Phase 3 RECITE Trial Shows Romiplostim Helps GI Cancer Patients Stay on Chemotherapy Despite Thrombocytopenia

The phase 3 RECITE trial evaluated romiplostim (Nplate) versus placebo for chemotherapy-induced thrombocytopenia (CIT) in patients with gastrointestinal cancers receiving oxaliplatin-based chemotherapy. CIT often forces chemotherapy delays or dose reductions, potentially compromising treatment effectiveness.

Romiplostim significantly improved treatment continuity. Eighty-four percent of patients receiving romiplostim required no CIT-related chemotherapy dose modifications during cycles 2 and 3, compared with 36% of those receiving placebo. In a post hoc analysis, 75% of romiplostim-treated patients maintained a relative dose intensity above 85%, versus 38% in the placebo group. Patients receiving romiplostim also achieved higher platelet counts and recovered more quickly from thrombocytopenia.

The study enrolled 165 patients with colorectal, gastroesophageal, or pancreatic cancers. Romiplostim was generally well tolerated, with few side effects directly attributed to the drug and no treatment-related deaths.

Although the trial’s short duration limited assessment of long-term survival outcomes, the results suggest romiplostim may help patients stay on optimal chemotherapy schedules by reducing the impact of CIT.