OBJECTIVE: Tislelizumab, a monoclonal antibody against programed death protein-1 (PD-1), has shown encouraging antitumor activity in urothelial cancer. This study was designed to assess the efficacy and safety of tislelizumab in urotelial cancer in a real-world setting.
METHODS: The study was a real-world retrospective study undertaken at Liaoning Cancer Hospital & Institute, China. Eligible patients were ≥18 years. Patients received 200-mg tislelizumab monotherapy intravenously every 3 weeks until the disease progressed to intolerable toxicity. Outcomes included an objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.
RESULTS: Between March 2020 and December 2022, 33 patients were enrolled. The median follow-up was 10.17 (IQR 5.73-12.47) months. Of all 33 patients, ORR and DCR were 30.30% (95% CI 15.6%-48.7%) and 42.42% (95% CI 25.48%-60.78%), respectively. The median PFS was 5.73 (95% CI 3.27-13.00) months, with a 12-month PFS rate of 31.90% (95% CI 19.20%-53.00%). The median OS was 17.7 (95% CI 12.80-not reach) months, with a 12-month OS rate of 67.50% (95% CI 52.70%-86.40%). Eleven (33.33%) and 8 (24.24%) experienced ≥grade 3 treatment-related adverse events (TRAEs) and immune-related Aes, respectively. No treatment-related deaths occurred.
CONCLUSIONS: The excellent efficacy and controllable safety of tislelizumab in locally advanced or metastatic urothelial cancer suggest that it may be a promising therapeutic option for this population.

In this study, we show the results of the subset of Spanish patients of the VERIFIE study, the first post-marketing study assessing the long-term safety and effectiveness of sucroferric oxyhydroxide (SFOH) in patients with hyperphosphatemia undergoing dialysis during clinical practice.
Patients undergoing hemodialysis and peritoneal dialysis with indication of SFOH treatment were included. Follow-up duration was 12-36 months after SFOH initiation. Primary safety variables were the incidence of adverse drug reactions (ADRs), medical events of special interest (MESIs), and variations in iron-related parameters. SFOH effectiveness was evaluated by the change in serum phosphorus levels.
A total of 286 patients were recruited and data from 282 were analyzed. Among those 282 patients, 161 (57.1%) withdrew the study prematurely and 52.5% received concomitant treatment with other phosphate binders. ADRs were observed in 35.1% of patients, the most common of which were gastrointestinal disorders (77.1%) and mild/moderate in severity (83.7%). MESIs were reported in 14.2% of patients, and 93.7% were mild/moderate. An increase in ferritin (386.66ng/mL vs 447.55ng/mL; p=0.0013) and transferrin saturation (28.07% vs 30.34%; p=0.043) was observed from baseline to the last visit (p=0.0013). Serum phosphorus levels progressively decreased from 5.69mg/dL at baseline to 4.84mg/dL at the last visit (p<0.0001), increasing by 32.2% the proportion of patients who achieved serum phosphorus levels ≤5.5mg/dL, with a mean daily SFOH dose of 1.98 pills/day.
SFOH showed a favorable effectiveness profile, a similar safety profile to that observed in the international study with most adverse events of mild/moderate severity, and a low daily pill burden in Spanish patients in dialysis.

BACKGROUND: Live surgery has become an excellent tool for medical training. Despite this, there is controversy about the safety of the patients involved.
OBJECTIVE: To analyze the results of live surgeries performed in 17 consecutive retroperitoneoscopy courses organized in our center. Procedures performed were partial nephrectomy (PN), radical nephrectomy (RN) and nephroureterectomy (NU).
METHODS: Review from January 2010 to October 2017 of all live surgeries carried out by an expert surgical team in the retroperitoneoscopy courses, compared with a control group of surgeries performed in standard conditions. A matching (1:1 for each RN and 1:2 for each PN and NU) according to age, body mass index and comorbidities was performed.
RESULTS: Twenty-one live surgeries were analyzed (eight PN, seven RN and six NU) with a global median follow-up of 38 months. No significant differences were observed between both groups in terms of perioperative variables (operative time, operative bleeding and intraoperative complications) or of postoperative complications and length of hospital stay. Likewise, there were no differences between recurrence rates (PN: 0% vs. 6.3%, p = 0.47, NU: 33.3% vs. 66.7%, p = 0.180, RN: 0% vs. 28.6%, p = 0,127).
CONCLUSIONS: Live surgery in the hands of expert surgeons in a suitable environment and with well-selected patients does not increase the risk of complications and allows maintaining the same oncological outcomes.

OBJECTIVE: To quantify the risk of dorsal innervation injury when performing direct metacarpophalangeal joint portals of the second to fifth fingers.
METHODS: An anatomical study of 11 upper limbs of fresh corpses was carried out. After placing them in a traction tower, the metacarpophalangeal portals were developed on both sides of the extensor tendon. The dorsal sensory branches were dissected and the distances between the portal and the nearest nerve were measured by a digital caliper. The portals of all the fingers were compared globally to assess the safest finger and two to two radial and ulnar portals were compared in each of the fingers to assess the safest portal within each finger.
RESULTS: The overall comparison of all portals and fingers showed that the third finger is the safest in any of its portals, while the ulnar side of the second and radial of the fourth are the portals with the highest risk of nerve injury (P=8.96·10-5). Comparing two to two of the radial and ulnar portals in each of the fingers showed that the ulnar portal is safer than the radial on the fourth finger (P=.042), while the radial is safer than the ulnar on the fifth finger (P=.003).
CONCLUSIONS: The third finger was the safest to perform metacarpophalangeal portals, while the ulnar side of the second finger and radial side of the fourth had the highest risk of nerve injury.

To determine whether dihydroartemisinin-piperaquine (DHA-PPQ) is non-inferior to artesunate-amodiaquine (ASAQ) for treating uncomplicated malaria infection in pregnancy.
A total of 417 second/ third trimester pregnant women with confirmed asymptomatic Plasmodium falciparum parasitaemia were randomised to receive DHA-PPQ or ASAQ over 3 days. Women were followed up on days 1, 2, 3, 7, 14, 28 and 42 after treatment start and at delivery for parasitological, haematological, birth outcomes and at 6-week post-partum to ascertain the health status of the babies. Parasitological efficacy (PE) by days 28 and 42 were co-primary outcomes. Analysis was per-protocol (PP) and modified intention-to-treat (ITT). Non-inferiority was declared if the two-sided 95% confidence interval for PE at the endpoints excluded 5% lower efficacy for DHA-PPQ. Secondary outcomes were assessed for superiority.
In PP analysis, PE was 91.6% for DHA-PPQ and 89.3% for ASAQ by day 28 and 89.0% and 86.5%, respectively, by day 42. DHA-PPQ was non-inferior to ASAQ with respect to uncorrected PE [adjusted difference by day 28 (DHA-PPQ-ASAQ); 3.5% (95%CI: -1.5, 8.5); and day 42: 3.9% (95%CI: -2.7, 10.4)]. ITT analysis gave similar results. PCR to distinguish recrudescence and reinfection was unsuccessful. DHA-PPQ recipients had fewer adverse events of vomiting, dizziness, and general weakness compared to ASAQ. Both drugs were well-tolerated, and there was no excess of adverse birth outcomes.
DHA-PPQ was non-inferior to ASAQ for treatment of malaria infection during pregnancy. No safety concerns were identified. Our findings contribute to growing evidence that DHA-PPQ is useful for control of malaria in pregnancy.

BACKGROUND: The increasing incidence of trigeminal neuralgia (TN) with age together with population ageing call for reexamination of surgical treatment options for refractory TN in elderly patients.
METHODS: Retrospective review of a consecutive series of patients older than 70 who underwent microvascular decompression (MVD) for refractory TN between 1997 and 2015. Outcomes based on the Barrow Neurological Institute pain intensity score (BNI score) and surgical complications were compared to those of patients younger than 70 undergoing MVD in the same period.
RESULTS: Forty patients older than 70 (mean = 74.8 years) underwent interventions. At a mean follow-up time of 34 months, 73% of the patients presented complete absence of pain without medication (BNI I) and 85% had good pain control with or without medication (BNI I-III). A comparison of these patients with the 85 patients younger than 70 treated surgically during the same period did not find a significant association between age and achievement of pain control (BNI I-II). However, there was a significant association between age older than 70 and complete pain relief (BNI I; P=.03). The mean hospital stay in patients over 70 was also significantly longer (P=.04), although the postsurgical complication rate was similar to that in younger patients.
CONCLUSIONS: Elderly patients with refractory TN may benefit from treatment with MVD and the probability of success and surgical risk are comparable to those in younger patients.

BACKGROUND: Extended-release (ER) paliperidone is an innovative atypical antipsychotic that allows minimal peak-to-through fluctuations with once-daily dosing.
OBJECTIVE: To evaluate effectiveness, safety and tolerability of flexible, once-daily doses of paliperidone ER (3-12 mg/day) in patients with schizophrenia from Argentina and Colombia who had previously failed treatment with other antipsychotic agents.
METHODS: The authors conducted a 6-month, open-label, prospective and multicentric study. Effectiveness was assessed with Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance scale (PSP). Other measures of effectiveness, safety and tolerability, were also conducted.
RESULTS: Paliperidone ER 3-12 mg/day improved Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint) from baseline to study end (p < 0,001). In the PANSS total score, the mean change from baseline (83, 9 units) to end point (53,7 units) was significant (p < 0,001). Flexible doses of paliperidone ER demonstrated a ≥20% reduction in the PANSS total score (p<0.001) in almost two-thirds of patients. PSP mean change from baseline (52 units) to end point (85 units) was significant (p < 0,001). Secondary effectiveness assessments, as well as safety and tolerability measures, demonstrated favourable results throughout the study.
CONCLUSIONS: Flexible doses of paliperidone ER over 6 months were effective, safe and well tolerated in patients with schizophrenia from Argentina and Colombia.

BACKGROUND: Country-specific information on pediatric GH therapy is available from multi-national studies.
METHODS: A total of 1294 children in Spain enrolled in the observational Genetics and Neuroendocrinology of Short-stature International Study (GeNeSIS). Adverse events were assessed in all GH-treated patients (n=1267) and effectiveness in those with GH deficiency (GHD, 78%).
RESULTS: Mean age at time of entry to the study was 9.8 years. GH was initiated at a median (Q1-Q3) 0.22 (0.20-0.25) mg/kg/week and administered for 2.8 (1.6-4.4) years. For 262 patients with GHD and 4-year data, mean (95% CI) height velocity was 4.3 (4.1 - 4.6) cm/year at baseline, 9.0 (8.7 to 9.4) cm/year at 1-year, and 5.5 (5.2 to 5.8) cm/year at 4-years. Height standard deviation score (SDS) was -2.48 (-2.58 to -2.38) at baseline and -1.18 (-1.28 to -1.08) at 4 years. Final height SDS minus target height SDS (n=241) was -0.09 (-0.20 to 0.02). In 1143 GH-treated patients with ≥1 year follow-up, 93 (8.1%) reported treatment-emergent adverse events. Serious events were reported for 7 children, with 2 considered GH-related.
CONCLUSIONS: These data confirm the benefit of GH replacement therapy on height gain for the patients in Spain. The safety profile was consistent with that already known for GH therapy.

BACKGROUND: There is scarce information on the use of ciclopirox olamine in children.
OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of ciclopirox olamine cream 1% for the treatment of dermatomycosis in pediatric patients.
METHODS: A multicenter, non-randomized, open-label, phase iii study was conducted on patients aged 3 months to 9 years diagnosed with dermatomycosis confirmed by direct microscopy and culture, and treated with ciclopirox olamine cream 1% for 28 days. Clinical and microbiological evaluations were performed before starting the treatment therapy, at 7, 14 and 28 days after starting the treatment, and 28 days after its completion.
RESULTS: Twenty-one patients with a median age of 2.7 years (range 3 months-9 years) were included. The most frequent mycosis location was the inguinal region (72%). The most frequently isolated etiological agent was Candida spp. (71%). No adverse events were reported in 62% of the patients. Among the mild and moderate reported adverse events, only one, irritative dermatitis, was considered as possibly related to the treatment. Safety evaluation was excellent in 95% of the patients, and good in 5%. After the first week of treatment, 12 patients out of 13 (92%) showed a clinical improvement, and 5 out of 7 (71%) had both clinical and mycological improvements. At the end of the treatment, clinical cure was observed in 7 out of 9 patients (78%). No relapses occurred.
CONCLUSIONS: Ciclopirox olamine cream 1% is a safe and feasible treatment for superficial cutaneous mycotic infections, especially Candida spp. infection, in children aged between 3 months and 10 years.

BACKGROUND: GIDEON is a non-interventional, prospective, international study that evaluated the safety of sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in daily clinical practice, including Child-Pugh B patients.
OBJECTIVE: To analyze data collected in Spain on the safety and efficacy of sorafenib and treatment patterns.
METHODS: Data were collected during follow-up on demographic and disease characteristics, the initial dose used, treatment-emergent adverse events (AEs) and dose modifications. Overall survival was evaluated, as well as time to disease progression. Efficacy and safety were analyzed according to the Child-Pugh classification and the initial dose.
RESULTS: We included 143 patients from 19 Spanish hospitals. A total of 24.5% of the patients were Child-Pugh B. An initial dose of 400 mg/12 h was used in 90.9% of patients. In Child-Pugh A patients, dose modifications occurred more frequently and the treatment duration was longer. The incidence of AEs and drug-related AEs were similar in Child-Pugh A and B patients, although serious AEs were more frequent in Child-Pugh B patients. The most common AEs were diarrhea, fatigue and hand-foot skin reactions. The median overall survival was 384 days and was higher in Child-Pugh A patients (593 vs. 211 days in Child-Pugh B). The median time to disease progression was 177 days, similar in both subgroups.
CONCLUSIONS: The safety profile of sorafenib in Spanish patients with unresectable HCC is independent of liver function. Child-Pugh status does not seem to influence the approach to sorafenib dosage or time to progression but does seem to be a strong prognostic factor for survival.