open access: PLoS ONE: Whole Brain Radiation-Induced Impairments in Learning and Memory Are Time-Sensitive and Reversible by Systemic Hypoxia

"Close to 1.6 million new cases of cancer [1] and 64,530 primary brain tumors are expected to be diagnosed in the United States in 2011 [2]. The most common form of treatment for metastatic or primary tumors located in brain regions that are difficult to surgically remove continues to be whole brain radiation therapy (WBRT) [3]. Although this treatment regimen is effective in eliminating tumors, damage to normal brain tissue is inevitable. Several studies have shown that cognitive deficits occur in a relatively large percentage of brain tumor survivors, becoming evident months to years after treatment [3]–[6]......"

open access: JCO - “Doctor, Will the Treatment You Are Recommending Cause Chemobrain?”

"For more than a decade, patients and their oncologists have been sharing conversations about cognitive complaints after chemotherapy treatment.¹ Early on, only occasional patients complained of trouble with concentration and memory during treatment, with a minority noting persistence beyond the end of treatment. The oncologist, who rarely heard this complaint, could be dismissive, saying that the drugs the patient received did not cross the blood-brain barrier, and therefore, it was unlikely that the difficulties were related to the cancer treatment........."

abstract: Whole-brain radiation therapy of brain metastasis.

Prog Neurol Surg. 2012;25:82-95. Epub 2012 Jan 6.

Source

Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Princess Margaret Hospital, University of Toronto, Toronto, Ont., Canada.

Abstract

The purpose of this report was to review the role of whole brain radiotherapy (WBRT) in the management of brain metastases. In particular, we review the role of WBRT as a prophylactic therapy, and the role of surgery and stereotactic radiosurgery (SRS) with respect to WBRT, by discussing the relevant randomized controlled trials. WBRT is associated with toxicities and this may influence the decision to use WBRT and, therefore, we review both the acute side effects of WBRT and the moreserious late side effects of neurocognitive impairment and leukoencephalopathy. As patients are living longer with brain metastases the role of WBRT is moving forward; however, using modern radiation technology we may be able to reduce the morbidity of this therapy. We present an extreme case of re-re-treatment WBRT with hippocampal sparing and simultaneous integrated boosts to multiple lesions as one of the future directions under evaluation.

open access: Development and validation of a prediction index for hand-foot skin reaction in cancer patients receiving sorafenib

Background: This study describes a repeated measures prediction index to identify patients at high risk of ≥ grade 2 hand-foot skin reaction (HFSR) before each week of sorafenib therapy.

Results: Pretreatment white blood cell count, female gender, good performance status, presence of lung and liver metastases and number of affected organs were predictors for ≥ grade 2 HFSR.

Study of Medicare Patients Finds Most Hospital Errors Unreported - NYTimes.com

WASHINGTON — Hospital employees recognize and report only one out of seven errors, accidents and other events that harm Medicare patients while they are hospitalized, federal investigators say in a new report.

Yet even after hospitals investigate preventable injuries and infections that have been reported, they rarely change their practices to prevent repetition of the “adverse events,” according to the study, from Daniel R. Levinson, inspector general of the Department of Health and Human Services.......

abstract: Mechanical bowel preparation does not influence outcomes following colonic cancer resection

CONCLUSION:

Neither postoperative complications nor long-term survival are improved by MBP before colonic cancer surgery.

abstract: Description of anaphylactic reactions to paclitaxel and docetaxel reported to the FDA, with a focus on the role of premedication

Purpose: Anaphylactic reactions (ARs) have been frequently reported with taxanes. The authors' purpose was to summarize published case reports and describe ARs from taxanes reported to the Food and Drug Administration (FDA) with a focus on use of package insert-specified prophylactic premedications (PPMs).

Methods: The authors searched PubMed for the relevant literature.............

Conclusions: Mortality was reported in more docetaxel ARs than paclitaxel. Documented use of PPMs did not significantly impact mortality from ARs with docetaxel, but was associated with significantly lower mortality from ARs with paclitaxel.

Evidence Updates including professional commentaries: Safety of Probiotics to Reduce Risk and Prevent or Treat Disease.

"....Existing studies primarily examined Lactobacillus alone or in combination with other genera, often Bifidobacterium.

Few studies directly compared the safety among different intervention or participant characteristics. Indirect comparisons indicated that effects of delivery vehicles (e.g., yogurt, dairy) should be investigated further.

Case studies suggested that participants with compromised health are most likely to experience adverse events associated with probiotics. However, RCTs in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants.

Conclusions. There is a lack of assessment and systematic reporting of adverse events in probiotic intervention studies, and interventions are poorly documented. The available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess, and despite the substantial number of publications, the current literature is not well equipped to answer questions on the safety of probiotic interventions with confidence."

abstract:Decreased hypersensitivity reactions with carboplatin-pegylated liposomal doxorubicin compared to carboplatin-paclitaxel combination: Analysis from the GCIG CALYPSO relapsing ovarian cancer trial.

Author Insights: Erythropoietin and Cardiovascular Concerns « news@JAMA (Epogen, Procrit, Patient Safety, adverse events)

PLoS Medicine: Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview

Note: PLOS Medicine is an open-text publisher (free full access), below are a couple of excerpts of interest

.....................................................

Background

There is considerable debate as to the relative merits of using randomised controlled trial (RCT) data as opposed to observational data in systematic reviews of adverse effects. This meta-analysis of meta-analyses aimed to assess the level of agreement or disagreement in the estimates of harm derived from meta-analysis of RCTs as compared to meta-analysis of observational studies.

Discussion Top

"............The increased risk in adverse effects in some studies was not consistently related to any particular study design—RCTs found a significant risk of adverse effects associated with the intervention under investigation in eight instances, while observational studies showed a significantly elevated risk in 11 cases.
............Although reasons for discrepancies are unclear, specific factors which may have led to differences in adverse effect estimates were discussed by the respective authors.................
..........While there are a few instances of sizeable discrepancies, the pooled estimates in Figure 2 and Table 2 indicate that in the scheme of things (particularly where larger, more precise primary studies are available), meta-analysis of observational studies yield adverse effects estimates that broadly match those from meta-analysis of RCTs..........."

When Combined with Chemotherapy, Bevacizumab Is Associated with Increased Risk of Death - National Cancer Institute (discusses various tumor types....

Note: this NCI article does not include ovarian cancer but does include platinum/taxane combination therapies (Carboplatin, Taxol); the JAMA paper most likely included ovarian cancer, however, the full text of the article is pay-per-view ($$$)

"The results were published February 2, 2011, in JAMA.":


JAMA abstract:
Treatment-Related Mortality With Bevacizumab in Cancer Patients
A Meta-analysis

"The overall incidence of FAEs (fatal adverse events) with bevacizumab was 2.5%."

Adverse-event figures could be far higher: study - Healthcare business news, research, information and opinions | Modern Healthcare

no abstract: Bilateral macular ischemia and severe visual loss following trastuzumab (Herceptin) therapy

Bevacizumab Doubles Risk of GI Adverse Events in Key Ovarian Cancer Trial : Internal Medicine News SGO/Dr Burger/O'Malley

Treatment-Related Mortality With Bevacizumab in Cancer Patients, February 2, 2011— JAMA review - 2.5 vs 1.7 % risk not dependent on type of solid tumor/dose

Data Synthesis: A total of 10 217 patients with a variety of advanced solid tumors from 16 RCTs were included in the analysis. The overall incidence of FAEs with bevacizumab was 2.5% (95% CI, 1.7%-3.9%). Compared with chemotherapy alone, the addition of bevacizumab was associated with an increased risk of FAEs, with an RR of 1.46 (95% CI, 1.09-1.94; P = .01; incidence, 2.5% vs 1.7%). This association varied significantly with chemotherapeutic agents but not with tumor types or bevacizumab doses.

abstract: Hospital costs associated with adverse events in gynecological oncology (patient safety)

excerpts:

BACKGROUND AND OBJECTIVE: Treatment for gynecological malignancies is complex and may cause unintended or accidental adverse events (AE)....RESULTS: A total of 369 patients had surgical procedures of which 95 patients (26%) had at least one AE.

Free App Helps Caregivers Record, Grade Side Effects in Clinical Trials

"...A physician or nurse making rounds can locate and page through a 200-page reference book that lists the possible adverse events that may occur to patients in a clinical trial, or can instead keep all the same information in their pocket, in a 4-ounce iPhone. For many in healthcare, that’s an easy choice.The classifications of adverse events originated in the National Cancer Institute as a way to help standardize record-keeping of side effects occurring in patients enrolled in clinical trials. Printed out, the Institute’s Common Terminology Criteria for Adverse Events (CTCAE) is a 200-page handbook in its most recent edition, version 4.0..cont'd

Walking the Talk to Ensure Patient Safety on Medical News Corporate

"It has been 10 years since the Institute of Medicine released its damning report, To Err is Human, but it has been 24 centuries since Hippocrates admonished physicians to do no harm," said Dennis S. O'Leary, MD, president emeritus of The Joint Commission and a founding member of the Lucian Leape Institute. "Today, although some progress in improving patient safety continues to be made, healthcare remains fundamentally unsafe as up to one in 10 people admitted to hospitals continue to experience significant, preventable adverse events."

Sorafenib in combination with carboplatin and paclitaxel as neoadjuvant chemotherapy in patients with advanced ovarian cancer.

RESULTS: .....Four patients were enrolled. After preoperative treatment and cytoreductive surgery, all patients were excluded from protocol due to severe toxicities. Three patients had life threatening events (cardiac output failure, myocardial infarction, anastomotic leak); two patients had primary progressive disease.
CONCLUSION: The addition of sorafenib to carboplatin/paclitaxel chemotherapy was not feasible within this neoadjuvant regimen in primary advanced ovarian cancer. Although the occurrence of serious adverse events might have emerged at random, a detrimental effect of preoperative study medication could not be denied. Further evaluations of sorafenib in ovarian cancer are warranted.