First-line single-agent regorafenib in frail patients with metastatic colorectal cancer: a pilot phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD).

BACKGROUND: Treatment of frail patients with advanced colorectal cancer (CRC) is controversial. This pilot phase II trial aimed to assess the efficacy and safety of regorafenib when administered in first-line to frail patients with advanced CRC. METHODS: Frail patients without prior advanced colorectal cancer treatment were included in the study. Definition of frailty was defined per protocol based on dependency criteria, presence of chronic comorbid pathologies and/or geriatric features. MAIN OBJECTIVE: to assess progression-free survival (PFS) rate at 6 months. Treatment consisted of 28-day cycles of orally administered regorafenib 160 mg/day (3 weeks followed by 1 week rest). RESULTS: Forty-seven patients were included in the study. Median age was 81 years (range 63-89). Frailty criteria: dependency was observed in 26 patients (55%), comorbidities in 27 (57%) and geriatric features in 18 (38%). PFS rate at 6 months was 45% (95% confidence interval [CI] 30-60]. Median PFS was 5.6 months (95%CI 2.7-8.4). Median overall survival (OS) was 16 months (95%CI 7.8-24). Complete response, partial response and stable disease were observed in one, two and 21 patients respectively (objective response rate 6.4%; disease control rate 51%). Thirty-nine patients (83%) experienced grade 3-4 adverse events (AEs). The most common grade 3-4 AEs were hypertension (15 patients; 32%), asthenia (14; 30%), hypophosphatemia (6; 13%); diarrhea (4; 8%), hand-foot-skin reaction (4; 8%). There were two toxic deaths (4.2%) (grade 5 rectal bleeding and death not further specified). Dose reduction was required in 26 patients (55%) and dose-delays in 13 patients (28%). CONCLUSIONS: The study did not meet the pre-specified boundary of 55% PFS rate at 6 months. Toxicity observed (83% patients experienced grade 3 and 4 AEs) preclude its current use in clinical practice on this setting. Disease control rate and overall survival results are interesting and might warrant further investigation to identify those who benefit from this approach. TRIAL REGISTRATION: This trial was prospectively registered at EudraCT ( 2013-000236-94 ). Date of trial registration: April 9th, 2013.

Risk and protective factors for drug abuse in adolescents. A longitudinal research.

INTRODUCTION: The aim of the present study was to identify possible risk and protective factors for the development of problems with the use of drugs in adolescents. METHODS: A two years follow-up was carried out (from the 2nd to the 4th year of the Compulsory Secondary Education). Sociodemographic variables, general and eating psychopathology, family functioning and patterns of drugs use were assessed in 1,076 students. RESULTS: After controlling the effect of having problems with the use of drugs at the beginning, cigarettes smoking at the age of 13 years predicted the consumption of alcohol 2 years later and vice versa. Independently of the effect of this association, general psychopathology, body image dissatisfaction and self-harm at the beginning were risk factors for alcohol consumption 2 years later. Moreover, besides female gender and high academic achievements, normal family functioning was a protective factor against the fact of suffering problems with drugs later on. CONCLUSIONS: These present findings might have relevance in the development of preventive strategies for the use of drugs in adolescent population.

Entubación endotraqueal submandibular: una alternativa a la traqueostomía temporal / Submandibular endotracheal entubation procedure: an alternative to tracheostomy

Presentamos el caso de un procedimiento de Intubación Endotraqueal Submandibular (SEI: Submandibular Endotracheal Intubation) realizado en un paciente de 48 años de edad, sexo masculino, de profesión médico-cirujano y con diagnóstico preoperatorio de Fractura Panfacial e Intubación Prolongada, quien había manifestado reiteradamente su negativa a ser traqueostomizado. La técnica requiere de un trabajo coordinado entre cirujano y anestesiólogo para alcanzar el éxito y lograr los beneficios del procedimiento. Luego de que el paciente es anestesiado, el cirujano realiza la disección roma del piso de la boca con la finalidad de introducir una pinza hemostática en la cavidad oral a través de la incisión de la piel; de otro lado, el anestesiólogo ha preparado un tubo endotraqueal con refuerzo metálico en espiral, el mismo que, después de ser introducido en la tráquea por intubación oral y ser desprovisto de su conectador, es clampado intraoralmente por la pinza del cirujano y guiado hacia el exterior donde es conectado a la pieza en Y de los tubos corrugados de la máquina de anestesia. Cuando el anestesiólogo confirma la correcta posición del tubo endotraqueal, se procede a fijarlo en la piel con un punto de sutura y se refuerza con una cinta de esparadrapo. Después de cuatro días se procedió al retiro del tubo endotraqueal en forma inversa al procedimiento de intubación y se suturó la herida submandibular. El paciente evolucionó favorablemente sin presentar infección de la herida, trayectos fistulosos u otra complicación atribuible a la técnica usada

Patterns of sulfadiazine acute nephrotoxicity.

Sulfadiazine acute nephrotoxicity is reviving specially because of its use in toxoplasmosis in HIV-positive patients. We report 4 cases, one of them in a previously healthy person. Under treatment with sulfadiazine they developed oliguria, abdominal pain, renal failure and showed multiple radiolucent renal calculi in echography. All patients recovered their previous normal renal function after adequate hydration and alcalinization. A nephrostomy tube had to be placed in one of the patients for ureteral lithiasis in a single functional kidney. None of them needed dialysis or a renal biopsy because of a typical benign course. Treatment with sulfadiazine requires exquisite control of renal function, an increase in water ingestion and possibly the alcalinization of the urine. We communicate a case in a previously healthy person, a fact not found in the recent literature. Probably many more cases are not detected. We think that a prospective study would be useful.

[Disseminated inflammatory pseudotumor of the lymph nodes]. / Seudotumor inflamatorio diseminado de los ganglios linfáticos.

Inflammatory pseudotumour of lymph nodes is a benign type of lymphadenopathy recently described as a peculiar nodal reaction, which displays distinctive clinical and histological features. The origin of the disease is unknown although an inflammatory etiology has been suggested. We study a new case of inflammatory pseudotumour of lymph nodes which had an unusual clinical presentation, with lymphadenopathy on both sides of the diaphragm and enlargement of liver and spleen. In addition, focal fibrinoid vascular necrosis was observed on histological examination, an unusual finding which makes difficult the differential diagnosis with other lesions, particularly vasculitis.