared with a historical cohort of overdose patients who received only supportive care.
A total of 137 of 142 overdose patients (96 percent) treated with uridine triacetate survived and had rapid reversal of severe acute cardiotoxicity and neurotoxicity; mucositis and leukopenia were prevented or recovered from. In the historical cohort, 21 of 25 patients (84 percent) died. Among the 141 treated overdose patients with a cancer diagnosis, 53 resumed chemotherapy. The authors concluded that uridine triacetate was a safe and effective lifesaving antidote for capecitabine and 5-fluorouracil overexposure.
- 137 of 142 overdose patients (96%) treated with uridine triacetate survived.
- In the historical supportive-care cohort, 21 of 25 patients (84%) died.
- 53 of 141 treated overdose patients with a cancer diagnosis resumed chemotherapy.
This is the evidence behind the December 2015 US approval of Vistogard, the only antidote for fluorouracil or capecitabine overdose and early life-threatening toxicity. Its main practical message is the 96-hour window: the drug must be started before toxicity is fully established.
- Open-label expanded-access studies with a historical comparison and no inferential statistics.
- The label pools 135 patients (Study 1 and Study 2) where the paper's survival analysis counts 142 evaluable overdose patients.
- The registry lists an expanded-access protocol with no phase, enrolment count or results.
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