M. C. Miranda

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.

Effectiveness of guaraná (Paullinia cupana) for postradiation fatigue and depression: Results of a pilot double-blind randomized study

CONTEXT AND OBJECTIVE Guaraná (Paullinia cupana) has been used medicinally for centuries. The aim of this study is evaluate the effectiveness of guaraná in the treatment of postradiation depression and fatigue. DESIGN AND SETTING This study had a double-blind randomized design with crossover between experimental arms, at Faculdade de Medicina da Fundação do ABC. METHODS We conducted a randomized double-blind crossover trial with 36 patients with breast cancer undergoing adjuvant radiation therapy. We randomized patients to either guaraná 75 mg daily p.o. or to placebo. Patients were switched to the other experimental arm at the middle of the radiation treatment, which consisted of 28 daily fractions of 180 cGy. Evaluations were conducted at the beginning, at the middle, and at the end of radiation therapy. RESULTS We were unable to show any statistically significant differences between the guaraná and the placebo-treated group with any of the measured scores. Also, within the same group, we did not see any statistically significant associations during either the guaraná- or placebo-treated periods with any of the aforementioned measures. CONCLUSIONS We were unable to show that patients with breast cancer undergoing radiation therapy derive any advantage with guaraná over placebo for both fatigue and depressive symptoms.

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.

Gabapentin for the prevention of chemotherapy- induced nausea and vomiting: a pilot study

INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) is a distressing side effect that affects many patients undergoing emetogenic chemotherapy, despite the use of antiemetic medications. The purpose of this trial was to evaluate the efficacy and safety of gabapentin for the prevention of CINV during the first cycle of treatment in patients receiving moderately or highly emetogenic chemotherapy. METHODS Eighty chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy, were enrolled in this randomised, double-blind, placebo-controlled clinical trial. All patients received intravenous ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg twice a day on days 2 and 3. Patients were randomly assigned to take gabapentin 300 mg or placebo on the following schedule: 5 and 4 days before chemotherapy once daily, 3 and 2 days before chemotherapy twice daily, 1 day before to 5 days after chemotherapy thrice daily. The primary endpoint was complete overall protection from both vomiting and nausea over the course of the entire study (day 1 through day 5), and complete protection during the delayed period (24-120 h after chemotherapy). RESULTS The proportion of patients achieving complete response improved from 40% to 62.5%, (p = 0.04) when comparing the control group and the gabapentin group, respectively. In the subset of patients who achieved complete control in the acute phase, the percentage of patients who achieved delayed complete control was higher in the gabapentin group (89.3 × 60.7%, p = 0.01). Adverse events did not significantly differ between study arms. CONCLUSIONS Gabapentin is a low-cost strategy to improve complete control of CINV, specially delayed CINV control.

The prevalence and influence of self-reported conflicts of interest by editorial authors of phase III cancer trials

PURPOSE To assess the frequency with which editorial authors report personal conflict of interest and investigate a possible association between the presence of such conflicts and favorable opinion. METHODS Eligible studies were editorials of phase III clinical trials of antitumor drugs or symptom management published from January 2007 to December 2009 in four top oncology journals. Data from the editorials were collected and each editorial opinion was classified as favorable, neutral or unfavorable with respect to the experimental therapy. RESULTS Fifty-four editorials were included: 23 (43%) reported at least one conflict of interest, with the most frequent one being consultancy fees. Conclusions of editorial authors were classified as favorable in 18 editorials (33%). Sensitivity analysis found an association between self-reported conflict of interest of the editorial author and editorial favorable opinion (RR:2.7; 95% CI 1.2-6.1; p=0.019). DISCUSSION Besides the high proportion of conflict of interest among editorial authors discussing phase III clinical trials, study interpretation may be influenced by their financial relationships with industry.

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.

Burden in caregivers of patients with cancer.

e19707 Background: Families and informal caregivers experience substantial psychological distress and fatigue. Their vital role play in supporting cancer patients is well recognized, but the burden and economic impact on these caregivers is poorly understood. We aimed at evaluating the prevalence of burden on informal caregivers of cancer patients and to relate possible predictors facing patients health and the information received concerning the disease and the proposed treatment for the patient. METHODS We examined 120 informal caregivers of patients with cancer in ABC Foundation School of Medicine affiliated service to answer to questionnaires of depression (The Hospital Anxiety and Depression Scale), fatigue (The Chalders Fatigue Scale) and Burden (the Zarit Burden Inventory). We also evaluated the quality of the clinical information conveyed to these families. Caregiver and patient sociodemographic data were collected. RESULTS Most of the caregivers were female; a half of caregivers showed from moderate to severe burden and has to diminish their job. There was a significant correlation between burden and depression (p <0.001, correlation coefficient = 0, 521) and fatigue (p <0.001, correlation coefficient = 0.520). Palliative care exclusively had significant association with both depression (p=0.002) and fatigue (p=0.022). Regression analysis showed that interference in their daily actives was a determinant of burden (OR 7.76; CI 2.79 - 21.5) as well as presence of physical fatigue (OR 2.96; CI 1.18-7.87). We also found that disagreement between caregiver and physician regarding the treatment was a determinant of dissatisfaction (OR 11.8; CI 1.48-94.6). CONCLUSIONS The change of daily activities of informal caregivers with restriction of their previous activities and incorporation of new tasks can cause fatigue and depression. Enhancing agreement regarding the proposed treatment and clarity of the diagnostic information may improve caregivers satisfaction.