A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis

Abstract INTRODUCTION: The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs. Miltefosine is an oral agent used for leishmaniasis treatment; however, no data exist regarding its use for ML in Brazil. In this study, we aimed to evaluate the efficacy of miltefosine for ML treatment compared to that of pentavalent antimonial in a pilot study. METHODS: We performed a randomized clinical trial with two parallel groups. The tested intervention consisted of miltefosine 1.3-2 mg/kg/day (two capsules) for 28 days or intravenous 20 mg SbV/kg/day of meglumine antimoniate (N-MA) for 30 days. The final endpoint was defined as complete healing of the lesion four years after treatment. We also analyzed an early endpoint at 90 days after treatment. RESULTS: Forty patients were included in this study: each experimental group comprised 20 patients. Applying a multivariate model in an intention-to-treat analysis, we observed that patients treated with miltefosine had a cure probability 2.08 times greater (95% confidence interval [CI] = 1.03-4.18) than those treated with N-MA at 90 days after treatment. At the final endpoint, we observed no differences in cure probability between miltefosine and N-MA (relative risk = 0.66; 95% CI = 0.33-1.32). With respect to adverse reactions, significant differences between groups were related to gastrointestinal effects, which were more frequent in the miltefosine group. CONCLUSIONS: Miltefosine may be an interesting alternative for treating ML because of its oral administration and cure rate after long-term follow-up.

Sarcoma sinovial cervical / Neck Synovial Sarcoma

Introdução: O sarcoma sinovial (SS) é uma neoplasia rara e agressiva, sendo a região da cabeça e pescoço envolvida em 5% a 10% dos casos. A apresentação clínica é uma massa indolor de crescimento progressivo. As metástases ocorrem em 10% a 15% dos casos, principalmente por via hematogênica, para pulmões, linfonodos e medula óssea. O tratamento inclui exérese cirúrgica ampla e radioterapia. Ainda não existem dados que comprovem a eficácia da quimioterapia neste tipo de tumor; seu principal benefício consistiria na prevenção de metástases à distancia. A sobrevida em 5 anos varia de 40% a 50%. Objetivo: Relatar um caso de sarcoma sinovial cervical em mulher de 21 anos. Resultados: Paciente com história de tumor cervical de crescimento rápido há 05 meses, inicialmente indolor. Ao exame a lesão apresentava consistência fibroelástica, superfície lisa, aderida a planos profundos, comprometendo os níveis II, III, IV e V à direita e dor à palpação. Tomografia Computadorizada evidenciando grande tumor homogêneo com efeito de massa nos níveis II a V à direita e ocupando espaço parafaríngeo. Punção aspirativa (PAAF) sugestivo de sarcoma. Foi submetida à ressecção do tumor cervical e quimioterapia adjuvante. O anatomopatológico da lesão, com estudo imunohistoquímico, foi compatível com sarcoma sinovial cervical. Está no o 3º ano de seguimento pós-operatório e encontra-se sem sinais de lesão residual ou recidiva. Conclusão: o sarcoma sinovial cervical é uma neoplasia rara e agressiva que demanda ressecção cirúrgica ampla.

Introduction: The synovial sarcoma (SS) is a rare and aggressive neoplasm, with the head and neck involved in 5% to 10% of cases. The clinical presentation is a painless mass with progressive growth. Metastases occur in 10% to 15% of cases, mainly hematogenic to lungs, lymph nodes and bone marrow. Treatment includes wide surgical excision and radiotherapy. There are no data to prove the effectiveness of chemotherapy in this tumor type, but its main benefit would be the prevention of distant metastases. The 5-year survival ranges from 40% to 50%. Objective: To report a case of synovial sarcoma of the neck in a 21 years old female. Results: female with history of cervical tumor of rapid growth for 05 months, initially painless. On examination the lesion presented fibroelastic consistency, smooth surface, adhered to deep planes, compromising levels II, III, IV and V to the right. Computed tomography revealed a large homogenous tumor with mass effect on levels II to V and occupying the right parapharyngeal space. Needle aspiration were suggestive of sarcoma. Underwent resection of the cervical tumor and adjuvant chemotherapy. Histopathological examination of the lesion with immunohistochemical study was consistent with cervical synovial sarcoma. She is in the 3rd year of postoperative follow-up and found no signs of residual lesion or recurrence. Conclusion: synovial sarcoma of the neck is a rare and aggressive neoplasm that requires wide surgical resection.