RESUMEN
INTRODUCTION: Immunotherapy is recommended as category 1 in first-line treatment in metastatic renal cancer (mRC), however the evidence on the management of toxicities in patients with chronic renal failure is limited. Description of the Cases: Case 1: Patient with mRC and renal failure on hemodialysis. After 25 months of treatment with Nivolumab, he presented a partial response, without toxicities. Case 2: Patient with mRC undergoing treatment with Nivolumab-Ipilimumab, who after 6 cycles was admitted for acute renal failure, compatible with grade 4 nephrotoxicity, requiring definitive suspension of treatment, corticosteroid therapy and hemodialysis. CONCLUSIONS: Nivolumab is a safe and effective therapy in hemodialysis patients, not increasing adverse events, nor requiring dose adjustment. Immunotherapy nephrotoxicity must be adequately managed in daily clinical practice in an interdisciplinary way with the nephrologist.
Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Insuficiencia Renal , Masculino , Humanos , Nivolumab/efectos adversos , Ipilimumab/efectos adversos , Neoplasias Renales/tratamiento farmacológico , Neoplasias Renales/patología , Inmunoterapia/efectos adversos , Insuficiencia Renal/inducido químicamente , Carcinoma de Células Renales/secundarioRESUMEN
Introduction: Immunotherapy is recommended as category 1 in first-line treatment in metastatic renal cancer (mRC), however the evidence on the management of toxicities in patients with chronic renal failure is limited. Description of the Cases: Case 1: Patient with mRC and renal failure on hemodialysis. After 25 months of treatment with Nivolumab, he presented a partial response, without toxicities. Case 2: Patient with mRC undergoing treatment with Nivolumab-Ipilimumab, who after 6 cycles was admitted for acute renal failure, compatible with grade 4 nephrotoxicity, requiring definitive suspension of treatment, corticosteroid therapy and hemodialysis. Conclusions: Nivolumab is a safe and effective therapy in hemodialysis patients, not increasing adverse events, nor requiring dose adjustment. Immunotherapy nephrotoxicity must be adequately managed in daily clinical practice in an interdisciplinary way with the nephrologist (AU)
Introducción: La inmunoterapia está recomendadacon categoría 1 en primera línea de tratamiento en cáncerrenal metastásico (CRm), sin embargo la evidencia sobre elmanejo de toxicidades en pacientes con insuficiencia renalcrónica es limitada.Descripción de los Casos: Caso 1: Paciente con CRme insuficiencia renal en hemodiálisis. Tras 25 meses detratamiento con Nivolumab, presenta respuesta parcial, sintoxicidades. Caso 2: Paciente con CRm en tratamiento conNivolumab-Ipilimumab, que tras 6 ciclos precisa ingresopor fracaso renal agudo, compatible con nefrotoxicidadgrado 4, requiriendo suspensión definitiva del tratamiento,corticoterapia y hemodiálisis.Conclusiones: El uso de Nivolumab es seguro y eficaz en pacientes en hemodiálisis, no incrementando losefectos adversos, ni precisando ajuste de dosis. Es fundamental conocer el manejo de la nefrotoxicidad por inmunoterapia en la práctica clínica diaria y establecer un enfoque multidisciplinar con nefrología. (AU)
Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Antineoplásicos Inmunológicos , Nivolumab/uso terapéutico , Ipilimumab/uso terapéutico , Neoplasias Renales/tratamiento farmacológico , Carcinoma de Células Renales/tratamiento farmacológico , Insuficiencia Renal/inducido químicamente , Antineoplásicos Inmunológicos/efectos adversos , Ipilimumab/efectos adversos , Nivolumab/efectos adversosRESUMEN
OBJECTIVES: This study aimed to externally validate the diagnostic accuracy of the Select MDx test for Significant prostate cancer (Sig PCa) (ISUP > 1), in a contemporaneous, prospective, multicenter cohort with a prostate-specific antigen (PSA) between 3 and 10 ng/ml and a non-suspicious digital rectal examination. METHODS AND PARTICIPANTS: For all enrolled patients, the Select Mdx test, the risk calculator ERSPC3 + DRE, and a prostatic magnetic resonance imaging (MRI) were carried out. Subsequently, a systematic 12-core trans-rectal biopsy and a targeted biopsy, in the case of a prostate imaging-reporting and data system (PIRADS) > 2 lesion (max three lesions), were performed. To assess the accuracy of the Select MDx test in the detection of clinically Sig PCa, the test sensitivity was evaluated. Secondary objectives were specificity, negative predictive value (NPV), positive predictive value (PPV), and area under the curve (AUC). A direct comparison with the ERSPC + DRE risk calculator and MRI were also performed. We also studied the predictive ability to diagnose Sig PCa from the combination of the Select MDx test with MRI using clinical decision-curve analysis. RESULTS: There were 163 patients enrolled after meeting the inclusion criteria and study protocol. The Select MDx test showed a sensitivity of 76.9% (95% CI, 63.2-87.5), 49.6% specificity (95% CI, 39.9-59.2), 82.09% (95% CI, 70.8-90.4) NPV, and 41.67% (95% CI, 31.7-52.2) PPV for the diagnosis of Sig PCa. COR analysis was also performed, which showed an AUC of 0.63 (95% CI, 0.56-0.71). There were no differences in the accuracy of Select MDx, ERSPC + DRE, or MRI. The combination of Select MDX + MRI showed the highest impact in the decision-curve analysis, with an NPV of 93%. CONCLUSION: Our study showed a worse performance for the SelectMdx test than previously reported, within a cohort of patients with a PSA 3-10 ng/ml and a normal DRE, with results similar to those from ERSPC + DRE RC and MRI, but with an improvement in the usual PSA pathway. A combination of the Select Mdx test and MRI could improve accuracy, but studies specifically evaluating this scenario with a cost-effective analysis are needed.