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BACKGROUND: Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy. METHODS: We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival. RESULTS: A total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; two-sided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects. CONCLUSIONS: In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy. (Funded by Genmab and Seagen [acquired by Pfizer]; innovaTV 301 ClinicalTrials.gov number, NCT04697628.).
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Protocolos de Quimioterapia Combinada Antineoplásica , Recurrencia Local de Neoplasia , Neoplasias del Cuello Uterino , Humanos , Femenino , Neoplasias del Cuello Uterino/tratamiento farmacológico , Neoplasias del Cuello Uterino/mortalidad , Persona de Mediana Edad , Recurrencia Local de Neoplasia/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Estimación de Kaplan-Meier , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/administración & dosificación , Análisis de Supervivencia , Supervivencia sin Progresión , Anciano de 80 o más AñosRESUMEN
PURPOSE: Renal cell carcinoma is an aggressive disease with a high mortality rate. Management has drastically changed with the new era of immunotherapy, and novel strategies are being developed; however, identifying systemic treatments is still challenging. This paper presents an update of the expert panel consensus from the Latin American Cooperative Oncology Group and the Latin American Renal Cancer Group on advanced renal cell carcinoma management in Brazil. METHODS: A panel of 34 oncologists and experts in renal cell carcinoma discussed and voted on the best options for managing advanced disease in Brazil, including systemic treatment of early and metastatic renal cell carcinoma as well as nonclear cell tumours. The results were compared with the literature and graded according to the level of evidence. RESULTS: Adjuvant treatments benefit patients with a high risk of recurrence after surgery, and the agents used are pembrolizumab and sunitinib, with a preference for pembrolizumab. Neoadjuvant treatment is exceptional, even in initially unresectable cases. First-line treatment is mainly based on tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs); the choice of treatment is based on the International Metastatic Database Consortium (IMCD) risk score. Patients at favourable risk receive ICIs in combination with TKIs. Patients classified as intermediate or poor risk receive ICIs, without preference for ICI + ICIs or ICI + TKIs. Data on nonclear cell renal cancer treatment are limited. Active surveillance has a place in treating favourable-risk patients. Either denosumab or zoledronic acid can be used for treating metastatic bone disease. CONCLUSION: Immunotherapy and targeted therapy are the standards of care for advanced disease. The utilization and sequencing of these therapeutic agents hinge upon individual risk scores and responses to previous treatments. This consensus reflects a commitment to informed decision-making, drawn from professional expertise and evidence in the medical literature.
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Carcinoma de Células Renales , Neoplasias Renales , Humanos , Carcinoma de Células Renales/tratamiento farmacológico , Carcinoma de Células Renales/patología , Neoplasias Renales/tratamiento farmacológico , Neoplasias Renales/patología , América Latina , Consenso , SunitinibRESUMEN
ABSTRACT Prostate cancer is the second most common cancer and the fifth leading cause of cancer deaths. In Brazil, it is likewise the second most common cancer among men, second only to non-melanoma skin cancers. The aim of this consensus is to align different opinions and interpretations of the medical literature in a practical and patient-oriented approach. The first Brazilian Consensus on the Treatment of Advanced Prostate Cancer was published in 2017, with the goal of reducing the heterogeneity of therapeutic conduct in Brazilian patients with metastatic prostate cancer. We acknowledge that in Brazil the incorporation of different technologies is a big challenge, especially in the Sistema Único de Saúde (SUS), which allows for the disparity in the options available to patients treated in different institutions. In order to update the recommendations and to make them objective and easily accessible, once more a panel of specialists was formed in order to discuss and elaborate a new Brazilian Consensus on Advanced Prostate Cancer. This Consensus was written through a joint initiative of the Brazilian Society of Clinical Oncology (SBOC) and the Brazilian Society of Urology (SBU) to support the clinical decisions of physicians and other health professionals involved in the care of patients with prostate cancer.
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Humanos , Masculino , Neoplasias de la Próstata/terapia , Guías de Práctica Clínica como Asunto , Consenso , Neoplasias de la Próstata/patología , Sociedades Médicas , Brasil , Toma de Decisiones Clínicas , Metástasis de la Neoplasia , Antineoplásicos/uso terapéuticoRESUMEN
ABSTRACT Introduction Prostate cancer still represents a major cause of morbidity, and still about 20% of men with the disease are diagnosed or will progress to the advanced stage without the possibility of curative treatment. Despite the recent advances in scientific and technological knowledge and the availability of new therapies, there is still considerable heterogeneity in the therapeutic approaches for metastatic prostate cancer. Objectives This article presents a summary of the I Brazilian Consensus on Advanced Prostate Cancer, conducted by the Brazilian Society of Urology and Brazilian Society of Clinical Oncology. Materials and Methods Experts were selected by the medical societies involved. Forty issues regarding controversial issues in advanced disease were previously elaborated. The panel met for consensus, with a threshold established for 2/3 of the participants. Results and Conclusions The treatment of advanced prostate cancer is complex, due to the existence of a large number of therapies, with different response profiles and toxicities. The panel addressed recommendations on preferred choice of therapies, indicators that would justify their change, and indicated some strategies for better sequencing of treatment in order to maximize the potential for disease control with the available therapeutic arsenal. The lack of consensus on some topics clearly indicates the absence of strong evidence for some decisions.
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Humanos , Masculino , Próstata/patología , Consenso , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/terapia , Brasil , Guías de Práctica Clínica como AsuntoRESUMEN
Este estudo incluiu 59 pacientes em que foram avaliadas as expressões das proteínas dos genes mdm-2, p53, e da família do gene bcl-2 por meio de método imunohistoquímico em carcinoma de células transicionais músculo-invasivo tratados com M-VAC, seguido do tratamento loco-regional. Este estudo procurou explorar a associação entre a expressão alterada destas proteínas com a sobrevida global. A expressão mínima ou ausente da proteína do gene p53 (p = 0.006) foi o único marcador que apresentou associação significativa, com taxas de sobrevida global mais favoráveis. /This study of 59 patients evaluated mdm-2, p53, and bcl-2 family gene protein expression by immunohistochemistry in muscle-invasive transitional cell carcinoma of urinary bladder treated with M-VAC, followed by locoregional treatment. This study explored the relationship between altered expression and long-term survival in this patient population. Absence or minimal p53 gene protein expression (p = 0.006) was the only molecular marker that statistically correlated with prolonged survival. However, the cooperative effects of mdm-2, p53, and bcl-2 genes represented a more robust prognostic model to delineate overall survival (p = 0.01) compared to isolated gene proteins...
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Carcinoma de Células Transicionales/genética , Neoplasias de la Vejiga Urinaria/genética , Proteína p53 Supresora de Tumor , Inmunohistoquímica , PronósticoRESUMEN
Paciente adulto, natural de regiao endemica para esquistossomose e portador cronico da doenca, apresenta queixa de febre ha sete dias, associada a ictericia e dor lombar em regiao direita. Os exames radiologicos mostraram abscessos hepaticos piogenicos multiplos, cuja causa predisponente e conhecida, segundo trabalhos da literatura, em 100 por cento dos casos. Atraves de parametros clinicos, laboratoriais e radiologicos todas as etiologias classicas foram afastadas. Sabe-se que a esquistossomose pode provocar, como complicacao, a pileflebite, alem de depressao imunologica e reacao granulomatosa com necrose lobular central e maior risco de infeccao. Os autores deste relato de caso sugerem ser a esquistossomose, na sua forma cronica, causa predisponente para formacao de abscessos hepaticos piogenicos multiplos, principalmente em regioes endemicas.
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Humanos , Masculino , Persona de Mediana Edad , Absceso Hepático/etiología , Esquistosomiasis mansoni/diagnóstico , Esquistosomiasis mansoni/complicacionesRESUMEN
Com o intuito de investigar o potencial neoplasico dos polipos juvenis foram analisados polipos de 45 pacientes, quatro deles portadores de polipos juvenil (tres do sexo feminino e um do masculino), sendo o restante dos pacientes portadores de polipos unicos (20 do sexo masculino e 21 do sexo feminino). A idade variou desde meses ate 32 anos. O exame microscopico de rotina revelou processos proliferativos epiteliasi, incluindo fenomenos regenerativos (51,5 por cento ), hiperplasia adenomatoide (6,7 por cento ) e adenomas (5 por cento ) alem de alteraçoes displasicas (5 por cento ), nao ocorrendo neoplasias maligna. Estes achados indicam que em nosso meio houve presença de potencial neoplasico em 2,3 por cento dos polipos unicos e em 13,6 por cento dos multiplos, o que sugere maior chance de degeneraçao carcinomatosa a partir destes ultimos, tanto pelo maior comprometimento da mucosa colica quanto pelo comportamento biologico mais agressivo
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Humanos , Masculino , Femenino , Recién Nacido , Lactante , Preescolar , Niño , Adolescente , Adulto , Neoplasias del Colon , Pólipos del Colon , PóliposRESUMEN
O objetivo deste trabalho foi o estudo anatômico da artéria cística. Para tal, estudamos 50 artérias císticas, por dissecaçao a olho nu, em blocos de vísceras humanas, formolizados. Em 80 por cento dos casos, a artéria cística originou-se da artéria hepática direita; nos 20 por cento restantes, a origem anatômica foi variada. Foram também estudadas as dimensoes e as relaçoes topográficas das artérias císticas, principalmente no que se refere aos elementos do pedículo hepático.