Evaluation of waiting times for breast cancer diagnosis and surgical treatment

Purpose: To analyse any delays in breast cancer diagnosis and surgical treatment, influence of clinical and biological factors and influence of delays on survival. Methods/patients: A descriptive, observational, and retrospective study was conducted between 2006 and 2016 on stages I-III breast cancer patients. This is a retrospective review of health records to collect data on delays, patients’ clinical data, biological features of the tumour and information on treatment. Mortality data from the National Death Index. Results: In 493 evaluable patients, the median of days from the first symptom to mammography, biopsy, and surgery was 41, 57, and 92, respectively. The median of days from screening mammography to biopsy and surgery was 10 and 51, respectively. From biopsy to surgery, the median was 34 days in every case. Over the last 5 years, an increase in biopsy-surgery delay has been observed (p = 0.0001). Tumour stages I and II vs. stage III (RR 1.74. 95% CI 1.08-2.80, p = 0.027), diagnosis in screening (RR 0.66. 95% CI 0.45-0.96, p = 0.030), and use of magnetic resonance imaging (RR 2.08. 95 CI 1.21-3.56, p = 0.008) condition a greater biopsy-surgery delay. No influence of delays on survival has been identified. Conclusions: Delays in diagnosis and surgery in the case of women diagnosed on the basis of symptoms may be improved. There is a temporary tendency to a greater delay in surgery. Some clinical and biological factors must be taken into account to optimise delays. Survival results are not adversely affected by delays

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Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice

Introduction: This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data. Materials and methods: Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile. Results: A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2− patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%). Conclusions: Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials

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Implementation of safeguards to improve patient safety in chemotherapy

Purpose. To evaluate the effectiveness of safeguards introduced in the process of using cytostatic agents for increasing the safety of oncology patients. Methods. Prospective hospital study conducted in two stages, before and after the implementation of safeguards: staff training, standardized procedures, computerized prescription, pharmaceutical validation, implementation of bar codes, and a new manual on drug interactions. Medication errors (MEs) were actively recorded during the process of administering chemotherapy in the Medical Oncology Department. The study classified MEs by the stage of the medication process in which they occurred and assessed their severity. Results. 500 patients, 250 before implementing safeguards and 250 afterward, were included in this study . Out of all patients included before, 43.1% had at least 1 error, compared to 27% of those included later. The number of MEs detected before and after was 144 vs. 95: 125 vs. 55 prescription errors, 2 vs. 5 validation errors, 14 vs. 4 preparation errors, 3 vs. 1 dispensation errors and 0 vs. 30 administration errors. The number of MEs that reached the patient before and after safeguard implementation was 16.7% vs. 6.3%. After the safeguards were introduced, all MEs that could have caused harm or required monitoring of some kind were prevented. Conclusions. Implementing safeguards in the hospital’s cytostatic treatment cycle is useful for preventing MEs. Computerized prescription, pharmaceutical validation, and the creation/dissemination of proper work procedures are effective barriers that keep MEs from reaching the patient. Administering chemotherapy with a bar-code system facilitates detection error detection at this stage of the cycle and prevents them from reaching the patient (AU)

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Análisis de la efectividad de un protocolo de antiemesis implantado en la Unidad de Oncología / Analysis of the effectiveness of an antiemetic protocol used in an oncology division

Objetivo Analizar la efectividad de un protocolo antiemético en pacientes que reciben quimioterapia. Método Estudio prospectivo en pacientes con tumores sólidos con quimioterapia en el hospital de día de Oncología entre enero 2006–2007.Se realizó una revisión bibliográfica analizando las recomendaciones de guías de práctica clínica. Se calculó el potencial emetógeno según nivel Hesketh (NH), estableciendo la premedicación antiemética de cada esquema. Se evaluó la efectividad de un protocolo antiemético mediante una encuesta como método de medida de episodios eméticos y náuseas en fase aguda y retardada. Resultados Ciento setenta y dos pacientes cumplimentaron la encuesta, 13,4% vomitaron en fase aguda y 16,9% en retardada, mediana número de veces 2 (1–8) y 1 (1–5) respectivamente. Con esquemas NH 4–5 18,5% experimentaron vómitos en fase aguda y 20,2% en retardada; náuseas en fase aguda 46% y 38,4% en retardada. El control de vómitos en pacientes con esquemas NH=1–3 fue del 100% en fase aguda y de 91,7% en retardada; notificaron náuseas un 27% en fase aguda y 31% en retardada. Los factores que más contribuyeron a la presencia de vómitos y náuseas fueron potencial emetógeno (p<0,05), vómitos en ciclo anterior (p<0,05) y edad<50 p lt 0 002DiscusiónLa pauta propuesta es eficaz en el control de vómitos para esquemas NH=–3. En esquemas altamente emetógenos, el protocolo antiemético es también eficaz aunque la protección no es completa. Este protocolo parece no ser tan efectivo en el control de náuseas, aunque este es un síntoma subjetivo de valoración compleja que no se mide de forma sistemática en ensayos clínicos (AU)

Objective To analyse the effectiveness of an antiemetic protocol in patients receiving chemotherapy treatment. Method Prospective study in patients with solid tumours receiving chemotherapy in an oncology day hospital between January 2006 and 2007. We conducted a literature review and an evaluation of the recommendations of different clinical practice guidelines. The emetogenic potential was calculated according to the Hesketh level (HL), and the antiemetic premedication was determined for each regimen. We evaluated the effectiveness of an antiemetic protocol by using a survey as a method for measuring emetic episodes and nausea in the acute and delayed phases.Results172 patients completed the survey. 13.4% vomited in the acute phase and 16.9% in the delayed phase; the median number of times was 2 (1–8) and 1 (1–5) for each respective phase. With treatment regimens classed as HL 4-5, 18.5% experienced vomiting in the acute phase and 20.2% in the delayed phase, with 46% experiencing nausea in the acute phase and 38.4% in the delayed phase. Control of vomiting in patients with treatment regimens classed as HL 1-3 was 100% in acute phase and 91.7% in the delayed phase; nausea was reported by 27% in the acute phase and 31% in the delayed phase. The factors that contributed the most to the presence of vomiting and nausea were the emetogenic potential of the treatment regimen (p<0.05), vomiting in the previous cycle (p<0.05) and age younger than 50 years (p<0.002).Discussion The proposed antiemetic protocol is effective for controlling vomiting in chemotherapy regimens with an HL of 1-3. For highly emetogenic regimens, the antiemetic protocol is also effective, but protection is not complete. This protocol seems less effective for controlling nausea, although this is a subjective symptom which is difficult to assess and not routinely measured in clinical trials (AU)

Impact of computerised chemotherapy prescriptions on the prevention of medication errors

OBJECTIVES: The authors sought to evaluate the impact of computerised chemotherapy prescription on the reduction of medication errors. The purpose of this study was to assess the incidence of errors present in electronic versus manual prescription. MATERIAL AND METHODS: The data gathered from computerised chemotherapy prescription sheets were submitted to a prospective analysis as cases of the intervention groups. The control group was comprised of the handwritten chemotherapy prescription sheets. Chemotherapy prescriptions for consecutive oncology patients were analysed by 2 independent examiners, who investigated errors of omission, commission, interpretation of dates, abbreviations and illegible handwriting. The proportion of treatment prescriptions containing one or more errors and the median of errors were calculated in order in both groups. RESULTS: At least one error was detected in 100% of the manual prescriptions and in 13% of computerised prescriptions (p < 0.001). The median of errors per computerised prescription was 0 (range: 0- 1), whereas in manual prescriptions the median was 5 (range: 1-12) (p < 0.001). Errors of omission were predominant in manual prescriptions. Errors of commission were limited to 1 case of unjustified cytostatic agent infra-dosage in a computerised prescription. This error was present in 3 cases in handwritten prescriptions and, in addition, 1 case of premedication drug substitution was detected. Errors of interpretation of the date, use of abbreviations and illegible handwriting were frequent among manual prescriptions and were absent from computerised prescriptions. CONCLUSIONS: Electronic chemotherapy prescription is a powerful tool. In this study it has been shown to decrease chemotherapy-related medication errors and ensure that safe chemotherapy practices were followed (AU)