RECITE: Romiplostim for CIT in GI cancer

At ASCO 2025, a significant late-breaking study in gastrointestinal oncology was presented by Prof Dr Hanny Al-Samkari, addressing a persistent and clinically impactful complication in GI malignancies: chemotherapy-induced thrombocytopenia (CIT).

The RECITE trial was a global, randomised, double-blind, placebo-controlled phase 3 study evaluating the thrombopoietin receptor agonist romiplostim in patients with gastrointestinal cancers — specifically colorectal, pancreatic, and gastroesophageal malignancies — who experienced persistent CIT while receiving oxaliplatin-based multiagent chemotherapy.

The trial enrolled patients whose platelet counts fell below 85,000/µL on day one of a chemotherapy cycle, rendering them ineligible to receive full-dose, on-schedule chemotherapy. Patients were randomised in a 2:1 ratio to receive weekly subcutaneous injections of romiplostim or placebo. The primary endpoint was the proportion of patients who avoided chemotherapy dose reductions or delays due to thrombocytopenia. Secondary objectives included safety, tolerability, and extended safety follow-up.

Results from RECITE demonstrated that romiplostim was highly efficacious, with 85% of patients in the romiplostim arm maintaining chemotherapy dose intensity and schedule, compared to just 35% in the placebo group. The treatment was well tolerated, with no significant increase in thromboembolic events, no development of myelodysplastic syndromes, and a reassuring safety profile over a year-long follow-up.

Prof Al-Samkari emphasised that this outcome addresses a common clinical dilemma, as dose reductions and delays are frequent in patients with GI malignancies, particularly those undergoing multiple lines of chemotherapy. He noted that retrospective data consistently show that reduced dose intensity compromises both PFS and OS, even in the metastatic setting.

The discussion then explored which patient populations might benefit most from romiplostim in routine practice. While the RECITE trial limited enrollment to patients with GI malignancies for trial homogeneity, prof Al-Samkari highlighted that CIT is a tumour-agnostic issue. In his own practice, he uses romiplostim in patients with platelet counts under 100,000/µL at the start of a chemotherapy cycle, with decisions tailored to the patient’s specific chemotherapy regimen, bleeding risk, and use of antithrombotic therapy. Dr Domen agreed, acknowledging the greater clinical urgency in patients receiving adjuvant or neoadjuvant therapy, though maintaining dose intensity remains equally important in metastatic disease.

A final point of discussion was the platelet threshold for intervention. Although the trial employed an eligibility cutoff of 85,000/µL, both experts acknowledged that clinical practice requires flexibility. Factors such as the intensity of the chemotherapy regimen, concurrent medications, and overall patient risk profile must inform individualised decision-making.

In conclusion, the RECITE trial offers practice-changing, randomised data confirming the efficacy and safety of romiplostim for managing CIT in patients with gastrointestinal cancers, enabling the maintenance of optimal chemotherapy dose intensity and schedule. The findings provide oncologists with a validated strategy for addressing a widespread, often overlooked complication, while the expert discussion reinforced the importance of individualised patient assessment when applying these results in daily clinical care.