A. B. Fede

Adverse drug reactions and drug interactions as causes of hospital admission in oncology

CONTEXT Although several studies have evaluated the frequency of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) in general medicine, few studies have looked at the epidemiology of adverse drug events (ADEs) in oncology. OBJECTIVES We sought to investigate how many hospital admissions in oncology are related to a DDI or an ADR. METHODS All cancer patients admitted to an oncology ward during an eight-month period had their charts retrospectively evaluated for reasons of hospitalization, using a 4-point scale (definitely, probably, possibly, or unlikely associated) to classify admissions by their probability of being associated with either a DDI or an ADR. RESULTS From September 2007 to May 2008, there were 550 hospital admissions and 458 were eligible. Among unplanned admissions (n=298), 39 (13.0%, 95% confidence interval [CI] 9.4%-17.4%) were considered to be associated with an ADE, 33 (11.0%, 95% CI 7.7%-15.2%) with an ADR, and six (2.0%, 95% CI 0.7%-4.3%) with a DDI. The most common DDIs involved warfarin, captopril, and anti-inflammatory agents, and the most frequent ADR was neutropenic fever post-chemotherapy. Most patients were discharged completely recovered, but two patients died. CONCLUSION Approximately one in 10 unplanned hospitalizations of cancer patients is associated with an ADE. Prospective and population-based studies are warranted to evaluate their magnitude in oncology.

Use of unnecessary medications by patients with advanced cancer: cross-sectional survey

BackgroundCancer patients at the end of life take numerous medications. However, it has not been assessed what proportion of patients take unnecessary medications and which patients are at risk for doing so.MethodsCross-sectional survey of medications utilized by terminally ill ambulatory cancer patients, with the aim of identifying medications considered unnecessary as per explicit criteria. The criteria took into account whether drugs could benefit patients with terminal cancer.ResultsAmong 87 patients, 21 (24%, 95% confidence interval [CI] 15.6–34.5%) were taking at least one unnecessary medication, the most common being gastric protectors. In multivariable analyses, patients with Charlson Comobidity Index ≤ 1 (OR: 4.49, CI95% 1.32–15.26; p = 0.01) or whose medication list had not been reconciled by physicians (OR: 6.38, CI95% 1.21–33.40; p = 0.02) were more likely to use an unnecessary medication.ConclusionPatients with advanced cancer take many medications considered unnecessary. Medication reconciliation should be performed routinely for these patients.

Experience with The ABC Foundation School of Medicine Undergraduate Meeting

OBJECTIVE To quantify the number of studies that were presented during oral sessions, selected for awards and published from 2002 to 2007 at the Undergraduate Medical Congress of ABC at the ABC Foundation School of Medicine. METHODS A retrospective systematic survey of papers selected for oral presentation and award at these undergraduate meeting from 2002 to 2007 was carried out by searching Medline and Lilacs databases and the annals of other medical meetings in order to ascertain which papers would eventually be published. RESULTS From 2002 to 2007, 408 papers were selected for oral presentation and 71 (17.4%) received at least one award. The total number of papers published was 138 (33.8%), of which 33 (8.1%) were in Medline, 57 (14%) in Lilacs and 48 (11.7%) in the annals of other scientific meetings. Receiving an award by the scientific committee was an independent variable for publication (OR: 2.05 95% CI 1.22-3.46, p = 0.006) as well as for publication in Medline (OR: 2.62 95% CI 1.21 - 5.69, p = 0.01). CONCLUSION The institutional scientific production of undergraduate medical students presented in Undergraduate Medical Meetings is relevant and should continue to be stimulated.

Formal statistical testing and inference in randomized phase ii trials in medical oncology

Objectives:With the growing number of new anticancer therapies, randomized phase II trials have been used more often in oncology. Although the primary objective of such trials is not to formally compare results between arms, this practice seems frequent. We sought to quantify the frequency of use of formal statistical testing or inference through the use of P values and confidence intervals (CIs) in randomized phase II trials. Methods:We searched PubMed for randomized phase II trials assessing systemic cancer therapies published in the years 1995/1996 and 2005/2006. For each study, 2 reviewers independently abstracted data, including reporting of P values and CIs for the primary endpoint. Results:We retrieved 288 articles, 107 of which were eligible for analysis. The median number of patients per trial was 94, the primary endpoint was response rate in 71 (66.4%) cases, and a control arm was present in 55 (51.4%) trials. Either P values or CIs for the primary endpoint were reported in 85 (79.4%; 95% CI, 70.8%-86.1%) cases. Year of publication, source of funding, and use of a control group were not associated with this practice. Conclusions:Formal statistical comparisons between arms of randomized phase II trials are frequently undertaken in medical oncology. The extent to which such a practice abrogates phase III testing is unknown.

Activity and safety of sunitinib in poor risk metastatic renal cell carcinoma patients

PURPOSE To assess the activity, safety and treatment patterns of sunitinib in patients with poor-risk metastatic renal cell carcinoma (mRCC). MATERIALS AND METHODS We retrospectively reviewed the charts of poor risk patients treated with sunitinib from October 2006 to July 2013 who met the eligibility criteria. The primary endpoint was overall survival (OS). Tumor radiological response was measured according to RECIST 1.1 and adverse events (AEs) were assessed through standard criteria. RESULTS Median OS was 8.16 months (95% CI, 5.73-10.59). Of the 53 patients included in this analysis, 9 (17.0%) achieved partial response, 12 (22.6%) had stable disease. Median treatment duration was 3.30 months (95% CI: 1.96-4.63) and 26.4% of patients discontinued treatment due to toxicity. Grade 3 or higher AEs occurred in 39.6% of patients, the most common being fatigue (15.1%), neutropenia (9.5%), nausea, vomiting and diarrhea (7.5% each). DISCUSSION Sunitinib may benefit some unselected poor-risk patients, although the rates of AEs and drug discontinuation suggest a need for careful patient monitoring.

Return to work after breast cancer diagnosis: An observational prospective study in brazil: Breast Cancer Survivors Return to Work

In North America and Europe, return‐to‐work (RTW) rates vary among breast cancer (BC) survivors, from 24% to 66% and from 53% to 82% at 6 and 36 months after diagnosis, respectively. To date, there is a lack of data on RTW rates after BC diagnosis in Latin America. Therefore, the primary objectives of this study were to define RTW rates at 12 and 24 months after BC diagnosis and to identify the factors associated with RTW in this population.