Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Valoración preoperatoria de la masa anexial

The adnexal mass is the tumor that can be located in the ovary, fallopian tube or the surrounding connective tissue (mesosalpinx, mesoovarian tissue and broad ligament). It is a common gynecological problem. The previous determination of benignancy or malignancy is essential for an adequate management. There is a variety of radiological methods, biomarkers and pre-surgical clinical methods and predictive models that have been studied and validated in the world to differentiate the etiology of the adnexal masses. J Kaijser et al performed a systematic review and meta-analysis on the use of predictive mathematical models in the presurgical diagnosis of adnexal masses. At present, the review of the different studies and systematic reviews show that both IOTA LR2 and Simple Rules are the best diagnostic methods available to differentiate benign and malignant adnexal masses preoperatively. In women in reproductive age this disquisition is of vital importance for the preservation of fertility. Likewise, the predictive results of benign disease could be treated by gynecologists-obstetricians or in the general hospitals, and patients with suspected malignancy can be referred and treated by gynecologist oncologists.

La masa anexial es la tumoración que puede localizarse en ovario, trompa de Falopio y el tejido conectivo que los rodea (mesosálpinx, mesoovario y ligamento ancho). Es un problema ginecológico común. La determinación del riesgo de benignidad o malignidad previa es esencial para un manejo posterior adecuado. Existe gran variedad de métodos radiológicos, biomarcadores o métodos clínicos prequirúrgicos y modelos predictivos que han sido estudiados y validados en diversas partes del mundo para poder diferenciar la etiología de las masas anexiales. J Kaijser y col. realizaron una revisión sistemática y metaanálisis del uso de modelos matemáticos predictivos en el diagnóstico prequirúrgico de masas anexiales. En la actualidad, la revisión de los diferentes estudios y revisiones sistemáticas muestran que ambos IOTA LR2 y Simple Rules son los mejores métodos de diagnóstico disponibles para poder diferenciar masas anexiales benignas y malignas en forma preoperatoria. En mujeres en edad reproductiva, esta disquisición es de vital importancia para la preservación de la fertilidad. Asimismo, los resultados predictivos de enfermedad benigna podrían ser tratados por especialistas ginecoobstetras o en hospitales generales y las pacientes con sospecha de malignidad ser referidas y tratadas por ginecólogos oncólogos.

Compromiso parametrial en pacientes con cáncer de cérvix IB-1 tratadas con histerectomía radical en Perú / Parametrial involvement in cervical cancer IB1 patients treated with radical hysterectomy in Peru

Objetivos. Evaluar la frecuencia y factores asociados al compromiso parametrial (CP) en pacientes con cáncer de cérvix IB-1 sometidas a histerectomía radical (HR) en el Instituto Nacional de Enfermedades Neoplásicas del Perú. Materiales y métodos. Estudio transversal analítico en 214 pacientes con cáncer de cérvix IB-1 sometidas a HR con linfadenectomía pélvica entre el 2007 y 2012. Se comparó la población con y sin CP según variables clinicopatológicas como edad, tamaño tumoral, profundidad de infiltración, grado histológico y afectación ganglionar pélvica. Resultados. Diez pacientes (4,6%) presentaron CP. El análisis multivariable mostró que la profundidad de la invasión (OR 8,37, IC 95%: 1,24-56,41, p=0,029) y el compromiso de ganglios pélvicos (OR 18,03, IC 95%: 3,30-98,44, p=0,001) resultaron ser predictores independientes del CP. La presencia de tamaño tumoral ≤ 2 cm, invasión ≤ 10 mm, ausencia de permeación linfovascular y ausencia de compromiso ganglionar permitió identificar 97 pacientes de bajo riesgo de CP, de los cuales ninguno tuvo CP en patología. Conclusiones. Confirmamos la baja frecuencia del CP en el subgrupo de cáncer de cervix IB-1 y su asociación con la profundidad de la invasión y con el compromiso ganglionar linfático sugeridos en estudios previos. Esta información permitirá identificar un subgrupo de pacientes con bajo riesgo de CP candidatas a una cirugía menos radical en nuestra institución. (AU)

Objectives. To assess the frequency and factors associated with parametrial involvement (PI) in patients with cervical cancer IB1 who underwent radical hysterectomy (RH) at the National Institute of Neoplastic Diseases in Peru. Materials and methods. Cross-sectional study of 214 patients with cervical cancer IB1 undergoing RH with pelvic lymphadenectomy between 2007 and 2012. The population was compared with and without clinicopathological variables associated with PI such as age, tumor size, depth of infiltration, histological grade and pelvic lymph node involvement. Results. Ten patients (4.6%) had PI. Multivariate analysis showed that the depth of invasion (OR 8.37, 95% CI 1.24- 56.41, p=0.029) and pelvic node involvement (OR 18.03; 95% CI 3.30-98.44, p=0.001) were all independent predictors of PI. The presence of tumor size ≤ 2 cm, invasion ≤ 10 mm, absence of lymphovascular permeation and absence of nodal involvement identified 97 patients at low risk of PI, none of whom had PI pathology. Conclusions. We confirmed the low frequency of PI in the cervical cancer IB1 subgroup and its association with the depth of invasion and lymph node involvement suggested in previous studies. This information will allow the identification of a subgroup of patients at low risk of PI for less radical surgery in our institution. (AU)

Factores pronósticos para pacientes con cáncer de ovario epitelial avanzado tratados con citoreducción óptima en el INEN 1998-2008 / Prognostic factors for patients with epithelial advanced ovarian cancer treated with optimal citoreduccion in INEN 1998-2008

Objetivo: El objetivo de este estudio fue determinar los factores pronóstico de la sobrevida global (SG) y la sobrevida libre de enfermedad (SLE) en las mujeres con cáncer de ovario epitelial (COE) estadio avanzado después de la cirugía citorreductora y quimioterapia de primera línea basada en platino. Material y métodos: Todas las mujeres con cáncer de ovario con estadios clínicos FIGO III y IV que tuvieron cito reducción óptima primaria seguida de seis cursos de quimioterapia basada en platino en el Instituto Nacional de Enfermedades Neoplásicas entre enero de 1998 y diciembre de 2008, fueron identificadas a partir de la base de datos de cáncer de ovario. Se evaluó la sobrevida global, la sobrevida libre de enfermedad y los factores que influyeron en ellas. Resultados: Se estudiaron un total de 56 pacientes. La sobrevida global a 5 años fue de 46,9 %. Se encontraron como factores pronósticos significativos de la sobrevida global al recuento plaquetario (p=0.002) y al dosaje de hemoglobina (p=0.003) preoperatoria. Y como factores pronósticos significativos de sobrevida libre de enfermedad al recuento plaquetario (p=0.002) y la enfermedad residual post operatoria (p=0.002).Conclusiones: El recuento de plaquetas preoperatorio y el volumen de enfermedad residual postoperatoria son factores pronósticos de la sobrevida libre de enfermedad, mientras que la hemoglobina sérica preoperatoria y el recuento plaquetario preoperatorio lo son para la sobrevida global.

Objective: The objective of this study was to determine prognostic factors of overall survival (OS) and disease-free survival (DFS) in women with epithelial ovarian cancer in advanced stage (EOC) after cytoreductive surgery and first-line chemotherapy based on platinum. Material and methods:All women with ovarian cancer FIGO clinical stages III and IV who had optimal primary cytoreduction followed by six courses of platinum-based chemotherapy at the Instituto Nacional de Enfermedades Neoplásicas between January 1998 and December 2008, were identified from the database of ovarian cancer. We assessed overall survival, disease-free survival and factors influencing them. Results: We studied a total of 56 patients. Overall survival at 5 years was 46.9%. Were found as significant prognostic factors of overall survival at platelet count (p = 0.002) and the dosage of hemoglobin (p = 0.003) preoperatively. And as significant prognostic factors for disease-free survival at platelet count (p = 0.002) and postoperative residual disease (p = 0.002).Conclusions: The preoperative platelet count and volume of postoperative residual disease were predictive of disease-free survival, whereas preoperative serum hemoglobin and platelet counts were for overall survival.