Multinational phase 3 trial of romiplostim versus placebo for chemotherapy-induced thrombocytopenia

Chemotherapy-induced thrombocytopenia (CIT) is a common complication of chemotherapy that is associated with bleeding, reduced relative dose intensity, and potentially worse outcomes. The multinational phase 3 RECITE trial evaluated romiplostim for persistent CIT (baseline platelet count ≤ 85 x 10⁹ per liter) in patients receiving oxaliplatin-based multiagent cytotoxic chemotherapy for gastrointestinal cancers. Patients were randomized 2:1 to romiplostim (n=109) or placebo (n=56) for three chemotherapy cycles. The primary endpoint was the absence of CIT-induced modification of the chemotherapy dose (reduction, delay, omission, or discontinuation) in the second and third chemotherapy cycles. This was the case for 84% of the patients in the romiplostim group and 36% of the patients in the placebo group (odds ratio 10.16; p<0.001; risk ratio 2.77; p<0.001), Adverse events of grade 3 or higher occurred in 37% of the romiplostim group and 22% of the placebo group. Thromboembolic events occurred in 2% of the patients in the romiplostim group and in none of the patients in the placebo group. The authors conclude that romiplostim was efficacious in treating CIT (quick take video summary).