OBJECTIVE: Pharmacovigilance revolves around the maintenance and understanding of drug safety through detection and evaluation of spontaneous adverse events (AE) reporting. However, underreported phenomenon occurs often due inefficient spontaneous reporting by patients, physicians, healthcare professionals and caregivers. Therefore, the aim of this survey was to evaluate the knowledge and perception related to pharmacovigilance in Brazil.
METHODS: From February to March 2015, 260 respondents answered an internet-based survey related to knowledge on pharmacovigilance from Oncoguia Institute, an independent non-profit cancer patient advocacy group. Descriptive analyses were performed according to answers frequency.
RESULTS: Among the respondents, 40.7% were diagnosed with breast cancer, followed by hematological malignancies (6.5%). Reported treatment included chemotherapy (35.9%), surgery (28.7%), and radiotherapy (16.4%). Most of the respondents were not aware of the importance of a pharmacovigilance AE report (51.7%). In fact, 21.3% of the respondents were not aware of what AEs are. In 65% of the cases, physicians have described the main AE expected to the prescribed treatment. Respondents reported nausea (23.6%), hair loss (22.8%), weight gain (14.5%) and vomiting (13.2%) as the most common AEs. Only 7.2% and 4.2% of the respondents were aware that AEs could be reported to pharmaceutical industry and ANVISA, respectively.
CONCLUSIONS: This survey demonstrates that knowledge and perception regarding AEs and pharmacovigilance activities are very poor among overall population, including cancer patients. Therefore, there is an enormous demand for educational awareness of AEs reporting importance in overall population, patients, and physicians, especially in oncology.
Keywords: Health Surveys; Medical Oncology; Drug-Related Side Effects and Adverse Reactions; Pharmacovigilance
OBJECTIVE: To infer overall survival (OS) and progression free survival (PFS) of patients with metastatic breast cancer who have started first line treatment between January 2009 and July 2010 in the Brazilian public healthcare system (SUS).
METHODS: This is a non-interventional, retrospective study, developed based on DATASUS, a Brazilian public claims database, that gathers information from all hospitals and outpatient providers reimbursed by SUS. Patients with breast cancer diagnosis (ICD10 = C50) starting first line treatment for metastatic disease between January 2009 and July 2010 were included in the analysis, so that they would have a relatively uniform follow-up of five years in the database. OS was defined as the time from the start of first line therapy for metastatic disease until the last treatment received for breast cancer or the last patient record in the database, irrespective of the type of intervention or diagnosis. PFS was defined as the time from the start of first line therapy for metastatic disease until the change of treatment regimen (change of drug used or inclusion of a new drug to the previously used regimen). Survival curves were built using the Kaplan-Meier method.
RESULTS: 15,696 patients were included in the analysis (average age = 55 years, 99% women). The median OS was 15 months and patients used on average 1.44 treatment lines until loss of follow-up. Median PFS was 4 months. Among patients included in the analysis, 94.2% started first line treatment with chemotherapy and 5.8% with hormone therapy.
CONCLUSION: OS and PFS inferred for patients with metastatic breast cancer starting first line treatment in the Brazilian SUS was lower than international references, which may be related to the lack of access to the most efficacious therapies for this disease stage, especially for HER2 positive patients.
Keywords: Breast neoplasms; Survival; Disease-free survival; Administrative claims; Healthcare
The treatment of metastatic prostate cancer has evolved over the decades focusing on manipulation of the androgen receptor pathway with or without chemotherapy. Despite new drugs discovered with incrementing survival benefits, the disease continues to be fatal after development of castration resistance and progression on abiraterone and enzalutamide. In this context, attempts of androgen pathway manipulation have led to the development of the Bipolar Androgen Therapy (BAT), which consists of a rapid transition from a castration state to supraphysiologic levels of testosterone and then back to castration levels. Pilot studies have shown this strategy to be safe and supported the development of further clinical trials. Phase II trials have demonstrated PSA response and disease control in a significant number of patients, including a resensitizing effect to enzalutamide. This promising strategy may become another available option for these patients.
Keywords: Prostatic Neoplasm; Castration-Resistant; Testosterone; Prostate-Specific Antigen