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Wednesday, April 04, 2012

financial news: Arrayit Diagnostics, Inc. Reports Results of Research Study for Ovarian Cancer Diagnostic Test (OvaDx)



Arrayit Diagnostics, Inc. Reports Results of Research Study for Ovarian Cancer Diagnostic Test

" Arrayit Corporation and Arrayit Diagnostics, Inc. ("AD") report significant results from a 257 patient research study on its pre-symptomatic ovarian cancer molecular diagnostic test in development, OvaDx(R). In this study, OvaDx(R) recorded sensitivity of 79.7%, correctly identifying patients known to have cancer, and specificity approaching 100%, correctly identifying the healthy controls, patients known not to have cancer......

NCCN.com - Evidence-Based Cancer Guidelines and Treatment Summaries for Patients (sundry topics)



NCCN.com - Evidence-Based Cancer Guidelines and Treatment Summaries for Patients

NCCN.com Puts the Focus on Living With Cancer...

VIDEO: How to Maintain Good Bone Health During Cancer Treatment

NCCN Guidelines: Ovarian Cancer March 2012



Blogger's Note: the pdf link below requires registration (free), alternatively go to: http://www.nccn.org and click on guidelines 3/2012 version shows (pages 4/5) changes from 2/2012  version; most recent version includes 'language' changes, category recommendations (eg. highly recommended, neoadjuvant therapy, CA125/clinical relapse/re-treatment, LMP, fertility issues, 'malignant' sex chord stromal, stage 1 added (stages 11-1V) to certain pages....) 

NCCN Guidelines: Ovarian Cancer 2012

Phase 2 Study Update of Selumetinib for Ovarian Cancer - MPR



Blogger's Note: more info req'd eg. side effects....

Phase 2 Study Update of Selumetinib for Ovarian Cancer - MPR

Array BioPharma announced results of a Phase 2 trial of selumetinib in women with recurrent low-grade serous ovarian or peritoneal cancer.

In the trial, 52 women each received 100mg doses of selumetinib orally twice daily in four-week cycles until disease progression or toxicity. The median number of cycles received was 4.5; 33% underwent ≥12 cycles. Prior to the trial, 58% of the patients in the trial had received three or more rounds of chemotherapy.

A disease control rate, defined as either complete or partial response or progression-free survival or progression-free survival of greater than 6 months, occurred in 81% of patients. Eight patients had complete (1) or partial (7) responses, and 34 (63%) had progression-free survival of >6 months. The median survival rate without cancer progression was 11 months.

Selumetinib is an anti-cancer drug in Phase 2 development in a range of tumors. It is a small molecule MEK inhibitor that targets a key position in the Ras-Raf-MEK-ERK signaling pathway. MEK has been shown to be frequently activated in cancer, in particular in tumors that have mutations in the RAS and RAF pathways.

For more information call (877) MED-CHEM or visit www.arraybiopharma.com

abstract: Incidence, prevalence and risk factors for peritoneal carcinomatosis from colorectal cancer - Segelman - 2012 - British Journal of Surgery - Wiley Online Library




Peritoneal Carcinomatosis (Creighton University) includes a variety of tumors that present with extensive metastasis throughout the peritoneal cavity (inside surface of the abdomen) and can be found with gall bladder, liver, colon, appendix, ovarian, pancreas, mesothelioma, pseudomyxoma peritonei, rectal, small bowel and stomach cancers. It is a broad description in which multiple tumors develop in and line the peritoneal abdominal cavity and linings.

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 Incidence, prevalence and risk factors for peritoneal carcinomatosis from colorectal cancer - Segelman - 2012 - British Journal of Surgery

Abstract

Background:

This was a population-based cohort study to determine the incidence, prevalence and risk factors for peritoneal carcinomatosis (PC) from colorectal cancer.

Methods:

Prospectively collected data were obtained from the Regional Quality Registry. The Cox proportional hazards regression model was used for multivariable analysis of clinicopathological factors to determine independent predictors of PC.

Results:

All 11 124 patients with colorectal cancer in Stockholm County during 1995–2007 were included and followed until 2010. In total, 924 patients (8·3 per cent) had synchronous or metachronous PC. PC was the first and only localization of metastases in 535 patients (4·8 per cent). The prevalence of synchronous PC was 4·3 per cent (477 of 11 124). The cumulative incidence of metachronous PC was 4·2 per cent (447 of 10 646). Independent predictors for metachronous PC were colonic cancer (hazard ratio (HR) 1·77, 95 per cent confidence interval 1·31 to 2·39; P = 0·002 for right-sided colonic cancer), advanced tumour (T) status (HR 9·98, 3·10 to 32·11; P < 0·001 for T4), advanced node (N) status (HR 7·41, 4·78 to 11·51; P < 0·001 for N2 with fewer than 12 lymph nodes examined), emergency surgery (HR 2·11, 1·66 to 2·69; P < 0·001) and non-radical resection of the primary tumour (HR 2·75, 2·10 to 3·61; P < 0·001 for R2 resection). Patients aged > 70 years had a decreased risk of metachronous PC (HR 0·69, 0·55 to 0·87; P = 0·003).

Conclusion:

PC is common in patients with colorectal cancer and is associated with identifiable risk factors.

Cancer effect on periprocedural thromboembolism and bleeding in anticoagulated patients



Cancer effect on periprocedural thromboembolism and bleeding in anticoagulated patients:

Background:
Patients with active cancer are often on chronic anticoagulation and frequently require interruption of this treatment for invasive procedures. The impact of cancer on periprocedural thromboembolism (TE) and major bleeding is not known.

Patients and methods:
Two thousand one hundred and eighty-two consecutive patients referred for periprocedural anticoagulation (2484 procedures) using a standardized protocol were followed forward in time to estimate the 3-month incidence of TE, major bleeding and survival stratified by anticoagulation indication. For each indication, we tested active cancer and bridging heparin therapy as potential predictors of TE and major bleeding.

Results:
Compared with patients without cancer, active cancer patients (n = 493) had more venous thromboembolism (VTE) complications (1.2% versus 0.2%), major bleeding (3.4% versus 1.7%) and reduced survival (95% versus 99%). Among active cancer patients, only those chronically anticoagulated for VTE had higher rates of periprocedural VTE (2% versus 0.16%;) and major bleeding (3.7% versus 0.6%). Bridging with heparin increased the rate of major bleeding in cancer patients (5% versus 1%;) without impacting the VTE rate (0.7% versus 1.4%,).

Conclusions:
Cancer patients anticoagulated for VTE experience higher rates of periprocedural VTE and major bleeding. Periprocedural anticoagulation for these patients requires particular attention to reduce these complications.

abstract: Cancer of unknown primary (CUP): does cause of death and family history implicate hidden phenotypically changed primaries?



Blogger's Note: paid subscription required to view full paper, the 'burning' question in the abstract is what other 7 cancers ??
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Cancer of unknown primary (CUP): does cause of death and family history implicate hidden phenotypically changed primaries?

Abstract

Background: Cancer of unknown primary (CUP) is diagnosed at the metastatic stage. We aimed to identify hidden primary cancers in CUP patients by comparison with cancers in family members. We take use of the fact that the cause of death in CUP patients is often coded as the cancer in the organ of fatal metastasis. 

Patients and methods: Forty-one thousand five hundred and twenty-three CUP patients were identified in the Swedish Family-Cancer Database, and relative risks (RRs) were calculated for cancer in offspring when family members were diagnosed with CUP and died of the cancer diagnosed in offspring. 

Results: The RR for lung cancer in offspring was 1.85 when a family member was diagnosed with CUP and died of lung cancer. Significant familial associations were found for seven other cancers. Many familial associations were also significant when offspring CUP patients died of the cancer diagnosed in family members. 

Conclusions: The cause of death after CUP diagnosis frequently matched the cancer found in a family member, suggesting that the CUP had originated in that tissue. The metastasis had probably undergone a phenotypic change, complicating pathological tissue assignment. These novel data suggest that some CUP cases are phenotypically modified primary cancers rather than cancers of unknown primaries.

Talking to Your Child About Cancer - MD Anderson



Talking to Your Child About Cancer

A cancer diagnosis can create a variety of questions for patients who have children. The first question many parents ask is, "How do I talk to my child about cancer?"

Whether you're wondering how to tell your child about your diagnosis, treatment, progression or recurrence, there are quite a few things to consider before beginning these important discussions.

To start, consider your child's age and developmental stage. Some children are too young to verbalize questions and others may be too afraid to ask. Also, what does your child already know about cancer?

What is the best approach?
It's common for parents to protect their children by withholding information that may be upsetting, but research shows the following:
  1. A parent's cancer diagnosis affects a child whether or not the child is informed of the condition. 1
  2. Anxiety levels are higher in children who aren't informed about their parent's condition, compared to children where the issue is discussed.
  3. For parents of teenagers, an important aspect of coping is ongoing communication between the teens and their parents during the course of the illness. 2
So, what does this research mean to parents? Simply put, it means that honest, age-appropriate communication is best. How do I talk to my child about cancer?
First, it's crucial to say the word "cancer." This is essential so the child will not associate the parent's diagnosis with another illness children can catch, like the flu or a cold. The following are common questions many children have, and they're important points to consider while talking with your child:
  • Can I catch cancer?
  • How does cancer happen?
  • Is it my fault my mom or dad got cancer?
  • Will my mom or dad die from cancer?
Remember that children may not ask these outright, but many will be wondering about them. Because children pick up on social cues, they may sometimes create scenarios in their heads far worse than reality when not given honest communication about what's happening.

Honest and age-appropriate communication with children models the behavior that it's OK to ask and talk about cancer. 

further details: FDA MedWatch - Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient



Subject: Apr 3rd FDA MedWatch - Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient


ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey).

BACKGROUND: Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI).  Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. Pictures of the counterfeit version of Altuzan are shown in the FDA statement. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit.
RECOMMENDATION: Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA.  The products should be retained and securely stored until further notice by the FDA.
FDA is asking the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc (BDMI), or other sources:
Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or  
Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
Email - DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the FDA statement, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

5 Health Problems Linked to Height - ABC News



5 Health Problems Linked to Height - ABC News

 5 Health Problems Linked to Height

Cancer
A new study suggests taller women have heightened risk for ovarian cancer, a disease that kills nearly 15,000 American women each year, according to the U.S. Centers for Disease Control and Prevention.
British researchers reviewed data from 47 studies involving more than 100,000 women. For every 5-centimeter (2-inch) increase in height above the average 5 feet 3, the risk of ovarian cancer rose 7 percent, according to the study published Tuesday in the journal PLoS Medicine.
In July 2011, a study published in the Lancet Oncology found taller women had an increased risk of 10 different cancers, including breast and skin cancer. And taller men have an increased risk of prostate cancer, according to a 2008 study published in the journal Cancer Epidemiology, Biomarkers & Prevention.
"One of the big surprises in cancer has been the potential impact of early life nutritional factors on long-term cancer risk," said Dr. Tim Byers, a professor of preventive medicine and biometrics at the University of Colorado Cancer Center in Denver. "I think height is an indicator of some risk factor, but we don't know what the mechanism is."
The findings offer little comfort for tall men and women, whose height -- guided by genes, nutrition and other environmental influences -- was established in their 20s. But Byers said taller people should not worry any more, nor should shorter people worry any less, about their cancer risk.

Heart Disease

Stroke

Alzheimer's Disease

Diabetes  



open access: Apr 3 - PLoS Medicine: Ovarian Cancer and Body Size: Individual Participant Meta-Analysis Including 25,157 Women with Ovarian Cancer from 47 Epidemiological Studies



 Published: April 3, 2012

PLoS Medicine: Ovarian Cancer and Body Size: Individual Participant Meta-Analysis Including 25,157 Women with Ovarian Cancer from 47 Epidemiological Studies

Background

Only about half the studies that have collected information on the relevance of women's height and body mass index to their risk of developing ovarian cancer have published their results, and findings are inconsistent. Here, we bring together the worldwide evidence, published and unpublished, and describe these relationships.........

Why Was This Study Done?

To date, there is no definitive information about the relevance of women's height, weight, and body mass index to their subsequent risk of developing ovarian cancer. There have been roughly 50 epidemiological studies of ovarian cancer, but only about half of these studies have published results on the association between body size and ovarian cancer risk, and so far, these findings have been inconsistent. Therefore, the researchers—an international collaboration of researchers studying ovarian cancer—re-analyzed the available epidemiological evidence to investigate the relationship between ovarian cancer risk and adult height, weight, and body mass index, and to examine the consistency of the findings across study designs.

Conclusions

Ovarian cancer is associated with height and, among never-users of hormone therapy, with body mass index. In high-income countries, both height and body mass index have been increasing in birth cohorts now developing the disease. If all other relevant factors had remained constant, then these increases in height and weight would be associated with a 3% increase in ovarian cancer incidence per decade.



Lists - Choosingwisely - "Five Things Physicians and Patients Should Question" 9 U.S. specialty society lists (gyn oncology is not specifically listed)



Lists - Choosingwisely

Lists

Nine United States specialty societies representing 374,000 physicians developed lists of "Five Things Physicians and Patients Should Question" in recognition of the importance of physician and patient conversations to improve care and eliminate unnecessary tests and procedures.
These lists represent specific, evidence-based recommendations physicians and patients should discuss to help make wise decisions about the most appropriate care based on their individual situation. Each list provides information on when tests and procedures may be appropriate, as well as the methodology used in its creation.
What tests and procedures should patients and physicians talk about? Read the lists:

open access: Microsatellite Instability and DNA Mismatch Repair Protein Deficiency in Lynch Syndrome Colorectal Polyps - multinational study



Blogger's Note: as determined by the title, focus is on colorectal cancer in Lynch Syndrome; see also prior posting Diagnosing Lynch Syndrome: More Light at the End of the Tunnel which gives a more comprehensive overall view of Lynch Syndrome

                           ~~~~~~~~~~~~~~~~~

Microsatellite Instability and DNA Mismatch Repair Protein Deficiency in Lynch Syndrome Colorectal Polyps

"Lynch syndrome results from germline mutations in one
of the genes involved with DNA mismatch repair (MMR):
MLH1, MSH2, MSH6, PMS2, or EPCAM/TACSTD."

"The aim of this study was to determine the prevalence
of MSI and loss of MMR protein expression by immunohistochemistry
in colorectal polyps from patients with genetically confirmed Lynch syndrome."






open access: Perspectives - Diagnosing Lynch Syndrome: More Light at the End of the Tunnel



Diagnosing Lynch Syndrome: More Light at the End of the Tunnel

"Lynch syndrome is one of the most commonly inherited
cancer conditions, accounting for 2% to 4% of colorectal
cancer (CRC) cases. The population frequency of Lynch
syndrome is slightly more than one in 500 individuals (1).
In addition to a 50% to 80% lifetime risk of CRC, patients
with Lynch syndrome have a 40% to 60% risk of uterine
cancer and an elevated risk of ovarian, pancreatic, gastric,
upper-urinary tract, renal, biliary, small bowel, and central
nervous system (CNS) malignancies.

"Colorectal surveillance of persons with this condition leads to greatly reduced CRC incidence and mortality. Appropriately timed hysterectomy and ovarectomy likewise results in a reduced incidence of malignancies in these organs. The diagnosis of Lynch syndrome is thus critical to the prevention and early detection of cancer in affected persons and families, notwithstanding that the effectiveness of screening patients with Lynch syndrome for non colorectal and non uterine malignancies remains uncertain. As will be discussed later, the article by Yurgelun and colleagues in this issue of the journal provides an important new tool for the diagnosis of Lynch syndrome (2).
The major issue in Lynch syndrome remains failure to
diagnose for a variety of reasons......."

".....It seems that MSI or immunohistochemical
testing in uterine cancers may be as effective as in
CRCs and therefore should also be considered in evaluating
persons and families for Lynch syndrome (17, 18). Whether
tumor testing in other (nonuterine or noncolorectal)
Lynch-associated malignancies would be as effective is
unclear....."

"............Next generation sequencing also may soon
be available for individual testing at reasonable costs.
Such new testing developments may well make direct-to-genetic
testing based on risk increasingly attractive. At
some point, general testing for an inherited syndrome
without regard to risk may even become a reality, which would get the diagnosis of Lynch syndrome out of the tunnel altogether."

open access: American Society of Clinical Oncology Identifies Five Key Opportunities to Improve Care and Reduce Costs: The Top Five List for Oncology



American Society of Clinical Oncology Identifies Five Key Opportunities to Improve Care and Reduce Costs The Top Five List for Oncology

 1. Do not use cancer-directed therapy for patients with solid tumors
who have the following characteristics: low performance status (3 or 4), no benefit from prior evidence-based interventions, not eligible for a clinical trial, and with no strong evidence supporting the clinical value of further anticancer treatment.
2. Don’t perform PET, CT and radionuclide bone scans in the staging of early prostate cancer at low risk for metastasis.
3. Don’t perform PET, CT and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis
4. Don’t perform surveillance testing (biomarkers) or imaging (PET, CT and radionuclide bone scans) for asymptomatic individuals who have been treated for breast cancer with curative intent.
5. Don’t use white cell stimulating factors for primary prevention of febrile neutropenia for patients with less than 20% risk for this complication