Avatrombopag Versus Placebo for Persistent Chemotherapy-Induced Thrombocytopenia in GI Cancers: The Phase II ACT-GI Trial.
Hanny Al-Samkari, Joseph J Shatzel, Sandhya R Panch et al.
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In 30 seconds
The phase II ACT-GI trial was a multicenter, randomized, double-blind, placebo-controlled study of avatrombopag for persistent chemotherapy-induced thrombocytopenia in patients with GI cancers. The primary outcome combined platelet recovery, no chemotherapy dose modification or delay, and prevention of recurrence during the on-study cycle. It was achieved by 16 of 23 patients (70% [95% CI, 47 to 87]) receiving avatrombopag versus 4/24 patients (17% [95% CI, 5 to 37]) receiving placebo (P < .001). Enrollment stopped at a planned interim analysis after prespecified efficacy criteria were met.
Key findings
- The primary end point was met by 70% of avatrombopag recipients versus 17% of placebo recipients (P < .001).
- Median end-of-treatment platelet counts were 157 (136-202) × 10 9 /L with avatrombopag and 72 (68-134) × 10 9 /L with placebo.
- Adverse events occurred in 78% versus 46% of patients, and serious adverse events in 17% versus 0%; none of the serious events was study drug-related.
Why it matters
Persistent thrombocytopenia can interfere with planned chemotherapy delivery in GI cancers. This trial found that avatrombopag improved a composite outcome requiring platelet recovery without dose modification or delay and without recurrence during the study cycle. The result is relevant to efforts to manage this treatment complication, while the trial’s size and early efficacy stopping warrant cautious interpretation.
What to keep in mind
The trial was small, and enrollment stopped at a planned interim analysis after prespecified efficacy criteria were met; the abstract does not report longer-term outcomes.