Prognosis research strategy (PROGRESS) 1: A framework for researching clinical outcomes

open access

Summary points

• The PROGRESS series (www.progress-partnership.org) sets out a framework of four interlinked prognosis research themes and provides examples from several disease fields to show why evidence from prognosis research is crucial to inform all points in the translation of biomedical and health related research into better patient outcomes. Recommendations are made in each of the four papers to improve current research standards
• What is prognosis research? Prognosis research seeks to understand and improve future outcomes in people with a given disease or health condition. However, there is increasing evidence that prognosis research standards need to be improved
• Why is prognosis research important? More people now live with disease and conditions that impair health than at any other time in history; prognosis research provides crucial evidence for translating findings from the laboratory to humans, and from clinical research to clinical practice
• This first article introduces the framework of four interlinked prognosis research themes and then focuses on the first of the themes—fundamental prognosis research, studies that aim to describe and explain future outcomes in relation to current diagnostic and treatment practices, often in relation to quality of care
• Fundamental prognosis research provides evidence informing healthcare and public health policy, the design and interpretation of randomised trials, and the impact of diagnostic tests on future outcome. It can inform new definitions of disease, may identify unanticipated benefits or harms of interventions, and clarify where new interventions are required to improve prognosis
• The other papers in the series are:
  • PROGRESS 2: PLoS Med 2013, doi:10.1371.journal/pmed.1001380
  • PROGRESS 3: PLoS Med 2013, doi:10.1371.journal/pmed.1001381
  • PROGRESS 4: BMJ 2013, doi:10.1136/bmj.e5793

Coping with the Cost of Care

Coping with the Cost of Care

(newest edition of Frankly Speaking About Cancer: Coping with the Cost of Care)

Why are one in four cancer patients only diagnosed when they end up in A&E? UK media

media
 
"...... She had been back and forward to her GP six or seven times in the five months since her persistent tummy pain and bloating started in January 2010.
In an interview before she died, she said: ‘It started with a niggly pain in my lower abdomen — but it came and went so I took painkillers and tried to ignore it. When it became more persistent I went to my GP.
‘She thought I was menopausal and ran hormone tests, but they proved negative. Then I was prescribed drugs for excess stomach acid — as my GP said I may have an ulcer — but the drugs had no effect.
‘As the months dragged on my symptoms worsened: the pain became more frequent and intense. I began to feel more bloated and full, too. I couldn’t face food and also had alternating diarrhoea and constipation......

Risk of transferring malignant cells with transplanted frozen-thawed ovarian tissue

Abstract


Ovarian tissue cryopreservation and transplantation is a real option to preserve and restore fertility in young cancer patients. However, there is a concern regarding the possible presence of malignant cells in the ovarian tissue, which could lead to recurrence of the primary disease after reimplantation. A review of the existing literature was done to evaluate the risk of transplanting malignant cells in case of the main malignant indications for ovarian tissue cryopreservation. For ovarian tissue from patients with hematologic malignancies, it is of paramount importance to identify minimal residual disease before ovarian tissue transplantation. Indeed, these pathologies, reviewed here in detail, are considered to be most at risk of ovarian metastasis."

Preserved foods associated with increased risk of ovarian cancer in sourthern Chinese women

Abstract

OBJECTIVE:

To investigate the association between consumption of preserved foods and risk of epithelial ovarian cancer in southern Chinese women.

METHODS:

A hospital-based case-control study was undertaken in Guangzhou, Guangdong Province, from 2006 to 2008. Participants were 500 incident epithelial ovarian cancer patients and 500 controls, with a mean age 59 years. Information on habitual food consumption was obtained by face-to-face interview using a validated and reliable food frequency questionnaire. Logistic regression analyses were performed to assess the association between preserved foods intake and the ovarian cancer risk.

RESULTS:

The ovarian cancer patients consumed more preserved foods (median 15.5, interquartile range (IQR) 18.2 g/day) than controls (median 13.8, IQR 20.5 g/day), p < 0.001. The adjusted odds ratios of ovarian cancer was 1.78 (95% confidence interval 1.35 to 2.34) for women consuming more than 13.5 g of preserved vegetables and preserved meats per day relative to those below. Similar two-fold increases in risk at high level of intake were also evident for serous and mucinous subtypes of epithelial ovarian tumours.

CONCLUSION:

Intake of preserved foods was positively associated with the incidence of epithelial ovarian cancer in southern Chinese women.

Repopulation of ovarian cancer cells after chemotherapy

Abstract

"The high mortality rate caused by ovarian cancer has not changed for the past thirty years. Although most patients diagnosed with this disease respond to cytoreductive surgery and platinum-based chemotherapy and undergo remission, foci of cells almost always escape therapy, manage to survive, and acquire the capacity to repopulate the tumor. Repopulation of ovarian cancer cells that escape front-line chemotherapy, however, is a poorly understood phenomenon. Here I analyze cancer-initiating cells, transitory senescence, reverse ploidy, and cellular dormancy as putative players in ovarian cancer cell repopulation. Under standard of care, ovarian cancer patients do not receive treatment between primary cytotoxic therapy and clinical relapse; understanding the mechanisms driving cellular escape from chemotherapy should lead to the development of low toxicity, chronic treatment approaches that can be initiated right after primary therapy to interrupt cell repopulation and disease relapse by keeping it dormant and, therefore, subclinical.

PLOS Genetics: Genome-Wide Association Study in BRCA1 Mutation Carriers Identifies Novel Loci Associated with Breast and Ovarian Cancer Risk

open access


Abstract
BRCA1-associated breast and ovarian cancer risks can be modified by common genetic variants. To identify further cancer risk-modifying loci, we performed a multi-stage GWAS of 11,705 BRCA1 carriers (of whom 5,920 were diagnosed with breast and 1,839 were diagnosed with ovarian cancer), with a further replication in an additional sample of 2,646 BRCA1 carriers. We identified a novel breast cancer risk modifier locus at 1q32 for BRCA1 carriers (rs2290854, P = 2.7×10(-8), HR = 1.14, 95% CI: 1.09-1.20). In addition, we identified two novel ovarian cancer risk modifier loci: 17q21.31 (rs17631303, P = 1.4×10(-8), HR = 1.27, 95% CI: 1.17-1.38) and 4q32.3 (rs4691139, P = 3.4×10(-8), HR = 1.20, 95% CI: 1.17-1.38). The 4q32.3 locus was not associated with ovarian cancer risk in the general population or BRCA2 carriers, suggesting a BRCA1-specific association. The 17q21.31 locus was also associated with ovarian cancer risk in 8,211 BRCA2 carriers (P = 2×10(-4)). These loci may lead to an improved understanding of the etiology of breast and ovarian tumors in BRCA1 carriers. Based on the joint distribution of the known BRCA1 breast cancer risk-modifying loci, we estimated that the breast cancer lifetime risks for the 5% of BRCA1 carriers at lowest risk are 28%-50% compared to 81%-100% for the 5% at highest risk. Similarly, based on the known ovarian cancer risk-modifying loci, the 5% of BRCA1 carriers at lowest risk have an estimated lifetime risk of developing ovarian cancer of 28% or lower, whereas the 5% at highest risk will have a risk of 63% or higher. Such differences in risk may have important implications for risk prediction and clinical management for BRCA1 carriers.

Bevacizumab in the treatment of ovarian cancer: a meta-analysis from four phase III randomized controlled trials

Avastin

Background

The aim of this meta-analysis was to summarize the efficacy and safety of bevacizumab in the treatment of ovarian cancer.

Methods

We sought to identify randomised controlled trials (RCTs) by searching PubMed and Web of Science. Outcomes were objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.

Results

Four studies with 4,246 patients were included. Combination of bevacizumab and chemotherapy resulted in a statistically significant improvement in ORR (OR 2.165, 95 % CI 1.511–3.103) and in PFS (HR 0.691, 95 % CI 0.517–0.865), compared with chemotherapy alone. There was no evidence of a significant improvement in OS (HR 0.934, 95 % CI 0.826–1.041). It also had significantly increased risk of gastrointestinal events (OR 2.743, 95 % CI 1.580–4.763; P < 0.001), hypertension (OR 4.630, 95 % CI 3.737 to 5.737; P < 0.001), proteinuria (OR 4.872, 95 % CI 2.617–9.069; P < 0.001), and arterial thromboembolism (OR 1.994, 95 % CI 1.210–3.286; P = 0.007).

Conclusion

This meta-analysis suggests that the addition of bevacizumab to chemotherapy offers meaningful improvement in objective response rate and progression-free survival in ovarian cancer treatment, but does not benefit overall survival. It also significantly increased the occurrence of gastrointestinal events, hypertension, proteinuria, and arterial thromboembolism.

European Association of Urology 2013: Urothelial Carcinomas of the Upper Urinary Tract

open access

 INTRODUCTION
The last European Association of Urology (EAU) guidelines on upper urinary tract tumours known as upper tract urothelial carcinomas (UTUCs) were published in 2011 (1). The EAU Guidelines Working Panel for UTUCs has prepared the current guidelines to provide evidence-based information for the clinical management of these rare tumours and to help clinicians incorporate these recommendations into their practice. The current update is based on a structured literature search........

"The natural history of UTUCs differs from that of bladder cancer: 60% of UTUCs are invasive at diagnosis compared with only 15-25% of bladder tumours (13,14). UTUCs have a peak incidence in people in
their 70s and 80s, and they are three times more prevalent in men than in women (15,16). There are familial/hereditary cases of UTUCs linked to hereditary non-polyposis colorectal carcinoma
(HNPCC (Lynch Syndrome)) (17).

European Guidelines on Upper Tract Urothelial Carcinomas: 2013 Update (Lynch Syndrome patients takes note)

Abstract

Context

The European Association of Urology (EAU) guideline group for upper tract urothelial carcinoma (UTUC) has prepared updated guidelines to aid clinicians in assessing the current evidence-based management of UTUC and to incorporate present recommendations into daily clinical practice.

Objective

To provide a brief overview of the EAU guidelines on UTUC as an aid to clinicians in their daily clinical practice.

Evidence acquisition

The recommendations provided in the current guidelines are based on a thorough review of available UTUC guidelines and articles identified using a systematic search of Medline. Data on urothelial malignancies and UTUCs in the literature were searched using Medline with the following keywords: urinary tract cancer; urothelial carcinomas; upper urinary tract, carcinoma; renal pelvis; ureter; bladder cancer; chemotherapy; nephroureterectomy; adjuvant treatment; instillation; neoadjuvant treatment; recurrence; risk factors; nomogram; and survival. References were weighted by a panel of experts.

Evidence synthesis

There is a lack of data in the current literature to provide strong recommendations

Anti-Malignin Antibody -- A Screening Test for Cancer? in historical context to present day

Anti-Malignin Antibody -- A Screening Test for Cancer?

Scholarships Available for OCNA's Annual Conference--Apply by April 15 - Discussion - Ovarian Cancer National Alliance Support Community - Inspire

media

Supplemental Soy of No Benefit After Menopause

Medpage

Action Points

• Taking soy supplements won't improve quality of life for postmenopausal women.
• Note that adverse events among women who got isoflavones included one woman diagnosed with breast cancer at 14 months and another diagnosed with adenocarcinoma of the endometrium at 21 months, but the findings need further investigation.

Development of a patient-centred care pathway across healthcare providers: a qualitative study

open access

Results

The development process was very challenging because of the differing perspectives on care and different organizational structures in specialist care and primary care. In this study, the disease perspective, being dominant in specialist care, was not found to be suitable for use in primary health care because of the need to cover a broader perspective including the patient's functioning, social situation and his or her preferences. Furthermore, managing several different disease-based care pathways was found to be unsuitable in home care services, as well as unsuitable for a population characterized by a substantial degree of comorbidity. The outcome of the development process was a consensus that outlined a single, common patient-centred care pathway for transition from hospital to follow-up in primary care. The pathway was suitable for most common diseases and included functional and social aspects as well as disease follow-up, thus merging the differing perspectives. The disease-based care pathways were kept for use within the hospitals.

Conclusions

Disease-based care pathways for older patients were found to be neither feasible nor sustainable in primary care. A common patient-centred care pathway that could meet the needs of multi- morbid patients was recommended.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

Systemic treatment for hereditary cancers: a 2012 update

open access

Breast cancer
Ovarian cancer
Pancreatic cancer
Colorectal cancer
Medullary thyroid cancer
Basal-cell nevus syndrome
Astrocytomas in tuberous sclerosis

Conclusions and perspectives
Recent studies have convincingly demonstrated that hereditary and sporadic tumors may indeed require distinct treatment approaches. Ongoing revolution in technologies of DNA analysis, particularly the invention of next-generation sequencing, allows to expect that
dozens of new familial cancer genes will be identified in the near future. Furthermore, dramatic increase of velocity and cost-efficiency of germ-line mutation testing provides the hope that virtually every cancer patient will soon be undergoing genetic examination right at
the time of tumor diagnosis [44]. Advances in the management of hereditary cancer syndromes may serve as an excellent example of the power of translational medicine.

Safety Alerts for Human Medical Products > Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates

Safety Alerts

[Posted 04/01/2013]
AUDIENCE: Risk Manager, Pharmacy
ISSUE: Hospira, Inc. notified healthcare professional of a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL, Flexible Container, NDC 0409-7983-09. This action is due to one confirmed customer report where brass particulate was identified in the primary container in the form of several small grey/brown particles. The affected lot number is 25-037-JT (the lot number may be followed by a -01 or -90), with an expiration date of January 1, 2015. Hospira is investigating to determine the root cause.
The brass particulate was identified as containing copper, zinc and lead. If administered, solution containing brass particulate may result in occlusion of small blood vessels. In a worst-case scenario, copper toxicity may potentially result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal.
BACKGROUND: The product is used as a source of water and electrolytes and is packaged in a 1000 mL flexible container. The affected lot was distributed nationwide between January 2013 and March 2013 to wholesalers/distributors, hospitals and pharmacies......

Caffeine as an Adjuvant Therapy to Opioids in Cancer Pain: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Conclusion

Caffeine infusion significantly reduced pain and drowsiness, but the reduction did not reach clinical significance in patients with advanced cancer undergoing opioid therapy. Further investigations are warranted.

Context

Opioid therapy often shows insufficient efficacy and substantial adverse events in patients with advanced cancer.

Objectives

To assess the efficacy of caffeine infusion as an adjuvant analgesic to opioid therapy in patients with advanced cancer.

Not every woman should get the BRCA gene test, U.S. task force says - latimes.com

media

"Certain mutations in the BRCA1 and BRCA2 genes can increase a woman's chances of developing breast cancer or ovarian cancer dramatically. But that doesn't mean all women should line up for laboratory testing to see if they have those risky versions of the genes, members of a government panel said Monday......

" In its report, the task force outlined the risks faced by women who have the dangerous mutations. In the general population, 12.8% of women are expected to develop breast cancer and 2.8% will die from it; 1.4% are expected to get ovarian cancer and 1% to die from it. But the chances climb steeply for women with the harmful BRCA variants, with the likelihood of getting breast cancer by age 70 increased to 34% to 70%. Bad versions of BRCA1 increase ovarian cancer risk by the age of 70 to 41% to 46%; BRCA2 mutations, to 17% to 23%."

Omega-3 Fatty Acid in Treating Pain in Patients With Breast or Ovarian Cancer Receiving Paclitaxel

clinical trial

DNA-Damaging Toxins Discovered In Common Plant-Based Foods - Liquid Smoke, Black And Green Teas And Coffee - MediLexicon

Article

01 Apr 2013


"Kern cautioned that his studies do not suggest people should stop using tea, coffee or flavorings, but do suggest the need for further research."

In a laboratory study pairing food chemistry and cancer biology, scientists at the Johns Hopkins Kimmel Cancer Center tested the potentially harmful effect of foods and flavorings on the DNA of cells. They found that liquid smoke flavoring, black and green teas and coffee activated the highest levels of a well-known, cancer-linked gene called p53.

The p53 gene becomes activated when DNA is damaged.

End-of-Life Wishes: Lack of Communication Persists

Medscape

"Although many elderly patients and their families discuss advance care planning (ACP) with their physicians, those wishes often fail to be added to patients' medical records, according to findings from a study carried out in Canada and published online April 1 in JAMA Internal Medicine......

Financial, nonfinancial and editors conflicts of interest in high-impact biomedical journals

Abstract

Purpose

To assess financial, nonfinancial and editors' conflicts of interest (COI) disclosure policies among the most influential biomedical journals publishing original research.

State health officials urge in putting patients under the robotic knife - robotic surgeries

media

"In some cases, it appears that doctors have used the aggressively marketed robots to perform hysterectomies and colorectal operations that were too complex for the technology, or for the surgeons’ skill level in directing the robots’ actions.
During one hysterectomy, two surgeons failed to coordinate their movement of the remote-controlled robotic arms, damaging the patient’s bowel and causing excessive bleeding, according to the letter from the Quality and Patient Safety Division, part of the agency that licenses Massachusetts doctors.
In another hysterectomy, a woman was anesthetized and placed for nearly four hours in a steep head-down angle — a position often used during robotic operations. She suffered shoulder injuries. The advisory described a number of mishaps but did not identify the doctors or hospitals involved.....

Cancer Immunotherapy: Present Status, Future Perspective, and a New Paradigm of Peptide Immunotherapeutics

Blogger's Note: includes small reference to ovarian cancer
open access

Removing the red tape from patient records - Forbes

 Forbes

Enabling a Platform for Patient Engagement
There’s growing evidence that doctors are becoming more open to allowing patients to update their records as long as certain protections are in place. In a recent Accenture survey, four out of five doctors (82 percent) said  that patients should be actively engaged in updating parts of their record......