Tuesday, April 30, 2013
Free Full-Text: Biomarkers for Anti-Angiogenic Therapy in Cancer
Free Full-Text
Conclusions
Anti-angiogenic therapy generally suffers from a high variability in the response by the individual patient. In order to select patients with the highest likelihood for a positive response to such a treatment, the availability of reliable predictive biomarkers for anti-angiogenic therapy will be a key factor. Although there are some promising preliminary results, no general or cancer-specific biomarker has yet emerged, which could help select patients with a positive prognosis for anti-angiogenic
therapy. For its future it is therefore of vital importance to conduct larger systematic trials to translate the preclinical data into clinically usable systems and to switch from unselective therapy to a more
individual drug selection based on the patients’ predispositions."
"Examples for drugs targeting the VEGF-A ligand are Bevacizumab and Aflibercept. Bevacizumab is a VEGF-binding humanized recombinant antibody, which inhibits the VEGF-VEGFR-interaction [44].
In the clinical context it has been used in lung [45–48], breast [49–53], colon [54–58], renal [59,60], gastric [61], pancreatic [62,63], and prostate cancer [64], as well as melanoma [65]. Aflibercept is a
fusion protein of the human Fc part of IgG1 and the extracellular domain of VEGFR. As such it is able to quench VEGF-A and -B, and PlGF-1 and 2, effectively removing the soluble ligands from the VEGF-VEGFR-cascade. So far Aflibercept has been applied in ovarian [66], colorectal [67], lung [68], Int. J. Mol. Sci. 2013, 14 9341 metastatic gynecologic soft-tissue [69], and urothelial metastatic transitional cell cancer [70], as well
as melanoma [71] and glioblastoma [72]."
66. Tew, W.P.; Colombo, N.; Ray-Coquard, I.; Oza, A.; del Campo, J.; Scambia, G.; Spriggs, D. VEGF-Trap for patients (pts) with recurrent platinum-resistant epithelial ovarian cancer (EOC), preliminary results of a randomized, multicenter phase II study. ASCO Meet. Abstr. 2007, 25, 5508
"Ramucirumab, a human antibody specific for the extracellular ligand-binding domain of VEGFR-2, belongs to the class of VEGFR-blocking drugs [73]. Ramucirumab has been used in studies for a multitude of different cancer types and has shown the best results for stable disease (only minor increases or decreases in tumor size) in renal, uterine, colorectal, and ovarian carcinoma [74]."
74. Spratlin, J. Ramucirumab (IMC-1121B), Monoclonal antibody inhibition of vascular endothelial growth factor receptor-2. Curr. Oncol. Rep. 2011, 13, 97–102.
Patient-Centered Outcomes Research Institute Names Regina Yan Chief Operating Officer -- USNewswire
PRNewswire-USNewswire/
About PCORI The Patient-Centered
Outcomes Research Institute (PCORI) is an independent, non-profit
organization authorized by Congress in 2010. Its mission is to fund
research that will provide patients, their caregivers and clinicians
with the evidence-based information needed to make better-informed
health care decisions. PCORI is committed to continuously seeking input
from a broad range of stakeholders to guide its work. More information
is available at www.pcori.org.
SOURCE Patient-Centered Outcomes Research InstituteAstex Pharmaceuticals Reports 2013 First Quarter Financial Results (SGI-110/ovarian)
(pharma) Financial Results
Data reported at AACR on several preclinical and clinical programs
DUBLIN, Calif., April 29, 2013 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (ASTX)
today announced financial results for the first quarter ended March 31,
2013.........
- SGI-110 is progressing in the hematologic and solid tumor Phase 2 clinical trials. The Phase 2 trial in myelodysplastic syndromes ("MDS") and acute myeloid leukemia ("AML") is more than 50% accrued and on track to complete overall patient accrual and report on the relapsed or refractory AML arm by the end of the year. Preclinical data was presented during several presentations at the American Association of Cancer Research meeting (AACR) that reconfirmed the potent demethylating activity of SGI-110 in different tumor models, and supports the potential of SGI-110 in the treatment of platinum-resistant ovarian cancer and as an immune-modulatory agent. Phase 2 studies in platinum-resistant ovarian cancer and hepatocellular cancer are both actively accruing patients with first data expected in 2014.
Dr. Heidi Gray on Symptoms of Ovarian Cancer
Seattle Cancer Care Alliance blog
Earlier this week Dr. Heidi Gray, a gynecologic oncologist at SCCA, was interviewed on KIXI’s Chat With Women about the symptoms of ovarian cancer. Ovarian cancer has been long thought to be a silent killer whose symptoms are non-existent. Dr. Gray, however, points out that most women who have ovarian cancer do have symptoms, it’s just that they are “vague” and often confused with something else. In the interview Dr. Gray spells out what women should watch for and also speaks to treatment options for patients who have been diagnosed with ovarian and other gynecologic cancers. You can listen to Dr. Gray’s interview here (it’s in the “Chat With Women 04-23-13” archive—Dr. Gray’s segment starts at 32:00 minutes).
For more information about the symptoms and risk factors for ovarian cancer, see the SCCA (Seattle Cancer Care Alliance) website.
Team finds markers related to ovarian cancer survival and recurrence | News Bureau | University of Illinois
University of Illinois
"Illinois animal sciences professor Sandra Rodriguez-Zas, left, and graduate student Kristin Delfino identified biomarkers that are used to determine ovarian cancer survival and recurrence and showed how the interactions between these biomarkers affect these outcomes.....
CHAMPAIGN, lll. — Researchers at the University of Illinois have identified biomarkers that can be used to determine ovarian cancer survival and recurrence, and have shown how these biomarkers interact with each other to affect these outcomes.
Their findings appear in the journal PLOS ONE.
Researchers try to find molecules called biomarkers that help determine a person’s likelihood of getting a disease or, if they have already been diagnosed, how far the disease has advanced. Genes, transcription factors and microRNAs are often used as biomarkers because these molecules can be heralds of disease or portents of susceptibility......
abstract: Vintafolide: a first-in-class small molecule drug conjugate targeting folate receptor positive tumors
| AACR Presentation Abstract | ||
| Abstract Number: | 5502 |
| Presentation Title: | Vintafolide: a first-in-class small molecule drug conjugate targeting folate receptor positive tumors |
| Presentation Time: | Wednesday, Apr 10, 2013, 8:00 AM -12:00 PM |
| Location: | Hall A-C, Poster Section 37 |
| Poster Board Number: | 12 |
| Author Block: | Christopher P. Leamon1, Joseph A. Reddy1, Brian B. Haines2, Isabelle Dussault2. 1Endocyte Inc, West Lafayette, IN; 2Merck & Co Inc, Boston, MA |
| Abstract Body: | Targeted anti-cancer therapies offer the promise of more efficacious treatments with fewer side effects. Vintafolide (also known as EC145) is a rationally designed small molecule drug conjugate consisting of one folic acid moiety which serves as a stable high affinity binding ligand for the folate receptor, and one vinca alkaloid unit (desacetylvinblastine hydrazide; DAVLBH), which serves as the cytotoxic warhead. Vintafolide is thus designed to target cancer cells by binding with high affinity to folate receptors which are more commonly expressed at high levels on tumors compared to normal tissues. Vintafolide is internalized following binding to folate receptors and is cleaved in endosomes to release DAVLBH. Like all vinca alkaloids, DAVLBH binds to tubulin and disrupts the mitotic spindle which leads to cell death. Pre-clinical in vitro and in vivo experiments show that vintafolide requires interaction with the folate receptor for its activity and that it is more efficacious and better tolerated than untargeted DAVLBH. Vintafolide is currently being investigated in clinical trials in ovarian (Phase III) and lung (Phase II) cancer patients who express folate receptors on their tumors as determined by the investigational companion imaging agent, etarfolatide. Etarfolatide is also a folate-based conjugate consisting of folic acid linked to a peptidic metal-chelating moiety labeled with 99mTechnetium. In a randomized Phase II study in patients with advanced ovarian cancer, patients treated with vintafolide had a significantly longer period of progression free survival compared with the control. This was driven by patients who were identified by etarfolatide as having tumors with functional folate receptors. Vintafolide and etarfolatide is the first pair of therapeutic and non-invasive, imaging diagnostic to be co-developed for the treatment of cancer. |
Access : Molecular imaging as a de-risking tool: coming into focus? ( vintafolide)
Abstract
Nature Reviews Drug Discovery 12, 251-252 (April 2013) |
Molecular imaging as a de-risking tool: coming into focus?
Abstract
When
Endocyte and Merck & Co. asked for European approval for
vintafolide in ovarian cancer late last year, the submission package
included a novel feature: a molecular imaging companion diagnostic.
Earnings Preview: Merck to key on coming new drugs - Businessweek (vintafolide/ovarian cancer)
Businessweek
Merck & Co., the world's third-biggest drugmaker by revenue, will tout a big surge in the company's pipeline of experimental drugs and a couple of promising new partnerships when it reports first-quarter results before the stock market opens Wednesday.WHAT TO WATCH FOR: CEO Kenneth Frazier will note the company has five new medicines under review by regulators, another just submitted and four others slated to be submitted for review sometime this year.
In addition, the Food and Drug Administration this month gave Merck's experimental cancer drug lambrolizumab a "breakthrough therapy" designation. That's meant to hasten final testing and the review process.
The drugs currently under regulatory review include insomnia pill suvorexant, ovarian cancer drug vintafolide and sugammadex for reversing effects of anesthesia after surgery.......
Monday, April 29, 2013
A qualitative study to explore psychological distress and illness burden associated with opioid-induced constipation in cancer patients with advanced disease
Abstract
Background:
Constipation affects many patients receiving long-term opioid therapy
for cancer pain. Little is known about the nature of
psychological distress and the burden associated
with this problem.
Search of: ovarian cancer | Interventional Studies | Adult | received on or after 01/01/2013 - List Results - ClinicalTrials.gov
received on or after 01/01/2013 - List Results
41 studies found for: ovarian cancer | Interventional Studies | Adult | received on or after 01/01/2013
Potential Role of mTORC2 as a Therapeutic Target in Clear Cell Carcinoma of the Ovary
Abstract
The goal of this study was to examine the
role of mTORC2 as a therapeutic target in ovarian clear cell carcinoma
(CCC), which
is regarded as an aggressive, chemoresistant
histological subtype.
Using tissue microarrays of 98 primary ovarian
cancers (52 CCCs and 46 serous adenocarcinomas (SACs)), activation of
mTORC2
was assessed by immunohistochemistry. Then, the
growth-inhibitory effect of mTORC2-targeting therapy, as well as the
role
of mTORC2 signaling as a mechanism for acquired
resistance to the mTORC1 inhibitor RAD001 in ovarian CCC, were examined
using
two pairs of RAD001-sensitive parental (RMG2 and
HAC2) and RAD001-resistant CCC cell lines (RMG2-RR and HAC2-RR).
mTORC2 was more frequently activated in CCCs than
in SACs (71.2% vs. 45.7%). Simultaneous inhibition of mTORC1 and mTORC2
by AZD8055 markedly inhibited the proliferation of
both RAD001-sensitive and RAD001-resistant cells in vitro. Treatment
with
RAD001 induced mTORC2-mediated AKT activation in
RAD001-sensitive CCC cells. Moreover, increased activation of mTORC2-AKT
signaling was observed in RAD001-resistant CCC
cells compared to the respective parental cells. Inhibition of mTORC2
during
RAD001 treatment enhanced the anti-tumor effect of
RAD001 and prevented CCC cells from acquiring resistance to RAD001.
In conclusion, mTORC2 is frequently activated, and
can be a promising therapeutic target, in ovarian CCCs. Moreover,
mTORC2-targeted
therapy may be efficacious in a front-line setting
as well as for second-line treatment of recurrent disease developing
after
RAD001-treatment.
An Exam (pelvic exam With Poor Results - NYTimes.com
An Exam With Poor Results - NYTimes.com
"...
In a multicenter trial supported by the National Cancer Institute, for instance, no cancers of the ovaries were detected by a pelvic examination alone. The test sometimes did produce suspicious findings that resulted in further procedures.
“The pelvic examination is not an effective screening tool for ovarian cancer,” Ms. Analia Stormo, a researcher at the Centers for Disease Control and Prevention, and colleagues wrote last March in the journal Preventive Medicine.
Yet Ms. Stormo also found that “almost 70 percent of obstetrician-gynecologists reported believing that a pelvic examination is an effective means of screening for ovarian cancer.”....
Sunday, April 28, 2013
(patient safety) Petition | Health Canada: Do not open paid blood donor clinics. | Change.org
Blogger's Note: James Kreppner was an outstanding patient safety advocate and if nothing else the petition is worth signing in his name/support
Petition (petition signature/s available to countries outside of Canada)
"Allowing paid blood donor clinics in Toronto and elsewhere
will increase the risk of another, tragic and unnecessary, tainted blood
crisis when tens of thousands of Canadians got infected with AIDS and
Hepatitis C through blood. One of those people was my late husband James
Kreppner. Another was my buddy, the late John Plater. I'm tired of
burying my loved ones.
Signing this petition will help send a message to our federal Health
Minister that Canadians do not want another tainted blood crisis. The
louder the message, the better. Please ask your family and friends to
sign this as well. Please ask Facebook friends to repost it....
Routine bimanual pelvic examinations + related references
Abstract
OBJECTIVE: Less-than-annual
cervical cancer screening is now recommended for most US women, raising
questions about the need for routine annual bimanual pelvic
examinations. Little is known about clinicians' bimanual pelvic
examination practices, their beliefs about its importance, or the
reasoning underlying its performance in asymptomatic women.
STUDY DESIGN: We
conducted a nationwide survey of US obstetrician-gynecologists.
Respondents (n = 521) reported their examination practices and beliefs
based on vignettes for asymptomatic women across the lifespan.
RESULTS: Nearly
all obstetrician-gynecologists perform bimanual pelvic examinations in
asymptomatic women across the lifespan, although it is viewed as less
important for a newly sexually active 18-year-old. Reasons cited as very
important included adherence to standard medical practices (45%),
patient reassurance (49%), detection of ovarian cancer (47%), and
identification of benign uterine (59%) and ovarian (54%) conditions.
CONCLUSION: Obstetrician-gynecologists
perform bimanual pelvic examinations in the vast majority of
asymptomatic women, but the importance placed on the examinations and
reasons for conducting them vary.
- "Pelvic: deferred"-have nongynecologists been right all along?Bump RC, et al. Am J Obstet Gynecol. 2013
- Routine bimanual pelvic examinations: practices and beliefs of US obstetrician-gynecologists.Henderson JT, et al. Am J Obstet Gynecol. 2013
- Pelvic examinations in asymptomatic women: tipping a sacred cow.Sawaya GF, et al. Arch Intern Med. 2011
- The pelvic examination as a screening tool: practices of US physicians.Stormo AR, et al. Arch Intern Med. 2011
- [Practice comparison offers clues for improvement of practice management: inspection obstetrics and gynecology as an example].Lombarts MJ, et al. Ned Tijdschr Geneeskd. 1995. Article in Dutch.
- Hypertension in pregnancy and preeclampsia. Knowledge and clinical practice among obstetrician-gynecologists.Repke JT, et al. J Reprod Med. 2002
- Obstetricians' and gynecologists' beliefs and preferred modes of treatment for women diagnosed with premenstrual symptoms.Rossignol AM, et al. Womens Health Issues. 1992
- Chaperone use by obstetrician/gynecologists.Johnson NR, et al. J Reprod Med. 1999
- Survey of knowledge, attitudes, and practice management patterns of Atlanta-area obstetricians regarding stillbirth.Duke W, et al. Womens Health Issues. 2010
- Obstetrician-gynecologists and perinatal infections: a review of studies of the Collaborative Ambulatory Research Network (2005-2009).Leddy MA, et al. Infect Dis Obstet Gynecol. 2010
Advances in Gynaecological Oncology Surgery
Abstract
Latest
surgical advances in the field of gynaecological oncology, a
sub-specialty of gynaecology, are reviewed in this chapter. The surgery
is mainly practised in cancer centres by board-certified gynaecologists,
and requires a 2–3 year period of additional training in gynaecological
oncology. Surgical treatment of gynaecological malignancies has
progressed in two directions: reduction of the invasiveness of the
surgery and expansion of the number and type of procedures performed.
Gynaecological oncology focuses on the pelvis to the upper abdomen and
the thorax to target (all visible disease) the last cancer cell in women
with advanced ovarian cancer. Minimal-access surgery has evolved to
include any operation by laparoscopy. It uses fewer ports (single-port
surgery), and robotic assistance improves the comfort of the surgeon.
The concept of fertility-sparing surgery for women with cervical cancer
is now supported by mature data. The indication and the aggressiveness
of the exenterative surgery are also broader than originally
recommended. The ideal timing of surgery is under investigation in
several areas, mainly in women with ovarian and cervical cancer. The aim
is to reduce morbidity and mortality of surgical procedures while
maintaining the survival outcome.
Best Practice & Research Clinical Obstetrics & Gynaecology - Future research in gynaecological surgery - UK
Abstract
Gynaecological
surgery is constantly evolving. To inform practice with high-impact
research, clinicians need to focus on areas of importance. Surveys of
specialist members of the British Society of Gynaecological Endoscopy
have revealed a range of areas for research: diagnostic performance of
laparoscopies; therapeutic laparoscopies in endometriosis; laparoscopic
versus hysteroscopic sterilisation; and laparoscopic surgical
techniques, among others. Clinical and economic outcomes are important
in evaluating effectiveness and use of surgical health technology. For
studies to be valid, reliable and generalisable, they would have to be
free of bias, large and multi-centred. In a time of financial
constraints, it is important to encourage clinicians and trainees to
participate in important research studies to improve outcomes for
patients.
- Fig. 4. Results for the 2010 survey showing areas of interest for future research in benign gynaecology surgery.
Precision Therapeutics Announces Topline Prospective Clinical Data Demonstrating Significant Improvement in Overall Survival and Progression Free Survival in Recurrent Ovarian Cancer using Personalized Chemotherapy Diagnostic ChemoFx® | Business Wire
Pharma
- First medical innovation in two decades using personalized medicine to show significant clinical results and improved outcomes for patients with ovarian cancer
- ChemoFx doubled the recurrent ovarian cancer patients with a responsive drug– a dramatic improvement to the one-in-four response rate observed in patients treated empirically
- Late-breaking data presented at Society of Gynecologic Oncology Annual Meeting
Women and Infants Researcher part of team showing connection between chemoresponse assays and improved ovarian cancer survival rates
Researcher part of team showing connection between chemoresponse assays and improved ovarian cancer survival rates
Press Release
| Research Focused on Improved Ovarian Cancer Survival Rates | ||
| 04/25/2013 | ||
| This spring, a team of researchers has released
results from an eight-year study that shows improved survival rates for
women diagnosed with ovarian cancer who undergo cancer tumor testing to
determine the best treatment. Part of the team was Richard G. Moore, MD, director of the Center for Biomarkers and Emerging Technologies and a gynecologic oncologist with the Program in Women's Oncology at Women & Infants Hospital of Rhode Island. "Essentially, we have demonstrated that by using a tissue sample from the patient's tumor and a chemoresponse assay, we are able to determine which treatment may or may not work for her," Dr. Moore explains of the study, which was presented at a recent meeting of the Society of Gynecologic Oncology and in the trade publication Cure. "This study shows that a woman with recurrent ovarian cancer could benefit from having a biopsy and chemosensitivity testing. The results from such testing will allow for the identification of chemotherapeutics that are active against the patient's disease and those that are not resulting in decreased toxicity from ineffective treatments. Learning that personal directed therapies may improve overall survival for these patients made this the first study in two decades to show a significant increase in survival in recurrent ovarian cancer." The study, launched in 2004, included 283 women. Of those, 262 had successful biopsies which were tested in vitro, or in a test tube. The assay ChemoFx®, by Precision Therapeutics, tested up to 15 approved treatment regimens on the samples, identifying chemotherapy drugs and regimens to which each tumor might be sensitive. The study was non-interventional, meaning that physicians chose the treatment regimens without knowing of the assay results. The researchers then evaluated the assay's result against actual patient outcomes. "The assay identified at least one treatment to which the tumor would be sensitive in 52% of patients in the study," Dr. Moore says. "Overall, median survival was 37.5 months for patients with treatment-sensitive tumors, compared to 23.9 months for intermediate and resistant tumors." Assay-directed therapy has long been debated among oncologists, he continues. Such debate provided the impetus for this study. About Women & Infants Hospital Women & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation's leading specialty hospitals for women and newborns. The primary teaching affiliate of The Warren Alpert Medical School of Brown University for obstetrics, gynecology and newborn pediatrics, as well as a number of specialized programs in women's medicine, Women & Infants is the ninth largest stand-alone obstetrical service in the country with nearly 8,400 deliveries per year.In 2009, Women & Infants opened the country's largest, single-family room neonatal intensive care unit. New England's premier hospital for women and newborns, Women & Infants and Brown offer fellowship programs in gynecologic oncology, maternal-fetal medicine, urogynecology and reconstructive pelvic surgery, neonatal-perinatal medicine, pediatric and perinatal pathology, gynecologic pathology and cytopathology, and reproductive endocrinology and infertility. It is home to the nation's only mother-baby perinatal psychiatric partial hospital, as well as the nation's only fellowship program in obstetric medicine. Women & Infants has been designated as a Breast Center of Excellence from the American College of Radiology; a Center for In Vitro Maturation Excellence by SAGE In Vitro Fertilization; a Center of Biomedical Research Excellence by the National Institutes of Health; and a Neonatal Resource Services Center of Excellence. It is one of the largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics in the nation, and is a member of the National Cancer Institute's Gynecologic Oncology Group and the National Institutes of Health's Pelvic Floor Disorders Network. About ChemoFx® ChemoFx®, is a proprietary, CLIA-certified and commercially-available chemoresponse assay which measures an individual's tumor response to a range of therapeutic alternatives under consideration by the treating physician. By testing multiple chemotherapies on a patient's tumor cells before clinically treating a cancer patient, ChemoFx® helps determine the chemotherapies more likely to be effective and, therefore, provides valuable insights that help inform physicians' treatment decisions with a goal of improving patient outcomes. Precision Therapeutics currently receives ChemoFx® specimens from 271 top medical institutions including 20 of the 21 National Comprehensive Cancer Network (NCCN) Member Institutions, and 8 of the US News and World Report Top 10 Hospitals for Cancer Care. Over 60,000 patient specimens to date have been tested with ChemoFx®. About Precision Therapeutics Precision Therapeutics, a leading life-science company based in Pittsburgh, Pennsylvania, is dedicated to utilizing precision medicine for personalized cancer care. Precision offers a portfolio of products developed to help guide physicians and patients with difficult clinical decisions throughout the cancer care continuum. The company's leading products for personalized cancer care include ChemoFx® and BioSpeciFx®, a select portfolio of clinically relevant molecular tests that provide information about drug response and patient prognosis. Additionally, in 2013 Precision is releasing two new gene signature products, under the GeneFx® brand. GeneFx Colon is a 634-transcript microarray assay that has been independently validated to predict risk of disease recurrence in stage II colon cancer patients. It is currently undergoing an additional independent validation using a large cooperative group cohort. GeneFxLung is a 15-gene microarray assay that has been independently validated in 5 separate patient groups to predict risk of mortality in early stage non-small cell lung cancer (NSCLC), and may also be able to predict which of those patients will experience benefit from chemotherapy. For more information, visit www.precisiontherapeutics.com or www.chemofx.com. |
(assay testing - repost) Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay
Abstract
Highlights
►
The multivariate index assay (MVA) was evaluated in an intended-use
population of non-gynecologic oncology practices.
► The MVA demonstrated high sensitivity and NPV for ovarian malignancy.
► The MVA correctly identified 83.3% malignancies missed by clinical impression and 70.8% cases missed by CA125-II.
► The MVA demonstrated high sensitivity and NPV for ovarian malignancy.
► The MVA correctly identified 83.3% malignancies missed by clinical impression and 70.8% cases missed by CA125-II.
- a University of California, Irvine-Medical Center, Orange, CA, USA
- b Applied Clinical Intelligence, Bala Cynwyd, PA, USA
- c The Johns Hopkins Medical Institutions, Baltimore, MD, USA
- d Vermillion, Inc., Mountain View, CA, USA
- e Vermillion, Inc., Austin, TX, USA
Objective
To
validate the effectiveness of a multivariate index assay in identifying
ovarian malignancy compared to clinical assessment and CA125-II, among
women undergoing surgery for an adnexal mass after enrollment by
non-gynecologic oncology providers.
Methods
A
prospective, multi-institutional trial enrolled female patients
scheduled to undergo surgery for an adnexal mass from 27 non-gynecologic
oncology practices. Pre-operative serum samples and physician
assessment of ovarian cancer risk were correlated with final surgical
pathology.
Results
A total of
494 subjects were evaluable for multivariate index assay, CA125-II, and
clinical impression. Overall, 92 patients (18.6%) had a pelvic
malignancy. Primary ovarian cancer was diagnosed in 65 patients (13.2%),
with 43.1% having FIGO stage I disease. For all ovarian malignancies,
the sensitivity of the multivariate index assay was 95.7%
(95%CI = 89.3–98.3) when combined with clinical impression. The
multivariate index assay correctly predicted ovarian malignancy in 91.4%
(95%CI = 77.6–97.0) of cases of early-stage disease, compared to 65.7%
(95%CI = 49.2–79.2) for CA125-II. The multivariate index assay correctly
identified 83.3% malignancies missed by clinical impression and 70.8%
cases missed by CA125-II. Multivariate index assay was superior in
predicting the absence of an ovarian malignancy, with a negative
predictive value of 98.1% (95%CI = 95.2–99.2). Both clinical impression
and CA125-II were more accurate at identifying benign disease. The
multivariate index assay correctly predicted benign pathology in 204
patients (50.7%, 95%CI = 45.9–55.6) when combined with clinical
impression.
Conclusion
The
multivariate index assay demonstrated higher sensitivity and negative
predictive value for ovarian malignancy compared to clinical impression
and CA125-II in an intended-use population of non-gynecologic oncology
practices.
Graphical abstract
Highlights
►
The multivariate index assay (MVA) was evaluated in an intended-use
population of non-gynecologic oncology practices. ► The MVA demonstrated
high sensitivity and NPV for ovarian malignancy. ► The MVA correctly
identified 83.3% malignancies missed by clinical impression and 70.8%
cases missed by CA125-II.
SGO | 2013 meeting abstracts to be published online july 2013
SGO
Annual Meeting Abstracts
The full list of abstracts from the 2013 SGO Annual Meeting on Women’s Cancer will be published in the July 2013 issue of Gynecologic Oncology through ScienceDirect.com. In keeping with the terms of agreement with Elsevier, Inc., the full abstracts have been removed from SGO.org.
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