Effectiveness of neoadjuvant intralesional methotrexate in cutaneous squamous cell carcinoma: A prospective cohorts study.

Intralesional methotrexate (il-MTX) has been used in cutaneous squamous cell carcinoma (cSCC) achieving important reductions in tumor size. However, there is a lack of controlled studies on this regard. The primary objective was to analyze the effect of il-MTX on tumor size in cSCC. As a secondary objective, we evaluated its impact on the surgical approach. We conducted a prospective cohorts study that included 200 patients with histologically confirmed cSCC. Patients in Group 1 (Cases) received neoadjuvant treatment with il-MTX prior to surgery. Patients in Group 2 (Controls) underwent scheduled surgery without prior neoadjuvant therapy. Clinical measurements of lesions were made at the time of inclusion in the study and before surgery. No intergroup statistical differences were found between the assessed variables. In Group 1, tumor size reduction occurred in 93% of the patients after il-MTX therapy. Tumor surface was reduced by 54%. Complex reconstructions were needed in 15% of these patients. In Group 2, tumor surface increased by 33.1% and complex reconstructions were needed in 40% of patients. Intergroup differences were statistically significant (p < 0.001). Neoadjuvant Il-MTX therapy achieves very important tumor size reduction and significantly simplifies surgical treatment.