How Can A Company Market An Ovarian Cancer Screening Test If The FDA Says Women Shouldn't Use It?

Blogger's Note: the editorial referenced in this article is not open access/1st page view only (j gynecologic oncology)

Forbes

 ...The FDA’s “safety communication” warned that no currently available test is accurate and reliable for screening women who don’t have symptoms of ovarian cancer. That helps explain why, according to the American Cancer Society , ovarian cancer represents  only 3% of all malignancies in U.S. women but causes more deaths than any other cancer of the female reproductive tract.....

 

Gastrointestinal Complications: constipation, impaction, bowel obstruction, diarrhea, radiation enteritis

updated Sept 2016

(U.S.) FDA weighs crackdown that could shut stem cell clinics

FDA

 There are now more than 500 stem cell clinics in the United States. Many charge $5,000 to $20,000 for injections of “stem cell” solutions that may not contain the same kind of stem cells used in controlled experiments — and indeed may not contain stem cells at all.

In vivo anti-tumor activity of the PARP inhibitor niraparib in homologous recombination deficient and proficient ovarian carcinoma

 in vi·vo:
(of a process) performed or taking place in a living organism.                        ```````````````
abstract

OBJECTIVE:

Poly(ADP-ribose) polymerase (PARP) inhibitors have yielded encouraging responses in high-grade serous ovarian carcinomas (HGSOCs), but the optimal treatment setting remains unknown. We assessed the effect of niraparib on HGSOC patient-derived xenograft (PDX) models as well as the relationship between certain markers of homologous recombination (HR) status, including BRCA1/2 mutations and formation of RAD51 foci after DNA damage, and response of these PDXs to niraparib in vivo.

METHODS:

Massively parallel sequencing was performed on HGSOCs to identify mutations contributing to HR deficiency. HR pathway integrity was assessed using fluorescence microscopy-based RAD51 focus formation assays. Effects of niraparib (MK-4827) on treatment-naïve PDX tumor growth as monotherapy, in combination with carboplatin/paclitaxel, and as maintenance therapy were assessed by transabdominal ultrasound. Niraparib responses were correlated with changes in levels of poly(ADP-ribose), PARP1, and repair proteins by western blotting.

RESULTS:

Five PDX models were evaluated in vivo. Tumor regressions were induced by single-agent niraparib in one of two PDX models with deleterious BRCA2 mutations and in a PDX with RAD51C promoter methylation. Diminished formation of RAD51 foci failed to predict response, but Artemis loss was associated with resistance. Niraparib generally failed to enhance responses to carboplatin/paclitaxel chemotherapy, but maintenance niraparib therapy delayed progression in a BRCA2-deficient PDX.

CONCLUSIONS:

Mutations in HR genes are neither necessary nor sufficient to predict response to niraparib. Assessment of repair status through multiple complementary assays is needed to guide PARP inhibitor therapy, design future clinical trials and identify ovarian cancer patients most likely to benefit from PARP inhibition.

Blue Ribbon Panel Recommendations (pg 42...) re: Lynch Syndrome (missed opportunity)

pdf

In response, the Blue Ribbon Panel recommendations call for a nationwide
demonstration project to systematically screen all people diagnosed with colorectal and endometrial cancer for Lynch syndrome. This demonstration project could be carried out via NCI’s established research network, including NCI-designated Cancer Centers, hospitals that are part of the NCI’s National Community Oncology Research Program, and other centers.

Use of presurgical (neoadjuvant) chemotherapy on the rise for advanced ovarian cancer, but may not be beneficial for some patients

Dana-Farber Cancer Institute

• September 06, 2016

The use of presurgical chemotherapy for patients with metastatic ovarian cancer has risen dramatically following research that showed potential benefits to the approach, investigators at Dana-Farber and other institutions report in a new study. In one set of patients, however, the approach generally resulted in shorter survival times than the traditional surgery-first method.
The researchers found that patients with stage IIIC ovarian cancer – in which the tumor is larger than 2 cm and the cancer has spread to the upper abdomen – tended to live significantly longer if they underwent surgery before chemotherapy treatment rather than receiving chemotherapy first. By contrast, patients with stage IV ovarian cancer – in which cancer growth has spread throughout the body – fared similarly whether they received surgery or chemotherapy first.
The findings suggest that in carefully selected patients with stage IIIC ovarian cancer, initial treatment with tumor-removal surgery may offer a survival advantage over presurgical, or “neoadjuvant,” chemotherapy. For patients with stage IV disease, however, neoadjuvant chemotherapy is at least as effective as initial surgery and decreases the chances of admission to an intensive care unit or re-hospitalization.
“We were surprised to find that women with stage IIIC disease who received neoadjuvant chemotherapy seemed to fare worse than those who had surgery first,” said study senior author Alexi Wright, MD, MPH, of Dana-Farber's Susan F. Smith Center for Women’s Cancers. “We expected the survival times for the two groups would be roughly equal since that is what prior studies had shown.” The first and corresponding author of the paper is Larissa A. Meyer, MD, MPH, of University of Texas MD Anderson Cancer Center.
By analyzing data on 1,538 women with advanced ovarian cancer, the investigators found that those with stage IV disease survived for a similar period whether they received neoadjuvant chemotherapy or primary cancer surgery. For patients with stage IIIC disease, however, the median survival was 33 months in the neoadjuvant chemotherapy group compared to 43 months in the primary surgery group.
Patients with stage IIIC disease who received neoadjuvant chemotherapy were more likely to have less than 1 cm of tumor left after surgery, but that extensive reduction in tumor volume didn’t confer a survival benefit, the investigators found. By contrast, patients who had similarly minute amounts of cancer after primary surgery survived longer than patients who received neoadjuvant chemotherapy. This suggests that the cancer cells remaining after neoadjuvant chemotherapy may be resistant to further chemotherapy.
The study sought to gauge the impact of a 2010 European clinical trial that found patients with advanced ovarian cancer who received neoadjuvant chemotherapy survived at least as long, and had fewer treatment-related complications, as those who initially underwent surgery to remove the tumor. (Neoadjuvant chemotherapy helps reduce the size of tumors, potentially making surgery easier. Whether or not neoadjuvant chemotherapy is used, surgery is typically followed by a course of chemotherapy to eliminate any remaining cancer cells.)
In their analysis of patient data, the investigators found that the use of neoadjuvant therapy for women with advanced ovarian cancer rose significantly between 2003 and 2012: from 16 percent to 34 percent for women with stage IIIC disease, and from 41 percent to 62 percent for women with stage IV disease.
“For years we thought that all women with ovarian cancer should have surgery before chemotherapy until two large European clinical trials found that giving chemotherapy first might be safer,” Wright said. “Many American physicians doubted the study results – and even spoke out against them publicly – but our study shows that physicians are using neoadjuvant chemotherapy a lot more frequently than we expected.”
The authors suggest that future studies should examine the effectiveness of neoadjuvant therapy in patients with different amounts of cancer remaining after surgery.

Preoperative predictors of delay in initiation of adjuvant chemotherapy in patients undergoing primary debulking surgery for ovarian cancer

abstract:
Preoperative predictors of delay in initiation of adjuvant chemotherapy in patients undergoing primary debulking surgery for ovarian cancer
 

Highlights

• •Risk factors for delay in chemotherapy are older age, low albumin, and high age-adjusted Charlson comorbidity score
• •Delay in chemotherapy is associated with a shorter progression-free survival.

Abstract

Objective

The objective of this study was to identify preoperative characteristics of patients that experience a delay in initiation of adjuvant chemotherapy after primary debulking surgery for ovarian cancer.

Materials/methods

We performed a retrospective review of patients with Stage II to IV high-grade epithelial ovarian, tubal, and peritoneal carcinoma who underwent primary debulking surgery followed by adjuvant chemotherapy from 2005 to 2013. Patients were divided into 2 groups: Control (those who received their first cycle of chemotherapy within 6 weeks of debulking surgery) vs. chemotherapy delay (those who received their first cycle of chemotherapy at an interval >6  weeks from primary debulking surgery). Relevant clinical variables and survival outcomes were compared between the 2 groups using standard statistical methods.

Results

A total of 221 patients were included in the analyses – 169 (76.5%) were in the control group and 52 (23.5%) were in the chemo delay group. On multi-variate analysis, risk factors that were significantly associated with a delay in initiation in chemotherapy included: age >65, albumin <3.5, and high age-adjusted Charlson Comorbidity Index score. Delay in chemotherapy initiation was associated with a shorter progression-free (p = 0.014) but not overall survival (p = 0.19).

Conclusions

Delay in initiation of chemotherapy affected 23.5% of patients in our study population. Easily identifiable risk factors for chemotherapy delay exist that can help us pre-operatively identify patients for which neoadjuvant chemotherapy may be a better treatment option. Further study into prospective modeling with these identified risk factors is warranted.

(Toronto) The effect of adjuvant radiation on survival in early stage clear cell ovarian carcinoma

abstract

Highlights

• •Clear cell carcinoma of the ovary is a rare subtype which is relatively resistant to platinum based chemotherapy.
• •Ovarian clear cell carcinoma is frequently diagnosed at early stage, the role of adjuvant treatment is disputable.
• •Our study did not demonstrate a survival benefit for adjuvant radiation in patients with ovarian clear cell carcinoma.

Abstract

Objective

To assess the impact of adjuvant radiotherapy (RT) on survival in patients with stage I and II ovarian clear cell carcinoma (OCCC).

Methods

Data collection and analysis of stage I and II OCCC patients treated at two tertiary centers in Toronto, between 1995 and 2014, was performed. Descriptive statistics and Kaplan-Meier survival probability estimates were completed. The log-rank test was used to compare survival curves.

Results

163 patients were eligible. 44 (27%) patients were treated with adjuvant RT: 37 of them received adjuvant chemotherapy (CT), and 7 had RT only. In the no-RT group, there were 119 patients: 83 patients received adjuvant CT and 36 had no adjuvant treatment. The 10 year progression free survival (PFS) was 65% for patients treated with RT, and 59% no-RT patients. There were a total of 41 (25%) recurrences in the cohort: 12 (27.2%) patients in RT group and 29 (24.3%) in the no-RT group. On multivariable analysis, adjuvant RT was not significantly associated with an increased PFS (0.85 (0.44–1.63) p = 0.63) or overall survival (OS) (0.84 (0.39–1.82) p  = 0.66). In the subset of 59 patients defined as high-risk: stage IC with positive cytology and/or surface involvement and stage II: RT was not found to be associated with a better PFS (HR 1.18 (95% CI: 0.55–2.54) or O S(HR 1.04 (95% CI: 0.40–2.69)).

Conclusion

Adjuvant RT was not found to be associated with a survival benefit in patients with stage I and II ovarian clear cell carcinoma or in a high risk subset of patients including stage IC cytology positive/surface involvement and stage II patients.

Extended mortality results for ovarian cancer screening in the PLCO trial with median 15years follow-up

abstract:
Extended mortality results for ovarian cancer screening in the PLCO trial with median 15years follow-up

Highlights

• •After 15 years median follow-up, screening with CA-125 and transvaginal ultrasound did not reduce ovarian cancer mortality
• •The risk ratio (intervention compared to usual care arm) for ovarian cancer mortality was 1.06 (95% CI: 0.87–1.30)
• •Ovarian cancer survival was not significantly different by trial arm, with similar survival rates at 10 years

Background

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial originally reported no mortality benefit of ovarian cancer screening after a median of 12.4 years of follow-up. The UKCTOCS screening trial failed to show a statistically significant mortality reduction in the primary analysis but reported an apparent increased mortality benefit in trial years 7–14 compared to 0–7. Here we report an updated analysis of PLCO with extended mortality follow-up.

Methods

Participants were randomized from 1993 to 2001 at ten U.S. centers to an intervention or usual care arm. Intervention arm women were screened for ovarian cancer with annual trans-vaginal ultrasound (TVU) (4 years) and CA-125 (6 years), with a fixed cutoff at 35 U/mL for CA-125. The original follow-up period was for up to 13 years (median follow-up 12.4 years); in this analysis follow-up for mortality was extended by up to 6 years.

Results

39,105 (intervention) and 39,111 (usual care) women were randomized, of which 34,253 and 34,304, respectively, had at least one ovary at baseline. Median follow-up was 14.7 years in each arm and maximum follow-up 19.2 years in each arm. A total of 187 (intervention) and 176 (usual care) deaths from ovarian cancer were observed, for a risk-ratio of 1.06 (95% CI: 0.87–1.30). Risk-ratios were similar for study years 0–7 (RR = 1.04), 7–14 (RR = 1.06) and 14+ (RR = 1.09). The risk ratio for all-cause mortality was 1.01 (95% CI: 0.97–1.05). Ovarian cancer specific survival was not significantly different across trial arms (p = 0.16).

Conclusion

Extended follow-up of PLCO indicated no mortality benefit from screening for ovarian cancer with CA-125 and TVU.

Occult and subsequent cancer incidence following risk-reducing surgery in BRCA mutation carriers (serous)

 Serous tubal intraepithelial carcinoma (STIC)

abstract

Highlights

• •In this cohort, 5.4% of asymptomatic BRCA mutation carriers had occult carcinomas in risk-reducing surgery specimens.
• •Patients with STIC had a higher incidence of subsequent serous cancer than those with benign adnexa.
• •The optimal postoperative management of patients with occult STIC lesions is unknown.

Objective

To report the frequency and features of occult carcinomas and the incidence of subsequent cancers following risk-reducing salpingo-oophorectomy (RRSO) in BRCA mutation carriers.

Methods

257 consecutive women with germline BRCA mutations who underwent RRSO between January 1, 2000 and December 31, 2014 were identified in an Institutional Review Board approved study. All patients were asymptomatic with normal physical exams, CA 125 values, and imaging studies preoperatively, and had at least 12 months of follow-up post-RRSO. All patients had comprehensive adnexal sectioning performed. Patient demographics and clinico-pathologic characteristics were extracted from medical and pathology records.

Results

The cohort included 148 BRCA1, 98 BRCA2, 6 BRCA not otherwise specified (NOS), and 5 BRCA1 and 2 mutation carriers. Occult carcinoma was seen in 14/257 (5.4%) of patients: 9 serous tubal intraepithelial carcinomas (STIC), 3 tubal cancers, 1 ovarian cancer, and 1 endometrial cancer. Three patients (1.2%) with negative pathology at RRSO subsequently developed primary peritoneal serous carcinoma (PPSC), and 2 of 9 patients (22%) with STIC subsequently developed pelvic serous carcinoma. 110 women (43%) were diagnosed with breast cancer prior to RRSO, and 14 of the remaining 147 (9.5%) developed breast cancer following RRSO. Median follow-up of the cohort was 63 months.

Conclusion

In this cohort, 5.4% of asymptomatic BRCA mutation carriers had occult carcinomas at RRSO, 86% of which were tubal in origin. The risk of subsequent PPSC for women with benign adnexa at RRSO is low; however, the risk of pelvic serous carcinoma among women with STIC is significantly higher.

Secondary debulking surgery for isolated pelvic nodal recurrence requiring external iliac vein excision and reconstruction in a patient with ovarian cancer

abstract:
Secondary debulking surgery for isolated pelvic nodal recurrence requiring external iliac vein excision and reconstruction in a patient with ovarian cancer 

Highlights

• •We present a cytoreduction technique for pelvic lymph node recurrence with involvement of the external iliac vein (EIV).
• •We show how a pelvic lymphadenectomy involving the excision and reconstruction of the EIV is a feasible surgical technique.
• •Technique for venous reconstruction depends on the extent of resection required and therefore the ensuing defect.

Objective

We report the details of a cytoreduction technique for pelvic lymph node recurrence with involvement of the external iliac vein (EIV) requiring a partial resection and reconstruction of the EIV.

Methods

A 51-year-old woman presented with ovarian cancer and isolated nodal recurrence located on the right side of the pelvis. As the tumor had infiltrated the EIV wall, we performed the EIV excision and reconstruction using an autogenous graft.

Trends in the use of neoadjuvant chemotherapy for advanced ovarian cancer in the United States

abstract

Highlights

• •Treatment of advanced ovarian cancer with neoadjuvant chemotherapy became more frequent between 2004 and 2013
• •Utilization of neoadjuvant chemotherapy began to increase in 2007
• •Neoadjuvant chemotherapy was adopted most rapidly among elderly women, and those with stage IV ovarian cancer

Objective

Neoadjuvant chemotherapy and interval debulking surgery for the treatment of advanced ovarian cancer has remained controversial, despite the publication of two randomized trials comparing this modality with primary cytoreductive surgery. This study describes temporal trends in the utilization of neoadjuvant chemotherapy and interval debulking surgery in clinical practice in the United States.

Methods

We completed a time trend analysis of the National Cancer Data Base. We identified women with stage IIIC and IV epithelial ovarian cancer diagnosed between 2004 and 2013. We categorized subjects as having undergone one of four treatment modalities: primary cytoreductive surgery followed by adjuvant chemotherapy, neoadjuvant chemotherapy followed by interval debulking surgery, surgery only, and chemotherapy only. Temporal trends in the frequency of treatment modalities were evaluated using Joinpoint regression, and χ² tests.

Results

We identified 40,694 women meeting inclusion criteria, of whom 27,032 (66.4%) underwent primary cytoreductive surgery and adjuvant chemotherapy, 5429 (13.3%) received neoadjuvant chemotherapy and interval surgery, 5844 (15.4%) had surgery only, and 2389 (5.9%) received chemotherapy only. The proportion of women receiving neoadjuvant chemotherapy and surgery increased from 8.6% to 22.6% between 2004 and 2013 (p < 0.001), and adoption of this treatment modality occurred primarily after 2007 (95%CI 2006–2009; p  = 0.001). During this period, the proportion of women who received primary cytoreductive surgery and chemotherapy declined from 68.1% to 60.8% (p < 0.001), and the proportion who underwent surgery only declined from 17.8% to 9.9% (p < 0.001).

Conclusion

Between 2004 and 2013 the frequency of neoadjuvant chemotherapy and interval surgery increased significantly in the United States.

Ovarian cancer - Wiki

Wikipedia

 Contents

• 1 Signs and symptoms
• 2 Risk factors
  • 2.1 Hormones
  • 2.2 Genetics
  • 2.3 Environmental factors
  • 2.4 Other
  • 2.5 Protective factors
• 3 Pathophysiology
• 4 Diagnosis
  • 4.1 Examination
  • 4.2 Pathology
  • 4.3 Staging
• 5 Screening
• 6 Prevention
• 7 Management
  • 7.1 Surgery
  • 7.2 Chemotherapy
  • 7.3 Radiation therapy
  • 7.4 Hormonal therapy
  • 7.5 Immunotherapy
  • 7.6 Follow-up
  • 7.7 Palliative care
• 8 Prognosis
  • 8.1 Prognostic factors
  • 8.2 Survival rates
  • 8.3 Recurrence rates
• 9 Epidemiology
• 10 In pregnancy
• 11 Other animals
• 12 Research
• 13 References
• 14 Further reading
• 15 External links
  

1000 images about Ovarian Cancer on Pinterest

1000 images about Ovarian Cancer on Pinterest

MRI Evaluation of the Urothelial Tract: Pitfalls and Solutions (radiology)

American Journal of Roentgenology

OBJECTIVE. MR urography (MRU) can be an alternative to CT urography (CTU) for imaging of the kidneys, urinary bladder, and collecting systems. MRU can be a challenging examination to perform and interpret, which may result in technical and interpretive errors being made. This article highlights the pitfalls associated with MRU and discusses how to recognize and avoid them.

CONCLUSION. When performed properly, MRU may provide imaging quality generally comparable to that of CTU, and it enables comprehensive evaluation of the entire urinary tract.

Ovarian Cancer and Us (blog): what your were reading this week (top 10)

http://feeds.feedburner.com/blogspot/UnpPW
 

#1 Adjuvant chemotherapy does not improve disease-fre... Sep 4, 2016
#2 Everyone Knows Someone (impacted by ovarian cancer... Sep 8, 2016
#3 (U.S.) The FDA recommends against using screening ... Sep 8, 2016
#4 Annals of Oncology Press Release: Deaths from Ovar... Sep 7, 2016
#5 report due publicly Sept 9th: Task force calls for... Sep 8, 2016
#6 MLH1 Ile219Val Polymorphism in Argentinean Familie... Sep 9, 2016
#7 Therapeutic and Preventive Implications of Moonsho... Sep 8, 2016
#8 (2008) Ovarian cancer and oral contraceptives: col... Sep 10, 2016
#9 (U.S.) FDA recommends against using screening test... Sep 9, 2016
#10 open access: full text - Global trends and predict... Sep 7, 2016

Lillian Siu talks 'big data' in cancer prevention and care - YouTube

YouTube (3:21 min)

Published on Sep 1, 2016

Dr. Lillian Siu (medical oncologist) recently co-led a study published
in Nature Medicine highlighting the potential of 'big data'
to transform cancer care and enable the development
of more effective personalized cancer treatments.
 

(California) Electronic Release of Pathology/Radiology Results to Patients: Opinions and Experiences of Oncologists

abstract (gyn/oncologists included)
 

Purpose: There is an emerging standard to provide patients rapid electronic access to elements of their medical records. Although surveys of patients generally support it, this practice is controversial among oncologists, because few empiric data are available for scenarios of potentially life-threatening conditions like cancer. We report the views of oncologists about patient electronic access to radiology and pathology results that could potentially indicate disease progression.

Methods: Four months before oncologists were surveyed, final results of radiology/pathology reports were routinely made available to patients online through a secure portal after a 7-day, hold to provide clinicians time to review and communicate results with the patients. Mixed methods were used to assess physician attitudes and experiences toward this change.

Results: One hundred twenty-nine oncologists were surveyed, and 82 (64%) responded. A small majority (54%) responded that the release of reports was somewhat or very beneficial for patients who received normal radiology/pathology results before discussion with a physician, but 87% said it was somewhat or very harmful for patients to receive abnormal results before discussion. Forty-nine percent reported that release of reports had a somewhat or very negative impact on communication with their patients.

Conclusion: Almost half of oncologists reported that sharing digital radiology and pathology records had a negative impact on their communication with patients. Patient surveys in similar cancer populations would complement the physician perspective. Efforts are needed to improve consensus among oncologists and patients on how to best communicate such results in a timely fashion.

 

Supplement material 

Participation: Power to the patients "“Every patient presents a vastly complicated data set that we're barely able to interpret,”

Participation: Power to the patients : Nature : Nature Research

(2008) Ovarian cancer and oral contraceptives: collaborative reanalysis of data from 45 epidemiological studies...

abstract - The Lancet

Long time response with chemotherapy in ROS1 NSCLC patient with unusual metastatic site (ovarian)

abstract: Cancer Biology & Therapy

During the last decade the therapeutic landscape of Non Small Cell Lung Cancer (NSCLC) has profoundly changed with the identification of actionable genetic alterations that defined molecularly selected subgroups of patients with specific clinic-pathological characteristics and increased sensitivity to specific targeted agents. The presence of ROS1 rearrangements defines a small subgroup of lung adenocarcinomas (∼1–2%) with peculiar clinic-pathological characteristics and increased sensitivity to Crizotinib. It has been reported that ROS1-tranlslocated NSCLCs may also respond well to Pemetrexed-based chemotherapy. Moreover, patients with oncogene-addicted NSCLC may present peculiar pattern of metastatization and, in some instances, are associated with unusual site of metastases. Herein, we present a case of a young woman with bilateral ovarian metastases from a ROS1-positive adenocarcinoma of the lung with a lengthy progression-free survival on Pemetrexed-containing chemotherapy.

Molecular determination of the clonal relationships between multiple tumors in BRCA1/2-associated breast and/or ovarian cancer patients is clinically relevant

Abstract
Molecular determination of the clonal relationships between multiple tumors in BRCA1|[sol]|2-associated breast and|[sol]|or ovarian cancer patients is clinically relevant : Modern Pathology

Female BRCA1/2 mutation carriers affected with breast and/or ovarian cancer may develop new tumor deposits over time. It is of utmost importance to know the clonal relationships between multiple tumor localizations, enabling differentiation between multiple primaries or metastatic disease with consequences for therapy and prognosis. We evaluated the value of targeted next generation sequencing in the diagnostic workup of BRCA1/2 mutation carriers with ≥2 tumor localizations and uncertain tumor origins. Forty-two female BRCA1/2 mutation carriers with ≥2 tumor localizations were selected. Patients with inconclusive tumor origin after histopathological revision were ‘cases’; patients with certain tumor origin of ≥3 tumors served as ‘controls’. Tumors of cases and controls were analyzed by targeted next generation sequencing using a panel including CDKN2A, PTEN and TP53, hotspot mutation sites for 27 different genes and 143 single nucleotide polymorphisms for detection of loss of heterozygosity. Based on prevalence of identical or different mutations and/or loss of heterozygosity patterns, tumors were classified as ‘multiple primaries’ or ‘one entity’. Conventional histopathology yielded a conclusive result in 38/42 (90%) of patients. Four cases and 10 controls were analyzed by next generation sequencing. In 44 tumor samples, 48 mutations were found; 39 (81%) concerned TP53 mutations. In all 4 cases, the intra-patient clonal relationships between the tumor localizations could be unequivocally identified by molecular analysis. In all controls, molecular outcomes matched the conventional histopathological results. In most BRCA1/2 mutation carriers with multiple tumors routine pathology work-up is sufficient to determine tumor origins and relatedness. In case of inconclusive conventional pathology results, molecular analyses using next generation sequencing can reliably determine clonal relationships between tumors, enabling optimal treatment of individual patients.

(U.S.) FDA recommends against using screening tests for ovarian cancer screening

Safety Communications > The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication

Summary of Problem and Scope:

Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results. However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer.
For example, recently, Abcodia Incorporated began marketing the Risk of Ovarian Cancer Algorithm (ROCA) test in the United States, with claims that the ROCA test can screen for and detect ovarian cancer before symptoms appear and increase the chance for survival. Yet, available data do not support its claims......

press release: Vermillion and ASPiRA LABs Applaud the FDA’s Position on Ovarian Cancer Screening

press release

Vermillion and ASPiRA LABs Applaud the FDA's Position on Ovarian Cancer Screening

AUSTIN, Texas, Sept. 9, 2016 /PRNewswire/ -- ASPiRA LABs, a Vermillion company (NASDAQ: VRML), today announced its support for the recent US Food and Drug Administration (FDA) safety communication which recommends against the use of any screening tests for ovarian cancer.

Earlier this week, the FDA announced that it is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency stated that it is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. 

As the medical community knows, ASPiRA LABs' FDA cleared technologies, OVA1® and Overa™, are NOT screening tests. OVA1/Overa are FDA cleared technologies to assess risk of ovarian cancer malignancy for women who present with a pelvic mass and are planned for surgery........

Six updates in ovarian cancer (September is Ovarian Cancer Awareness Month)

medical news September 9, 2016

• READ/SUBMIT COMMENTS
• EMAIL

HemOnc Today presents six updates in gynecological cancer treatment and surveillance methods.

• The FDA granted priority review to rucaparib (Clovis Oncology) for the treatment of advanced ovarian cancer in patients with germline or somatic BRCA–mutated tumors. Read more.
• The use of power morcellation among women undergoing minimally invasive hysterectomy significantly decreased in the wake of an FDA recommendation against its use; however, the use of abdominal hysterectomy increased during this period. Read more.
• The FDA granted orphan drug designation to ZW25 and ZW33 for the treatment of ovarian cancer, according to the agents’ manufacturer. Read more.
• Neoadjuvant chemotherapy is the optimal first-line treatment for certain women with newly diagnosed advanced ovarian cancer, according to a joint clinical practice guideline from ASCO and the Society of Gynecologic Oncology. Read more.
• Cancer antigen 125 tests and CT scans are routinely used for surveillance of patients with ovarian cancer despite a lack of proven benefit, according to results of a prospective cohort study. Read more.
• The FDA issued a warning to alert patients and physicians that screening tests for ovarian cancer have been found unreliable and could lead to false diagnoses. Read more.

Newsroom : Ontario Taking Action to Prevent Sexual Abuse of Patients

press release

News Release

Ontario Taking Action to Prevent Sexual Abuse of Patients

Changes to Legislation to Protect and Support Patients

September 9, 2016 11:00 A.M.

Ministry of Health and Long-Term Care

Ontario is taking concrete action to uphold and reinforce a zero tolerance policy on sexual abuse of patients by any regulated health professional.
In fall 2016, Ontario intends to bring forward legislative amendments that would:

• Add to the expanded list of acts that will result in the mandatory revocation of a regulated health professional's license
• Remove the ability of a college to allow a regulated health professional to continue to practice on patients of one gender after an allegation or finding of sexual abuse
• Increase fines for health professionals and organizations that fail to report a suspected case of patient sexual abuse to a college
• Increase transparency by adding to what colleges must report on their public register and website
• Clarify the time period after the end of a patient-provider relationship in which sexual relations are prohibited 
• Fund patient therapy and counselling from the moment a complaint of sexual abuse is made.

The government's actions are based on recommendations from the Minister's Task Force on the Prevention of Sexual Abuse of Patients and the Regulated Health Professions Act, 1991.
In the immediate term, Ontario will also engage an expert to work with the province to improve the processes that health regulatory colleges must follow when dealing with sexual abuse complaints, investigations and disciplinary measures.
Ontario will bring forward further measures by winter 2017 to:

• Identify more ways for patients to participate in the complaints, investigation and discipline processes at health regulatory colleges
• Enhance knowledge and education among the public, patients and health professionals.

The province will consult with key partners, including patients, to make policy and program changes throughout the health system to uphold and reinforce a zero tolerance policy on sexual abuse of patients by any regulated health professional.
Strengthening the prevention of, and the response to, sexual abuse of patients is part of the province's commitment to protect patients through its Patients First: Action Plan for Health Care. It also supports It's Never Okay: An Action Plan to Stop Sexual Violence and Harassment, which is helping to ensure that everyone in the province can live in safety - free from the threat, fear or experience of sexual violence and harassment.  

Quick Facts

• The province appointed the Task Force on the Prevention of Sexual Abuse of Patients and the Regulated Health Professions Act,1991 in December 2014. This Task Force submitted a report entitled To Zero: Independent Report of the Minister’s Task Force on the Prevention of Sexual Abuse of Patients and the Regulated Health Professions Act, 1991. The government’s actions are based on the Task Force’s recommendations from this report.
• The Task Force included human rights advocate Professor Marilou McPhedran, Chair, and educator and registered nurse Sheila Macdonald.

Additional Resources

• Recommendations of the Task Force on the Prevention of Sexual Abuse of Patients and the Regulated Health Professions Act, 1991
• The Progress Report of It’s Never Okay: Action Plan to Stop Sexual Violence and Harassment
• Patients First: Action Plan for Health Care

Quotes

“Acts of professional misconduct involving the sexual abuse of a patient are deplorable – and I will do everything necessary to protect patient safety. These concrete actions will increase transparency and help prevent and better respond to sexual violence and harassment in Ontario. I will continue to work in partnership with our health regulatory colleges, health care professionals, educators and patients to implement these changes.”

Dr. Eric Hoskins

Minister of Health and Long-Term Care

Media Contacts

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