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Tuesday, October 25, 2016

open access: (review) Major clinical research advances in gynecologic cancer in 2015



JGO :: Journal of Gynecologic Oncology
 J Gynecol Oncol. 2016 Oct;27
In 2015, fourteen topics were selected as major research advances in gynecologic oncology. For ovarian cancer, high-level evidence for annual screening with multimodal strategy which could reduce ovarian cancer deaths was reported. The best preventive strategies with current status of evidence level were also summarized. Final report of chemotherapy or upfront surgery (CHORUS) trial of neoadjuvant chemotherapy in advanced stage ovarian cancer and individualized therapy based on gene characteristics followed. There was no sign of abating in great interest in immunotherapy as well as targeted therapies in various gynecologic cancers. The fifth ovarian cancer consensus conference which was held in November 7–9 in Tokyo was briefly introduced..... 

Table 1. Fourteen topics of major clinical research advances in gynecologic cancer in 2015
 
Site of cancer Topic Reference
Ovary 1. Prevention and screening of ovarian cancer [2, 4, 5, 12]
2. Update of neoadjuvant chemotherapy in ovarian cancer: right therapy to right person [15]
3. Personalized therapy for the best possible chance of survival in ovarian cancer [21, 22, 23, 24]
4. Fifth Ovarian Cancer Consensus Conference in Tokyo
5. Immunotherapy update: anti-PD-1/PD-L1 antibody in ovarian cancer [25, 26]
Uterine cervix 6. HPV vaccine update: two dose, 9-valent, therapeutic vaccine [28, 36, 42]
Uterine corpus 7. Old age as a reason for abandoning power morcellation in presumed fibroids [43, 44, 45]
8. Hormone therapies and endometrial cancer risk [48, 49]
9. Trabectedin: another FDA-approved option for leiomyosarcoma [56]
10. Endometrial cancer and Lynch syndrome [58, 59]
11. Radiation therapy in endometrial cancer: ESMO-ESGO-ESTRO consensus conference guidelines [63, 64, 65]
Others 12. Vulvar cancer adjuvant therapy [71]
13. Targeted therapy update in gynecologic cancer

1) Update of anti-angiogenic drugs in ovarian cancer [74, 75, 76]

2) Other promising targeting agents in ovarian cancer [81, 82, 84, 85]

3) Update of targeted therapy in cervical and endometrial cancer [88, 90, 91]
Female breast 14. Breast cancer

1) Palbociclib in hormone-receptor-positive advanced breast cancer [93]

2) Oncotype DX Recurrence Score in low-risk breast cancer [97]

3) Regional nodal irradiation to internal mammary, supraclavicular, and axillary lymph nodes in breast cancer [98, 99]

4) Cavity shave margins in breast cancer [100]
  ESGO, European Society of Gynecologic Oncology; ESMO, European Society of Medical Oncology; ESTRO, European Society for Radiotherapy and Oncology; FDA, the Food and Drug Administration; HPV, human papillomavirus; PD-1, programmed cell death protein-1; PD-L1, programmed cell death protein-ligand 1.

triage - definition (s) in practice or theory?



triage 

  tri·age trēˈäZH,ˈtrēˌäZH/
noun noun: triage
  1. 1.
    (in medical use) the assignment of degrees of urgency to wounds or illnesses to decide the order of treatment of a large number of patients or casualties.
    • the process of determining the most important people or things from amongst a large number that require attention.
verb
verb: triage; 3rd person present: triages; past tense: triaged; past participle: triaged; gerund or present participle: triaging
  1. 1.
    assign degrees of urgency to (wounded or ill patients).

New: Ovarian Cancer Research Fund Alliance + notice of 2017 conference



Ovarian Cancer Research Fund Alliance

 link to:

Associations of Premenopausal Hysterectomy and Oophorectomy With Breast Cancer Among Black and White Women (North Carolina)



Medscape
 Associations of Premenopausal Hysterectomy and Oophorectomy With Breast Cancer Among Black and White Women: The Carolina Breast Cancer Study, 1993–2001

 In the present study, our objective was to assess the association between premenopausal gynecologic surgeries and risk of breast cancer in a population-representative sample of black and white women living in the US South, a region in which hysterectomy rates are particularly high.[1,13,21] We examined whether associations differed by race, breast cancer hormone-receptor status, or use of MHT.
  In summary, this research adds further evidence that premenopausal hysterectomy and oophorectomy may reduce the long-term risk of breast cancer. Further, the higher prevalence of premenopausal surgery among black women indicates that these surgeries could be an important contributor to race-specific trends in breast cancer incidence. Historically higher rates of premenopausal hysterectomy and oophorectomy may have transiently lowered breast cancer rates among black women. As hysterectomy rates decline, breast cancer incidence may increase among older black women and in the US South, a trend that has been observed in recent surveillance.[34,37] Monitoring the long-term effects of changing clinical practice in gynecologic surgery may inform strategies to mitigate the growing breast cancer burden among US black women.

Review: Early Detection of Ovarian Cancer with Transvaginal Microbubble Sonography: Current and Potential Applications



pdf open access

Abstract
Contrast Enhanced microbubble Transvaginal Sonography (CE-TVS) can distinguish benign and malignant ovarian tumors. Initial results from several medical centers around the world have indicated that there are unique enhancement patterns in ovarian neoplasms. Challenges to the implementation of CE-TVS remain since some
aggressive ovarian tumors (type 2) that arise in the tubal epithelium and metastasize without producing a clinically detectable mass may be difficult to detect. This is being addressed through the use of labelled microbubbles which
can detect rapidly growing tumor vessels. As shown in an avian model, labelled microbubbles can be used to detect neoplastic vessels associated with tumor neoangiogenesis. This has been achieved in vitro by fabrication of microbubbles that have antibody attached to the lipid coat. In this manner, microscopic tumors that arise in the tubal epithelium might be detected in patients. This short communication describes the potential for contrast enhanced sonography to provide a means for early detection of ovarian cancer.

Summary
Whether the addition of CE-TVS in screening/early detection
programs could further the long-term survival of screened women
awaits further investigation. With that said, CE-US is probably best
suited as a secondary test after a "liquid biopsy" and/or an initial
morphologic assessment of the lesion with standard morphologic TVS
identifies women at risk. The basis for optimism concerning the use of
CE-TVS for the early detection of ovarian cancer is substantiated and
this author encourages further multicenter investigation.

Monday, October 24, 2016

Cochrane: Short-term and long-term effects of tibolone in postmenopausal women + comments



New Articles

 Formoso G, Perrone E, Maltoni S, et al. Short-term and long-term effects of tibolone in postmenopausal women. Cochrane Database Syst Rev. 2016 Oct 12;10:CD008536. (Review) PMID: 27733017

Read Abstract Read Comments
DISCIPLINERELEVANCE TO PRACTICEIS THIS NEWS?
General Internal Medicine-Primary Care(US)
General Practice(GP)/Family Practice(FP)
Gynecology



Comments from Clinical Raters
General Practice(GP)/Family Practice(FP)
It is very good to have this meta-analysis information about tibolone vs placebo & vs other forms of HRT.
General Practice(GP)/Family Practice(FP)
As a family physician with menopause affecting half of my patient population, I believe this is important to know. My understanding is that because tibolone 2.5 is an equivalent to a low dose of hormone replacement, therefore, it not likely to control symptoms in the perimenopause. Its main use is for women who are postmenopausal, that is, whose last natural period was more than two or perhaps even five years ago, for whom a lower dose of hormone is often sufficient to help any remaining symptoms. This review does not seem to discuss this aspect.
                           ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Plain language summary

Cochrane Database: Plain language summary

Short-term and long-term effects of tibolone in postmenopausal women
Review question
Cochrane review authors aimed to evaluate the effectiveness and safety of tibolone for treatment of postmenopausal and perimenopausal women.
Background
Tibolone is an available option for the treatment of menopausal symptoms, and short-term data suggest its efficacy. However, healthcare providers must consider the balance between benefits and risks of tibolone, as concerns have arisen about breast and endometrial cancer and stroke.
Study characteristics
We included 46 randomised controlled trials (RCTs), which included 19,976 postmenopausal women. Most studies evaluated tibolone for treatment of menopausal vasomotor symptoms. Some studies reported other objectives: Four RCTs aimed to assess endometrial safety, four bleeding patterns, five bone loss or fracture prevention, one sexual outcomes and three safety in women with a history of breast cancer; two studies examined use of tibolone in women with fibroids or lupus erythematosus. The evidence is current to October 2015.
Key results
Moderate-quality evidence suggests that tibolone is more effective than placebo and less effective than combined hormone therapy (HT) in reducing vasomotor symptoms in postmenopausal women. Data suggest that if 67% of women taking placebo experience vasomotor symptoms, then between 35% and 45% of women taking tibolone will do so; and if 7% of women taking combined HT experience vasomotor symptoms, then between 8% and 14% of women taking tibolone will do so. Moderate-quality evidence also suggests that tibolone is associated with a higher rate of unscheduled bleeding than placebo, but a lower rate than HT.
Compared with placebo, tibolone increases the risk of recurrent breast cancer in women with a history of breast cancer, and may increase the risk of stroke in women over 60 years of age. No evidence suggests that tibolone increases the risk of other serious adverse events, and no evidence shows differences between tibolone and HT with respect to long-term adverse events. Nearly all evidence on adverse events was of very low quality, and reported events were scarce.
Quality of the evidence
Much of the evidence obtained was of low or very low quality. Limitations included high risk of bias in the included trials, very low event rates and potential conflicts of interest. Twenty-six of the studies were financed by drug manufacturers, and another 14 studies failed to disclose their source of funding.

Sunday, October 23, 2016

Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study



Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study  Full Text
 
While international policies suggest that there may be an ethical duty of care to communicate individual genetic research results if certain conditions are met [8], there is a lack of agreement in guidance between countries [9], and the potential benefits or harm of sharing non-accredited research results requires further evaluation [10].

Background

There are numerous arguments in favor of individual genetic research results being communicated to study participants, including the right of the participants to receive potentially important research information about themselves and the possible benefit from clinically actionable findings to both participants and their families [1]. Indeed, research has shown that most research participants are interested in receiving their genomic research results [2] and that this interest extends to participants in different countries [3]. Arguments against communicating individual results include the fact that the significance of the genetic research results may be uncertain and that there may be a potential for participants to misinterpret their results or make ill-informed treatment decisions [4], unless they receive genetic counselling and their results are confirmed in clinically accredited laboratories. Many countries have ethics guidelines recognizing that exploratory genetic results may have limited clinical utility; while in some other countries regulation provides participants with the right to access their individual results [5]. In the United States, where there is no explicit legal requirement to return genetic research findings [6], the American College of Medical Genetics and Genomics suggested that pathogenic mutations in 56 specified genes should be returned to patients undergoing clinical exome and genome sequencing [7], a position that has further added to the debate on whether similar recommendations are required in the genetic research setting....

Conclusion
This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results.

Trial registration

This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees (Additional file 1).

BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18–30 years) exposed to a high familial breast/ovarian cancer risk



BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18–30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial | Trials | Full Text

link to clinical trial  BRACAVENIR
 Trial status: The trial was not started when this article was written (October 18th, 2016).
In parallel, these young women stand in the cross fire of an abundance of contradictory information spread by the media, websites, or internet forums. The rapid evolution of medicine adds to this cacophony in terms of possible prophylactic surgery, assisted procreation, embryo selection, and gene therapies, with discordant voices between specialists, even in Western countries. Unfortunately, prophylactic interventions directly address the intimate sphere of these young women who are still maturing.

 Finally, we as yet have no idea how our proposal will be perceived by our young asymptomatic women. The rate of refusal and the reasons by which they will justify their not entering the study will be analyzed and will help us develop better prevention strategies for the youngest counselees. One of the purposes of this phase II trial is to verify the feasibility and acceptability of the intervention to participants, evaluate its effect size on the various scales, and prepare a larger national phase III trial based on a more solid hypothesis. The acceptability is of major importance, and a better definition of the young population that we target may need some adjustments. In particular, the birth of one child does not eliminate worries regarding new procreation projects; perhaps it even increases them as questions about the long-term security of the child (Will I live long enough to ensure his future?) are suddenly raised by his arrival. So, the inclusion criteria of our pilot study will probably need to be widened in a further trial to include young women facing more concretely not only the transmission dilemma of their mutation but also familial existential issues.

3 Questions on...Perceptions About Palliative Care Across the Globe



Oncology Times
 

1 What would you say are the key findings from this research? And were you surprised by the findings?

2 What should practicing oncologists (in any country) know about this research?

3 How will you continue this research? What are the next steps?

Colorado Ovarian Cancer Resource Guide (free)



Colorado Ovarian Cancer Resource Guide
  Table of Contents
Download PDF chapters

The information and listings provided in this guide should not be construed as an endorsement or recommendation by the Colorado Ovarian Cancer Alliance. The content is for informational purposes only. Colorado Ovarian Cancer Alliance does not provide medical advice or endorse providers of medical services.
The information presented in this guide is not intended in any way to be a substitute for medical advice or professional counseling. Please always include your health care providers in any decisions you make regarding changes in nutrition, exercise routine, and before you include complementary, alternative or integrative care into your treatment regimen.
Sources are cited for information, and the descriptions of services are from the websites of those businesses or nonprofits included herein.
While we have tried to include many listings, we were unable to include everything. Please forgive any important omissions or errors, and contact us if you have any corrections: 303.506.7014.

open access: Outcome of ovarian cancer after breast cancer in BRCA1 and BRCA2 mutation carriers



open access

Table 1. Patient, tumour and treatment characteristics of OC in BRCA1/2 patients with and without a history of BC

Histology:
Serous
Mucinous
Endometrioid
Clear cell
Undifferentiated
Adenocarcinoma
Other
Unknown

The results of this study underline the importance of offering
genetic testing to BC patients being at risk of BRCA1/2 mutation
carriership. Newly diagnosed mutation carriers can then be
informed about risk reducing salpingo-oophorectomy, which has
been associated with improved survival (Finch et al, 2014). Further,
we suggest that studies on survival in BRCA1/2-associated EOC
should stratify for BC history.

(worth reading) Impaired Quality of Death Not necessarily a result of toxic and ineffective chemotherapy



Editorial
 
Newspapers in July 2015 were filled with reports about second-line chemotherapy impairing the quality of the last week of life for cancer patients. The basis of the reports was the multicenter CwC1 (Coping with Cancer 1) study that associated impaired quality of death (QOD) with prior administration of second-line chemotherapy.1 These reports are misleading because although there are many reasons not to administer toxic and ineffective therapy, impaired quality of the last week of life is one of the lesser ones; the relationship between such therapy and impaired QOD likely is an association, not a cause-and-effect relationship.
The authors asked primary caregivers (family member or life partner in about 97% of the cases) within a few weeks after a patient’s death to rate the quality of the last week of the patient’s life. After dividing the responses at the median score, they found more responses below the median among caregivers of patients who had received second-line chemotherapy for a variety of common epithelial cancers.
Rather than being cause and effect, this finding most likely is a result of the association of use of second-line chemotherapy—which in 2002 to 2008, when the study accrued, was largely toxic and ineffective—with an aggressive posture toward aggressive care at the end of life that prolongs suffering and impairs the dignity of both patient and family.

In another report based on the CwC1 cohort, the authors reported an increased frequency of end-of-life hospitalizations and futile interventions, such as resuscitations, mechanical ventilation, and intensive care among patients subjected to second-line chemotherapy.2 These futile and unpleasant interventions are likely what caused the impaired QOD, not the ineffective and toxic chemotherapy given months earlier. Although I do not wish to advocate for toxic and ineffective second-line chemotherapy, this therapy given a median of 3.5 months before death is not what impaired the family’s recollection of the patient’s last week. The futile and unpleasant interventions that were chosen by the patients, families, and physicians are what did that!......

Saturday, October 22, 2016

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Novel BRCA1 and BRCA2 Tumour Test as Basis for Treatment Decisions and Referral for Genetic Counselling of Patients with Ovarian Carcinomas - Weren - Human Mutation - Wiley Online Library



 open access pdf (technical)

 For the evaluation of our approach 127 ovarian tumour samples derived from 96 271 patients were tested: 29 with a BRCA1, 14 with a BRCA2 and 53 without a germline mutation 272 in either gene.
 Histology review of the ovarian carcinomas
Histology revision by an expert pathologist revealed that 83% of the carcinomas derived from germline mutation carriers had a high grade serous histology (n=35). The other patients with a germline mutation in BRCA1 or BRCA2 presented carcinomas with a mixed (n=2), high grade endometrioid (n=1), clear cell (n=1) and poorly/undifferentiated (n=3) histology (Supp. Table S6a)......
abstract:
Novel BRCA1 and BRCA2 Tumour Test as Basis for Treatment Decisions and Referral for Genetic Counselling of Patients with Ovarian Carcinomas
 
With the recent introduction of Poly(ADP-ribose) polymerase (PARP) inhibitors, a promising novel therapy has become available for ovarian carcinoma patients with inactivating BRCA1 or BRCA2 mutations in their tumour. To select patients who may benefit from these treatments, assessment of the mutation status of BRCA1 and BRCA2 in the tumour is required. For reliable evaluation of germline and somatic mutations in these genes in DNA derived from formalin-fixed, paraffin-embedded (FFPE) tissue, we have developed a single molecule molecular inversion probe (smMIP)-based targeted next generation sequencing (NGS) approach. Our smMIP-based NGS approach provides analysis of both strands of the open-reading frame of BRCA1 and BRCA2, enabling the discrimination between real variants and formalin induced artefacts. The single molecule tag enables compilation of unique reads leading to a high analytical sensitivity and enabling assessment of the reliability of mutation-negative results. MLPA and MS-MLPA were used to detect exon deletions of BRCA1 and methylation of the BRCA1 promoter, respectively. Here, we show that this combined approach allows the rapid and reliable detection of both germline and somatic aberrations affecting BRCA1 and BRCA2 in DNA derived from FFPE ovarian carcinomas, enabling improved hereditary cancer risk assessment and clinical treatment of ovarian cancer patients.

Prevalence of Lynch syndrome in unselected patients with endometrial or ovarian cancer (+ dual malignancies)



abstract (German)

INTRODUCTION:

Lynch syndrome is known by healthcare providers mainly for patients with colorectal cancer. Awareness of other associated tumors, such as endometrial or ovarian cancer, is low. This study aimed to analyze the prevalence of Lynch syndrome in unselected patients with endometrial or ovarian cancer. In addition, the willingness of patients and family members to undergo germline mutation testing was investigated.

METHODS:

The medical records of all patients diagnosed with endometrial or ovarian cancer at the Department of Gynecology and Obsterics, University Hospital Dresden, between 1998 and 2012, were screened for a family history of HNPCC-associated cancer. Telephone interviews were used to screen, inform, and enroll patients in this genetic analysis study. Molecular analysis was performed by prescreening of tumor tissue, followed by germline mutation analysis.

RESULTS:

Two hundred and eighty-three patients were diagnosed with endometrial cancer, 291 with ovarian cancer, and 14 with both. A positive family history for tumors associated with Lynch syndrome was documented for 61 patients. Two pathogenic mutations in the genes MLH1 and MSH2 in nine genetic analyses had already been detected before. After genetic counseling, only 10 of 31 index patients (32.3 %) consented for mutation analysis. However, no additional pathogenic heterozygous mutations were found.

CONCLUSION:

In this retrospective cohort study in unselected patients with endometrial or ovarian cancer, only a small number of patients with suspected Lynch syndrome could be identified. Of those, acceptance of germline analyses was moderate, only. As a result, the rate of identified pathogenic germline mutations was lower than expected. Therefore, we are convinced that more information on cancer risks, options for predictive molecular testing and preventive procedures, needs to be provided to patients and gynecologists.


Survival Outcome and Risk of Metachronous Colorectal Cancer After Surgery in Lynch Syndrome



(Stedman's)  metachronous - Not synchronous; multiple separate occurrences, such as multiple primary cancers developing at intervals.

abstract (Korea)

BACKGROUND:

The survival benefit of extensive colectomy is controversial in Lynch syndrome, and risk factors for metachronous colorectal cancer (CRC) after segmental colectomy are unclear.

OBJECTIVE:

The aim of this study was to investigate the survival outcome and risk of metachronous CRC after surgery in Lynch syndrome patients diagnosed with their first CRC.

METHODS:

Overall, 106 patients with Lynch syndrome who underwent surgery for CRC were included in the study. The demographics, genotype, clinicopathological characteristics of the index CRC, and follow-up data were reviewed from a single-institution Lynch syndrome database.

RESULTS:

Of 30 patients who underwent extensive surgery, no metachronous CRC was developed during a mean follow-up of 68.1 months. Of 76 patients who underwent segmental colectomy, 13 (17.1 %) developed metachronous CRC during a mean follow-up of 77.2 months. The cumulative risk of metachronous CRC was 8.4 % at 5 years and 20.4 % at 10 years after segmental colectomy. No difference in overall and CRC-specific survival was observed between segmental colectomy and extensive colectomy (p = 0.277 and p = 0.659, respectively). A 25 cm or longer resection of bowel decreased the risk of metachronous CRC after segmental colectomy compared with less extensive resection (hazard ratio 0.10, 95 % confidence interval 0.01-0.86). Annual surveillance colonoscopy did not decrease the risk of metachronous CRC compared with less frequent surveillance colonoscopy. Although not statistically significant, none of the MSH6 gene mutation carriers were diagnosed with metachronous CRC.

CONCLUSIONS:

Although no survival benefit was identified, surgeons and patients might consider extensive colectomy to prevent metachronous CRC in Lynch syndrome patients regardless of their clinicopathological characteristics.