Luis F. Oñate-Ocaña

Validation of the Mexican–Spanish version of the EORTC QLQ-C15-PAL questionnaire for the evaluation of health-related quality of life in patients on palliative care

Background: Health‐related quality of life (HRQL) is an important outcome in oncology, particularly in the palliative care setting. The European Organization for Research and Treatment of Cancer (EORTC) QLQ‐C15‐PAL questionnaire is a brief version of QLQ‐C30. Our aim is to validate the Mexican–Spanish version of the QLQ‐C15‐PAL questionnaire to measure HRQL in patients with terminal cancer.

Phase II study of gemcitabine plus cisplatin in metastatic breast cancer.

Our objectives were to assess the efficacy and toxicity of gemcitabine plus cisplatin as first-line therapy in metastatic breast cancer (MBC). Patients with stage IV MBC and no prior chemotherapy for metastatic disease were treated with gemcitabine 1200u2009mg/m2 on days 1 and 8, and cisplatin 75u2009mg/m2 on day 1 every 21 days. Up to 6 cycles were given. A total of 46 patients with a median age of 49 years (range 24–77) and Karnofsky performance status ofu200980 or above were enrolled. In total, 238 cycles were administered. Of the 42 patients evaluable for response, seven (17%) achieved a complete response and 27 (64%) a partial response, for an overall response rate of 81% [95% confidence interval (CI) 69–93%]. Median time to progression was 14.9 months (95% CI 0–30.2 months). Median duration of response was 24.2 months (95% CI 11.2–37.3 months). The median survival was 27.9 months (95% CI 23.1–32.7 months), and the 1- and 2-year survival probabilities were 71.4 and 61.4%, respectively. All patients were evaluable for toxicity, and grade 3/4 WHO toxicities included neutropenia (41.3%), anemia (8.7%), thrombocytopenia (8.7%), alopecia (26.1%) and nausea/vomiting (32.6%). We conclude that gemcitabine plus cisplatin is a highly effective and safe first-line treatment for patients with MBC. The time to progression of 14.9 months compares favorably with other standard treatments (anthracyclines, taxanes). A randomized study is required to further investigate the role of this combination as first-line treatment for MBC.

Dietary folate and vitamin B12 intake before diagnosis decreases gastric cancer mortality risk among susceptible MTHFR 677TT carriers.

OBJECTIVEnTo assess gastric cancer survival in relation to dietary intake of methyl donors and the methylenetetrahydrofolate reductase 677C>T (MTHFR 677C>T) polymorphism.nnnMETHODSnA prospective cohort of 257 incidental, histologically confirmed gastric cancer cases was assembled in January 2004 and followed until June 2006. Patients were recruited from the main oncology and/or gastroenterology units in Mexico City and were queried regarding their sociodemographic information, clinical history, and dietary habits 3 y before the onset of their symptoms. The intake of methyl donors was estimated with a food-frequency questionnaire and the MTHFR 677C>T polymorphisms were determined by polymerase chain reaction/restriction fragment length polymorphism analysis. Coxs multivariate regression models were used to estimate the mortality risk of gastric cancer.nnnRESULTSnMTHFR 677TT carriers with low folate and vitamin B12 intakes had the lowest survival rate in cases of gastric cancer. High intakes of folate and vitamin B12 before diagnosis was associated with decreased gastric cancer mortality risk in susceptible MTHFR 677TT carriers (mortality risk for folate 0.14, 95% confidence interval 0.04-0.46, P for trend=0.001; mortality risk for vitamin B12 0.23, 95% confidence interval 0.08-0.66, P for trend=0.008).nnnCONCLUSIONnFolate and related B vitamins may be used as an intervention strategy to improve the survival outcome of gastric cancer.

The Role of Pretherapeutic Laparoscopy in the Selection of Treatment for Patients With Gastric Carcinoma: A Proposal for a Laparoscopic Staging System

Background:A pretherapeutic staging system to design nonoperative or neoadjuvant treatments in gastric cancer is required. In this study, a simple staging system based on laparoscopic findings to define a treatment algorithm was developed.Methods:A retrospective cohort study was conducted of 151 patients allocated into four stages based on laparoscopic findings. The depth of tumor invasion and the presence of metastasis based on laparoscopic findings were used to construct these stages. Laparoscopic findings were compared with histopathology.Results:An excellent agreement of the laparoscopy-defined depth of invasion and the surgical pathology standard was found (weighted kappa 0.85). The likelihood ratios for a positive and negative laparoscopic diagnosis of metastasis were 40.4 and 0.015, respectively (98.5% sensitivity, 97.6% specificity). Those for positive and negative diagnosis of resectability were 2.6 and 0.03, respectively (98.4% sensitivity, 62% specificity). The laparoscopic stages presented significant prognostic value. Two-year survival was 93%, 69%, 60%, and 17%, respectively. Surgical resection was possible in 100%, 100%, 49%, and 12%, respectively.Conclusions:The proposed laparoscopic staging system is a simple and reproducible way for selection of a suitable therapy. It allows for adequate stratification of the main risk factors in the setting of clinical trials evaluating preoperative treatments.

Functional Evaluation After Reconstruction With Myocutaneous and Fasciocutaneous Flaps for Conservative Oncological Surgery of the Extremities

BackgroundLimb-preservation surgery has evolved during the last two decades through application of pedicled and free flaps and has obtained oncological results similar to those with amputation for malignant neoplasms of the extremities. However, functional evaluation has not been performed comprehensively after these advanced reconstructive procedures. The aim of this study was to describe the oncological, surgical, and functional outcomes achieved in these patients.MethodsPatients had malignant neoplasms of the extremities and/or shoulder and hip girdle, underwent resective surgery and reconstruction with limb-preservation purposes, and were treated from 1997 to 2002. Survival analysis was performed, and functional evaluation after resection was performed with the Enneking system 1 year after surgery.ResultsThirty-two patients were included. The mean overall survival of the cohort was 5.6 years. Functional evaluation mean rating percentages for the upper and lower extremities were 86.5% and 75.2%. Functional outcomes were better for reconstruction with free flaps than with pedicled flaps in the lower extremities (rating percentages, 67% and 79.6%, respectively; P = .018).ConclusionsLimb-preservation surgery is a safe treatment for malignant neoplasms. It can be performed with low morbidity and good oncological outcomes. Functional results in our series were good. Lower limb preservation has superior scores with free flap reconstructions because of their potential to cover extensive defects, and better results were obtained in walking, gait, and weight bearing.

Serum nucleosomes during neoadjuvant chemotherapy in patients with cervical cancer. Predictive and prognostic significance

BackgroundIt has been shown that free DNA circulates in serum plasma of patients with cancer and that at least part is present in the form of oligo- and monucleosomes, a marker of cell death. Preliminary data has shown a good correlation between decrease of nucleosomes with response and prognosis. Here, we performed pre- and post-chemotherapy determinations of serum nucleosomes with an enzyme-linked immunosorbent assay (ELISA) method in a group of patients with cervical cancer receiving neoadjuvant chemotherapy.MethodsFrom December 2000 to June 2001, 41 patients with cervical cancer staged as FIGO stages IB2-IIIB received three 21-day courses of carboplatin and paclitaxel, both administered at day 1; then, patients underwent radical hysterectomy. Nucleosomes were measured the day before (baseline), at day seven of the first course and day seven of the third course of chemotherapy. Values of nucleosomes were analyzed with regard to pathologic response and to time to progression-free and overall survival.ResultsAll patients completed chemotherapy, were evaluable for pathologic response, and had nucleosome levels determined. At a mean follow-up of 23 months (range, 7–26 months), projected progression time and overall survival were 80.3 and 80.4%, respectively. Mean differential values of nucleosomes were lower in the third course as compared with the first course (p >0.001). The decrease in the third course correlated with pathologic response (p = 0.041). Survival analysis showed a statistically significant, better progression-free and survival time in patients who showed lower levels at the third course (p = 0.0243 and p = 0.0260, respectively). Cox regression analysis demonstrated that nucleosome increase in the third course increased risk of death to 6.86 (95% confidence interval [CI 95%], 0.84–56.0).ConclusionSerum nucleosomes may have a predictive role for response and prognostic significance in patients with cervical cancer patients treated with neoadjuvant chemotherapy.

Facing Death in Clinical Practice: A View from Physicians in Mexico

OBJECTIVEnPhysicians decisions and actions, once they know that their patients death is inevitable, will influence how patients are going to live their last moments. The purpose of the present study was to explore the views of physicians about death in their clinical practices.nnnMETHODSnPhysicians who work at four high-specialty public hospitals and two private hospitals in Mexico City provided responses to the Physicians Views about Death Questionnaire, which was developed for this study.nnnRESULTSnFour hundred thirteen physicians were surveyed. The majority treat terminally ill patients (73.3%), but only 28% received training regarding death. Nearly half of the physicians reported a personal formative experience related to death which, together with the experience of being exposed to terminally ill patients, appear to be the manner in which the majority of physicians learn to deal with death. The great majority of participants (90.6%) would personally like to know the truth if they were going to die. Younger physicians, those with <6 years of medical practice, those with no death-related personal formative experience, no death-related academic training, and no experience treating terminally ill patients were most likely to avoid telling patients about their imminent death.nnnCONCLUSIONSnDeath is an important topic for physicians in Mexico. There is a relation between lack of information, experience, and formal training, and the withholding of information from dying patients. This suggests a possible value for interventions to enhance and develop coping skills for professionals who deal with end-of-life situations.

Intraoperative ultrasound for ethanol tumor ablation and liver resection for malignant tumors

IntroductionIntraoperative ultrasound (IOUS) is a safe and reproducible tool and it is considered an essential component of major hepatobiliary procedures. The aim of this study was to define the place of IOUS as an adjuvant for ethanol tumor ablation and liver resection.Material and methodsA review of clinical files of patients operated with liver tumors between August 1998 and January 2001 was performed.ResultsFifty-two patients (30 men, 22 women) age ranging from 17 and 86 years (mean=45) were included for analysis and 26 had primary liver carcinomas (24 HCC and 2 CCC), 16 were considered resectable by preoperative imaging studies. However, IOUS avoid resection in 6 patients (37.5%). in 2 patients (20%) a change in the plane of resection was made. Eight patients with large single HCC lesions were managed with a single session of large volume intraoperative ethanol injection. IOUS detected the distribution of ethanol within the lesion and helped determine the dosage. This technique detected spillage of ethanol into a hepatic vein and helped to avoid a major complication in one patient (12.5 %). Twenty patients presented liver metastases of which, 16 were resected. IOUS avoid resection in 4 patients (20%); a change in the plane of resection was made in 5 (31%). Of 6 benign liver tumors that were operated with an unconfirmed diagnosis, IOUS made the diagnosis in 4. In all, IOUS influenced in the final decision in 70% of patients.ConclusionIOUS has become in creasingly important in hepatic resection in our center and is an essential tool for intraoperative elthanol tumor ablation.ResumenIntroducciónEl ultrasonido intraoperatorio (UI) es una herramienta de diagnóstico útil, segura y actualmente considerada como un componente esencial durante la cirugía hepatobiliar. El objetivo de este estudio fue evaluar el lugar que ocupa el UI como herramienta adyuvante en la ablación tumoral y en la resección hepática.Material y métodosSe revisaron los expedientes clínicos de los pacientes con tumores hepáticos operados de agosto de 1998 a agosto del 2001.ResultadosCincuenta y dos pacientes (30 varones y 22 mujeres), con una edad entre los 17 y 86 años (promedio=45 años) fueron incluidos en este estudio. Veintiséis presentaron carcinomas primarios de hígado (24 hepatocarcinomas y 2 colangiocarcinomas). Dieciséis fueron considerados resecables por estudios de imagen. Sin embargo, el Ul demostró enfermedad que contraindicó la resección en 6 pacientes (37,5%). En 2 pacientes (20%) se cambió la forma de manejo y fueron resecados; 8 pacientes con hepatocarcinomas no candidatos a reseción fueron sometidos a inyección intraoperatoria de grandes volúmenes de alcohol. El Ul fue vital para observar la distribución del mismo dentro de la lesión, determinando así la dosis. Esta técnica detectó la extravasación del alcohol hacia la vena hepática y previno complicaciones mayores en un paciente (12,5%). Veinte pacientes presentaron metástasis hepáticas, de los cuales 16 fueron resecados. El Ul evitó la resección en 4 pacientes (20%), se cambió el plano de la resección en 5 pacientes (31%). De los 6 pacientes operados con lesiones benignas, el Ul confirmó el diagnóstico en 4. En el 70% de los pacientes el Ul tuvo un papel importante en la decisión final.ConclusiónEn nuestro centro el Ul se ha convertido en una herramienta de gran valor en la reseción hepática, así como en la ablación de tumores con la inyección de alcohol intraoperatoria.

The prognostic value of serum carcinoembryonic antigen in colorectal carcinoma

AbstractBackground. Carcinoembryonic antigen (CEA) is a non-specific tumor marker, however some clinical applications have been reported.nAims. Our aim is to define the role of pretherapeutic serum CEA level (SCEAL) as prognostic factor and to describe the usefulness of serial SCEAL in the follow-up of Mexican patients with completely resected colorectal carcinoma (CRC).nPatients and methods. A retrospective cohort study of 580 patients with CRC treated in Mexico City in a 12-year period. The Cox’s model was used to evaluate prognostic factors predicting survival and the logistic regression model was used to test recurrence determinants in completely resected CRC. Sensitivity and specificity for SCEAL as diagnostic aid of recurrence after complete resection is reported and receiver-operating characteristic curve (ROC) analysis was performed to choose the best cutoff point.nResults. Histologic grade, Dukes’ stage, curative resection and age were independent factors determining survival. Preoperative SCEAL was not found to be significant, however a bivariate correlation between preoperative SCEAL and Dukes’ stage was found. Dukes’ stage and specially lymph node metastasis were significant recurrence determinants in completely resected CRC. The sensitivity and specificity of serial SCEAL as diagnostic aid for recurrence after complete resection was 58% and 91%, respectively, using 10 ng/ml as cutoff point.nConclusions. Preoperative SCEAL is neither a significant prognostic factor nor a significant determinant of recurrence. Serial SCEAL has a limited role in the follow-up of patients with completely resected CRC. However, the high specificity for diagnosis of recurrences supports its use in CEA-based second-look surgery.ResumenFundamento. El antígeno carcinoembrionario (ACE) es un marcador tumoral inespecífico, sin embargo se han reportado algunas aplicaciones clínicas.nObjetivos. Nuestro objetivo es difinir el papel de la determinación preterapéutica de ACE sérico como factor predictivo y describir su utilidad de la determinación seriada del ACE sérico en el seguimiento de pacientes mexicanos con carcinoma colorrectal (CCR) completamente resecado.nPacientes y métodos. Es un estudio retrospectivo de cohortes de 580 pacientes con CCR tratados en la ciudad de México durante un período de 12 años. Se usó el modelo de Cox para evaluar los factores predictivos de supervivencia y se usó el modelo de regresión logística para probar los determinantes de recurrencia en CCR completamente resecado. Se evaluó la sensibilidad y especificidad del ACE sérico como prueba diagnóstica de recurrencia y el mejor punto de corte se calculó mediante análisis de característica operativa del receptor (ROC).nResultados. Los determinantes independientes de la supervivencia fueron el grado histológico, la etapa clínica de Dukes, la resección curativa y la edad. El nivel de ACE sérico preoperatorio no fue un factor significativo, sin embargo, se encontró una asociación entre el ACE sérico y la etapa clínica de Dukes. La etapa clínica de Dukes y especialmente la presencia de ganglios linfáticos con metástasis fueron los más importantes determinantes de recurrencia en CCR completamente resecado. La sensibilidad y especificidad de las determinaciones seriadas del ACE sérico como prueba diagnóstica de recurrencia fue de 58% y 91%, respectivamente, usando 10 ng/ml como punto de corte.nConclusiones. El ACE sérico preoperatorio no es ni factor predictivo ni determinante de recurrencia. La determinación seriada de ACE sérico tiene un papel limitado en el seguimiento de pacientes con CCR completamente resecado. Sin embargo, su alta especificidad en el diagnóstico de recurrencias apoya su uso en cirugía de segunda mirada basada en ACE.