Dr Soff on the Role of Romiplostim in Managing CIT in GI Cancers

"The goal was to avoid modifications of the chemotherapy regimen because of recurrent CIT, and the [results] were quite dramatic. We clearly proved that romiplostim is effective. We already knew that because it's been published in smaller studies, but it's good to have a large single study like this [to validate them]."

Gerald Soff, MD, a professor of clinical medicine in the Division of Hematology and chief of the Classical Hematology Section at the University of Miami Miller School of Medicine, detailed the results of the phase 3 RECITE trial (NCT03362177).

This pivotal study evaluated the efficacy of the thrombopoietin receptor agonist (TPO-RA) romiplostim in managing persistent chemotherapy-induced thrombocytopenia (CIT) among patients with gastrointestinal (GI) cancers. CIT represents a significant clinical hurdle, as low platelet counts often necessitate chemotherapy dose delays or reductions, potentially undermining the effectiveness of the oncologic treatment.

To ensure the study's scientific validity, the investigators restricted the patient population to a homogeneous group of patients with GI cancers receiving specific chemotherapy regimens, Soff explained. This design choice facilitated a clearer assessment of statistical benefit. The primary objective was to determine if romiplostim could prevent the need for treatment modifications caused by recurrent CIT episodes.

The results, published in March 2025, were characterized by Soff as "quite dramatic." Among patients receiving romiplostim (n = 109), 84% did not require any dose modifications to their chemotherapy regimens. In contrast, only 36% of patients in the placebo arm (n = 56) were able to maintain their treatment schedules without adjustment. This disparity was highly significant, yielding an OR of 10.16 (95% CI, 4.44-23.72; P < .001) and a risk ratio of 2.77 (95% CI, 1.78-4.30; P < .001).

Soff asserted that data from RECITE clearly prove the effectiveness of romiplostim in this setting. Although smaller studies had previously suggested its utility, this large, phase 3 trial provides the robust level of evidence needed to integrate TPO-RAs into standard care for GI cancer patients suffering from persistent CIT. By maintaining chemotherapy dose intensity, romiplostim serves as a vital supportive care tool to optimize the delivery of primary cancer treatments, he concluded.