Intralesional versus intramuscular methotrexate in the treatment of non-melanoma skin cancers

Abstract Background: Intralesional methotrexate (MTX) could be a promising conservative alternative therapy for non-melanoma skin cancers (NMSCs). Systemic MTX was previously attempted as adjuvant for locally-advanced NMSCs. Aim: To compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management. Methods: Sixty patients with histologically-proven NMSCs [keratoacanthoma (KA), basal cell carcinoma (BCC), or squamous cell carcinoma (SCC)], were randomly-assigned into two equal groups: Group A received intralesional MTX injections, and group B was intramuscularly injected with MTX. Injections were repeated weekly until clearance or for 8 sessions. Patients were classified into: responders (>50% improvement), partial responders (<50% improvement), and non-responders to the treatment intervention. Results: In terms of responders, there was a statistically-significant difference in favor of the intralesional MTX group (53.3%) as compared to the intramuscular MTX group (26.7%) (P value=0.04). In groups A and B, respectively, 1-For KA, 88.9% vs 71.4% of patients had a complete resolution; 2-For BCC, 42.8% vs 30% were responders; 3-For SCC, 28.6% vs 0% were responders. Limitations: Low sample size and short follow up. Conclusions: Intralesional MTX is significantly more effective than systemic MTX in the treatment of NMSCs. In KA and lip tumors, both treatment approaches showed excellent response. Trial registration: Registered and approved prospectively by the ethical review board at Faculty of Medicine, Zagazig University.