ScienceDirect.com - Gynecologic Oncology - Hormonal therapy for recurrent low-grade serous carcinoma of the ovary or peritoneum
Thursday, May 17, 2012
paywalled - Gynecologic Oncology - Hormonal therapy for recurrent low-grade serous carcinoma of the ovary or peritoneum
ScienceDirect.com - Gynecologic Oncology - Hormonal therapy for recurrent low-grade serous carcinoma of the ovary or peritoneum
paywalled - Gynecologic Oncology - A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: GOG
ScienceDirect.com - Gynecologic Oncology - A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: A Gynecologic Oncology Group study
Conclusion
A6 was well tolerated but had minimal activity in patients with persistent or recurrent EOC/FTC/PPC.paywalled- Gynecologic Oncology - Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer ($8,699,872 monthly.
ScienceDirect.com - Gynecologic Oncology - Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer
Objective
To determine the potential economic impact of a paclitaxel drug shortage in patients with newly diagnosed, untreated ovarian cancer.Methods
A modified Markov state transition model with a 6 cycle time horizon compared two scenarios: (1) Standard treatment (STD): paclitaxel 175 mg/m2/carboplatin AUC 5 × 6 cycles; (2) Paclitaxel drug shortage (DS): docetaxel 75 mg/m2/carboplatin AUC 5 × 6 cycles. Adverse events, quality of life, and costs of chemotherapy, neuropathy, febrile neutropenia, and anemia were incorporated. Key assumptions: (1) Costs and consequences were assigned only to grade 2 + neuropathy, febrile neutropenia, and grade 3–4 anemia; (2) Grade 2 + neuropathy prompted a switch from paclitaxel/carboplatin to docetaxel/carboplatin or from docetaxel/carboplatin to carboplatin alone; (3) Febrile neutropenia resulted in inpatient hospitalization followed by G-CSF prophylaxis.Results
The mean cost of 6 cycles of chemotherapy was $4939 in the STD and $16,107 in the DS scenario, for a cost difference of $11,168 per patient over 6 cycles of treatment. STD was the dominant strategy (less expensive and more effective than the drug shortage scenario). In sensitivity analysis, DS was more costly over a wide range of clinical estimates in each arm. A drug shortage that affects approximately 50% of women initiating chemotherapy is expected to impact 779 women and cost third party payers an additional $8,699,872 monthly.Conclusions
Our model indicates that chemotherapy drug shortages can have a significant negative impact on the average cost of primary treatment for ovarian cancer and have the potential to negatively impact health system costs.paywalled - Gynecologic Oncology - Predictors of severe and febrile neutropenia during primary chemotherapy for ovarian cancer
ScienceDirect.com - Gynecologic Oncology - Predictors of severe and febrile neutropenia during primary chemotherapy for ovarian cancer
Objective
To identify factors that increase the risk of neutropenic events in women with advanced ovarian carcinoma receiving initial chemotherapy.Methods
Multi-center retrospective study of women with FIGO stage III–IV epithelial ovarian cancer treated postoperatively with multi-agent intravenous chemotherapy from 1995 to 2008. Outcomes were severe (SN; absolute neutrophil count [ANC] < 500/mm3) and febrile neutropenia (FN; ANC < 1000/mm3 and temperature > 38.1 °C). Cumulative risk of neutropenic events was estimated by Kaplan Meier method. Multivariate analysis was by Cox proportional hazard regression.Results
Three hundred twenty-six patients met inclusion criteria. There were 251 SN events among 140 (43%) patients and 24 FN events among 22 (7%) patients. Univariate predictors of SN were body surface area < 2.0 m2 (p = 0.03), body mass index (BMI) < 30 kg/m2 (p < 0.01), Caucasian race (p < 0.01), treatment on research protocols (p < 0.01), non-carboplatin-containing regimens (p < 0.01), and planned relative dose intensity (RDI) > 85% of standard (p = 0.02). Women over age 60 were more likely to develop FN (p = 0.05). Multivariate predictors of SN were treatment on research protocols (hazard ratio [HR] 1.93; p < 0.01), Caucasian race (HR 2.13; p = 0.01), and planned RDI > 85% (HR 1.69; p = 0.05); predictors of FN were age > 60 (HR 2.84; p = 0.05) and non-carboplatin containing regimens (HR 4.06; p < 0.01).Conclusion
While SN is fairly common, FN occurs infrequently in women with EOC undergoing taxane and platin-based chemotherapy and primary prophylactic growth factor support is not indicated. However, women older than 60 years of age receiving non-carboplatin containing regimens are at higher risk for FN and warrant closer surveillance.paywalled - Gynecologic Oncology - Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer
ScienceDirect.com - Gynecologic Oncology - Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer
Highlights
► GOG 172 showed improved outcomes for optimally debulked ovarian carcinoma patients treated with IV/IP chemotherapy compared to IV chemotherapy.► The regimen has not been widely accepted due to its inpatient administration, toxicity profile, and limited completion rate.
► A modified GOG 172 treatment regimen improved convenience, toxicity, and tolerability, with outcomes similar to those of GOG 172.
paywalled - Gynecologic Oncology - Impact of smoking on perioperative pulmonary and upper respiratory complications after laparoscopic gynecologic surgery
ScienceDirect.com - Gynecologic Oncology - Impact of smoking on perioperative pulmonary and upper respiratory complications after laparoscopic gynecologic surgery
Abstract
Objective
To determine the impact of smoking on the rate of pulmonary and upper respiratory complications following laparoscopic gynecologic surgery.Methods
We retrospectively identified all patients who underwent laparoscopic gynecologic surgery at one institution between January 2000 and January 2009. Pulmonary and upper respiratory complications were defined as atelectasis, pneumonia, upper respiratory infection, acute respiratory failure, hypoxemia, pneumothorax, or pneumomediastinum occurring within 30 days after surgeryResults
Nine hundred three patients underwent attempt at laparoscopic surgery. Fifty-four were excluded because of conversion to laparotomy and 31 because of insufficient data. Of the 818 patients included, 356 (43%) had cancer. A total of 576 (70%) patients were never smokers, 156 (19%) were past smokers, and 86 (10%) were current smokers (smoked within 6 weeks before surgery). These three groups were similar with regard to median body mass index, operative time, and length of hospital stay. Compared to never and past smokers, current smokers were more likely to undergo high-complexity laparoscopic procedures (10.4%, 15.4%, and 19.8%, respectively; p = 0.015) and had younger median age 49 years, 51 years, and 46 years, respectively; p = 0.035. Nineteen (2.3%) patients experienced pulmonary complications — symptomatic atelectasis (n = 9), pneumonia (n = 5), acute respiratory failure (n = 2), hypoxemia (n = 1), pneumomediastinum (n = 1), and pneumothorax (n = 2). The rate of pulmonary complications was 2.1% (12 of 564 patients) in never smokers, 4.5% (7 of 156 patients) in past smokers, and zero in current smokers.Conclusion
In this cohort, smoking history did not appear to impact postoperative pulmonary and upper respiratory complications. In smokers scheduled for operative procedures, laparoscopy should be considered when feasible.paywalled: Current advances in the management of malignant germ cell and sex cord-stromal tumors of the ovary
Current advances in the management of malignant germ cell and sex cord-stromal tumors of the ovary:
Abstract | References
No abstract is available for this article.
paywalled: Incidence of and risk factors for postoperative ileus in women undergoing primary staging and debulking for epithelial ovarian carcinoma
Blogger's Note/Opinion: in ovarian cancer this issue is seemingly underreported; from a patient's perspective it is underreported, abstract does not indicate expertize/impact/outcomes according to surgical skill/professional nor long term effects/in depth cause-related issues;
Medscape: Ileus occurs from hypomotility (decreased motility) of the gastrointestinal tract in the absence of mechanical bowel obstruction. Presumably, the muscle of the bowel wall is transiently impaired and fails to transport intestinal contents. This lack of coordinated propulsive action leads to the accumulation of gas and fluids within the bowel.....
~~~~~~~~~~~~~
Incidence of and risk factors for postoperative ileus in women undergoing primary staging and debulking for epithelial ovarian carcinoma:
Objective
Thorough primary cytoreduction for epithelial ovarian carcinoma (EOC) improves survival. The incidence of postoperative ileus (POI) in these patients may be underreported because of varying POI definitions and the evolving, increasingly complex contemporary surgical approach to EOC. We sought to determine the current incidence of POI and its risk factors in women undergoing debulking and staging for EOC.
Methods
We retrospectively identified the records of women who underwent primary staging and cytoreduction for EOC between 2003 and 2008. POI was defined as a surgeon's diagnosis of POI, return to nothing-by-mouth status, or reinsertion of a nasogastric tube. Perioperative patient characteristics and process-of-care variables were analyzed.
Results
Among 587 women identified, the overall incidence of POI was 30.3% (25.9% without bowel resection, 38.5% with bowel resection; P =.002). Preoperative thrombocytosis, involvement of bowel mesentery with carcinoma, and perioperative red blood cell transfusion were independently associated with increased POI. Postoperative ibuprofen use was associated with decreased POI risk. Women with POI had a longer length of stay (median, 11 vs 6days) and increased time to recovery of the upper (7.5 vs 4days) and lower (4 vs 3days) gastrointestinal tract (P <.001 for each).
Conclusions
The rate of POI is substantial among women undergoing staging and cytoreduction for EOC and is associated with increased length of stay. Modifiable risk factors may include transfusion and postoperative ibuprofen use. Alternative interventions to decrease POI are needed.
press release: In drug-approval race, US FDA ahead of Canada, Europe (range: 322-393 days)
In drug-approval race, US FDA ahead of Canada, Europe
Public release date: 16-May-2012
The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow.
Led by second-year medical student Nicholas Downing and senior author Joseph S. Ross, M.D., assistant professor of internal medicine at Yale School of Medicine, the study will be published May 16 online by the New England Journal of Medicine.
Regulatory review represents the final step in the process of bringing new medical technologies from the lab to the bedside. Efficient regulatory review processes may enable patients to get access to promising new therapies sooner, while ensuring drug safety.
"The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications," said Downing, who decided to conduct the study because there have been no recent comparisons of the FDA's regulatory review speed with those of regulating agencies in other countries.
Downing, Ross, and colleagues reviewed drug approval decisions of the FDA, the Canadian drug regulator, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. They studied each regulator's database of drug approvals to identify novel therapeutics as well as the timing of key regulatory events, allowing regulatory review speed to be calculated. Canada and Europe were chosen as a comparison because they face similar pressures to approve new drugs quickly while ensuring they do not put patients at risk.
The team found that the median total time to review was 322 days at FDA, 366 days at EMA and 393 days at Health Canada.
"Among the subsample of drugs approved for all three regulators, the FDA's reviews were over three months faster than those of the EMA or Health Canada," said Downing. "The total review time at the FDA was faster than EMA, despite the FDA's far higher proportion of applications requiring multiple regulatory reviews."
Downing added that most new drug therapies were first approved for use in the U.S. "Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86% of medicines approved in both the U.S. and Canada were also approved first in the U.S." he said.
###
Other authors on the study included Jenerius A. Aminawung, Nilay D. Shah, Joel B. Braunstein, and Harlan M. Krumholz.The study was funded by the Pew Charitable Trusts.
Citation: New England Journal of Medicine, doi: 10.1056/NEJMoa1200223
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM (U.S./Canada/Europe) note references to safety
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM
"In conclusion, we found that among novel (new) therapeutics approved between 2001 and 2010, the FDA reviewed applications more quickly, on average, than did the EMA and Health Canada, and the vast majority of these novel therapeutics were first approved for use in the United States. Our findings contradict recent criticisms of the speed of review by the FDA and lead to questions about whether the speed of the review process is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian peers."
Functional profiling of clear cell ovarian cancer. | 2012 ASCO Annual Meeting Abstracts
Functional profiling of clear cell ovarian cancer. | 2012 ASCO Annual Meeting Abstracts
Abstract:
Background: Clear cell ovarian cancer represents up to 15% of epithelial ovarian cancers. In comparison to other subtypes, clear cell ovarian carcinomas have a poorer prognosis and are relatively resistant to standard platinum based chemotherapy. Recently, loss of function mutations in the tumour suppressor gene ARID1A were identified in up to 50% of ovarian clear cell carcinomas. We have adopted an integral functional and molecular profiling approach as a route to identify new genetic dependencies and therapeutic targets for this disease.
Methods: Clear cell ovarian cancer cell lines were functionally profiled using high throughput screening with chemical and siRNA libraries. This has been integrated with molecular profiling data generated from exome and transcriptome sequencing to aid the discovery of novel targets.
Results: Using functional screens we have now identified critical gene dependencies and potential therapeutics in a series of clear cell ovarian cancer models. The comparison of functional viability profiles for models characterized by ARID1A loss of function mutations is now enabling an analysis of synthetic lethal effects that could be used to target clear cell ovarian cancers carrying these mutations.
Conclusions: The work undertaken so far provides the framework for the discovery of therapeutic targets for clear cell ovarian cancer using an integrated approach. Revalidation of these preliminary results is now underway to characterize new genetic dependencies for this disease.
ASCO '12 Abstract Dump: Cancer Stocks in Focus - TheStreet (financial)
ASCO '12 Abstract Dump: Cancer Stocks in Focus - TheStreet
.....While investors were flooded with new cancer drug data Wednesday, ASCO did hold back some of the some important and potentially stock-moving research for a more high-profile release at the meeting itself.
The following pages summarize new and important cancer drug data released tonight by ASCO from research abstracts for its upcoming annual meeting.......
paywalled: Two-marker Combinations for Preoperative Discrimination of Benign and Malignant Ovarian Masses
Two-marker Combinations for Preoperative Discrimination of Benign and Malignant Ovarian Masses
Abstract
Background:
When caring for patients with
ovarian neoplasms, correct preoperative discrimination of benign and
malignant disease
is deemed vital. In this study, we tested serum
biomarkers' alone and in combination, to achieve this aim.
Conclusion:
A combination of CA-125
with HE4 could facilitate the identification of women at risk for
ovarian
cancer.
paywalled: Long-term results of screening with magnetic resonance imaging in women with BRCA mutations : British Journal of Cancer
Long-term results of screening with magnetic resonance imaging in women with BRCA mutations : British Journal of Cancer
Background:
The
addition of breast magnetic resonance imaging (MRI) to screening
mammography for women with BRCA mutations significantly increases
sensitivity, but there is little data on clinical outcomes. We report
screening performance, cancer stage, distant recurrence rate, and breast
cancer-specific mortality in our screening study.
Methods:
From 1997 to 2009, 496 women aged 25 to 65 years with a known BRCA1/2
mutation, of whom 380 had no previous cancer history, were enrolled in a
prospective screening trial that included annual MRI and mammography.
Results:
In
1847 screening rounds, 57 cancers were identified (53 screen-detected, 1
interval, and 3 incidental at prophylactic mastectomy), of which 37 (65%) were invasive. Sensitivity of MRI vs mammography was 86% vs 19% over the entire study period (P<0.0001), but was 74% vs 35% from 1997 to 2002 (P=0.02) and 94% vs 9%
from 2003 to 2009 (P<0.0001), respectively. The relative
sensitivities of MRI and mammography did not differ by mutation, age, or
invasive vs non-invasive disease. Of the incident cancers, 97%
were Stage 0 or 1. Of 28 previously unaffected women diagnosed with
invasive cancer, 1 BRCA1 mutation carrier died following relapse of a 3 cm, node-positive breast cancer diagnosed on her first screen at age 48 (annual breast cancer mortality rate=0.5%).
Three patients died of other causes. None of the 24 survivors has had a
distant recurrence at a median follow-up of 8.4 years since diagnosis.
Conclusion:
Magnetic resonance imaging surveillance of women with BRCA1/2
mutations will detect the majority of breast cancers at a very early
stage. The absence of distant recurrences of incident cancers to date is
encouraging. However, longer follow-up is needed to confirm the safety of breast surveillance.
media: Doctor-bashing’s not the cure for health-care costs
......the government has gone to war against the doctors again.....
"Politicians and bureaucrats are always attracted to simple ways to control health-care spending. In the early 1990s, they decided the best way to control spending was to cut down on doctors. This brilliant idea resulted in a doctor shortage that has taken the past decade to fix......
Wednesday, May 16, 2012
Healthnewsreviews blog: The marketing of anemia drugs - a story we shouldn't forget (including comments)
The marketing of anemia drugs - a story we shouldn't forget
"In an opinion piece on TheScientist.com, Daniel W. Coyne writes, “Amgen’s incomplete report on an early major trial of epoetin misled the medical community about the anemia drug’s risks and benefits—and helped make Amgen rich.”
In the book, “How We Do Harm,” Otis Brawley, MD, chief medical and scientific officer of the American Cancer Society, writes quite a bit about hemoglobin-building drugs. He discusses:.....
FAQ: Adverse Events(search by drug name)
FAQ: Adverse Events
Adverse Events,
Inc. (AEI) is a provider of up-to-the-minute, critical, potentially
life-saving information regarding side effects associated with
FDA-approved prescription medications. AEI has created a unique set of
online tools that are optimized to provide un-paralleled access to
adverse event information on over 4,000 drugs, in an easy to understand
and navigate format. AEI’s tools give control over treatment plans back
to patients and their doctors, while providing an immediate view of
potential trends and problems in the drug industry to pharmaceutical,
healthcare, insurers, financial institutions and media.
RxFilter™ is a proprietary 17-step data refinement process developed by AdverseEvents, Inc. that standardizes and normalizes the Federal Drug Administration (FDA) Adverse Events Reporting System (AERS) database. Combining complex computer algorithms with hands-on data analysis by highly trained researchers, the RxFilter process is the most thorough optimization procedure ever applied to the FDA's drug safety database. It accurately measures and tracks adverse events associated with medications reported to the FDA.
RxFilter™ is a proprietary 17-step data refinement process developed by AdverseEvents, Inc. that standardizes and normalizes the Federal Drug Administration (FDA) Adverse Events Reporting System (AERS) database. Combining complex computer algorithms with hands-on data analysis by highly trained researchers, the RxFilter process is the most thorough optimization procedure ever applied to the FDA's drug safety database. It accurately measures and tracks adverse events associated with medications reported to the FDA.
Top 10 Drugs with the Highest Number of Adverse Events Reported
| Browse all by letter: example:
|
A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z |
Oxaliplatin-related thrombocytopenia
Oxaliplatin-related thrombocytopenia
Oxaliplatin is a third generation platinum compound that inhibits DNA synthesis, mainly through intrastrandal cross-links in DNA. Most of the experience with the clinical use of this drug is derived from colorectal cancer but it is also used in other tumor types such as ovary, breast, liver and non-Hodgkin's lymphoma. Thrombocytopenia is a frequent toxicity seen during oxaliplatin treatment, occurring at any grade in up to 70 % of patients and leading to delays or even discontinuation of the chemotherapy. Although myelossupression is recognized as the main cause of oxaliplatin-related thrombocytopenia, new mechanisms for this side-effect have emerged, including splenic sequestration of platelets related to oxaliplatin-induced liver damage and immune thrombocytopenia. These new pathophysiology pathways have different clinical presentations and evolution and may need specific therapeutic maneuvers. This article attempts to review this topic and provides useful clinical information for the management of oxaliplatin-related thrombocytopenia...........
Seth's blog: Dedicating the merit
Dedicating the merit:
For an author, one of the nicest parts of the traditional book is the dedication page. The dedication is far more than an acknowledgement to someone who helped you write the book, it's a permanent signpost, a capstone to the work of a year or more.
Even if the person you've dedicated the book to can't read it, the writer benefits from the knowledge that a connection was made and that a memory was preserved.
Here's the thing: you can dedicate just about anything. A project, a meeting, a tweet. You don't have to tell anyone but yourself. This blog post, like all the posts before it, has a dedication page, at least in my head.
When you start creating for and in honor of those that have made a difference to you, your work changes.
Even if the person you've dedicated the book to can't read it, the writer benefits from the knowledge that a connection was made and that a memory was preserved.
Here's the thing: you can dedicate just about anything. A project, a meeting, a tweet. You don't have to tell anyone but yourself. This blog post, like all the posts before it, has a dedication page, at least in my head.
When you start creating for and in honor of those that have made a difference to you, your work changes.
paywalled: MR Imaging of Malignancies Arising in Endometriomas and Extraovarian Endometriosis
MR Imaging of Malignancies Arising in Endometr... [Radiographics. 2012] - PubMed - NCBI
Radiographics. 2012 May
Abstract:
Cancers that arise in ovarian or extraovarian endometriosis are a distinct disease category with a histologic profile different from that of the more common epithelial ovarian cancers and with a better prognosis.
Because the malignant transformation of endometriomas is rarely associated with lymphadenopathy or peritoneal carcinomatosis, a high index of suspicion on the part of the radiologist is necessary to establish a timely diagnosis of endometriosis-related ovarian cancers and allow appropriate oncologic management. Although imaging is not currently performed for surveillance of endometriosis, magnetic resonance (MR) imaging is often performed when surgical treatment is under consideration................. For definitive diagnosis, histopathologic analysis is required.
paywalled: Treatment of Chemotherapy-Induced Anemia in Ovarian Cancer Patients: Does the Use of Erythropoiesis-Stimulating Agents Worsen Survival?
Treatment of Chemotherapy-Induced Anemia in Ovarian Cancer P... : International Journal of Gynecological Cancer
Abstract
Objective:
Considering the paucity of data relating
erythropoiesis-stimulating agent (ESA) use to ovarian cancer survival,
our objective was to evaluate the effect of ESA as used for the
treatment of chemotherapy-induced anemia (CIA) on survival in ovarian
cancer patients.
Materials and Methods:
A multi-institution retrospective
chart review was performed on ovarian cancer patients. Data collection
included patient demographic, surgicopathologic, chemotherapy, ESA, and
survival data. Patients were stratified by ever-use of ESA and were
compared using appropriate statistical methods.
Results: A total of 581 patients were eligible for
analysis with 39% (n = 229) patients with ever-use of ESA (ESA-YES) and
61% (n = 352) never-use ESA (ESA-NO). Mean age was 60.4 years with most
patients having stage IIIC (60%) of papillary serous histological
diagnosis (64%) with an optimal cytoreduction (67%). Median follow-up
for the cohort was 27 months. Both ESA-YES and ESA-NO groups were
similar regarding age, body mass index, race, stage, histological
diagnosis, and debulking status. Compared with the ESA-NO group, ESA-YES
patients were significantly more likely to experience recurrence (56%
vs 80%, P < 0.001) and death (46% vs 59%, P = 0.002). Kaplan-Meier
curves demonstrated a significant reduction in progression-free survival
for ESA-YES patients (16 vs 24 months, P < 0.001); however, overall
survival was statistically similar between the 2 groups (38 vs 46
months, P = 0.10). When stratifying by ever experiencing a CIA, ESA-YES
patients demonstrated a significantly worse progression-free survival
(17 vs 24 months, P = 0.02) and overall survival (37 vs 146 months, P
< 0.001).
Conclusions:
Our data evaluating the use of ESA as a
treatment of CIA in ovarian cancer patients are similar to reports in
other tumor sites. Considering that patients who used ESA were more
likely to experience recurrence and death and to have decreased
survival, the use of ESA in ovarian cancer patients should be limited.
paywalled: Differential diagnosis of a pelvic mass: improved algorithms and novel biomarkers.
Differential diagnosis of a pelvic mass: improved algorithms and novel biomarkers.:
ABSTRACT:
More than 200,000 women undergo exploratory surgery for a pelvic mass in the United States each year and 13%-21% of pelvic lesions are found to be malignant. Individual reports and meta-analysis indicate better outcomes when cancer surgery is performed by gynecologic oncologists. Despite the advantages provided by more thorough staging and cytoreductive surgery, only 30%-50% of women with ovarian cancer are referred to surgeons with specialized training in the United States. Imaging, menopausal status and biomarkers can aid in distinguishing malignant from benign pelvic masses to inform decisions regarding appropriate referral. The risk of malignancy index (RMI) uses ultrasound, menopausal status and CA125 and has been utilized in the United Kingdom for two decades, providing sensitivity that has ranged from 71%-88% and specificity it from 97%-74% for identifying patients with malignant disease. Criteria have been established by the Society of Gynecology Oncology and American College of Obstetrics and Gynecology for referral to a gynecologic oncologist, but these have lower sensitivity and specificity than the RMI.
Recently, two new algorithms have been developed to identify women at sufficiently high risk to prompt referral to a specialized surgeon. The OVA1 multivariate index incorporates imaging, menopausal status, CA125 and four other proteomic biomarkers. Use of OVA1 provides 85%-96% sensitivity at 28%-40% specificity depending upon menopausal status. The negative predictive value for women judged to be at low risk is 94%-96%.
The risk of malignancy algorithm (ROMA) includes CA125, human epididymal protein 4 and menopausal status, but not imaging results.
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