ABSTRACT
Introduction: Registries based on Real-World Data (RWD) are those obtained outside of systematised and randomised clinical trials. They allow the collection of information from a large number of patients and enable the participation of a significant number of professionals. PrecisaXperta is a web platform developed for this purpose with more than 2 years of operation, parameterised for oncology. Its design allows the construction of an epidemiological database in real time and exportable for processing. Objective: To describe the characteristics and operation of this online data recording tool, explain how it was developed and analyse the quality of the information recorded, taking as an example the data obtained for breast cancer. Materials and methods: Physicians, computer scientists and data science analysts participated in the development. Patient data, history, educational level, diagnosis, staging, molecular markers, quality of life, types of treatments, progression and response, imaging, complications, adverse events are some of the fields included. Data treatment in terms of encryption, anonymisation, protection and validation is also explained. The selected breast cancer data for description were processed with medium-level statistical programmes, since the number required to apply Big Data engines is not yet available. Results: From a total of 6,892 solid tumours, 1,892 were breast cancer and 1,654 were selected that complied with a data set minimum elaborated ad hoc. Cases from 13 provinces showed a geolocation bias according to the place of practice of the professionals in the collaborative network. The predominant lack of data was detected in molecular markers (ki67) and correlativity in some lines of treatment. Inconsistencies in dates and therapeutic schemes were also detected. Data curation made it possible to exclude them. The age of the patients was 55.3 ± 11.88 years. At the time of diagnosis, the predominance was in stage I: 36.48% and II 30.06%, with positive hormone receptors in 1,424 (89.96%) cases. The predominant treatments were hormonal (61.54%) and target directed with 30.85% for HER2(+) and 39.14% for HER2(-) accompanied in most cases (85.9%) by some period of chemotherapy. Immunotherapy was much less represented (0.36%). Data were processed, homogenised, pooled and presented and made accessible in a form suitable for application to RWD analyses. Conclusions: PrecisaXperta fulfils this purpose of systematising the information to facilitate its loading with its simple and intuitive interface. From the analysis of the data obtained in breast cancer, it is clear that some fields should be mandatory in order to improve the quality of the information. The results describing the registered breast cancers give us a surface view of the affected population and prepare us to design future studies when we have local Big Data. This type of development, with continuous improvements and online results, will allow with its dissemination, that the participating professionals have information of what happens in the real world, having available in a democratic way, the epidemiology to be able to study, publish and investigate with these data.
ABSTRACT
PURPOSE: Patients with pretreated estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer have poor prognosis. Elacestrant is a novel, oral selective ER degrader that demonstrated activity in early studies. METHODS: This randomized, open-label, phase III trial enrolled patients with ER-positive/HER2-negative advanced breast cancer who had one-two lines of endocrine therapy, required pretreatment with a cyclin-dependent kinase 4/6 inhibitor, and ≤ 1 chemotherapy. Patients were randomly assigned to elacestrant 400 mg orally once daily or standard-of-care (SOC) endocrine monotherapy. Primary end points were progression-free survival (PFS) by blinded independent central review in all patients and patients with detectable ESR1 mutations. RESULTS: Patients were randomly assigned to elacestrant (n = 239) or SOC (n = 238). ESR1 mutation was detected in 47.8% of patients, and 43.4% received two prior endocrine therapies. PFS was prolonged in all patients (hazard ratio = 0.70; 95% CI, 0.55 to 0.88; P = .002) and patients with ESR1 mutation (hazard ratio = 0.55; 95% CI, 0.39 to 0.77; P = .0005). Treatment-related grade 3/4 adverse events occurred in 7.2% receiving elacestrant and 3.1% receiving SOC. Treatment-related adverse events leading to treatment discontinuations were 3.4% in the elacestrant arm versus 0.9% in SOC. Nausea of any grade occurred in 35.0% receiving elacestrant and 18.8% receiving SOC (grade 3/4, 2.5% and 0.9%, respectively). CONCLUSION: Elacestrant is the first oral selective ER degrader demonstrating a significant PFS improvement versus SOC both in the overall population and in patients with ESR1 mutations with manageable safety in a phase III trial for patients with ER-positive/HER2-negative advanced breast cancer.
Subject(s)
Breast Neoplasms , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Breast Neoplasms/genetics , Breast Neoplasms/metabolism , Cyclin-Dependent Kinase 4 , Estrogen Antagonists/therapeutic use , Female , Humans , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , TetrahydronaphthalenesABSTRACT
Chemotherapy is increasingly being administered in patients' homes, improving quality of life and patient comfort as well as reducing use of inpatient facilities and costs. This article describes outcomes of home chemotherapy administered by trained nurses to adult patients with solid tumors or hematological diseases. This descriptive study was conducted between February 2018 and May 2020. Variables examined included age, sex, diagnosis, routes of administration, adverse effects, tolerance, and patient satisfaction. One hundred forty-seven patients (57.14% male) with an average age of 67.8 years agreed to participate. A total of 1018 chemotherapy sessions were examined. The most common diagnoses were prostate cancer, colon cancer, and high-risk myelodysplastic syndromes. Thirty-five percent (n = 356) of the sessions were conducted with: Azacytidine, 5-Fluoruracil, Oxaliplatin + Docetaxel + Leucovorin + Fluorouracil, and Leuprolide Acetate. The routes of administration included: intravenous (69.25%), intramuscular (13.75%), subcutaneous (15.32%), and intravesical (1.66%). Very good tolerance was reported after 87.81% of sessions and good after 8.45%. Adverse events during administration occurred in 7 sessions (0.7%); all were considered minor events. In the 24 hours following administration, 62 adverse events (6.1%) were reported, again all considered minor. All patients reported feeling just as safe as in the hospital. Our results contribute to the feasibility and safety of home chemotherapy.
Subject(s)
Patient Safety , Quality of Life , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols , Female , Humans , Male , Patient Satisfaction , Personal SatisfactionABSTRACT
El cáncer de próstata es el cáncer más frecuente en hombres en los países occidentales. En Argentina, representa la segunda causa principal de muerte por cáncer. Algunos casos de pacientes con diagnóstico de cáncer de próstata tratados con radioterapia se someten a la recaída. Por esta razón, hemos decidido analizar qué grupos de pacientes requieren tratamientos más agresivos para evitar una recaída.
Subject(s)
Prostatic Neoplasms , RadiotherapyABSTRACT
El cáncer de próstata es el cáncer más frecuente en hombres en los países occidentales. En Argentina, representa la segunda causa principal de muerte por cáncer. Algunos casos de pacientes con diagnóstico de cáncer de próstata tratados con radioterapia se someten a la recaída. Por esta razón, hemos decidido analizar qué grupos de pacientes requieren tratamientos más agresivos para evitar una recaída.(AU)
