Oral Gefitinib and methotrexate combo has no clinical advantage over methotrexate for tubal ectopic pregnancy

A new study found that combining oral gefitinib with parenteral methotrexate has no clinical advantage over methotrexate alone. The study results were published in the journal The Lancet.  

Tubal ectopic pregnancies are a significant contributor to maternal morbidity and mortality. Methotrexate or surgery are the present management techniques.  Rescue surgery is planned in approximately 30% of women where methotrexate treatment fails. Gefitinib is an epidermal growth factor receptor inhibitor that improves the effects of methotrexate and disrupts the ectopic implantation site. Hence, researchers assessed the efficacy of oral gefitinib with methotrexate, versus methotrexate alone, to treat tubal ectopic pregnancy.  

A multicenter, randomized, double-blind, placebo-controlled trial was carried out across 50 UK hospitals between Nov 2, 2016, and Oct 6, 2021. Participants diagnosed with tubal ectopic pregnancy were administered a single dose of intramuscular methotrexate (50 mg/m2) and randomized (1:1 ratio) to 7 days of additional oral gefitinib (250 mg daily) or placebo. The primary outcome was a surgical intervention to resolve the ectopic pregnancy as analyzed by intention to treat. Secondary outcomes included time to resolution of ectopic pregnancy and serious adverse events.