Romiplostim for chemotherapy induced thrombocytopenia in pediatric cancers.
Shivam Bansal, Aditya Kumar Gupta, Jagdish Prasad Meena et al.
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In 30 seconds
This investigator-initiated, open-label randomized trial at a tertiary centre in India evaluated prophylactic romiplostim in 93 children aged 1–14 years with AML, non-Hodgkin lymphoma, or solid tumours receiving myelosuppressive chemotherapy. Platelet recovery within three weeks was similar with romiplostim and standard care (91.3% vs. 88.1%; risk difference, 3.2 percentage points; 95% CI, -9.5 to 15.9; P = 0.73). Clinically significant bleeding was less frequent in the romiplostim group, while platelet transfusion volume was numerically lower. No thrombotic events occurred.
Key findings
- Platelet recovery within three weeks occurred in 91.3% with romiplostim and 88.1% with standard care (P = 0.73).
- Clinically significant bleeding occurred in none of 46 romiplostim recipients and 6 of 43 controls (14%; P = 0.01).
- Median platelet transfusion volume was 19.3 vs. 29.6 mL/kg (P = 0.06).
- Day-16 immature platelet fraction increased by 258% vs. 47.7% from baseline (p = 0.016); no thrombotic events occurred.
Why it matters
Chemotherapy-induced thrombocytopenia can disrupt cancer care, and evidence for its management in children is limited. This trial found no improvement in the primary platelet-recovery outcome, but the lower observed bleeding rate suggests a potentially relevant benefit that merits further evaluation. The findings also provide evidence of a biological response, without establishing that romiplostim improves overall cancer-treatment delivery.
What to keep in mind
The trial was open-label and conducted at a single tertiary centre. The primary outcome did not differ significantly between groups, and the bleeding finding comes from a relatively small trial.