Thursday, May 09, 2013
Incidence and risk of treatment-related mortality in cancer patients treated with the mammalian target of rapamycin inhibitors
Abstract
Conclusion The use of mTOR inhibitors is associated with a small but higher risk of FAEs (fatal adverse events) compared to control patients. In the appropriate clinical scenario, the use of these drugs remains justified in their approved indications.
National Patient Advocate Foundation's Annual Capitol Hill Briefing Focuses on Patient Access Barriers
WASHINGTON, May 8, 2013 /PRNewswire
Congressional Staff Discuss Legislative Proposals to Eliminate and Reduce the High Cost of Specialty Tiers
WASHINGTON, May 8, 2013 /PRNewswire-USNewswire/ -- The National Patient Advocate Foundation (NPAF) today convened a briefing on Capitol Hill to highlight the patient perspective on specialty tier prescription medicines and the barriers to their access for patients with cancer, multiple sclerosis, arthritis and other life-threatening and debilitating diseases. The medicines are some of the only therapies available to treat these conditions. The office of Congressman David McKinley (R-WV) and the Senate Finance Committee were represented at today's briefing to review legislative strategies to address specialty tiers in both commercial insurance plans and Medicare.......2012 Patient Data Analysis Report Shows Rise in Number of Patients Denied
May 8, 2013 /PRNewswire
HAMPTON, Va., May 8, 2013
/PRNewswire-USNewswire/ -- The oldest national non-profit organization
providing patients with chronic, debilitating and/or life-threatening
diseases with one-on-one case management addressing insurance obstacles,
medical debt crisis and other barriers to health care today released
its annual Patient Data Analysis Report (PDAR). The report issued by Patient Advocate Foundation (PAF) is a statistical analysis of the
109,147 patients from all 50 states assisted by PAF in 2012 and
documents mediation and arbitration services necessary to resolve a
variety of issues within the health care system as well as the initial
impact of newly implemented health care laws.
PAF
assisted patients from across the country and several territories;
however 11.3 percent of all patient calls were from the state of Florida, followed by Texas (9.1%). The increase in number of requests for direct mediation was greatest in Ohio (47.1%) and Pennsylvania (27.9%).
In
the 2012 report, for the first time the uninsured represented the
largest group of patients served by PAF at 34.4%, an increase of more
than 25% since 2011. Uninsured issues increased from 17.7% in 2011 to
19.1% in 2012 while debt crisis/cost of living issues decreased,
suggesting PAF patients are facing more difficulties accessing care than
affording care. The report shows specialty tiers for prescription drugs
and
drug shortages have impacted ability to access medications...........
Myriad Genetics rises on 3Q and stronger outlook - Businessweek
Myriad Genetics rises on 3Q and stronger outlook - Businessweek
".....In mid-April the Supreme Court heard a case related to the patenting of human genes: the case challenges two patents Myriad holds on genes related to the BRACAnalysis test. The American Civil Liberties Union and other groups have argued that the government shouldn't award patents on genes. The Patent & Trademark office has been awarding such patents for decades.
A ruling is expected by June. Analysts expect Myriad's patents to be upheld and note that even if the Supreme Court invalidates the patents, the company has other patents supporting the test."
Effect of Hormone Replacement Therapy on Cardiovascular Outcomes: A Meta-Analysis of Randomized Controlled Trials
Blogger's Note: Table 3 included: 1) vascular risk factors; 2) health women or hysterectomy
open access
Background
Hormone replacement therapy (HRT) is widely used to controlling menopausal symptoms and prevent adverse cardiovascular events. However, the benefit and risk of HRT on cardiovascular outcomes remains controversial.......Table 3. Subgroup analysis for the effect of hormone replacement therapy on coronary events, and stroke.
Discussion
Recently, evidence from large-scale randomized controlled trials [17]–[19] has shown that HRT is not significantly more effective than placebo in reducing the rate of coronary events. In addition, the risk of life-threatening stroke events has been shown to increase with HRT. This comprehensive systematic review included 38908 individuals in 10 trials with a broad range of baseline characteristics. The results of our study suggest that HRT does not effect on the incidence of coronary events, myocardial infarction, cardiac death, total mortality, or revascularization. In addition, estrogen therapy alone significantly increased the risk of stroke events when compared with placebo.The relationship between HRT and coronary heart disease were described initially by observational studies [3], [26], however, the effect of HRT in reducing the risk of coronary events has not been confirmed by randomized controlled trials. The reason for this could be as follows: observational studies and randomized controlled trials may be at least partially attributable to differences in the clinical characteristics of the study populations, including differences in age, years since menopause; furthermore, the possibility that these associations mere reflect the effects of the diet or lifestyle on cardiovascular disease rates cannot be ruled out, which led us may overestimate the effect of this relationship. Therefore, we carried out a systematic review and meta-analysis based on randomized controlled trials to explain the possible effect of HRT on coronary events, and any possible drug-related adverse events.
The Central America Gynecologic Oncology Education Program (CONEP): Improving gynecologic oncology education and training on a global scale
Highlights (only)
Clinical Commentary
Highlights
- •
- 85% of cervical cancer cases occur in developing countries where it is the first or second cause of cancer-related death.
- •
- CONEP is a Central America initiative focused on education and training for the prevention and treatment of gynecologic cancers
FDA Warns Against Products From The Compounding Shop - Florida May 08, 2013
medscape
Healthcare providers should not administer any products produced by The Compounding Shop of St. Petersburg, Florida, the US Food and Drug Administration (FDA) advised today.
During a recent inspection of the facility, FDA inspectors observed "poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop's sterile drug products. Therefore, these products should not be administered to patients," according to the agency.
"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"We do not have reports of patient infections. However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients," she added.
The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers, the agency said.
The FDA advises healthcare providers and hospital staff to immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products..........
Continuing routine cardiac surveillance in long-term use of pegylated liposomal doxorubicin: Is it necessary?
Abstract
Highlights
- •
- Pegylated liposomal doxorubicin (PLD) is commonly used for long term maintenance in solid gynecologic cancers.
- •
- There are no guidelines regarding routine surveillance of LVEF in patients on PLD.
- •
- Routine surveillance of LVEF may not be indicated with the use of PLD in the absence of risk factors.
Objective
The
objective of this study was to determine the cardiac safety of high
cumulative doses of pegylated liposomal doxorubicin (PLD) in patients
with gynecologic malignancies and the need for routine evaluation of
left ventricular ejection fraction (LVEF).
Methods
Data
were collected for all patients treated with PLD with at least one
evaluation of LVEF with either Multi-Gated Acquisition (MUGA) scan or
echocardiogram from January 2006 to May 2012. Evaluation of LVEF was
used to detect PLD-related cardiac toxicity (defined as a decline in
LVEF of greater than 10% compared to baseline measurements).
Results
A total of 141 patients were included. Twenty-two patients were treated with a cumulative dose of 500 mg/m2 or more, and five patients with 1000 mg/m2
or more. Ten patients (7%) had a reduction in LVEF of greater than 10%,
38 had no significant change or increase in LVEF throughout the
duration of treatment, and 93 did not require a follow-up evaluation of
LVEF. The LVEFs of two patients dropped below 50% at cumulative doses of
1110 mg/m2 and 1670 mg/m2; one began with a baseline of 52%.
Conclusions
Only one patient had a clinically significant decrease in LVEF at a cumulative dose of 1670 mg/m2,
suggesting that PLD does not carry a significant risk of
cardiotoxicity, as evidenced by the stability of LVEF even after
treatment with large cumulative doses. Routine surveillance of LVEF does
not seem to be necessary or cost effective in the absence of other risk
factors.
Postoperative outcomes after continent versus incontinent urinary diversion at the time of pelvic exenteration for gynecologic malignancies
Abstract
Highlights
►
Complications between continent and incontinent conduits are the same
except for stone formation.
► The incidence of urinary incontinence in continent urinary diversion is 28.3%.
► The incidence of urinary incontinence in continent urinary diversion is 28.3%.
Objective
To
compare outcomes of patients undergoing continent or incontinent
urinary diversion after pelvic exenteration for gynecologic
malignancies.
Methods
Data on
patients who underwent pelvic exenteration for gynecologic malignancies
at The University of Texas MD Anderson Cancer Center between January
1993 and December 2010 were collected. A multivariate logistic
regression model was used and statistical significance was P < 0.05.
Results
A
total of 133 patients were included in this study. The mean age at
exenteration was 47.6 (range, 30–73) years in the continent urinary
diversion group and 57.2 (range, 27–86) years in the incontinent urinary
diversion group (P < 0.0001). Forty-six patients (34.6%)
had continent urinary diversion, and 87 patients (65.4%) had incontinent
urinary diversion. The rates of postoperative complications in patients
with continent and incontinent urinary diversion, respectively, were as
follows: pyelonephritis, 32.6% versus 37.9% (P = 0.58); urinary stone formation, 34.8% versus 2.3% (P < 0.001); renal insufficiency, 4.4% versus 14.9% (P = 0.09); urostomy stricture, 13.0% versus 1.2% (P = 0.007); ureteral (anastomotic) leak, 4.4% versus 6.9% (P = 0.71); ureteral (anastomotic) stricture, 13.0% versus 23% (P = 0.25); fistula formation, 21.7% versus 19.5% (P = 0.82); and reoperation because of complications of urinary diversion, 6.5% versus 2.3% (P = 0.34).
Among patients with continent urinary diversion, the incidence of
incontinence was 28.3%, and 15.2% had difficulty with
self-catheterization.
Conclusion
There
were no differences in postoperative complications between patients
with continent and incontinent conduits except that stone formation was
more common in patients with continent conduits.
Wednesday, May 08, 2013
JAMA Network: The Cochrane Collaboration Turns 20 Assessing the Evidence to Inform Clinical Care
The Cochrane Collaboration Turns 20
"....In 2010, through dogged determination, Gøtzsche and his colleagues obtained access to unpublished trials and protocols from the European Medicines Agency (EMA) for the purpose of including these unpublished data in their systematic reviews. The EMA has recommended that the US Food and Drug Administration and other drug regulatory agencies also provide such access, he said."
Medical News and Perspectives
|
May 08, 2013
"About
2 decades ago, a group of dedicated researchers set out to help
clinicians make well-informed decisions for patient care based on the
best available evidence. These early members of the Cochrane
Collaboration, an international not-for-profit organization that
celebrates its 20th anniversary this year, started the daunting task of
compiling and analyzing the thousands of studies that come out annually
in the medical literature.
Since
that time, this pioneering cadre has grown into an international
network of more than 28 000 people from more than 100 countries who sort
through the relevant randomized clinical trials (RCTs) of health care
interventions. Following a well-defined process and research methodology
to minimize bias, the reviewers synthesize the results into digestible
systematic reviews in every area of clinical care.......
Cancer survival disparities by health insurance status
Blogger's Note: ovarian cancer was not included in this study; data taken from New Jersey registry ("All first primary invasive breast, cervical, colorectal, lung, prostate, and bladder (also in situ) cancers and NHLs in the NJSCR diagnosed during 1999–2004 in persons aged 18–64 years were included.")
open access
Background
Previous
studies found that in the United States, uninsured and Medicaid insured
patients with breast, cervical, colorectal, head and neck, lung,
prostate or uterine cancer have higher mortality or lower survival than
do patients with private insurance or Medicare, even after adjustment
for other factors [1-13].
Authors of studies comparing cancer survival among Canadian residents
with U.S. residents concluded that low-income Canadians have a survival
advantage over low-income U.S. residents, probably due to Canada's
universal health care system which provides equal access to medically
necessary care [14, 15].
These and other studies also found that age, sex, race, ethnicity,
socioeconomic status (SES), marital status, stage at diagnosis,
comorbidities, behavioral risk factors, and treatment significantly
impact survival from cancer [1-25].
As substantial proportions of the U.S. population are uninsured or
enrolled in Medicaid – 48.6 million (15.7%) and 50.8 million (16.5%),
respectively, in 2011 [26], it is important to determine differential effects of health insurance on health status. We examined the association between health insurance status and
cause-specific survival from seven common cancers diagnosed in New
Jersey (NJ) residents aged 18–64 using a high-quality population-based
cancer registry and adjusting for other significant factors. We excluded
patients aged 65 or older because nearly all are insured through
Medicare. We also compared cancer survival by insurance status between
two time periods. The cancers we examined, female breast (breast),
cervical, colorectal, lung and bronchus (lung), non-Hodgkin lymphoma
(NHL), prostate and urinary bladder (bladder), accounted for 61% of the
incident cancers and 56% of cancer deaths among NJ residents during
2005–2009 [27].
To our knowledge, this is the first study of survival disparities by
insurance status to include NHL and urinary bladder cancer, as well as
changes in the relationship between health insurance status and cancer
survival over time....
Conclusions
Survival
from cancer appears to be related to a complex set of interrelated
demographic and clinical factors of which insurance status is a part......
Potential effect of the risk of ovarian cancer algorithm (ROCA) on the mortality outcome of the Prostate, Lung, Colorectal and Ovarian (PLCO) trial
Abstract
Recently, the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial reported no mortality benefit for annual screening with CA-125 and transvaginal ultrasound (TVU). Currently ongoing is the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), which utilizes the risk of ovarian cancer algorithm (ROCA), a statistical tool that considers current and past CA125 values to determine ovarian cancer risk. In contrast, PLCO used a single cutoff for CA125, based on current levels alone. We investigated whether having had used ROCA in PLCO could have, under optimal assumptions, resulted in a significant mortality benefit by applying ROCA to PLCO CA125 screening values. A best-case scenario assumed that all cancers showing a positive screen result earlier with ROCA than under the PLCO protocol would have avoided mortality; under a stage-shift scenario, such women were assigned survival equivalent to Stage I/II screen-detected cases. Updated PLCO data show 132 intervention arm ovarian cancer deaths versus 119 in usual care (relative risk, RR = 1.11). Forty-three ovarian cancer cases, 25 fatal, would have been detected earlier with ROCA, with a median (minimum) advance time for fatal cases of 344 (147) days. Best-case and stage-shift scenarios gave 25 and 19 deaths prevented with ROCA, for RRs of 0.90 (95% CI: 0.69-1.17) and 0.95 (95% CI: 0.74-1.23), respectively. Having utilized ROCA in PLCO would not have led to a significant mortality benefit of screening. However, ROCA could still show a significant effect in other screening trials, including UKCTOCS.
Ovarian tumor-derived ectopic hyperprolactinemia [Pituitary. 2012] - PubMed - NCBI
Abstract
To
describe extreme hyperprolactinemia originating from a pituitary
adenoma in the wall of an ovarian dermoid. This is a description of an
unusual case and a review of ectopic prolactin production. Ectopic
production of prolactin is a rare condition that has been reported in
isolated organ system pathology including ovaries. An ovarian dermoid is
a benign neoplasm that has the potential for active unregulated
endocrine function. Hyperprolactinemia can result from functioning
lactotrophs found in ovarian dermoids and can lead to clinical sequelae.
Definitive treatment of the condition requires surgical removal of the
functioning endocrine tissue. Extreme hyperprolactinemia caused by a
pituitary tumor located within a dermoid has not been reported before.
We present a case of profound hyperprolactinemia originating from a
pituitary adenoma found in the wall of an ovarian dermoid and give a
broad overview of the condition and literature. Ectopic prolactin
production should always be considered in symptomatic patients found to
have elevated serum levels and no findings on brain imaging.
Tubal ligation, hysterectomy, and epithelial ovarian cancer in the New England case-control study
Abstract
Previous studies have observed that tubal ligation and hysterectomy are associated with a decreased risk of ovarian cancer; however little is known about whether these associations vary by surgical characteristics, individual characteristics, or tumor histology. We used logistic regression to examine tubal ligation, simple hysterectomy, and hysterectomy with unilateral oophorectomy in relation to risk of epithelial ovarian cancer in the New England Case-Control study. Our primary analysis included 2,265 cases and 2,333 controls. Overall, tubal ligation was associated with a lower risk of epithelial ovarian cancer (OR: 0.82, 95%CI: 0.68-0.97), especially for endometrioid tumors (OR=0.45, 95%CI: 0.29-0.69). The inverse association between tubal ligation and ovarian cancer risk was stronger for women who had undergone the procedure at the time of last delivery (OR=0.60, 95%CI: 0.42-0.84) rather than at a later time (OR=0.93, 95%CI: 0.75-1.15). Overall, simple hysterectomy was not associated with ovarian cancer risk (OR: 1.09, 95%CI: 0.83, 1.42), although it was associated with a non-significant decreased risk of ovarian cancer among women who underwent the procedure at age 45 or older (RR: 0.64, 95%CI: 0.40, 1.02) or within the last 10 years (OR=0.65, 95%CI: 0.38, 1.13). Overall, women who had a hysterectomy with a unilateral oophorectomy had significantly lower risk of ovarian cancer (OR=0.65, 95%CI: 0.45-0.94). In summary, tubal ligation and hysterectomy with unilateral oophorectomy were inversely associated with ovarian cancer risk in a large population-based case-control study. Additional research is necessary to understand the potential biologic mechanisms by which these procedures may reduce ovarian cancer risk.
Nutritional status, CT body composition measures and survival in ovarian cancer
Abstract
Highlights
- •
- The role of CT body composition measures in predicting outcomes was tested in ovarian cancer patients.
- •
- CT body composition measures are independent predictors of overall survival and length of hospital stay in ovarian cancer.
- •
- Pre-operative albumin level is the strongest predictor of surgical complications.
Objective
Body
composition measures (BCMs) are an important predictor of nutritional
status in patients with cancer. Poor nutritional status is common in
ovarian cancer (OC) and is a well-known variable that influences cancer
treatment and outcome. We aim to establish the role of BCMs measured by
computed tomography (CT) in predicting outcomes in patients with OC.
Methods
We
retrospectively searched our institutional database for patients with
stage IIIC/IV OC who underwent surgery as primary treatment at Mayo
Clinic between 1996 and 2005 and had adequate presurgical CT images
available. For each patient, 1 axial CT image at the level of the 3rd
lumbar vertebra was evaluated. Adipose and lean tissues were
discriminated using commercially available software. Cox models were fit
to evaluate the relationship between patient factors and overall
survival (OS). Associations were summarized using hazard ratios (HRs)
and corresponding 95% CIs.
Results
A
total of 82 patients were identified, with a median age of 68.4 years.
OS at 1 and 5 years was 84.1% and 24.1%, respectively. Older age (P = .01), stage IV disease (P < .001), and subcutaneous and muscular fat < 77.21 cm2 (P < .001) were independently associated with poor OS. Longer hospital stay was independently predicted by albumin ≤ 3 g/dL (P = .03), suboptimal surgery (P = .02), and subcutaneous and muscular fat < 77.21 cm2 (P < .001). Surgical complications were independently predicted only by albumin ≤ 3 g/dL (P < .01).
Conclusions
CT
BCMs, as indicators of nutritional status, are independent predictors
of longer hospital stay and poor OS in patients with OC.
Abbreviations
- ASA, American Society of Anesthesiologists;
- BCMs, body composition measures;
- BMI, body mass index;
- CT, computed tomography;
- HR, hazard ratio;
- LOS, length of stay;
- OC, ovarian cancer;
- OS, overall survival;
- RD, residual disease;
- SMF, subcutaneous plus muscular fat;
- TFF, total free fat mass;
- TMM, total muscle mass;
- TWOI, total mass without intestinal content;
- VF, visceral fat
What to Look for at ASCO 2013 « OncoFacts (Gyn/ovarian cancer)
What to Look for at ASCO 2013 « OncoFacts
Gynecologic Oncology
Abstract 3 – Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: A phase III randomized trial of the GOGAbstract 5500 – Chemotherapy or upfront surgery for newly diagnosed advanced ovarian cancer: Results of the MRC CHORUS Trial
Abstract 5501 – A randomized phase III study of weekly versus every 3 week carboplatin-paclitaxel in advanced ovarian cancer: ENGOT-OV-10/GCIG trial
Abstract 5503 – Randomized, double blind, phase III trial of pazopanib versus placebo in women who have not progressed after first line chemotherapy for advanced epithelial ovarian, fallopian tube or primary peritoneal cancer
Abstract 5504 – Phase II trial of volasertib versus chemotherapy in platinum resistant ovarian cancer
Abstract 5520 – Phase II study of lenvatinib in advanced or recurrent endometrial carcinoma
Abstracts | ASCO June 2013 Annual Meeting - May 15th release date
Abstracts | ASCO Annual Meeting
The majority of the 2013 Annual Meeting abstracts will be publically released here on May 15 at 6:00 PM (EDT).
Full-text versions of Plenary, Late-Breaking, and Clinical Review Abstracts will be publically released during the Annual Meeting, on the scheduled day of their presentation.
The Mount Sinai Hospital - Google+ : World Ovarian Cancer Day/Ovarian Cancer and Us
The Mount Sinai Hospital - Google+
Thank you
+Ovarian Cancer National Alliance,
+Ovarian Cancer and Us ,
+Ovarian Cancer Alliance of Greater Cincinnati,
+Chase Powell,
+OvarianCancerAction UK
and all others that are helping in the fight against this disease.
High-level Microsatellite Instability in Appendiceal Carcinomas
abstract
High-level
microsatellite instability (MSI-high) is found in approximately 15% of
all colorectal adenocarcinomas (CRCs) and in at least 20% of right-sided
cancers. It is most commonly due to somatic hypermethylation of the
MLH1 gene promoter region, with familial cases (Lynch syndrome)
representing only 2% to 3% of CRCs overall. In contrast to CRC, MSI-high
in appendiceal adenocarcinomas is rare. Only 4 MSI-high appendiceal
carcinomas and 1 MSI-high appendiceal serrated adenoma have been
previously reported, and the prevalence of MSI in the appendix is
unknown. We identified 108 appendiceal carcinomas from MD Anderson
Cancer Center in which MSI status had been assessed by
immunohistochemistry for the DNA mismatch-repair proteins MLH1, MSH2,
MSH6, and PMS2 (n=83), polymerase chain reaction (n=7), or both (n=18).
Three cases (2.8%) were MSI-high, and 1 was MSI-low. The 3 MSI-high
cases included: (1) a poorly differentiated nonmucinous adenocarcinoma
with loss of MLH1/PMS2 expression, lack of MLH1 promoter methylation,
and lack of BRAF gene mutation, but no detected germline mutation in
MLH1 from a 39-year-old man; (2) an undifferentiated carcinoma with loss
of MSH2/MSH6, but no detected germline mutation in MSH2 or TACSTD1,
from a 59-year-old woman; and (3) a moderately differentiated mucinous
adenocarcinoma arising in a villous adenoma with loss of MSH2/MSH6
expression, in a 38-year-old man with a strong family history of CRC who
declined germline testing. When the overall group of appendiceal
carcinomas was classified according to histologic features and precursor
lesions, the frequencies of MSI-high were: 3 of 108 (2.8%) invasive
carcinomas, 3 of 96 (3.1%) invasive carcinomas that did not arise from a
background of goblet cell carcinoid tumors, and 0 of 12 (0%) signet
ring and mucinous carcinomas arising in goblet cell carcinoid tumors.
These findings, in conjunction with the previously reported MSI-high
appendiceal carcinomas, highlight the low prevalence of MSI in the
appendix as compared with the right colon and suggest that MLH1 promoter
methylation is not a mechanism for MSI in this location.
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
full text
Verified by: Tesaro, Inc., April 2013
First Received: April 11, 2013 | Last Updated: May 3, 2013
Phase: Phase 3 | Start Date: May 2013
Overall Status: Not yet recruiting | Estimated Enrollment: 360
First Received: April 11, 2013 | Last Updated: May 3, 2013
Phase: Phase 3 | Start Date: May 2013
Overall Status: Not yet recruiting | Estimated Enrollment: 360
Brief Summary
Official Title: "A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer."This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.....
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