- •Examined when women with serous ovarian cancer prefer to be offered genetic testing
- •The majority felt that the best time for genetic testing was at initial diagnosis.
- •Family history of cancer was associated with a preference for earlier testing.
Thursday, April 16, 2015
Controversies in Clinical Care: Questioning Research (Markman) 3 cancers as examples
Questioning Research
Although publication of clinical trial findings in a peer-reviewed journal is a vital step in disseminating emerging research developments, there is a critical need for all readers of oncology literature to approach these reports with a healthy degree of skepticism. Among the important questions that readers should ask are whether the conclusions are truly meaningful to patients and why the study was initiated in the first place......
Although
publication of clinical trial findings in a peer-reviewed journal is a
vital step in disseminating emerging research developments, there is a
critical need for all readers of oncology literature to approach these
reports with a healthy degree of skepticism. Among the important
questions that readers should ask are whether the conclusions are truly
meaningful to patients and why the study was initiated in the first
place.
This commentary offers examples of clinical trials where the interpretation of study results is worthy of considerable additional discussion or where justification for the actual conduct of the study can be called into question. In fact, it is not hard to find studies in the peer-reviewed oncology literature where an objective observer could lodge a serious challenge against the conclusions reached by the study investigators. - See more at: http://www.onclive.com/publications/Oncology-live/2015/march-2015/Controversies-in-Clinical-Care-Questioning-Research#sthash.d2himgx1.dpuf
This commentary offers examples of clinical trials where the interpretation of study results is worthy of considerable additional discussion or where justification for the actual conduct of the study can be called into question. In fact, it is not hard to find studies in the peer-reviewed oncology literature where an objective observer could lodge a serious challenge against the conclusions reached by the study investigators. - See more at: http://www.onclive.com/publications/Oncology-live/2015/march-2015/Controversies-in-Clinical-Care-Questioning-Research#sthash.d2himgx1.dpuf
Although
publication of clinical trial findings in a peer-reviewed journal is a
vital step in disseminating emerging research developments, there is a
critical need for all readers of oncology literature to approach these
reports with a healthy degree of skepticism. Among the important
questions that readers should ask are whether the conclusions are truly
meaningful to patients and why the study was initiated in the first
place.
This commentary offers examples of clinical trials where the interpretation of study results is worthy of considerable additional discussion or where justification for the actual conduct of the study can be called into question. In fact, it is not hard to find studies in the peer-reviewed oncology literature where an objective observer could lodge a serious challenge against the conclusions reached by the study investigators. - See more at: http://www.onclive.com/publications/Oncology-live/2015/march-2015/Controversies-in-Clinical-Care-Questioning-Research#sthash.d2himgx1.dpuf
This commentary offers examples of clinical trials where the interpretation of study results is worthy of considerable additional discussion or where justification for the actual conduct of the study can be called into question. In fact, it is not hard to find studies in the peer-reviewed oncology literature where an objective observer could lodge a serious challenge against the conclusions reached by the study investigators. - See more at: http://www.onclive.com/publications/Oncology-live/2015/march-2015/Controversies-in-Clinical-Care-Questioning-Research#sthash.d2himgx1.dpuf
Ovarian Cancer Expert (Markman) Says Olaparib Label Is Too Restrictive
Olaparib
The FDA’s recent approval of olaparib (Lynparza) for women with BRCA-mutated advanced ovarian cancer marks a significant therapeutic advance for women with the malignancy, but the specific indication is far too restrictive and the drug should be offered to many more patients, according to Maurie Markman, MD.
In fact, Markman said, clinical trial evidence indicates that some women with high-grade serous ovarian cancer who do not test positive for a BRCA mutation also may respond to olaparib, and they should have an opportunity to decide in consultation with their physicians whether the drug is appropriate for them......
The FDA’s recent approval of olaparib (Lynparza) for women with BRCA-mutated
advanced ovarian cancer marks a significant therapeutic advance for
women with the malignancy, but the specific indication is far too
restrictive and the drug should be offered to many more patients,
according to Maurie Markman, MD.
In fact, Markman said, clinical trial evidence indicates that some women with high-grade serous ovarian cancer who do not test positive for a BRCA mutation also may respond to olaparib, and they should have an opportunity to decide in consultation with their physicians whether the drug is appropriate for them. - See more at: http://www.onclive.com/web-exclusives/Expert-Says-More-Women-Should-Qualify-for-Olaparib-Than-Label-Allows#sthash.wy7W6grb.dpuf
In fact, Markman said, clinical trial evidence indicates that some women with high-grade serous ovarian cancer who do not test positive for a BRCA mutation also may respond to olaparib, and they should have an opportunity to decide in consultation with their physicians whether the drug is appropriate for them. - See more at: http://www.onclive.com/web-exclusives/Expert-Says-More-Women-Should-Qualify-for-Olaparib-Than-Label-Allows#sthash.wy7W6grb.dpuf
The FDA’s recent approval of olaparib (Lynparza) for women with BRCA-mutated
advanced ovarian cancer marks a significant therapeutic advance for
women with the malignancy, but the specific indication is far too
restrictive and the drug should be offered to many more patients,
according to Maurie Markman, MD.
In fact, Markman said, clinical trial evidence indicates that some women with high-grade serous ovarian cancer who do not test positive for a BRCA mutation also may respond to olaparib, and they should have an opportunity to decide in consultation with their physicians whether the drug is appropriate for them. - See more at: http://www.onclive.com/web-exclusives/Expert-Says-More-Women-Should-Qualify-for-Olaparib-Than-Label-Allows#sthash.wy7W6grb.dpuf
In fact, Markman said, clinical trial evidence indicates that some women with high-grade serous ovarian cancer who do not test positive for a BRCA mutation also may respond to olaparib, and they should have an opportunity to decide in consultation with their physicians whether the drug is appropriate for them. - See more at: http://www.onclive.com/web-exclusives/Expert-Says-More-Women-Should-Qualify-for-Olaparib-Than-Label-Allows#sthash.wy7W6grb.dpuf
Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results
PLOS: open access
.....The Declaration of Helsinki and other statements have outlined the compelling reasons why interventional clinical trials should be reported in a timely fashion [8–10]. In brief, not reporting clinical trial results is likely to lead to dissemination bias. This bias has the following major adverse consequences:
- It affects understanding of the scientific state of the art.
- It leads to inefficiencies in resource allocation for both research and development and financing of health interventions.
- It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.
- It potentially distorts regulatory and public health decision making.
WHO Statement on Public Disclosure of Clinical Trial Results
Wopen access
..... In the latest version of the Declaration of Helsinki it is stated that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” and that “Researchers have a duty to make publicly available the results of their research .... Negative and inconclusive as well as positive results must be published or otherwise made publicly available”. There is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past. Furthermore poor allocation of resources for product development and financing of available interventions, and suboptimal regulatory and public health recommendations may occur where decisions are based on only a subset of all completed clinical trials......
How to Get All Trials Reported: Audit, Better Data, and Individual Accountability
open access
....Delivering definitive change, however, will require more than positive statements and good intentions. The first quantitative data demonstrating publication bias in clinical trials—and clear call for trial registries—was published in 1986 [6]. Anyone withholding the methods and results of a clinical trial is already in breach of multiple codes and regulations, including the Declaration of Helsinki, various promises from industry and professional bodies, and, in many cases, the United States Food and Drug Administration (FDA) Amendment Act of 2007. Indeed, a recently published cohort study of trials in clinicaltrials.gov found that more than half had failed to post results; and even though the FDA is entitled to issue fines of $10,000 a day for transgressions, no such fines have ever been levied [3].
In the face of such slow progress, this commentary sets out some practical suggestions for auditing, performance tables, accountability, codes of conduct, and better data that should help to drive up standards and prevent trial reports being withheld from those who need them most......
The sooner the better: Genetic testing following ovarian cancer diagnosis
abstract
Highlights
Objective
As treatment based genetic testing becomes a reality, it is important to assess the attitudes and preferences of women newly diagnosed with ovarian cancer regarding genetic testing. The objective of this study was to determine when women with a diagnosis of high grade serous ovarian cancer would prefer to undergo genetic testing and factors that influence this preference.Methods
Women over 18 years of age with a known diagnosis of high grade serous ovarian cancer diagnosed between October 2010–2013 were identified via the Princess Margaret Cancer Center Registry. Participants completed a questionnaire, which obtained preferences and attitudes towards genetic testing, cancer history, and demographic information.Results
120 of the 355 women identified (33.8%) completed the questionnaires. The median age at time of ovarian cancer diagnosis was 57 years (range 35–84). The majority of participants in this study were offered (94.6%) and pursued (84.8%) genetic testing. In this cohort, testing was most frequently offered at diagnosis (41.8%) or during treatment (19.1%). In this study, women with high grade serous ovarian cancer felt that genetic testing should be offered before or at the time of diagnosis (67.8%). Having a family history of breast or ovarian cancer was significantly (p = 0.012) associated with preferring genetic testing at an earlier time point in the disease course.Conclusions
Our results demonstrate that women with high grade serous ovarian cancer acknowledge the personal and clinical utility of genetic testing and support test implementation at the time of cancer diagnosis.Breast Cancer After Use of Estrogen Plus Progestin and Estrogen Alone: Analyses of Data From 2 WHI Randomized Clinical Trials
JAMA - open access
At a Glance
- We examined influences of menopausal hormone therapy on breast cancer incidence during intervention and early and late postintervention phases in the Women’s Health Initiative trials (13 years of follow-up)
- Estrogen plus progestin use significantly increased breast cancer incidence while patients were receiving the agents, but the hazard ratio (HR) decreased when the therapy was discontinued.
- An elevated HR persisted (HR, 1.37; 95% CI, 1.06-1.77) years after stopping combined hormone therapy.
- Use of estrogen alone significantly reduced breast cancer incidence.
- For estrogen alone, the reduction of breast cancer incidence persisted throughout the early postintervention phase but was lost during the late postintervention phase (HR, 1.17; 95% CI, 0.73-1.87) (P = .03).
CONCLUSIONS
ABSTRACT | INTRODUCTION | METHODS | RESULTS | DISCUSSION | CONCLUSIONS | ARTICLE INFORMATION | REFERENCESWith longer follow-up of the 2 WHI hormone therapy trials, a complex pattern of changing year-to-year influences on breast cancer was observed. The ongoing influences on breast cancer after stopping hormone therapy in the WHI trials require recalibration of breast cancer risk and benefit calculation for both regimens, with greater adverse influence for estrogen and progestin use and somewhat greater benefit for use of estrogen alone.
A targeted analysis identifies a high frequency of BRCA1/2 mutation carriers in women with ovarian cancer from a founder population
Journal of Ovarian Research - open access
Background
The frequency of BRCA1 and BRCA2 mutations in ovarian cancer patients varies depending
on histological subtype and population investigated. The six most commonly recurring
BRCA1 and BRCA2 mutations previously identified in a founder French Canadian population
were investigated in 439 histologically defined ovarian, fallopian tube and primary
peritoneal cancer cases that were ascertained at one hospital servicing French Canadians.
To further assess the frequency of BRCA1/BRCA2 mutations, a defined subgroup of 116
cases were investigated for all mutations previously reported in this population.
Conclusions
Our results reaffirm that specific BRCA1 and BRCA2 mutations found previously to recur
in French Canadian breast cancer and breast-ovarian cancer families, also recur in
women with ovarian cancer not selected for family history of cancer. The high frequency
of mutation carriers rationalizes genetic testing of ovarian cancer patients in this
demographically defined population.
........During the course of this investigation
the Society for Gynecologic Oncology issued a clinical practice statement encouraging
the medical community to offer genetic counselling and testing to all women with ovarian,
fallopian tube and peritoneal carcinoma (www.sgo.org webcite), but The Society of Gynecologic Oncology of Canada (www.g-o-c.org webcite) has yet to propose its own recommendations......
Webinar Tues Apr 21: Lynch Syndrome: A Public Health Approach
Upcoming Webinar
Genetic Alliance Webinars offer information and discussion on a variety of topics, including hot-button issues in genetics and advocacy, public policy, and organizational development. Genetic Alliance presents a new webinar at least once a month. Visit our webinar archive for previous webinar recordings and presentations:
Lynch Syndrome: A Public Health Approach
Date: Tuesday, April 21, 2015 Time: 12:00 p.m. - 1:00 p.m. ETAppropriate management of individuals with Lynch syndrome can significantly reduce morbidity and mortality in this population. Therefore, an integrated public health approach focused on the identification of individuals with Lynch syndrome is critical to impacting health outcomes of individuals and families.
This webinar will highlight real world examples of successful programs that address Lynch syndrome, describe available screening programs and other resources related to Lynch syndrome and provide patient perspectives on the importance of identifying individuals and families with Lynch syndrome.
Introduction:
Summer L. Cox, MPH
Genetics Analyst, Public Health Division, Oregon Health Authority
Panel:
Heather Hampel, MS, LGC
Associate Director, Division of Human Genetics; Associate Director, Biospecimen Research; The Ohio State University Comprehensive Cancer Center
Jay McDaniel
Colon Cancer Survivor; Diagnosed with Lynch syndrome through a universal tumor screening
Debra Duquette, MS, CGC
Genomics Coordinator, Michigan Department of Community Health
Jan Lowery, PhD, MPH
Assistant Professor, Colorado School of Public Health
Epidemiology of ovarian cancer in North Sardinia, Italy, during the period 1992-2010
abstract
INTRODUCTION:
The aim of this study was to analyze and describe the incidence and mortality trends of ovarian cancer in North Sardinia, Italy, in the period 1992-2010.
MATERIALS AND METHODS:
Data were obtained from the tumor registry of Sassari province which makes part of a wider registry web, coordinated today by the Italian Association for Tumor Registries.RESULTS:
The overall number of ovarian cancer cases registered in the period under investigation was 600. The mean age of the patients was 62 years. The standardized incidence and mortality rates were 11.2/100,000 and 5.1/100,000 respectively. A substantially stable trend in incidence and mortality of ovarian cancer was evidenced. Relative survival at five years from diagnosis was 44.2%.CONCLUSIONS:
The incidence and mortality trends of ovarian cancer in North Sardinia remained relatively stable in the last decades, while prognosis remains relatively poor.Surgical technique of en bloc pelvic resection for advanced ovarian cancer
Blogger's Note: the abstract does not discuss the patient outcomes related to quality of life
abstract
OBJECTIVE:
The aim of this paper was to describe the operative details for en bloc removal of the adnexal tumor, uterus, pelvic peritoneum, and rectosigmoid colon with colorectal anastomosis in advanced epithelial ovarian cancer patients with widespread pelvic involvement.METHODS:
The patient presented with good performance status and huge pelvic tumor extensively infiltrating into adjacent pelvic organs and obliterating the cul-de-sac. The patient underwent en bloc pelvic resection as primary cytoreductive surgery. En bloc pelvic resection procedure is initiated by carrying a circumscribing peritoneal incision to include all pan-pelvic disease within this incision. After retroperitoneal pelvic dissection, the round ligaments and infundibulopelvic ligaments are divided. The ureters are dissected and mobilized from the peritoneum. After dissecting off the anterior pelvic peritoneum overlying the bladder with its tumor nodules, the bladder is mobilized caudally and the vesicovaginal space is developed. The uterine vessels are divided at the level of the ureters, and the paracervical tissues (or parametria) are divided. The proximal sigmoid colon is divided above the most proximal extent of gross tumor using a ligating and dividing stapling device. The sigmoid mesentery is ligated and divided including the superior rectal vessels. The pararectal and retrorectal spaces are further developed and dissected down to the level of the pelvic floor. The posterior dissection is progressed and moves to the right and then to the left of the rectum. The rectal pillars including the middle rectal vessels are ligated and divided. Hysterectomy is completed in a retrograde fashion. The distal rectum is divided using a linear stapler. The specimen is removed en bloc with the uterus, adnexa, pelvic peritoneum, rectosigmoid colon, and tumor masses leaving a macroscopically tumor-free pelvis. Colorectal anastomosis was completed using stapling device.RESULTS:
En bloc pelvic resection was performed by total abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic peritonectomy, and rectosigmoid colectomy with colorectal anastomosis using a stapling device. Complete clearance of pelvic disease leaving no gross residual disease was possible using en bloc pelvic resection.CONCLUSION:
En bloc pelvic resection is effective for achieving maximal cytoreduction with the elimination of the pelvic disease in advanced primary ovarian cancer patients with extensive pelvic organ involvement.Major clinical research advances in gynecologic cancer in 2014 (Korea)
abstract
In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review.
Prognostic significance of lymphovascular space invasion in epithelial ovarian cancer - early vs advanced stages
abstract
OBJECT:
To assess the effects of lymphovascular space invasion (LVSI) on cancer recurrence and survival in patients with primary epithelial ovarian cancer.METHODS:
A retrospective study was conducted of patients with stage I-IV primary epithelial ovarian cancer who underwent cytoreductive surgery. LVSI is defined as the presence of tumor cells within an endothelium-lined space, and the patients' pathologic slides were reevaluated by gynecological pathologists. Survival analysis was performed to compare risk factors.RESULTS:
A total of 492 patients were included in the analysis. The incidence of LVSI was 58.5% in our cohort (288 cases), and it was significantly associated with advanced stage, high-grade serous histology, high grade, and lymph node metastasis (P<0.001). Kaplan-Meier analysis demonstrated that LVSI was only correlated with decreased PFS (5-year rate, 39% vs. 66%, P<0.001) and OS (5-year rate, 44% vs. 78%, P<0.001) in patients at early stage but not at advanced stage (5-year rate, PFS: 14% vs. 11%, P<0.001; OS: 29% vs. 29%, P=0.141). Multivariate analysis showed that LVSI remained a significant variable with PFS and OS in early-stage ovarian cancer (PFS: HR 2.29, 95% CI 1.45-3.57; OS: HR 2.20, 95% CI 1.59-3.44, both P<0.001).CONCLUSION:
LVSI is an independent predictor of progression and survival in patients with primary epithelial ovarian cancer at early stage but not at advanced stage.A primary retroperitoneal mucinous tumor
Abstract
A twenty-five-year-old female presented with a large retroperitoneal mass. Workup included history and physical exam, imaging, biopsy, colonoscopy, and gynecologic exam. After surgical resection, the mass was determined to be a primary retroperitoneal mucinous tumor (PRMT). Clinically and histologically, these tumors are similar pancreatic and ovarian mucinous neoplasms. PRMTs are rare and few case reports have been published. PRMTs are divided into mucinous cystadenomas, mucinous borderline tumors of low malignant potential, and mucinous carcinoma. These tumors have malignant potential so resection is indicated and in some cases adjuvant chemotherapy and/or surveillance imaging.
Cancer Gene Tests Should Include Healthy Tissue, Too: Study - Drugs.com MedNews
Drugs.com MedNews
WEDNESDAY April 15, 2015, 2015 -- If genetic tests are only done on cancer tissue, as many as half of patients may not receive the most appropriate treatment for their cancer, a new study reports.
Cancer doctors increasingly rely on genetic testing to look for opportunities to use treatments that target specific genetic causes of cancer -- called targeted therapy.
But doctors often examine just the genetics -- or DNA -- of a patient's cancerous tissue, and don't compare it against a genetic analysis of normal tissue, explained study senior author Dr. Victor Velculescu. He is a professor of oncology and pathology at Johns Hopkins University School of Medicine, and co-director of the school's Cancer Biology Program.....
http://ovariancancerandus.blogspot.com/feeds/posts/default
Wednesday, April 15, 2015
Patient Perception of Physician Compassion After a More Optimistic vs a Less Optimistic Message: A Randomized Clinical Trial
JAMA Network (open access)
At a Glance
- Better compassion scores were given to physicians delivering a more optimistic vs less optimistic message.
- Physicians delivering the more optimistic message were ranked as more trustworthy.
- Effort to structure less optimistic message content to support health care professionals in delivering bad news is needed.
Information regarding treatment options and prognosis is essential for patient decision making at the end of life. Patients report the need to access this information to make a decision about future planning.1 When this information is delivered appropriately, it can have a positive impact on the patient and promote patient reassurance.2- 7 The timing, amount, and quality of the information provided should be tailored to patients’ specific needs, given that information preferences vary among patients and along the disease trajectory.2,5,6,8- 11.....
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