Romiplostim Reduces the Need for Dose Modifications in Chemotherapy-Induced Thrombocytopenia

Clinical Summary:

• Design/Population: The phase 3 RECITE trial assessed romiplostim to reduce the need for chemotherapy dose modifications in patients with gastrointestinal cancers who developed chemotherapy-induced thrombocytopenia during oxaliplatin-based chemotherapy. 
• Key Outcomes: Romiplostim significantly reduced chemotherapy dose modifications compared with placebo. Safety was manageable, with most adverse events attributable to chemotherapy.
• Clinical Relevance: These results support romiplostim as an effective supportive care strategy in patients receiving myelosuppressive chemotherapy.

Results from the phase 3 RECITE trial demonstrated that romiplostim significantly reduced the need for chemotherapy dose modifications among patients with chemotherapy-induced thrombocytopenia.

“Chemotherapy-induced thrombocytopenia is a common complication of chemotherapy that is associated with bleeding, reduced relative dose intensity, and potentially worse outcomes… [however] no widely available therapies are approved,” stated Hanny Al-Samkari, MD, Mass General Brigham Cancer Institute, Boston, Massachusetts and coauthors. 

In this double-blind, placebo-controlled study, 165 patients with gastrointestinal cancers who developed persistent chemotherapy-induced thrombocytopenia (platelet count ≤85×10⁹/L) following oxaliplatin-based chemotherapy were randomized 2:1 to receive either romiplostim (n = 109) or placebo (n = 56) over 3 chemotherapy cycles. The primary end point was the absence of chemotherapy-induced thrombocytopenia-related chemotherapy dose modifications, including reductions, delays, omissions, or discontinuations during the second or third cycles.  

At analysis, no chemotherapy-induced thrombocytopenia-induced dose modifications were reported in 84% of patients in the romiplostim arm and 36% of patients in the placebo arm (P < .001). Grade ≥3 adverse events were reported in 37% of patients in the romiplostim arm and 22% in the placebo arm. Treatment-related adverse events occurred in 12% of patients and 7% of patients, respectively, and most frequently included nausea (2%) and headache (2% of patients in the romiplostim arm). Thromboembolic events were reported in 2% of patients in the romiplostim arm. No treatment-related serious adverse events, deaths, or discontinuations were reported.

Results demonstrated that “romiplostim was efficacious in treating [chemotherapy-induced thrombocytopenia],” concluded Dr Al-Samkari et al. 

Source:

Al-Samkari H, Muñoz C, Geredeli Ç, et al. Romiplostim versus placebo for chemotherapy-induced thrombocytopenia. N Engl J Med. Published online: March 11, 2026. doi:10.1056/nejmoa2511882