Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain.

Belantamab-mafodotin (belamaf) is a novel antibody-drug conjugate targeting B-cell maturation antigen that showed anti-myeloma activity in patients with relapsed and refractory multiple myeloma (RRMM). We performed an observational, retrospective, and multicenter study aimed to assess the efficacy and safety of single-agent belamaf in 156 Spanish patients with RRMM. The median number of prior therapy lines was 5 (range, 1-10), and 88% of patients were triple-class refractory. Median follow-up was 10.9 months (range, 1-28.6). The overall response rate was 41.8% (≥CR 13.5%, VGPR 9%, PR 17.3%, MR 2%). The median progression-free survival was 3.61 months (95% CI, 2.1-5.1) and 14.47 months (95% CI, 7.91-21.04) in patients achieving at least MR (p < 0.001). Median overall survival in the entire cohort and in patients with MR or better was 11.05 months (95% CI, 8.7-13.3) and 23.35 (NA-NA) months, respectively (p < 0.001). Corneal events (87.9%; grade ≥ 3, 33.7%) were the most commonly adverse events, while thrombocytopenia and infections occurred in 15.4% and 15% of patients, respectively. Two (1.3%) patients discontinued treatment permanently due to ocular toxicity. Belamaf showed a noticeably anti-myeloma activity in this real-life series of patients, particularly among those achieving MR or better. The safety profile was manageable and consistent with prior studies.

Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP).

INTRODUCTION: Belantamab mafodotin (BM) is a new anti-BCMA antibody-drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP). METHODS: We conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs). RESULTS: Thirty-three patients were included with a median of 70 years of age (range, 46-79 years). Median time from diagnosis was 71 months (range, 10-858 months). Median prior lines was 5 (range, 3-8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1-16 doses), with a median follow-up of 11 months (6-15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92-5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10-0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107-740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient's decision (3%). CONCLUSIONS: BM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial.

Complete spontaneous regression of a primary renal cell carcinoma. Report of a pathological proven case and review of the literature.

Regression of primary renal cell carcinoma (RCC) is a rare phenomenon and for several reasons many of the reported cases have been questioned. We present a case that can be considered a true spontaneous and complete regression of a primary RCC. A 79-year-old female underwent nephrectomy because a renal tumor. At the time of surgery image studies showed a small para-aortic lymph node. The tumor measured 3cm and was analyzed completely. Histology showed a fibro-inflammatory lesion with necrosis, foamy macrophages and inflammatory cells. No neoplastic cells were observed and the lesion was interpreted as a localized type of xanthogranulomatous pyelonephritis. One year later a CT control scan, showed that the para-aortic lymph node had increased in size to 4cm. Fine needle aspiration revealed features of clear RCC. Metastatic dissemination was limited so surgical removal of the para-aortic lymph node was performed and the cytologic diagnosis confirmed.

Health care activity at the endocrinology and nutrition outpatient clinics of Castilla-La Mancha (the AACENCAM study).

INTRODUCTION: This study was promoted by Sociedad Castellano Manchega de Endocrinología, Nutrición y Diabetes to ascertain the characteristics of patients seen at the outpatient clinics of endocrinology and nutrition of the Castilla-La Mancha Health Authority and the case mix of diagnoses. PATIENTS AND METHODS: This was a retrospective, cross-sectional study of the activity of the endocrinology and nutrition outpatient clinics of public hospitals of Castile-La Mancha during 2018. All visits made on 10% of the working days were analyzed. Data collected comprised patient age and sex, whether a first or subsequent had been made, and whether this was face-to-face or not, and up to five diagnoses per visit. RESULTS: A total of 10,709 visits with a subsequent/first visit ratio of 3.4 were analyzed. Patient age was 52.1?±?18.2 years, and 67.1% were women. Type 2 diabetes mellitus, primary hypothyroidism, thyroid nodular disease, and obesity/overweight were the most common conditions recorded as first diagnosis, accounting for more than half of the total number of visits. Type 1 diabetes mellitus and thyroid cancer were the diagnoses in which the subsequent/first visit ratio was greater. Type 2 diabetes mellitus, obesity, and primary hypothyroidism accounted for almost half of the first visits. CONCLUSIONS: A wide variety of conditions were seen, some of which are among the most prevalent in the general population, while others are not so prevalent, but are complex and difficult to manage by other specialties. Improved knowledge and analysis of the data should allow for the identification of opportunities for improvement and for the implementation of specific actions.

Risk Factors and Mortality of COVID-19 in Patients With Lymphoma: A Multicenter Study.

Patients with cancer are poorly represented in coronavirus disease 2019 (COVID-19) series, and heterogeneous series concerning hematology patients have been published. This study aimed to analyze the impact of COVID-19 in patients with lymphoma. We present a multicenter retrospective study from 19 centers in Madrid, Spain, evaluating risk factors for mortality in adult patients with COVID-19 and lymphoma. About 177 patients (55.9% male) were included with a median follow-up of 27 days and a median age of 70 years. At the time of COVID-19 diagnosis, 49.7% of patients were on active treatment. The overall mortality rate was 34.5%. Age >70 years, confusion, urea concentration, respiratory rate, blood pressure, and age >65 score ≥2, heart disease, and chronic kidney disease were associated with higher mortality risk (P < 0.05). Active disease significantly increased the risk of death (hazard ratio, 2.43; 95% confidence interval, 1.23-4.77; P = 0.01). However, active treatment did not modify mortality risk and no differences were found between the different therapeutic regimens. The persistence of severe acute respiratory syndrome coronavirus 2-positive polymerase chain reaction after week 6 was significantly associated with mortality (54.5% versus 1.4%; P < 0.001). We confirm an increased mortality compared with the general population. In view of our results, any interruption or delay in the start of treatment should be questioned given that active treatment has not been demonstrated to increase mortality risk and that achieving disease remission could lead to better outcomes.

Health care activity at the endocrinology and nutrition outpatient clinics of Castile-La Mancha (the AACENCAM study). / Actividad asistencial en las consultas de Endocrinología y Nutrición de Castilla-La Mancha (estudio AACENCAM).

INTRODUCTION: This study was promoted by Sociedad Castellano-Manchega de Endocrinología, Nutrición y Diabetes to ascertain the characteristics of patients seen at the outpatient clinics of endocrinology and nutrition of the Castilla-La Mancha Health Authority and the case mix of diagnoses. PATIENTS AND METHODS: This was a retrospective, cross-sectional study of the activity of the endocrinology and nutrition outpatient clinics of public hospitals of Castile-La Mancha during 2018. All visits made on 10% of the working days were analyzed. Data collected comprised patient age and sex, whether a first or subsequent had been made, and whether this was face-to-face or not, and up to five diagnoses per visit. RESULTS: A total of 10,709 visits with a subsequent/first visit ratio of 3.4 were analyzed. Patient age was 52.1 ± 18.2 years, and 67.1% were women. Type 2 diabetes mellitus, primary hypothyroidism, thyroid nodular disease, and obesity/overweight were the most common conditions recorded as first diagnosis, accounting for more than half of the total number of visits. Type 1 diabetes mellitus and thyroid cancer were the diagnoses in which the subsequent/first visit ratio was greater. Type 2 diabetes mellitus, obesity, and primary hypothyroidism accounted for almost half of the first visits. CONCLUSIONS: A wide variety of conditions were seen, some of which are among the most prevalent in the general population, while others are not so prevalent, but are complex and difficult to manage by other specialties. Improved knowledge and analysis of the data should allow for the identification of opportunities for improvement and for the implementation of specific actions.

Impact of hematologic malignancy and type of cancer therapy on COVID-19 severity and mortality: lessons from a large population-based registry study.

BACKGROUND: Patients with cancer have been shown to have a higher risk of clinical severity and mortality compared to non-cancer patients with COVID-19. Patients with hematologic malignancies typically are known to have higher levels of immunosuppression and may develop more severe respiratory viral infections than patients with solid tumors. Data on COVID-19 in patients with hematologic malignancies are limited. Here we characterize disease severity and mortality and evaluate potential prognostic factors for mortality. METHODS: In this population-based registry study, we collected de-identified data on clinical characteristics, treatment and outcomes in adult patients with hematologic malignancies and confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection within the Madrid region of Spain. Our case series included all patients admitted to 22 regional health service hospitals and 5 private healthcare centers between February 28 and May 25, 2020. The primary study outcome was all-cause mortality. We assessed the association between mortality and potential prognostic factors using Cox regression analyses adjusted for age, sex, comorbidities, hematologic malignancy and recent active cancer therapy. RESULTS: Of 833 patients reported, 697 were included in the analyses. Median age was 72 years (IQR 60-79), 413 (60%) patients were male and 479 (69%) and 218 (31%) had lymphoid and myeloid malignancies, respectively. Clinical severity of COVID-19 was severe/critical in 429 (62%) patients. At data cutoff, 230 (33%) patients had died. Age ≥ 60 years (hazard ratios 3.17-10.1 vs < 50 years), > 2 comorbidities (1.41 vs ≤ 2), acute myeloid leukemia (2.22 vs non-Hodgkin lymphoma) and active antineoplastic treatment with monoclonal antibodies (2·02) were associated with increased mortality; conventional chemotherapy showed borderline significance (1.50 vs no active therapy). Conversely, Ph-negative myeloproliferative neoplasms (0.33) and active treatment with hypomethylating agents (0.47) were associated with lower mortality. Overall, 574 (82%) patients received antiviral therapy. Mortality with severe/critical COVID-19 was higher with no therapy vs any antiviral combination therapy (2.20). CONCLUSIONS: In this series of patients with hematologic malignancies and COVID-19, mortality was associated with higher age, more comorbidities, type of hematological malignancy and type of antineoplastic therapy. Further studies and long-term follow-up are required to validate these criteria for risk stratification.

Development of an index of complexity for outpatient endocrinology and nutrition clinics. / Desarrollo de un índice de complejidad en consultas externas de Endocrinología y Nutrición.

INTRODUCTION: The tools for analyzing the case-mix in outpatient clinics are scarce few and unsatisfactory. The objective of this study conducted by Sociedad Castellano Manchega de Endocrinología, Nutrición y Diabetes (SCAMEND) was to develop a tool that allows for analyzing the case-mix in outpatient endocrinology and nutrition clinics, considering bearing in mind the complexity of the conditions seen. MATERIAL AND METHODS: Using the Delphi method, the SCAMEND index of complexity in outpatient endocrinology and nutrition clinics (ISCCE-EyN) was developed by endocrinologists in two rounds, comparing the complexity of each condition being compared with that of a review visit of primary hypothyroidism. RESULTS: The first visits were considered more complex than the subsequent visits. Non-neoplastic thyroid disease and uncomplicated overweight/obesity were considered as the least complex diseases, while metabolic diseases, multiple endocrine neoplasia syndromes, and adrenal carcinoma were considered as the most complex. The degree of agreement was high in most of the diseases analyzed. CONCLUSIONS: This tool allows for analyzing the case-mix in outpatient endocrinology and nutrition clinics, based on the inherent complexity of the disease of the patient is reported. This tool may be used for comparisons between centers, to better allocate resources within a given service, or for self-evaluation.

Fine needle aspiration cytology of the normal kidney: A cyto-histological and immunocytochemical correlation study.

BACKGROUND: Differentiation between normal renal cellular structures and renal tumors can be a diagnostic challenge during fine needle aspiration. It is of particular relevance during percutaneous thermal ablation because of the small size of tumors and when performing rapid on-site evaluation. METHODS: A cyto-histological correlation study assisted by immunocytochemistry was performed. The study was based on 10 nephrectomy specimens. For the identification of proximal tubular cells we used CD10 and α-methylacyl coenzyme A racemase (AMACR). PAX8 and GATA3 were used for the recognition of distal and collecting duct cells. For a precise correlation representative cytologic groups were photographed before and after immunocytochemistry. RESULTS: All cases showed: (a) glomeruli; (b) presence of at least 2 different epithelial cell populations that distribute separately, one representing the proximal tubule and the other more distal segments; and (c) existence of isolated, laminar basement fragments and slender, intact tubular structures. Proximal tubular cells were large with granular cytoplasm, indistinct cell borders, moderate anisonucleosis, and variable presence of pigment. Their immunophenotype was CD10+, AMACR+, PAX8-, and GATA3-. In all cases, cellular aggregates different of nonproximal tubular cells were present. They were smaller than proximal tubular cells with less cytoplasm, better-defined cell borders and uniform nuclei. Their immunophenotype was CD10-, AMACR-, PAX8+, and GATA3+ CONCLUSION: Aspirates from the normal kidney show characteristic features that permit a specific recognition. Different segments of the tubular system can be specifically recognized avoiding confusion with renal tumors. In difficult cases immunocytochemistry is a very helpful aid.

Difilobotriosis humana: primer caso por consumo de sushi en Buenos Aires, Argentina / Human diphyllobothriosis: first case by consumption of sushi in Buenos Aires, Argentina

La difilobotriosis es una parasitosis intestinal causada por cestodes del género Diphy-llobothrium. Son consideradas áreas endémicas de esta parasitosis Escandinavia, zonas de los Grandes Lagos de América del Norte, la Patagonia Andina, entre otras. Este sería, hasta el presente, el primer informe de un caso de difilobotriosis por consumo de sushi en Buenos Aires, Argentina.

Síndrome de Brooke-Spiegler simulando esclerosis tuberosa / Brooke-Spiegler Syndrome simulting tuberose sclerosis

Se presenta una mujer de 18 años de edad sin antecedentes familiares ni personales de interés que consulta por tricoepiteliomas en cara y cilindromas en cuero cabelludo. En el examen físico hallamos máculas hipomelanóticas en abdomen y en muslo, y un fibroma periungueal en el 5º dedo de pie derecho que obligaron a descartar otras entidades. Se realizó el diagnóstico de síndrome de Brooke-Spiegler, y se revisan los diagnósticos diferenciales de papulosis faciales

[Absence/disappearance of gallbladder in a patient diagnosed with cholelithiasis]. / Ausencia-desaparición de la vesícula biliar en un paciente diagnosticado de colelitiasis.

We report the case of a patient with preoperatively demonstrated cholecystitis due to cholelithiasis but with no presence of gallbladder at laparoscopy or on conversion to open surgery. Gallbladder ectopy was ruled out and the possibility of gallbladder agenesia was discussed. However, four preoperative ultrasound scans performed within a protocol of treatment with octreotide, in the setting of acute cholecystitis, ruled out this possibility. We discuss the possibility of gallbladder destruction and digestion after a severe inflammatory process, as well as Frey's criteria for gallbladder agenesia. We believe that this is a case of complete gallbladder lysis due to an inflammatory process.

Aspectos importantes sobre el uso de las soluciones desinfectantes / Important aspects about the use of desinfectant solutions

Se hace un breve recuento histórico sobre los primeros agentes desinfectantes y se clasifican los que se emplean hoy en día de acuerdo con el grupo al cual pertenecen. Se señalan los efectos que cada uno de ellos tiene sobre los principales gérmenes presentes en las heridas de los pacientes y como contaminantes en distintas áreas. Se presenta una lista detallada sobre las distintas sustancias que son capaces de inactivar las soluciones desinfectantes, y finalmente se hacen consideraciones sobre la manipulación de estas soluciones para que no se contaminen y cumplan su objetivo