Estudio observacional restrospectivo para evaluar la efectividad y seguridad de esquemas de tratamiento con bortezomib para el mieloma múltiple en nuestro hospital / Observational retrospective study to evaluate the effectiveness and safety of treatment schemes with bortezomib for multiple myeloma in our hospital

RESUMEN

Objetivo: Analizar los esquemas terapéuticos que incluyen bortezomib utilizados en nuestro centro para el tratamiento del mieloma múltiple, evaluar su efectividad y seguridad en la práctica clínica de nuestro hospital, y el grado de adecuación a las indicaciones descritas en ficha técnica. Material y métodos Análisis retrospectivo incluyendo los pacientes diagnosticados de mieloma múltiple que en el periodo de enero de 2008 a diciembre de 2009 (24 meses) recibieron tratamiento con un esquema que incluía bortezomib. Se analizaron variables demográficas (edad, sexo), características de la enfermedad (tipo de mieloma múltiple, estadio, anomalías citogenéticas y clínica), fármacos concomitantes, respuesta y efectos secundarios de los diferentes esquemas de tratamiento que incluían bortezomib. Resultados Se incluyeron 59 pacientes diagnosticados de mieloma múltiple (25 varones y 34 mujeres) con una mediana de edad de 63 años (rango 30-82). La respuesta global para los pacientes que recibieron esquemas con bortezomib en primera línea osciló entre un 69% (vincristina, carmustina, ciclofosfamida, melfalán y prednisona/vincristina, carmustina, doxorubicina y dexametasona, más bortezomib) y un 82% (bortezomib, melfalán y prednisona oral). Cuando analizamos los esquemas de rescate: bortezomib-dexametasona, bortezomib-ciclofosfamida-dexametasona y bortezomib, doxorubicina, melfalán alternando con talidomida, ciclofosfamida, dexametasona, se (..) (AU)

ABSTRACT

Objectives: To analyse therapeutic regimens including bortezomib used in our centre for the treatment of multiple myeloma, to evaluate its effectiveness and safety in clinical practice in our hospital, and to assess the appropriateness of the indications described in guidelines. Material and methods: Retrospective analysis of patients diagnosed with multiple myeloma in the period between January 2008 and December 2009 (24 months) that received treatment with a regimen including bortezomib. We analysed demographic variables (age, sex), disease characteristics (type of multiple myeloma, stage, and clinical cytogenetic abnormalities), concomitant drugs, response, and side effects of the regimen including bortezomib. Results: We included 59 patients who were diagnosed with multiple myeloma (25 males and34 females) with an average age of 63 years (range 30-82 years). The overall response rate for patients who received first-line regimens with bortezomib ranged between 69% (vincristine, carmustine, cyclophosphamide, melphalan and prednisone / vincristine, carmustine, doxorubicin, and dexamethasone plus bortezomib) and 82% (bortezomib, melphalan and oral prednisone).When we analysed the salvage treatment regimens: Bortezomib-Dexamethasone, BortezomibCyclophosphamide-Dexamethasone and bortezomib, doxorubicin, melphalan alternating with thalidomide, cyclophosphamide, and dexamethasone achieved overall response rates of 72%,77% and 89%, respectively. Adverse reactions to bortezomib or a treatment regimen that included it occurred in 32 (54%) patients, highlighting neurotoxicity in 19 patients (32%) and gastrointestinal toxicity in 12 (20%).Conclusions: The results of our study show the important role of bortezomib in the treatment of multiple myeloma, with response rates and side effects comparable to published data, although the conditions for using it in clinical practice are not yet recognized in the guidelines for use (AU)