Thursday, April 25, 2013
CBC News - Ontario hospitals surveyed on outsourcing IV drugs (diluted chemotherapy issues)
CBC News
"A total of 10 hospitals in Ontario say they bought bulk IV medications from Marchese Hospital Solutions, a company linked to an underdosing of chemotherapy patients, a survey suggests.....
Lynch Syndrome for the Gynecologist
Lynch Syndrome for the Gynecologist
68th Annual Obstetrical and Gynecological
Assembly of Southern California
April 26, 2013
A Decade After Decoding the Human Genome | The 23andMe Blog
Blog
".....Some of the most dramatic breakthroughs in genetic science have been in the treatment of rare diseases. While rare diseases are individually rare, when you add up all the people who suffer from a rare disease it amounts to about one in ten, or about 30 million people in the United States. Doctors now know the genetic underpinnings of almost 5,000 rare diseases, more than twice as many as a decade ago.....
AAPS Sues the American Board of Medical Specialties for Restraining Trade through Its Burdensome Recertification Program
USNewswire
April 24, 2013 /PRNewswire-USNewswire/ -- The Association of American Physicians & Surgeons (AAPS) has filed suit today in federal court against the American Board of Medical Specialties (ABMS) for restraining trade and causing a reduction in access by patients to their physicians. The ABMS has entered into agreements with 24 other corporations to impose enormous "recertification" burdens on physicians, which are not justified by any significant improvements in patient care.
ABMS
has a proprietary, trademarked program of recertification, called the
"ABMS Maintenance of Certification®" or "ABMS MOC®," which brings in
many tens of millions of dollars in revenue to ABMS and the 24 allied
corporations. Though ostensibly non-profit, these corporations then pay
prodigious salaries to their executives, often in excess of $700,000
per year. But their recertification demands take physicians away from
their patients, and result in hospitals denying access by patients to
their physicians.....
Lost in hospital: a qualitative interview study that explores the perceptions of NHS inpatients who spent time on clinically inappropriate hospital wards (patient safety)
Blogger's Note: although not specifically mentioned in this abstract, the impact of inappropriate placement, as an example, would be placing an ovarian cancer patient in a maternity ward (it has been done)
~~~~~~~~~~~~~
Abstract
Background
Prior
research suggests that the placement of patients on clinically
inappropriate hospital wards may increase the risk of experiencing
patient safety issues.
Objective
To
explore patients' perspectives of the quality and safety of the care
received during their inpatient stay on a clinically inappropriate
hospital ward.
Design
Qualitative study using semi-structured interviews.
Participants and setting
Nineteen
patients who had spent time on at least one clinically inappropriate
ward during their hospital stay at a large NHS teaching hospital in
England.
Results
Patients
would prefer to be treated on the correct specialty ward, but it is
generally accepted that this may not be possible. When patients are
placed on inappropriate wards, they may lack a sense of belonging.
Participants commented on potential failings in communication, medical
staff availability, nurses' knowledge and the resources available, each
of which may contribute to unsafe care.
Conclusions
Patients
generally acknowledge the need for placement on inappropriate wards due
to demand for inpatient beds, but may report dissatisfaction in terms
of preference and belonging. Importantly, patients recount issues
resulting from this placement that may compromise their safety. Hospital
managers should be encouraged to appreciate this insight and potential
threat to safe practice and where possible avoid inappropriate ward
transfers and admissions. Where such admissions are unavoidable, staff
should take action to address the gaps in safety of care that have been
identified.
Familial and Atypical Urothelial Cancer Registry (still recruiting)
ClinicalTrials.gov
Purpose
This
study is being done to create a registry to help us learn more about
urinary and other cancers. This will let us look at large groups of
people who do and do not have this kind of cancer.
The investigators will
look at risk factors to learn more about how these impact cancer. The
investigators will also look at genetic markers. These are genes that
are found in a known place. They are often associated with a particular
trait. If the gene changes in some way, it may predict cancer or
response to treatment. The investigators will look for markers in your
saliva.
This registry will help us develop better methods of:
Preventing these cancers. Diagnosing these cancers. Treating these cancers.
| Condition | Intervention |
|---|---|
|
Urothelial Cancer Renal Pelvis Cancer Ureter Cancer Bladder Cancer |
Other: saliva sample and questionaire Other: saliva sample, questionaire |
| Study Type: | Observational | ||||||||||
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
||||||||||
| Official Title: | Familial and Atypical Urothelial Cancer Registry | Eligibility
Study Population
A
member of the patient's treatment team, the protocol investigator, or a
member of the research team at Memorial Sloan-Kettering Cancer Center
(MSKCC) will identify potential research subjects. At MSKCC the
following outpatient clinics will be used to recruit UC cases: Urology
and Genitourinary Oncology. Patients and families may also be directly
referred to the study team by any MSKCC physician, external physician,
or by the family itself.
Criteria
Inclusion Criteria:
Urothelial Cancer Cases
|
Belief in numbers: When and why women disbelieve tailored breast cancer risk statistics
Abstract
Risk communication
Objective
To examine when and why women disbelieve tailored information about their risk of developing breast cancer.
Methods
690
women participated in an online program to learn about medications that
can reduce the risk of breast cancer. The program presented tailored
information about each woman's personal breast cancer risk. Half of
women were told how their risk numbers were calculated, whereas the rest
were not. Later, they were asked whether they believed that the program
was personalized, and whether they believed their risk numbers. If a
woman did not believe her risk numbers, she was asked to explain why.
Results
Beliefs
that the program was personalized were enhanced by explaining the risk
calculation methods in more detail. Nonetheless, nearly 20% of women did
not believe their personalized risk numbers. The most common reason for
rejecting the risk estimate was a belief that it did not fully account
for personal and family history.
A proportion of (Lynch Syndrome) hereditary upper urinary tract urothelial carcinomas are misclassified as sporadic according to a multi-institutional database analysis: proposal of patient-specific risk identification tool
Abstract
What's known on the subject? and What does the study add? Hereditary non-polyposis colorectal cancer (HNPCC), also known as Lynch syndrome, is an autosomal dominant multi-organ cancer syndrome. Upper urinary tract urothelial carcinomas belong to HNPCC-related tumours and rank third within this group after colorectal and endometrial cancer. However, many urologists are not aware of this association and it is presumed that some hereditary cancers are misclassified as sporadic and that their incidence is underestimated. Consequently, family members of patients with upper urinary tract urothelial carcinomas secondary to HNPCC may be denied appropriate surveillance and early detection. A significant proportion of patients (21.3%) with newly diagnosed upper urinary tract urothelial carcinomas may have underlying HNPCC. Demographic and epidemiological characteristics suggest different mechanisms of carcinogenesis among this population. Recognition of such potential is essential for appropriate clinical and genetic management of patients and family. In order to help to identify these patients, we propose a patient-specific checklist.
OXiGENE Announces Completion of Enrollment of ZYBRESTAT(R) Phase 2 Ovarian Cancer Trial - GOG-0186I
media
April 24, 2013 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that enrollment has been completed in a randomized Phase 2 clinical trial testing the combination of ZYBRESTAT(R) (fosbretabulin; CA-4P) plus bevacizumab to treat patients with advanced ovarian cancer. This trial, GOG-0186I, is being conducted by the Gynecologic Oncology Group (GOG) under the sponsorship of Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). This is the first and currently the only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent in ovarian cancer, without including any cytotoxic chemotherapy......
Are randomized trials obsolete or more important than ever in the genomic era?
abstract
Musings
Genome Medicine 2013, 5:32 doi:10.1186/gm436
Published: 18 April 2013
Published: 18 April 2013
First paragraph (this article has no abstract)
"The genomic era has raised the possibility of major changes in the design, conduct, and even the existence of randomized trials as we know them [1-3]. Randomized trials are often seen as a slow, laborious, expensive, and difficult step in the translational process and are associated with a high attrition rate for drugs. Indeed, most tests that are in use for the screening, diagnosis, prognosis, monitoring or management of patients have never been scrutinized by a randomized trial. This has largely been due to a failure to realize that tests can do as much harm and as much good as drugs or devices; thus, a rigorous appraisal of their clinical utility, including both the possible benefits and the possible harms, is necessary. Moreover, numerous new omics-based tests are continually being proposed, especially in the context of targeted preventive or therapeutic interventions. Given rapid development of these new biomarkers, can we make randomized trials more adaptable to a changing landscape? Furthermore, do we still need randomized trials at all? Our answers to these two questions are: yes, to some extent; and yes, definitely. We will explain our reasoning in this article."Prolanta - Ovarian Cancer - Oncolix (pharma)
Blogger's Note: 'About Us' section is typically a 'forward-thinking' statement by the manufacturer - clinical trials will determine the results
Prolanta - Ovarian Cancer
Ovarian Cancer
Ovarian Cancer Monotherapy
Ovarian Cancer Combination Therapy
Breast Cancer
Breast Cancer Monotherapy
Breast Cancer Combination Therapy
About Us
Oncolix, Inc. (Oncolix) is a clinical-stage bio-pharmaceutical company
based in Houston, Texas.
The company is developing Prolanta™, a targeted therapeutic protein
for the treatment of ovarian and breast cancer.
Prolanta is an antagonist of the human prolactin receptor, blocking
the effects of human prolactin.
There is substantial scientific
evidence that human prolactin is associated with the growth of certain
gynecological cancers as well as resistance to platinum and taxane
therapies.
By blocking the effects of prolactin,Prolanta has demonstrated a high
level of efficacy in ovarian and breast cancer models.
Our initial focus is ovarian cancer, an Orphan Drug
indication where there is a significant unmet medical need.
The first clinical trial of Prolanta to treat ovarian cancer is
anticipated to begin in 2013. The preclinical testing required prior to
the first-in-human clinical trial was completed in 2011, and the
IND
was cleared by the FDA in 2012.
Prolactin is mainly synthesized and secreted by lactotroph cells in the
anterior pituitary gland, but is also produced at sites outside the
pituitary gland, such as mammary gland, ovary, uterus, prostate,
lymphocytes, brain, and several types of tumor cells.
This extra-pituitary prolactin can act as a tumor growth factor
in an autocrine-paracrine fashion, both on the tumor cells that secrete
prolactin (autocrine) as well as on nearby cells (paracrine).
Prolactin binds with its cell surface receptor through dimerization,
activating various proliferation and chemo-resistance pathways.
Prolanta is an analogue to prolactin, with a single amino acid
substitution mutation at position 129 to create a receptor-specific
antagonist (also referred to as G129R).
This glycine to arginine substitution interferes with the binding
of the mutated ligand at the second receptor site, thereby disrupting
dimerization of the receptors necessary for activation.
As illustrated in the following figure, prolactin
binds to two receptors and initiates various growth pathways, the most
well known of which is the Jak2/STAT pathway.
In contrast,
Prolanta (G129R) binds to one receptor but the arginine mutation
blocks dimerization with a second receptor. As a result, the
intra-cellular profileration pathways are not initiated. Prolanta
binding also competitively blocks the binding of prolactin.
Additionally, our collaborators at MD Anderson Cancer Center have
discovered that Prolanta can also initiate a cell death pathway, known
as autophagy, initiated through PEA-15.
Not only does Prolanta block cell proliferation pathways, our drug also
triggers autophagic cell death of tumor cells..........The aim of Oncolix's
product development is to bring to market agents with increased efficacy
and decreased toxicity in cancer therapy through targeted therapies.
Prolanta is anticipated to be effective in the majority of ovarian and
breast cancer patients as this therapy targets tumors that express the
prolactin receptor which occurs in the majority of these tumors.
Oncolix gets key FDA backing for ovarian cancer drug - Prolanta - media
media
An ovarian cancer drug developed by Houston-based Oncolix Inc. has been granted orphan drug designation by the U.S. Food and Drug Administration and is ready to begin Phase I clinical trials later this year.
Orphan drug designation is granted to promising drugs geared to treat a population of fewer than 200,000 people who live with the disease in the U.S. Currently, about 170,000 women are living with ovarian cancer.
For Oncolix, this means the $1.9 million registration fee will be waived once the company submits its drug, known as Prolanta, for approval. Also, if Prolanta receives approval, the drug will be given seven years of market exclusivity.
Currently, the only treatment option available for patients with ovarian cancer is chemotherapy, Michael Redman, CEO of Oncolix, told HBJ.
The orphan drug designation was granted on April 18. Redman said the company applied for the status about 70 days before it received notification from the FDA.
The company is applying for the same status in Europe and Japan. If granted, the designation would guarantee 10 years of exclusivity.
The Phase I trial, slated to begin later this year, would involve between 12 to 18 patients and be performed in connection with The University of Texas M.D. Anderson Cancer Center.
Redman was a co-founder of The Woodlands-based Opexa Therapeutics Inc. (NASDAQ: OPXA). He sold the company in 2004.
(paywalled) Discussion: ‘Ovarian epithelial carcinoma with pelvic endometriosis,’ by Wang et al
Discussion
Journal club roundtable
Discussion: ‘Ovarian epithelial carcinoma with pelvic endometriosis,’ by Wang et al
- Professor, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC
- Second-Year Fellow, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC
- Third-Year Fellow, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC
- Third-Year Fellow, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC
- First-Year Fellow, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC
- First-Year Fellow, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC
- Assistant Professor, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC
- Refers To
Clinical analysis of ovarian epithelial carcinoma with coexisting pelvic endometriosis
- American Journal of Obstetrics and Gynecology, Volume 208, Issue 5, May 2013, Pages 413.e1-413.e5
PDF (232 K)- Referred to by
Ovarian epithelial carcinoma with pelvic endometriosis: Wang et al
- American Journal of Obstetrics and Gynecology, Volume 208, Issue 5, May 2013, Pages 415-416
In
the roundtable that follows, clinicians discuss a study published in
this issue of the Journal in light of its methodology, relevance to
practice, and implications for future research. Article discussed:
Wang
S, Qui L, Lang JH, et al. Clinical analysis of ovarian epithelial
carcinoma with coexisting pelvic endometriosis. Am J Obstet Gynecol
2013;208:413.e1-5.
There are no figures or tables for this document.
- L. V. L. is on the Advisory board for Biologics Inc., Speaker's Bureau for Eisai, Inc. Funded research by Abbott Labs.
- The other authors report no conflict of interest.
Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy
ClinicalTrials.gov
This study is currently recruiting participants.
Verified April 2013 by Chinese PLA General Hospital
Sponsor:
Chinese PLA General Hospital
Information provided by (Responsible Party):
DuNan, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01838538
First received: April 19, 2013
Last updated: NA
Last verified: April 2013
Cancer risks and immunohistochemical profiles linked to the Danish MLH1 Lynch syndrome founder mutation
Abstract
In conclusion, the Danish MLH1 founder mutation that accounts for a
significant proportion of Lynch syndrome and is associated with a lower
risk for extracolonic cancers.
(2012) Consumer awareness and attitudes about insurance discrimination post enactment of the Genetic Information Nondiscrimination Act
Abstract
To
examine the awareness and attitudes about the Genetic Information
Nondiscrimination Act in individuals who made contact with a Hereditary
Breast and Ovarian Cancer
Syndrome advocacy group. This is a descriptive study of individuals
(n = 1,699) who were invited via email and advertisements to complete an
online questionnaire available from August 2009 through December 2010.
Response distributions of relevant subgroups were compared using cross
tabulation and Chi-squared tests were used. The majority of respondents
(69.2 %) had undergone genetic testing (n = 1,156) and 30.2 % had not.
Of those who did not undergo genetic testing, the most common reason
given for declining testing was cost (28.8 %), followed by concerns
about insurance discrimination (19.5 %). More than half (60.5 %) were
worried about health insurance discrimination when they first considered
genetic testing and 28.6 % were worried about employment
discrimination. Slightly more individuals were worried about health
insurance discrimination if they had no prior knowledge of GINA. While
"cost" was cited most frequently as the reason not to test, "fear of
insurance discrimination" was the second most common reason. Knowledge
of GINA among consumers is still limited and public education may help
promote reduction in fear.
Wednesday, April 24, 2013
+blogger's opinion: Living with the BRCA1 and BRCA2 genetic mutation: Learning how to adapt to a virtual chronic illness
Blogger's Opinion: based on this abstract, not worth reading nor pay-per-view; the question is this: what does this study add to existing research; research has been inundated with similar studies over years; assuming from the text this was a study done with a breast cancer population then it should be made thus clear; the psychosocial/oncology aspects of living with genetic mutations is well known; BRCA genes confer risks: ovarian, prostate, pancreatic; the medical vs patient definition of chronic disease remains a point of ongoing debate
~~~~~~~~~~~~~~~
Abstract
The
objective of this study was to understand how women living with the
BRCA1 and BRCA2 genetic mutation adapt to this life transition and to
identify the main adaptive tasks. A qualitative inquiry inspired by
grounded theory revealed that participants cognitively appraised their
test result in the same manner as women who have been diagnosed with
breast cancer.
Consequently, participants had to adapt to a condition that they
perceived as a chronic illness. The following three main tasks were
identified: Physical Task: Attempting to Limit the Impact of the Test
Result, Psychological Task: Living with Uncertainty, and Social Task:
Finding Effective Support. In conclusion, although these women live with
the possibility of developing breast cancer,
their experiences mirror those of individuals living with a chronic
illness, and they must therefore adapt accordingly in a physical,
psychological, and social manner.
Gastric perforation secondary to metastasis from ovarian cancer: Case report
Abstract
INTRODUCTION:
Metastasis from ovarian cancer occurs frequently through the peritoneal cavity in the form of peritoneal carcinomatosis; isolated gastric (stomach) metastasis is rarely reported in literature.PRESENTATION OF CASE:
We present a case of 43-year-old infertile lady, who developed a picture of acute abdomen four days post total abdominal hysterectomy and salpingoopherectomy for ovarian cancer. Further contrast-enhanced CT scan demonstrated massive free gas and fluid in the abdomen. She underwent antrectomy with truncal vagotomy due to 3cm×4cm prepyloric gastric ulcer. Final pathology proved the presence of metastatic serous cystadenocarcinoma of ovarian origin.DISCUSSION:
Our patient had a gastric perforation secondary to ovarian metastasis. Being isolated, the absence of ascites and the transmural nature of the gastric metastasis suggest haematogenous spread .To the best of our knowledge perforated gastric metastasis secondary to ovarian cancer was not reported in literature before.CONCLUSION:
Gastric metastasis should be kept in mind in patients with a well-known ovarian cancer who present with gastric lesions, ulcers, bleeding or perforation.Frontiers | The impact of cancer therapy on cognition in the elderly | Frontiers in Pharmacology of Anti-Cancer Drugs
open access
Cancer treatment is a field that has made great advances in the last century. Survival has been greatly affected by novel therapies. However, with increased long-term survival from cancer, the long-term effects of treatment remain to be seen. The notion of the effects of chemotherapy on cognition, although initially described in the 1970s, only began to garner attention in the late 1990s as it became increasingly recognized as a common and significant symptom in cancer survivors (Hede, 2008). Aging is not only the most important risk factor for developing cancer but also a major predisposing factor to cognitive dysfunction......
A study of docetaxel weekly or every three weeks in combination with carboplatin as first line chemotherapy in epithelial ovarian cancer: Hematological and non-hematological toxicity profiles
open access
The purpose of this study was to compare the toxicity profiles of docetaxel administered on a weekly schedule and the standard three-week schedule in the treatment of advanced primary ovarian carcinoma. Eligible patients were treated with intravenous docetaxel (30 mg/m2) on days 1, 8 and 15, and carboplatin (AUC 5) on day 1 or with docetaxel (75 mg/m2) and carboplatin (AUC 5) on day 1; Q21 days for 6 cycles. This study was a pooled study of two primary phase II studies. A total of 108 patients received the weekly schedule and 59 patients received the three-week schedule. All patients were evaluated for toxicity. The overall response rate was 79% and the biochemical response 93% for the weekly schedule.....
Drug administration
Response evaluation
Toxicity analysis
Statistical analysis
Results
".... The two docetaxel schedules studied showed different toxicity profiles favoring weekly administration with regard to neutropenia, fever and infections as well as problems with oral mucositis and myalgia. Fatigue, epiphora, taste disturbances and nail changes were more specific side-effects of the weekly schedule and in a number of cases a clinical problem. Peripheral sensory neuropathy is a more limited problem with docetaxel compared with paclitaxel but no significant differences were noted between the two regimens studied.
Docetaxel
is an alternative to paclitaxel in first-line and second-line
chemotherapy regimens for advanced ovarian cancer. Dose-dense schedules
with weekly or twice-weekly administrations of the drug should be
further explored to improve and optimize the efficacy and the toxicity
profile of docetaxel chemotherapy combinations."
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