August 2015
The American Journal of Managed Care - Evidence-Based Oncology
Next-Generation Sequencing: Are We There Yet?
The Diagnosis for Diagnostics: Changes to Medicare Payment and Coverage of Clinical Laboratory Tests
Wednesday, August 19, 2015
Abraxane (Albumin-bound Paclitaxel for Injectable Suspension) Drug Information: Description, User Reviews, Drug Side Effects....Interactions - Prescribing Information at RxList
RxList
WARNING
NEUTROPENIA
Do not administer ABRAXANE therapy to patients who
have baseline neutrophil counts of less than 1,500 cells/mm³. In order to monitor
the occurrence of bone marrow suppression, primarily neutropenia, which may be
severe and result in infection, it is recommended that frequent peripheral
blood cell counts be performed on all patients receiving ABRAXANE [see
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
Acute and chronic effects of hydration status on health | Nutrition Reviews
open access
Abstract
Maintenance
of fluid and electrolyte balance is essential to healthy living as
dehydration and fluid overload are associated with morbidity and
mortality. This review presents the current evidence for the impact of
hydration status on health. The Web of Science, MEDLINE, PubMed, and
Google Scholar databases were searched using relevant terms. Randomized
controlled trials and large cohort studies published during the 20 years
preceding February 2014 were selected. Older articles were included if
the topic was not covered by more recent work. Studies show an
association between hydration status and disease. However, in many
cases, there is insufficient or inconsistent evidence to draw firm
conclusions. Dehydration has been linked with urological,
gastrointestinal, circulatory, and neurological disorders. Fluid
overload has been linked with cardiopulmonary disorders, hyponatremia,
edema, gastrointestinal dysfunction, and postoperative complications.
There is a growing body of evidence that links states of fluid imbalance
and disease. However, in some cases, the evidence is largely
associative and lacks consistency, and the number of randomized trials
is limited.
- dehydration
- disease
- electrolytes
- fluid
- fluid overload
- hydration status.
INTRODUCTION
Table 2
Summary of the evidence linking dehydration and overhydration to health disorders
Cancer - Religion and Spirituality Series (5 articles)
Cancer
Religion and Spirituality Series
Religion, spirituality, and health outcomes in cancer: A case for a meta-analytic investigation
Religion/spirituality and health in the context of cancer: Cross-domain integration, unresolved issues, and future directions
A Meta-analytic approach to examining the correlation between religion/spirituality and mental health in cancer
A Meta-analytic review of religious or spiritual involvement and social health among cancer patients
Religion, spirituality, and physical health in cancer patients: A meta-analysis
Intratumoral interleukin-6 predicts ascites formation in patients with epithelial ovarian cancer
abstract
Intratumoral interleukin-6 predicts ascites formation in patients with epithelial ovarian cancer: A potential tool for close monitoring
CONCLUSIONS:
Having the capability to predict the ascites formation, IL-6 might serve as a biomarker and a useful tool in EOC for monitoring purposes. IL-6 targeting for the prevention of the ascites development is a potential avenue for further investigation.Population-Wide Screening for Germline BRCA1/2 Mutations: Too Much of a Good Thing?
open access
Germline testing for highly penetrant mutations in cancer susceptibility genes such as BRCA1 and BRCA2 (BRCA1/2) can prevent cancer and save lives. Inherited BRCA1/2 mutations confer a 39% to 85% lifetime risk of female breast cancer and an 11% to 62% lifetime risk of ovarian cancer.1–7 Identifying BRCA1/2 mutation carriers thus allows for prophylactic surgeries, which can markedly decrease cancer incidence, morbidity, and mortality.8–11 Despite these benefits and increasing public awareness, a low fraction (35% in a recent Israeli study)1 of women with high-risk histories have undergone BRCA1/2 testing. Moreover, women from families with few female relatives are unlikely to recognize their risk of carrying a BRCA1/2 mutation until they themselves develop cancer. Recently, citing the impact of risk-reducing surgeries, King et al12 published a high-profile appeal for BRCA1/2 mutation screening to be offered to all US women at age 30 years.12–14 King is to be commended for stimulating a serious discussion on the potential impact of bringing modern genetic medicine to the general population in a compelling circumstance. However, because testing all women for BRCA1/2 mutations would represent the first population-based screening for a hereditary cancer syndrome, careful consideration of the potential limitations, risks, and benefits of population-wide BRCA1/2 testing is essential......
Gender-specific aspects of Lynch syndrome - an update
abstract
Approximately 3 - 5 % of all colorectal cancers are based on a hereditary predisposition, of which Lynch syndrome is by far the most frequent hereditary cancer syndrome. Beside colorectal cancer Lynch-Syndrome is the most frequent predisposing hereditary cause of endometrial cancer and is also associated with gastric cancer, ovarian cancer, cancer of the urinary tract as well as several other cancers. Genetically Lynch syndrome is caused by a germline mutation in one of the so-called mismatch-repair-genes. Based on several epidemiological studies, increasingly differences in the penetrance of the different cancers occurring are associated with the affected gene and also gender of the patient have been reported. The lifetime risk of colorectal cancer for males with Lynch syndrome generally is significantly higher and the age of first manifestation significantly earlier compared to females. The difference is especially notable in men with a MSH6-mutation. Moreover, the lifetime risk for gastric, bladder, and urothelial cancer is much higher in males. Women with an MSH6 mutation have a much higher risk for endometrial (and ovarian) cancer than for colorectal cancer. In patients with Muir Torre syndrome again males are predominantly affected and almost all affected have a mutation in MSH2 rather than in any other MMR gene. This review is an update of the literature analyzing gen and gender specific aspects of Lynch syndrome. To date these associations are based on retrospective studies, that require confirmation in a prospective setting with large patient numbers in order to identify validated, individualized gene and gender screening recommendations in the future. Especially in a syndrome with multiple potential cancer targets, an intense yearly program comprising several invasive procedures has a negative effect on patient compliance.
Tuesday, August 18, 2015
Journal Hopes Stomach-Churning Essay Will Spur Change
Medscape
This week’s issue of the Annals of Internal Medicine includes a disturbing essay that recounts two incidents of abuse or disrespect of unconscious patients. The journal’s editors say they hope it will disturb readers, who may recall similar behaviors, and spur change.
The essay is published anonymously, in only the second instance the journal has ever allowed an author to remain unknown. In both cases, the intent was to avoid unintentional identifications, especially of patients.....
Bevacizumab Combined With Weekly Paclitaxel, Pegylated Liposomal Doxorubicin, or Topotecan in Platinum-Resistant Recurrent Ovarian Cancer
open access
Bevacizumab Combined With Weekly Paclitaxel, Pegylated Liposomal Doxorubicin, or Topotecan in Platinum-Resistant Recurrent Ovarian Cancer: Analysis by Chemotherapy Cohort of the Randomized Phase III AURELIA Trial
To the Editor:
In a previous issue of Journal of Clinical Oncology,
we reported results from the open-label, randomized phase III AURELIA
(Avastin Use in Platinum-Resistant Epithelial Ovarian
Cancer) trial demonstrating that combining
bevacizumab with single-agent chemotherapy for treatment of
platinum-resistant
recurrent ovarian cancer (PROC) significantly
improved progression-free survival (PFS), the primary end point, as well
as
the objective response rate (ORR) and the
patient-reported outcome end point of abdominal/GI symptoms in the
intent-to-treat
population of 361 patients.1,2
We observed no significant difference in overall survival (OS) between
treatment arms, though the trial was not designed
for us to formally compare OS. In addition, the
extensive cross-over of 40% of patients to bevacizumab from chemotherapy
alone
complicated interpretation......
.... The main limitation of these exploratory analyses is that assessing
individual chemotherapy partners for bevacizumab was not
an objective of AURELIA. However, exploring
consistency of effect in clinical trials is important, not necessarily
for guiding
treatment practice, but at least for hypothesis
generation, particularly if a plausible biologic explanation for
differences
exists. Although consistency, on the basis of
treatment effect estimates and 95% CIs, was seen between cohorts, the
effect
on PFS, ORR, and OS of combining bevacizumab with
weekly paclitaxel was remarkable. These hypothesis-generating
observations
should be considered when investigators design new
trials in PROC.
NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial
NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial
The Trial
NCI-MATCH precision medicine clinical trial will explore treating patients based on the molecular profiles of their tumors.
NCI-MATCH can add new treatments or drop treatments over time. Each treatment will be used in a unique arm, or substudy, of the trial.
The trial opened for enrollment in August 2015 with 10 arms. Each arm will enroll adults 18 years of age and older with advanced solid tumors and lymphomas that are no longer responding (or never responded) to standard therapy and have begun to grow......
Enrolling in NCI-MATCH
To learn more about this trial, patients should start by speaking with their doctors or healthcare team. More details about the trial are available in the protocol summary. As the year progresses, the list of clinical sites will continue to grow as new sites are added.
Patients, families, and clinicians can also call NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for assistance in English and Spanish or contact NCI's LiveHelp service.
Clinicians and organizations that are interested in participating in this trial should contact NCI's Cancer Trials Support UnitExit Disclaimer.
Review: The optimal organization of gynecologic oncology services: a systematic review
open access - Current Oncology
Abstract
Background
A system-level organizational guideline for
gynecologic oncology was identified by a provincial cancer agency's (Ontario, Canada) a
key priority based on input from stakeholders, data showing more limited
availability of multidisciplinary or specialist care in lower-volume
than in higher-volume hospitals in the relevant jurisdiction, and
variable rates of staging for ovarian and endometrial cancer patients.
Methods
A systematic review assessed the relationship of the
organization of gynecologic oncology services with patient survival and
surgical outcomes. The electronic databases medline and embase (ovid:
1996 through 9 January 2015) were searched using terms related to
gynecologic malignancies combined with organization of services,
patterns of care, and various facility and physician characteristics.
Outcomes of interest included overall or disease-specific survival,
short-term survival, adequate staging, and degree of cytoreduction or
optimal cytoreduction (or both) for ovarian cancer patients by hospital
or physician type, and rate of discrepancy in initial diagnoses and
intraoperative consultation between non-specialist pathologists and
gyne-oncology–specialist pathologists.
Results
One systematic review and sixteen additional primary
studies met the inclusion criteria. The evidence base as a whole was
judged to be of lower quality; however, a trend toward improved outcomes
with centralization of gynecologic oncology was found, particularly
with respect to the gynecologic oncology care of patients with
advanced-stage ovarian cancer.
Conclusions
Improvements in outcomes with centralization of
gynecologic oncology services can be attributed to a number of factors,
including access to specialist care and multidisciplinary team
management. Findings of this systematic review should be used with
caution because of the limitations of the evidence base; however, an
expert consensus process made it possible to create recommendations for
implementation.
RESEARCH QUESTIONS
-
□ Are outcomes better for patients with gynecologic cancer treated in designated centres (“centralized care”) compared with non-designated centres (“decentralized care”)?
-
□ Are outcomes better for patients treated by gynecologic oncologists than by non-subspecialist physicians?
CONCLUSIONS
The evidence found in the present review is
consistent with previous research showing a likely benefit from the
delivery of gynecologic oncology care in specialized centres with
subspecialists working as part of a multidisciplinary team—particularly
for patients with more advanced ovarian cancer. It should be cautioned,
however, that unlike other disease sites such as pancreas and esophagus4, the evidence for this finding is far from strong.
Because of the lower-quality nature of the evidence
base, an expert consensus process was used to create an organizational
guideline, the results of which are published separately40.
Views of family physicians about survivorship care plans to provide breast cancer follow-up care
Blogger's Note/Opinion: this is not the first research paper on this issue with the conclusions being basically the same (eg. communication...); given the complexities of genetics today this paper is limited in its scope
open access - breast cancer follow-up care Current Oncology
Cancer Rehabilitation and Survivorship
Views of family physicians about survivorship care plans to provide breast cancer follow-up care: exploration of results from a randomized controlled trial
Background
The U.S. Institute of Medicine recommends that cancer
patients receive survivorship care plans, but evaluations to date have
found little evidence of the effectiveness of such plans. We conducted a
qualitative follow-on study to a randomized controlled trial (rct)
to understand the experiences of family physicians using survivorship
care plans to support the follow-up of breast cancer patients.
Methods
A subset of family physicians whose patients were enrolled in the parent rct
in Ontario and Nova Scotia were eligible for this study. In interviews,
the physicians discussed survivorship care plans (intervention) or
usual discharge letters (control), and their confidence in providing
follow-up cancer care.
Results
Of 123 eligible family physicians, 18 (10
intervention, 8 control) were interviewed (Halifax, Hamilton, Toronto). In general, physicians
receiving a survivorship care plan found only the 1-page care record to
be useful. Physicians who received only a discharge letter had variable
views about the letter’s usefulness; several indicated that it lacked
information about potential cancer- or treatment-related problems. Most
physicians were comfortable providing care 3–5 years after diagnosis,
but desired timely and informative communication with oncologists.
Conclusions
Although family physicians did not find extensive
survivorship care plans useful, discharge letters might not be
sufficiently comprehensive for follow-up breast cancer care. Effective
strategies for two-way communication between family physicians and
oncologists are still lacking.
INTRODUCTION
Commentary: Professionalism (Current Oncology)
Commentary - Current Oncology
I have been reading medical literature since 1970. I
started medical school in 1970, and from then to this present day, I
find it shocking how little is written in medical literature and how
little education is required about professional behavior.
The doctor–patient relationship—or rather the lack
thereof—is a very important factor in litigation. However, that fact
should not be the “prime mover” causing practitioners to abide by very
high ethical standards. We should not be threatened into professionalism
and ethical behavior. Our pride, our professionalism, and our inherent
integrity as physicians and surgeons should motivate us. There are few,
if any other, professions in which so much emphasis is placed on
integrity, honesty, and good relations.
Nothing breeds more contempt and suspicion than a
lack of transparency and a perception by patients that “I was not heard”
or “My interaction was played down.”
A patient with a very anxious demeanor and four
pressing questions went to see a physician. During consultation, the
physician took over the conversation and pre-emptively answered the
questions that physicians expect the patient to ask. The patient went
home with none of the important questions (to that patient) answered.....
Commentary: Is it time to offer BRCA1 and BRCA2 testing to all Jewish women?
Commentary-Current Oncology
It was 2007 when Women’s College Hospital first began to test for BRCA1 and BRCA2 mutations among all Jewish women in Ontario. On a research basis, testing was performed regardless of personal or family history of cancer for three recurrent Jewish founder BRCA mutations1. To date, more than 7000 women have been tested, and the program remains active. Recently, two studies have supported the conclusion that population-based testing is a rational approach to identifying BRCA mutation carriers. In an Israeli study of 8105 unselected Jewish men2 and a British study of 1034 unselected Jewish men and women3, more than one half of the identified mutation carriers failed to qualify for genetic testing based on family history.......
SUMMARY
Given that the prevalence of BRCA1 and BRCA2 mutations in unselected Jewish women is 1%–2%; that most women with a BRCA
mutation identified through population screening would not qualify for
testing based on current testing criteria; that population-based genetic
testing results in the identification of more unaffected BRCA
mutation carriers than does clinical testing (which relies on personal
or family history of cancer) and is less expensive; that women
identified with a BRCA mutation through population screening opt
for intensive breast screening and preventive surgeries; that preventive
oophorectomy and mastectomy reduce cancer deaths dramatically; that
cancer-related distress is transient; and that almost all tested women
are satisfied with testing, we consider genetic testing of the general
population of Jewish women to be justified.
BRCA1/2 population screening: embracing the benefits
Blogger's Note: register for free access
Editorial-Current Oncology
Whether all adult Ashkenazi women should be offered population screening for recurrent BRCA1 and BRCA2 founder mutations is an important question to me both personally as an Ashkenazi Jewish woman and professionally. I was a junior faculty member and a newly certified medical geneticist in 1995 when I participated in the first research study offering 185delAG mutation testing (the other two founders weren’t known at the time) to the Ashkenazi Jewish community in Houston1........
.... The remaining obstacles to population screening are those of cost and appropriate staffing or counselling guides. Instituting population screening in the United States without a national health care system (such as in Canada or Israel) will be more challenging. Insurance coverage of genetic testing will likely begin only if a guideline from a professional medical organization recommends population screening. But, there were obstacles when population screening for Tay–Sachs carriers was first recommended in the 1970s, and medical professionals and the Ashkenazi Jewish community found ways to overcome those barriers to effectively perform population screening and drastically reduce births of children with Tay–Sachs disease16. I hope that, in 2015, professional societies will thoughtfully embrace the potential benefits of adult population screening for Ashkenazi founder mutations in BRCA1 and BRCA2, with the goal of decreasing the untimely death of individuals from breast and ovarian cancer.
SMARCA4 (BRG1) Loss of Expression Is a Useful Marker for the Diagnosis of Ovarian Small Cell Carcinoma of the Hypercalcemic Type....
abstract
SMARCA4 (BRG1) Loss of Expression Is a Useful Marker for the Diagnosis of Ovarian Small Cell Carcinoma of the Hypercalcemic Type (Ovarian Rhabdoid Tumor): A Comprehensive Analysis of 116 Rare Gynecologic Tumors, 9 Soft Tissue Tumors, and 9 Melanomas
Ovarian small cell carcinoma of the hypercalcemic type (SCCOHT)/ovarian rhabdoid tumor is a rare and highly malignant tumor that typically occurs in young women. Up until now the diagnosis has been made on the basis of morphology without any specific immunohistochemical (IHC) markers. However, several authors have shown recently that SCCOHTs are characterized by inactivation of the SMARCA4 gene (encoding the BRG1 protein) resulting in a loss of BRG1 protein expression in IHC. We evaluated BRG1 and INI1 expression in 12 SCCOHTs and in a series of 122 tumors that could mimic SCCOHT morphologically: 9 juvenile granulosa cell tumors, 47 adult granulosa cell tumors, 33 high-grade ovarian serous carcinomas,
Identification of germline variants in cancer susceptibility genes in patients with multiple primary cancers
Abstract 4663
The occurrence of multiple primary (MP) cancers in a patient suggests a genetic predisposition to tumor formation. Multiplex panel testing may be an efficient way of evaluating MP patients for the presence of germline mutations in cancer susceptibility genes. However the spectrum of mutations in many cancer susceptibility genes in the MP patient population is largely unknown. We performed massively parallel sequencing using targeted capture of 15 genes with well-established risks of breast and/or other cancers, specifically TP53, CDH1, PTEN, STK11, ATM, CHEK2, MRE11A, NBN, RAD50, PALB2, MLH1, MSH2, MSH6, PMS2, and MUTYH. Our patient cohort consisted of 221 BRCA1/2 negative patients diagnosed with breast cancer and at least one other primary cancer, excluding non-melanoma skin cancer. Patients diagnosed with contralateral breast cancer were included.
Histology-specific patterns of DNA methylation in Lynch-associated and sporadic ovarian cancer
Abstract 2964
Epithelial ovarian cancer is a heterogeneous group of
cancers, and molecular tools are urgently needed for a better
understanding
and targeted management of this often lethal
disease. Since epigenetic methods can offer new tools for the management
of ovarian
cancer, our aim was to investigate epigenetic
mechanisms in ovarian tumorigenesis representing different histological
types.
Expression profiling of ovarian and endometrial
cancer cell lines treated with demethylating agents as well as
literature
were used to select gene candidates for epigenetic
regulation. A methylation-specific multiplex ligation-dependent probe
amplification
(MS-MLPA) assay was constructed for thirteen genes
to study methylation in 104 (85 sporadic and 19 Lynch
syndrome-associated)
ovarian carcinomas.
Increased methylation (hypermethylation)
was characteristic of ovarian cancer tissues relative to the
corresponding normal
tissues and hypermethylation was consistently more
prominent in non-serous than serous tumors. The highest frequencies of
hypermethylation were detected in Lynch-associated
clear cell ovarian carcinomas.
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