Mifamurtide for the treatment of non-metastatic osteosarcoma: Evaluation of the effectiveness and safety

• Autores: S. Pablos Bravo, Susana Cortijo Cascajares, Andrea Lázaro Cebas, M. P. Goyache-Goñi, José Miguel Ferrari Piquero
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 19, Nº. 4, 2017, págs. 253-257
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • The addition of mifamurtide to standard chemotherapy after surgery has been shown to improve the survival in osteosarcoma, according to clinical trials. However, not much information is available about this treatment in daily clinical practice. Our objective was to evaluate effectiveness and safety profile of mifamurtide in combination with standard chemotherapy or in monotherapy, as first-line therapy in high-grade, resectable, non-metastatic osteosarcoma. Method: Retrospective observational study of patients with osteosarcoma who were treated with mifamurtide since September 2010 to March 2017. The patient followed a schedule of mifamurtide, which was administered at a dose of 2 mg/m2 twice weekly during the first 12 weeks, followed by weekly administration until 48 doses, in monotherapy or with chemotherapy. The effectiveness variables considered in the study were the complete response at six months and the end of treatment, the relapse rates measured as 3-year event-free survival (EFS) rate, and relapse. All adverse effects were registered. Results: Four patients (three boys) with a median age of 15 years (rank: 8-21), were included in this study. Complete response was reached in all patients (100%). At the cut-off date, the 3-year EFS to patients with information available (No. = 2) was 100%. No patient had relapsed nor died. Administration of mifamurtide was associated with fever (No. = 2), chills (No. = 1), nausea (No. = 1) and headache (No. = 1). The rest of adverse events were considered to be related to standard chemotherapy. Conclusion: According to our experience, the addition of mifamurtide to standard chemotherapy or in monotherapy seems to be an effective and well tolerated schedule in nonmetastatic osteosarcoma following surgical resection. This drug, with or without chemotherapy, has allowed these patients to have a complete response of this disease without relapse. However, this study had few patients, therefore it is necessary to do more studies with a bigger sample size