Outcome of neoadjuvant chemotherapy in BRCA1/2 mutation positive women with advanced stage Müllerian cancer

abstract

Highlights

• •Patients with germline BRCA mutations had improved outcomes with NAC compared to patients with unknown BRCA status.
• •The outcomes of NAC in BRCA mutation positive patients were more favorable than the outcomes reported in the literature.
• •This is the first study evaluating the outcome of NAC in BRCA mutation positive patients with advanced-stage mullerian cancer.

Objectives

To investigate whether patients with germline BRCA1/2 mutations who received neoadjuvant chemotherapy (NAC) for advanced stage Mullerian cancer (MC) have an improved outcome compared to patients who did not undergo genetic testing.

Methods

Three hundred and two patients who received NAC for stage III-IV MC were identified from a multi-institutional study involving Cleveland Clinic and Brigham and Women’s Hospital for 2000–2014 and 2010–2014 respectively. Patients were divided into 3 cohorts: patients with germline BRCA 1/2 mutations (BRCA_mut+; N = 30), patients with no genetic testing (BRCA_unk; N = 166) and patients with negative genetic testing (BRCA mut-, N = 106).

Results

There were no differences in the clinical characteristics and rates of complete cytoreduction and bowel resection between the three groups. BRCA_mut + had longer PFS compared to BRCA_unk and BRCA_mut- (19.1 vs. 15.1 vs. 15.7 months respectively. However, this difference was not statistically significant (p = 0.48). Patients with BRCA 2 mutation had non-significant trend toward longer PFS compared to patients with unknown BRCA or BRCA 1 mutation (20.2 vs. 15.1 vs. 14.8 months respectively, p = 0.58). BRCA-mut + and BRCA_mut-had longer overall survivals (OS) compared to BRCA_unk patients (50.5 vs. 54.1 vs. 36.5 months respectively, p = 0.009). In multivariable analyses, controlling for age, stage and complete cytoreduction, BRCA_mut_unk was associated with worse PFS (HR 1.44, 95% CI 1.01-2.05, p = 0.045) and OS (HR 2.67, 95% CI 1.33-5.36, p = 0.006).

Conclusions

Patients with germline BRCA mutations had improved outcomes with NAC compared to patients with unknown BRCA status. These outcomes were more favorable compared to the outcome of NAC in prior studies.

Ascites predicts treatment benefit of bevacizumab in front-line therapy of advanced epithelial ovarian, fallopian tube and peritoneal cancers: An NRG Oncology/GOG study

Abstract

Highlights

• •
  We analyzed data from GOG 0218 to determine if ascites predicts response to bevacizumab.
• •
  Ascites was shown to be a negative prognostic factor in epithelial ovarian cancers.
• •
  Ascites is a significant clinical factor that may predict response to bevacizumab.

Objectives

Predictive factors for efficacy of bevacizumab in advanced ovarian cancer have remained elusive. We investigated ascites both as a prognostic factor and as a predictor of efficacy for bevacizumab.

Methods

Using data from GOG 0218, patients receiving cytotoxic therapy plus concurrent and maintenance bevacizumab were compared to those receiving cytotoxic therapy plus placebo. The presence of ascites was determined prospectively. Chi-square and Wilcoxon–Mann–Whitney tests compared baseline variables between subgroups. Survival was estimated by Kaplan–Meier method, and Cox proportional hazard models were used to evaluate independent prognostic factors and estimate their covariate-adjusted effects on survival.

Results

Treatment arms were balanced with respect to ascites and other prognostic factors. Overall, 886 (80%) women had ascites, 221 (20%) did not.

Postoperative hormone replacement therapy for epithelial ovarian cancer patients: a systematic review and meta-analysis - Gynecologic Oncology

abstract
 

Highlights

• •This is the first meta-analysis on the effect of HRT on prognosis and recurrence of EOC survivors.
• •Postoperative HRT use is not associated with poorer clinical outcomes of EOC patients.

Background

. Hormone replacement therapy (HRT) has been proven highly effective for menopausal symptoms caused by radical surgery. However, the impact of postoperative HRT on the clinical outcomes of patients previously treated for epithelial ovarian cancer (EOC) remains unclear.

Objective

. To determine whether postoperative HRT use has any positive or negative impacts on prognosis and recurrence among EOC survivors.

Methods

. Studies that provided an assessment of postoperative HRT use and prognosis or recurrence in EOC patients were included for analysis. Two reviewers independently evaluated the eligibility of identified studies and abstracted the data. A fixed effects model was used to pool study-specific estimates of hazard ratios (HRs) or relative risks (RRs) with 95% confidence intervals (CIs).

Results

. Two randomized controlled trials (RCTs) and four cohort studies included 419 EOC survivors who used HRT and 1,029 non-users. The aggregated HR of overall survival (OS) suggested that HRT use after surgery for EOC had a favorable impact on OS (HR = 0.69, 95% CI: 0.61–0.79), but when these studies were categorized into cohort study and RCT subgroups, not all of them demonstrated positive results (HR = 0.63, 95% CI: 0.49–0.81 and HR = 1.03, 95% CI: 0.58–1.83, respectively). The meta-analysis of EOC recurrence of three available studies demonstrated that postoperative HRT use was not associated with an increased risk of recurrence in EOC survivors (RR = 0.83, 95% CI: 0.64–1.07). This pattern also emerged in the subgroup analysis for the stage and type of HRT.

Conclusions

. In EOC patients, postoperative HRT does not have a negative effect on overall survival and tumor recurrence. However, well-designed and large-scale RCTs are needed to verify this relationship in the future.

Keywords:

Hormone replacement therapy, Epithelial ovarian cancer, Overall survival, Recurrence, Meta-analysis

Setting the bar: compliance with ovarian cancer quality indicators at a NCI-designated Comprehensive Cancer Center

abstract
 

Highlights

• •Appropriate quality indicator thresholds must take into account our complex patients
• •Complete surgical staging and timely administration of chemotherapy warrant attention
• •Existing perioperative quality measures demonstrate excellent compliance

Objectives

Ovarian cancer quality measures are being developed to improve health care delivery and outcomes. Our objective is to evaluate compliance with 8 quality indicators proposed by the Society of Gynecologic Oncology.

Methods

Review of 123 ovarian cancer patients who underwent primary surgical staging/cytoreduction and chemotherapy from 2010–2012 was undertaken. Medical records were reviewed, and descriptive statistics were performed to determine compliance.

Results

A timely operative report documenting residual disease was dictated for 121/123 (98.4%) patients. Complete surgical staging was performed in 33/55 (60.0%) stage I-IIIB patients, with lymphadenectomy most frequently omitted. For optimally debulked stage III patients, 52/56 (92.9%) were offered intraperitoneal chemotherapy. Ultimately, 29/56 (51.8%) received this route and 19/56 (33.9%) within 42 days (range 18–48, median 40 days). Clinical trial randomization and co-morbidities accounted for most cases of non-compliance. All 105 patients for whom chemotherapy was indicated received platin/taxane therapy, and 79/105 (75.2%) within 42 days (range 4–82, median 37 days). Venous thromboembolism prophylaxis was provided mechanically in 122/123 (99.2%) and pharmacologically in 99/123 (80.5%) patients within 24 hours of surgery. Prophylactic parenteral antibiotics were administered within 60 minutes of cytoreduction in 119/123 (96.7%) and discontinued within 24 hours after surgery in 120/123 (97.6%) cases.

Conclusions

Compliance with strict definitions of ovarian cancer quality indicators varies depending on the care delivered and documentation of that care. Increased attention to comprehensive surgical staging and timely initiation of chemotherapy appears warranted. With the move toward value-based payment models, quality indicators will play a significant role in health care delivery.

Biobank consent models – are we moving toward increased participant engagement in biobanking?

open access

 Abstract: Engagement, involvement, and active participation are buzzwords used in today's ethical debate on research biobanking. There are a variety of context-sensitive governance frameworks for research biobanks. However, many biobanks, especially large-scale population-based ones, seem to endorse a framework of broad consent, participation with minimal or no ongoing engagement, and no return of results. An alternative vision of involvement and active participation in this type of research has become increasingly visible in the literature. The problem, seen from the biobankers' perspective, is that the alternative vision might be costly, cumbersome, and risky, while the prevailing system for governance will maximize the scientific value of the biobank with minimal ethical, legal, and social efforts. Therefore, solid and convincing arguments are needed to determine if biobank institutions should take a radical step toward more ongoing engagement and donor involvement. In this paper, we review the arguments found in articles addressing dynamic consent, participatory research, reciprocity, and participant engagement in biobank research. We identify four core ideas on which the arguments for increased involvement are based. The strength of the arguments are then analyzed. We conclude that despite challenges with increased engagement, there seem to be substantial reasons to increase participant engagement in biobanking.

Keywords: biobank ethics, participatory research, dynamic consent, reciprocity
Download Article [PDF]

Doctors busy prolonging life have lost sight of end of life care - audio (25 min)

 CBC Radio
 

Oncologist Atul Gawande believes doctors spend so much time helping people live longer, they've neglected how to improve the quality of life at the end. (Tim-Llewellyn)

Listen 24:59

The Dr. Henry T. Lynch Symposium: Advances in Hereditary Cancer Sept 2015

announcement

 The Dr. Henry T. Lynch Symposium: Advances in Hereditary Cancer

Creighton University Health Sciences Continuing Education

Thursday, September 17, 2015 at 7:00 AM - Friday, September 18, 2015 at 5:00 PM (CDT) Omaha, NE

Survivor, Previvor, Family Member, Fellow, Resident, Full-Time Student

Sep 7, 2015

Free

$0.00

 

Non-genetic cancer mechanism found - Akt pathway (Oncogene)

Cancer can be caused solely by protein imbalances within cells, a study of ovarian cancer has found. The discovery is a major breakthrough because, until now, genetic aberrations have been seen as the main cause of almost all cancer.

.....The research, led by scientists at the University of Leeds and The University of Texas MD Anderson Cancer Center, focused on the "Akt pathway," ( Protein kinase B (PKB), also known as Akt ) a signalling pathway within cells that drives cancer formation and the spread of cancers through the body......

ScienceDaily 


Journal Reference:

1. Z Timsah, Z Ahmed, C Ivan, J Berrout, M Gagea, Y Zhou, G N A Pena, Xin Hu, C Vallien, C V Kingsley, Y Lu, J F Hancock, J Liu, A B Gladden, G B Mills, G Lopez-Berestein, M-C Hung, A K Sood, M Bogdanov, J E Ladbury. Grb2 depletion under non-stimulated conditions inhibits PTEN, promotes Akt-induced tumor formation and contributes to poor prognosis in ovarian cancer. Oncogene, 2015; DOI: 10.1038/onc.2015.279

Too much, too late: Aggressive measures and the timing of end of life care discussions in women with gynecologic malignancies

abstract
  
Highlights

•

Reviews timing and location of end of life discussions with gyn-oncology patients

•

Evaluates compliance with National Quality Forum (NQF) metrics of care

•

A high rate of inpatient and late end of life discussions is noted in this cohort.

---

Objective

This study describes the patterns of end of life (EOL) discussions and their impact on the use of aggressive measures in women with terminal gynecologic malignancies at a single institution.

Methods

An IRB-approved retrospective chart review identified 136 patients who died of gynecologic cancer between 2010 and 2012 with at least one interaction with their oncologists in the last 6 months of life. Aggressive measures were defined as chemotherapy within the last 14 days of life, emergency department (ED) visits, hospital and intensive care unit (ICU) admissions within the last 30 days of life, and inpatient deaths. The frequency and timing of EOL conversations were recorded. Utilization of hospice care was also described.

Results

In the last 30 days of life, 54 (40%) patients were evaluated in the ED, 67 (49%) were admitted into hospital, and 16 (12%) were admitted to the ICU. Thirteen patients (10%) had chemotherapy in the last 14 days of life. Ninety-seven (71%) patients had a documented EOL conversation, eighteen (19%) as outpatients, and 79 (81%) as inpatients. Thirty (22%) patients died in the hospital. At the time of death, 55 (40%) patients were enrolled in outpatient hospice care. The mean amount of time in hospice was 28 days.

Conclusions

End of life care discussions rarely occurred in the outpatient setting or > 30 days before death. Inpatient encounters led to discussions about hospice and code status. Evaluation in the ED frequently resulted in escalation of care. Earlier EOL care discussions resulted in less aggressive measures.

Do All BRCA Mutations Come with the Same Cancer Risk?

Insight


Women born with mutations in the genes BRCA1 or BRCA2 have an increased risk of developing breast and ovarian cancer, but the degree of increase depends on a variety of factors.

Not all mutations within these genes raise the risk equally. A study published earlier this year tracked breast and ovarian cancer occurrences over a 75-year period in 31,000 women who had inherited mutations BRCA1 or BRCA2. The researchers found that mutations at either end of the BRCA1 gene increased the risk of breast cancer more than the risk of ovarian cancer. A group of mutations that occur in the middle portion of the gene, by contrast, raised ovarian cancer risk more than breast cancer risk.....

....Investigators at Dana-Farber are tracking the links between environment, heredity, and cancer in a study known as Project SEARCH.....

Cancer symptom awareness and barriers to symptomatic presentation in England[mdash]are we clear on cancer[quest]

open access

.... Women were significantly more likely than men to both recognise common cancer symptoms and to report barriers. Women were much more likely compared with men to report that fear would put them off from going to the doctor......Women were more likely than men to recognise each cancer symptom, except ‘persistent unexplained pain’.....

..... Finally, understanding the reasons why people in our sample identified certain barriers, for example, why people worry about wasting the doctor’s time, could further improve the effectiveness of future campaigns. Our findings could contribute to improving cancer survival in England to match the best in Europe by helping to develop targeted campaigns promoting early presentation of cancer symptoms.

BRCA1 and BRCA2 mutations sensitize to chemotherapy in patient-derived pancreatic cancer xenografts

open access

.... Clinical data in ovarian cancer show that patients with BRCA1 and BRCA2 mutations show higher response rates to treatment with cisplatin and other DNA-damaging agents resulting in improved outcome (Dann et al, 2012; Muggia and Safra, 2014). Similar observations have been made in case reports of patients with pancreatic cancer, suggesting that BRCA1 and BRCA2 mutations may sensitise to treatment with platinum drugs (Lowery et al, 2011; Sonnenblick et al, 2011). This is supported by preclinical studies using established pancreatic cancer cell lines (van der Heijden et al, 2005), and also by a large retrospective analysis of 71 pancreatic cancer patients with germline BRCA1 and BRCA2 mutations, where it was reported that patients with stage 3/4 disease who were treated with a platinum-containing regimen had a median survival of 22 months, compared with 9 months for those who did not receive platinum (Golan et al, 2014).

There are important unanswered questions concerning the optimum design of platinum-containing treatment protocols for this group of patients, as well as the role of newer agents such as inhibitors of poly-ADP-ribose polymerase (PARP) that have shown early promise in other cancer patients carrying germline BRCA mutations......

 Discussion

• Background:
• Methods:
• Results:
• Discussion:
• Materials and methods
• Results
• Discussion
• Conflict of interest
• References
• Acknowledgements
• Figures and Tables

....Germline mutations in BRCA1 and BRCA2 result in defects in BRCA-mediated HR, which is important for the maintenance of genome stability (Venkitaraman, 2001; Gudmundsdottir and Ashworth, 2006). These mutations predispose to breast and ovarian cancers (Foulkes and Shuen, 2013; Kobayashi et al, 2013), and are associated with increased risk of pancreatic cancer (Fernandes et al, 1994; Klein et al, 2001; Bartsch et al, 2004; Grant et al, 2014). In addition to a role in tumour development, BRCA1 and BRCA2 mutations are associated with sensitivity to platinum drugs and other DNA-damaging agents in ovarian cancers (Dann et al, 2012; Muggia and Safra, 2014), and there are anecdotal reports that this is also the case in pancreatic cancers (Lowery et al, 2011; Sonnenblick et al, 2011).....

Tumour response, correlates of survival and clinical benefit

 Nature Reviews Clinical Oncology

 We are all familiar with the metrics of tumour shrinkage and time to the development of disease progression as important end points in clinical trials. This tenet is based on findings of numerous studies over several decades that have demonstrated a link between agents that cause tumour shrinkage in a cancer population and its correlation with an overall survival improvement. The problem is that the inevitable variation in how these definitions and criteria have been applied over many decades in clinical trials has led to different conclusions about the efficacy of a treatment. Added to this complexity are the following issues: non-measurable lesions, differences obtained with the method of assessment of progression (imaging versus clinical examination), changes in non-target lesions versus target lesions, impact of lesions that coalesce or split on treatment, to name but a few. When considering the additional complexities posed by these factors, it is perhaps not surprising that tumour response is often a poor indicator of survival outcome. Yet, how can this be reconciled to allow the field of oncology to move forward............

AllTrials US campaign officially launched

announcement
 29th July 2015
 

We are delighted to announce that today AllTrials USA has officially launched. Today 50 patient support groups, medical societies, universities and consumer groups are coming together to launch the AllTrials campaign in the US and to say:

“We are calling on everyone in our sector to join us in supporting the AllTrials campaign. Hundreds of thousands of patients have taken part in clinical trials which have never reported results. For every day that passes, more information is at risk of being lost forever. We have to make every clinical trial count. Join us today.”

See the list of US organisations that have joined here.

 

AllTrials – AllTrials US campaign officially launched

announcement
 29th July 2015
 

We are delighted to announce that today AllTrials USA has officially launched. Today 50 patient support groups, medical societies, universities and consumer groups are coming together to launch the AllTrials campaign in the US and to say:

“We are calling on everyone in our sector to join us in supporting the AllTrials campaign. Hundreds of thousands of patients have taken part in clinical trials which have never reported results. For every day that passes, more information is at risk of being lost forever. We have to make every clinical trial count. Join us today.”

See the list of US organisations that have joined here.

ecancer - Cancer and metabolism (special issue)

ecancer

 Cancer and metabolism
Guest Editor: Luca Mazzarella

This special issue centres around the field of metabolism, which has become one of the hot topics of the moment, especially as applied to cancer.....

Special Issue articles

Special Issue: Lifestyle, nutrition and breast cancer: facts and presumptions for consideration

Special Issue: Oxidative stress and the unfulfilled promises of antioxidant agents

Special Issue: Metabolic serum biomarkers for the prediction of cancer: a follow-up of the studies conducted in the Swedish AMORIS study

Special Issue: Why does obesity promote cancer? Epidemiology, biology, and open questions

Why does obesity promote cancer?

open access

Special Issue

Why does obesity promote cancer? Epidemiology, biology, and open questions

 Keywords: obesity, body mass index, insulin, inflammation, DNA damage

  
Abstract

The association between obesity and/or metabolic syndrome and an elevated mortality from cancer has been confirmed by an astonishing number of studies across nations and ethnicities, such that obesity is now recognised to be among the most prominent cancer risk factors worldwide.

Despite this overwhelming evidence and the societal impact of obesity, we know surprisingly little about the underlying molecular mechanisms. This knowledge gap is a major obstacle to the implementation of effective lifestyle change policies. As the scientific community is insecure on what messages it should deliver, administrators are uncertain as to what exactly to recommend, and consumers are confused about whom to believe. This leaves the field flooded with pseudo-scientific recommendations that are hard to eradicate.....

Gynaecological cancers (note: nothing on ovarian cancer)

Conclusion

The discourse on obesity and cancer has become dominant in public debate. Some aspects of this issue are clearly established beyond any reasonable doubt, namely the impact of obesity prior to diagnosis on specific cancer risks and on survivor outcome. Other aspects, such as the exact molecular mechanisms and the extent to which lifestyle changes can modify risk, still await definitive proof. Ultimately, the debate revolves on how much we can modify our cancer risk by intervening on the most basic of animal activities: nutrition. Some might find it tempting to dismiss this debate on the grounds that cancer risk (especially for those cancers where a single environmental factor cannot be identified) is mostly determined by ‘bad luck’, an un-escapable randomness in our stem cells’ DNA mutation accumulation rate [52]. It is clearly not so, but it is also true that our understanding of how nutrition impacts on cancer is far from complete. This creates fertile ground for the proliferation of pseudo-scientific recommendations and bogus ‘super healthy’ nutritional supplements. Likely, some mechanisms and specific lifestyle interventions may have stronger impact on specific cancers. It is also likely that an individual’s genetic makeup may influence response to diet, as we find variable genetic predisposition to specific cancers and genetically determined differences in metabolism. In the wave of medicine personalisation, it is not hard to imagine a future in which lifestyle plans will be tailored to individual risk profile and metabolism.

Is RMI a Useful Tool for Predicting Malignant Ovarian Masses in Developing Countries?

open access

Prognostic Value of Residual Disease after Interval Debulking Surgery for FIGO Stage IIIC and IV Epithelial Ovarian Cancer

open access

Pharmacological treatments for fatigue associated with palliative care

Cochrane: Featured Review (update)

Objectives

To evaluate the efficacy of pharmacological treatments for fatigue in palliative care, with a focus on patients at an advanced stage of disease, including patients with cancer and other chronic diseases.

 Authors' conclusions

Based on limited evidence, we cannot recommend a specific drug for the treatment of fatigue in palliative care patients. Fatigue research in palliative care seems to focus on modafinil and methylphenidate, which may be beneficial for the treatment of fatigue associated with palliative care although further research about their efficacy is needed. Dexamethasone, methylprednisolone, acetylsalicylic acid, armodafinil, amantadine and L-carnitine should be further examined. Consensus is needed regarding fatigue outcome parameters for clinical trials.

Screening for pancreatic cancer in familial high-risk individuals: A systematic review

HRI = High Risk Individuals


open access

..... We chose familial HRIs as research subjects. In this population, there are also individuals with high risks for other diseases. Peutz-Jeghers syndrome with STK11/LKB1 gene mutation[³⁶], hereditary pancreatitis with PRSS1 gene[^37,38] or SPINK1 gene mutation[³⁹], familial atypical multiple mole melanoma syndrome with CDKN2A or p16 gene mutations[⁴⁰], hereditary breast ovarian cancer syndrome with BRCA2 and BRCA1 gene mutations[^41,42], and Lynch syndrome with mismatch repair genes[⁴³] are found in high risk populations, who should also receive attention. Nevertheless, these are not completely independent. Familial HRIs may also have gene mutations. The PRSS1 gene mutation is the main influencing factor in hereditary pancreatitis, an autosomal dominant disease. BRCA2 is one of the most common mutations, and was as high as 17% in one study[⁴⁴]. Future studies on HRIs with gene mutations should be carried out to determine if they have a higher risk than HRIs without gene mutations. In addition, because of the complex nature of the pedigrees in pancreatic cancer, Wang et al[⁴⁵] designed a tool known as PancPRO to identify familial HRIs, which was used for selecting and screening......
 

Peer-review

This is a good systematic review in which the authors analyzed the benefits and harms of pancreatic cancer screening in familial high-risk individuals. The results are interesting, and suggest that pancreatic cancer screening in familial HRIs can improve detection rate and prolong lifetime. In addition, it can influence psychological functions and increase the economic burden.

selected references (all references see article above)

36. (open access - pdf file link)

Giardiello FM, Brensinger JD, Tersmette AC, Goodman SN, Petersen GM, Booker SV, Cruz-Correa M, Offerhaus JA. Very high risk of cancer in familial Peutz-Jeghers syndrome. Gastroenterology. 2000;119:1447-1453.[PubMed]

41. (open access)

Thompson D, Easton DF. Cancer Incidence in BRCA1 mutation carriers. J Natl Cancer Inst. 2002;94:1358-1365.[PubMed]

 

42. (open access)

van Asperen CJ, Brohet RM, Meijers-Heijboer EJ, Hoogerbrugge N, Verhoef S, Vasen HF, Ausems MG, Menko FH, Gomez Garcia EB, Klijn JG. Cancer risks in BRCA2 families: estimates for sites other than breast and ovary. J Med Genet. 2005;42:711-719.[PubMed] [DOI]

43. (open access)

Kastrinos F, Mukherjee B, Tayob N, Wang F, Sparr J, Raymond VM, Bandipalliam P, Stoffel EM, Gruber SB, Syngal S. Risk of pancreatic cancer in families with Lynch syndrome. JAMA. 2009;302:1790-1795.[PubMed] [DOI]

Vitamin D and Cancer: Diversity, Complexity, and Still a Ways to Go

 

abstract

 Vitamin D has taken a center-stage role in our basic and population research quest for the panacea for all human maladies, including cancer, yet sufficient evidence for a beneficial role has existed only for bone health. This Commentary discusses and places into a broader context the report of Chandler and colleagues that found a protective association for higher vitamin D status in colorectal cancer in women, consistent with most other cohort studies but not with limited supplementation trial data. Little human evidence exists for the preventive potential in other malignancies, including breast cancer, with the exception of possible benefit in bladder cancer and an adverse serologic association with prostate cancer (pancreatic cancer risk may be similarly influenced) that is supported by vitamin D genetic data. Current vitamin D trials are examining high-dose supplementation (i.e., 1,600–3,333 IU daily) for effects on multiple outcomes, but they may not have sufficient power to test efficacy in colorectal or other specific malignancies and are unlikely to inform any benefit for higher physiologic levels. A more complete understanding of vitamin D and human carcinogenesis will come from multifaceted lines of research, including elucidation of organ site–specific biologic mechanisms, prospective serologic analyses, testing of vitamin D–related genetic variation, and short-term clinical–metabolic biomarker studies of multidose vitamin D supplementation, including metabolomic profiling of controlled supplementation in these and past or ongoing trials. Cancer Prev Res; 8(8); 1–5. ©2015 AACR.

 See related article by Chandler et al., p. 675
 

Research Article Circulating Vitamin D Levels and Risk of Colorectal Cancer in Women  

Cancer Prev Res canprevres.

• Abstract

European Union Bans Hundreds of Drugs Over Clinical Trial Studies

media

Canada Takes Long to Approve New Drugs - and That's Good

media

CMAJl: Need to define patient engagement in research

article

Initial assessment of patient handoff in accredited general surgery residency programs in the U.S. & Canada

 Can J Surg, Vol. 58, No. 4, August 2015

....our study was restricted to junior surgical residents and did not include senior
level residents, which may overstate the lack the training and/or inexperience with handoffs.....

open access: Initial assessment of patient handoff in accredited

general surgery residency programs in the United States and Canada: a cross-sectional survey

 .....Of the American residents, 67% and 6% reported receiving an incomplete handoff that resulted in minor and major patient harm, respectively. These results mirrored those from Canadian reidents (63% minor and 7% major harm). The most frequent factor reported to improve the patient handoff process was standardization of the verbal handoff.....

 

Conclusion:

Our survey results indicate that the current patient handoff system con

tributes to patient harm. More efforts are needed to establish standardized forms of

verbal and written handoff to ensure patient safety and continuity of c

1 in 3 Patients With Cancer Meets the Criteria for Mental Disorders: What Does That Mean?

Blogger's Note: gynecologic cancers were grouped together in the original study

Correspondence (open access)

Author's Response (open access) (to Correspondence above)

open access: link to original article
 Four-Week Prevalence of Mental Disorders in Patients With Cancer Across Major Tumor Entities

Four challenges we have to crack before immune therapy can revolutionize how we fight cancer

The Conversation (blog)
 Author 

Sri Krishna PhD Candidate, Biological Design, School of Biological and Health Systems Engineering at Arizona State University

Most of us know about the conventional treatment of cancer: surgery to remove tumors, chemotherapy and radiation. But within the last five years, a new class of drugs that use our immune systems to fight cancer are gaining traction in cancer treatment. This is called “immunotherapy.” Instead of killing cancer cells with radiation or chemotherapy, immunotherapy mobilizes the immune system to fight against cancer much like it does against bacteria and viruses.
For a training immunologist like myself, immune therapies have opened new doors to understanding and treating cancers. In the future, immunotherapy could mean a personalized treatment, entirely tailored to an individual. As exciting as that sounds, we still have plenty of work to do, as there remains a lot we don’t know about the immune system. Here are some of the challenges we need to overcome to create these personalized treatments......

FDA Alert: Gadolinium-based Contrast Agents for MRI: Drug Safety Communication - FDA Evaluating

FDA Alert

 July 27, 2015
Audience: Radiology

ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.
FDA, including its National Center for Toxicological Research (NCTR), will study this possible safety risk further. FDA is working with the research community and industry to understand the mechanism of gadolinium retention and to determine if there are any potential adverse health effects. Based on the need for additional information, at this time, FDA is not requiring manufacturers to make changes to the labels of GBCA products.

Management of Patients With a Genetic Variant of Unknown Significance

Medscape

Industry influences osteoporosis treatment - without evidence (vitamin D/calcium)

Healthnewsreview

Pragmatic Randomized Trials Without Standard Informed Consent?

Abstract

Pragmatic Randomized Trials Without Standard Informed Consent?: A National SurveyPragmatic Randomized Trials Without Standard Informed Consent? | Annals of Internal Medicine


Background: Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk.
Objective: To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs.
Design: National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios.
Setting: Web-based survey conducted in December 2014.
Participants: 2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%).
Measurements: Respondent's recommendation to an ethics review board and personal preference as a potential participant for how to obtain consent or notification in the 2 research scenarios.
Results: A majority of respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in line with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent.
Limitation: Framing effects could have impacted respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions.
Conclusion: A majority of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent.

Ovarian vein thrombosis after debulking surgery for ovarian cancer: epidemiology and clinical significance

abstract

Objective

Ovarian vein thrombosis is associated with pregnancy and pelvic surgery. Postpartum ovarian vein thrombosis is associated with infection and a high morbidity rate and is treated with anticoagulant and intravenous antibiotic therapy. The natural history of such thrombotic events after debulking surgery for ovarian cancer has not been well described. Our objective was to characterize the presentation and outcomes for patients with this condition at our institution.

Study Design

We conducted a retrospective study of patients who underwent surgical debulking for ovarian cancer at Memorial Sloan Kettering Cancer Center between the years 2001 and 2010. Patients were included if contrast computed tomography scans of both the abdomen and pelvis were performed within 12 weeks before and 12 weeks after the surgery. The images were reviewed to assess for the presence and extent of a new postoperative ovarian vein thrombosis. When available, subsequent studies were assessed for thrombus progression. Medical records were reviewed to determine whether anticoagulation was used for treatment of the thrombotic episode and to record the occurrence of any new significant venous thromboembolic event in the next year.

Results

One hundred fifty-nine patients had satisfactory imaging. New ovarian vein thrombosis was a common complication of debulking surgery, as found in 41 of patients (25.8%). Only 5 women with ovarian vein thrombosis were started on anticoagulation, of which 2 individuals had an independent venous thromboembolic event as indication for treatment. Only 2 of the ovarian vein thromboses (4.9%) progressed to the inferior vena cava or left renal vein on subsequent scan. The estimated cumulative incidence of venous thromboembolism 1 year after the first postoperative scan was 17.1% for patients in the new ovarian vein thrombosis group vs 15.3% of individuals for the group without a postoperative ovarian vein thrombosis (P = .78).

Conclusion

Ovarian vein thrombosis is commonly encountered after debulking surgery for ovarian cancer. Anticoagulation is usually not indicated, and clinically meaningful thrombus progression rarely occurs.

Identifying novel hypoxia-associated markers of chemoresistance in ovarian cancer

open access
 

Conclusions

Overall, these results show that the most important determining factor for development of resistance is the presence of hypoxia during the treatment period, not prior to treatment thus highlighting the potential importance of simultaneously reducing tumour hypoxia and treating with chemotherapy. This may have particular importance in patients with large tumours who receive neoadjuvant chemotherapy. A number of pathways are responsible for the resistance to cisplatin observed due to hypoxia, and that there are many candidate biomarkers of hypoxia which could be explored in the context of ovarian cancer. We have also provided an initial validation of selected hypoxia-associated biomarkers in ovarian tumour samples. It will be important to expand the study and to validate these results at the protein level in future studies in order to elucidate their true importance.

The role of diagnostic ureteroscopy in the era of computed tomography urography

 Blogger's Note: of interest to Lynch Syndrome patients

open access 
 

Background

Upper urinary tract urothelial carcinoma (UTUC) is an uncommon malignancy, accounting for ~5 % of urothelial tumors [1]. The diagnosis of UTUC can be challenging, requiring a combination of radiographic, cytologic and endoscopic means. Time honored radiological tools such as intravenous urography and retrograde uretropyelograpy are currently replaced by modern computerized tomography urography (CTU) [2]. Diagnostic ureteroscopy is often performed following CTU. Flexible ureteroscopy allows exploration of the upper urinary tract and is beneficial when diagnostic uncertainty exists. It has the advantages of offering direct view of the tumor, ruling out other pathologies and achieving tissue diagnosis. Although nephrouereterectomy is considered the gold standard treatment of UTUC, endoscopic ablation and resection of the tumor can be successfully utilized in selected cases based on tumor size and histology, as determined during ureteroscopoy.......

Late Breaking Abstracts deadline notice: ECCO/ESMO 2015

Late Breaking Abstracts Deadine Dates
 The European Cancer Congress 2015

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Late Breaking Abstracts

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Abstract submission open: 22 July 2015
Abstract submission deadline: 5 August 2015, 21:00 Central European time

Tea consumption and the incidence of cancer: a systematic review

abstract

The aim of this study was to summarize the current evidence on the strength of associations between tea consumption and the incidence of cancer at different sites. We searched PubMed, Embase and the Cochrane Library for relevant articles published before October 2013. Prospective studies that reported effect estimates of cancer incidence, with 95% confidence intervals (CIs), for more than two categories of tea consumption were included. We analysed 87 datasets (57 articles), which included a total of 49 812 incident cases. Overall, high tea consumption had no significant effect on the risk of gastric, rectal, colon, lung, pancreatic, liver, breast, prostate, ovarian, bladder cancers or gliomas. However, high tea consumption was associated with a reduced risk of oral cancer (risk ratio 0.72; 95% CI 0.54–0.95; P=0.021). A dose–response meta-analysis suggested that an increase in tea consumption by one cup per day was associated with a reduced risk of oral cancer (risk ratio 0.89; 95% CI 0.80–0.98; P=0.022), but had little effect on the incidence of other cancers. Subgroup analysis indicated that an increase in the consumption of black tea by one cup per day was associated with an increased risk of breast cancer. Moreover, in western countries, we found that an increase in the consumption of tea by one cup per day was associated with a reduced risk of bladder cancer. Increased tea consumption has no significant effect on the risk of common malignancies. For some cancer types, associations differ according to sex, ethnicity and tea type.

Blog Archive: OvarianCancerandUs (see right hand column)

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An overview of early investigational therapies for chemoresistant ovarian cancer

Abstract

 INTRODUCTION:

Epithelial ovarian cancer (EOC) is the fourth commonest cause of female cancer death in the developed world. Although progress in treatment has improved survival, ∼ 80% of patients with advanced EOC will experience a recurrence and eventually will become resistant to chemotherapy. The aim of treatment for chemoresistant EOC has traditionally been limited to palliation of symptoms but the recent introduction of new therapies targeting molecular pathways is beginning to demonstrate improvements in disease control.

Areas covered:
This review provides an overview of early investigational drugs for the treatment of 'platinum-resistant' EOC. The article is based on English peer-reviewed articles located on MEDLINE and related abstracts presented at major international meetings.

Expert opinion:
Drugs targeting several pathways are increasingly used to treat 'platinum-resistant' EOC. Currently, drugs targeting the angiogenesis pathway have been shown to significantly improve patient outcome. Studies are also being undertaken with inhibitors of poly(ADP-ribose) polymerase (PARP), targeting the DNA repair pathway as it is possible that the benefits seen with these agents in 'platinum-sensitive' disease will apply to those with 'platinum-resistant' disease. The discovery of predictive biomarkers that identify patients which benefit from these targeted therapies is paramount to the success of these treatments in the future.

LIFE AND DEATH CAN BE STRONG MOTIVATION media (ovarian cancer....)

media
 
Rule No. 218 is “Grand passion will take you further than good grades,” and nothing focuses a passion more than when a problem is directly connected to your own life, as in living or dying.
Meet Laura Shawver. At the age of 49 in 2006, she was diagnosed with clear cell ovarian cancer. After getting the diagnosis, she was first surprised, then shocked and finally angry to learn that doctors had no idea what treatment to recommend for her particular case. This disease did not know who it was dealing with. Shawver was not your typical patient.
First, she has a Ph.D. in pharmacology, and second, she is relentless. She knew that a molecular profile of her tumor would help in determining the options, and she was upset that she could not easily get this done for ovarian cancer, even though it was being done regularly for patients with breast, lung and colon cancers......

Sweet and Vicious: Sugar and Sugar Substitutes

CureToday article

Sugar does not feed cancer cells any differently than it feeds healthy cells. - See more at: http://www.curetoday.com/community/amanda-bontempo/2015/07/sweet-and-vicious-sugar-and-sugar-substitutes?utm_source=Informz&utm_medium=Cure+Today&utm_campaign=CURExtra%2Demail%2DIncyte%2DJakafi%2D7%2D24%2D15#sthash.0JDxNJwB.dpuf

Sugar does not feed cancer cells any differently than it feeds healthy cells. - See more at: http://www.curetoday.com/community/amanda-bontempo/2015/07/sweet-and-vicious-sugar-and-sugar-substitutes?utm_source=Informz&utm_medium=Cure+Today&utm_campaign=CURExtra%2Demail%2DIncyte%2DJakafi%2D7%2D24%2D15#sthash.0JDxNJwB.dpuf

 Sugar does not feed cancer cells any differently than it feeds healthy cells......

Thesis: Drugs with potential chemopreventive properties in relation to epithelial ovarian cancer

pdf file Danish Medical Journal

 Drugs with potential chemopreventive properties in relation to epithelial ovarian cancer –a nationwide case-control study (note: includes section on statins)

......The results of this PhD thesis add important knowledge to the
area of chemoprevention in relation to epithelial ovarian cancer......

Impact of statins on risk and survival of ovarian cancer

KoreaMed Synapse

 J Gynecol Oncol. 2015 Jul;26(3):240-241. English.
Published online July 08, 2015.  http://dx.doi.org/10.3802/jgo.2015.26.3.240
Copyright © 2015. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology

 Table 1. Summary of the evidence regarding impact of statin therapy on risk and survival of ovarian cancer

.....When findings of five studies [8, 10, 11, 12, 13] were pooled in a meta-analysis conducted by Liu et al. [14], a significant 21% risk reduction was seen (relative risk [RR], 0.79; 95% confidence interval [CI], 0.64 to 0.98). The RR reduction was found to be 52% when long term statin usage was considered (RR, 0.48; 95% CI, 0.28 to 0.80). In conclusion, we suggest that statins impact on ovarian cancer warrants further investigation with larger randomized controlled trials as observational studies are subject to bias and may lead to false slight benefits. Effect of statins with respect to different histological subtypes also need to be further studied.

Important molecule in ovarian cancer: (LKB1) Molecule plays pivotal role in making ovarian cancer cells so lethal

science news

....... Recently, Dr. Shepherds' lab discovered that the spheroids activate a 'stress signal', and the major molecule controlling this signal is called LKB1. "Previous studies stated that LKB1 was a tumour suppressor in ovarian cancer, meaning that tumour cells need to get rid of LKB1 to cause cancer," says Dr. Shepherd "but our work is in direct conflict with these studies, because we definitively show that ovarian cancer cells still have LKB1 and that this molecule allows ovarian cancer spheroids to change their metabolism, promote tumour cell survival and make them more resistant to chemotherapy."
By refuting these previous studies, Dr. Shepherd has uncovered a new target for future therapy. "There are currently no therapies or drugs that target LKB1," states Dr. Shepherd. "Based on these findings our lab is exploring several different strategies to understand and target LKB1 and its related molecules in ovarian cancer spheroids, and developing the essential pre-clinical models to see if this can be translated to ovarian cancer patients."

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Story Source:
The above post is reprinted from materials provided by Lawson Health Research Institute.

Update: AllTrials – Pharma company investors call for clinical trials transparency

AllTrials


Read more in the Financial Times(£) and at Wall Street Journal.
Read today’s Economist editorial “The evidence base for new medicines is flawed. Time to fix it” and their longer piece “Spilling the beans. Failure to publish the results of all clinical trials is skewing medical science.“(

The Art of the Second Opinion

Cancer Network

‘Zombie report’ on health-care innovation in Canada gets new life (maybe)

media

In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs - Mayo Clinic

open access

 ....A cancer patient–based grassroots movement that advocates against the high price of cancer drugs can accomplish a great deal. One such movement, a petition, is already available and is actively collecting signees. It has been designed to be signed online on Change.org (short link URL: http://chn.ge/1DCWT1M) and is publicized on e-mail (stophighdrugcosts@gmail.com), on Facebook (https://www.facebook.com/stophighdrugcosts), and on Twitter (@StopHighRxCosts), thus using contemporary methods to address a contemporary crisis. Those encouraged to sign the petition include patients, relatives, friends, supporters, health care professionals, and others. Should this petition or any other similar grassroots efforts generate in aggregate an immense number of unique supporters (eg, >1 million petition signees or a comparable mass action quantified in other terms), this quantified support can then be used by advocates, lobbyists, and others to advocate against the aforementioned harms generated by the high price of cancer drugs. With proper support of these grassroots efforts, and proper use of that support downstream, it should be possible to focus the attention of pharmaceutical companies on this problem and to encourage our elected representatives to more effectively advocate for the interests of their most important constituents among the stakeholders in cancer—American cancer patients.

Systematic review of the relationship between artificial sweetener consumption and cancer in humans: analysis of 599,741 participants

abstract 

BACKGROUND:

The effect of artificial sweetener consumption on cancer risk has been debated in animal models for over four decades. To further investigate this relationship, this study aims to synthesise results from several of the most recent studies in humans.

METHODS:

An online literature search was performed in MEDLINE from 2003 to 2014 using Ovid, PubMed, Web of Science, and Scopus using keywords 'artificial', 'sweetener' and 'cancer'. Ninety-two results were then manually assessed for eligibility. Studies were included if the relationship between artificial sweeteners and cancer was their central hypothesis, and if they adjusted for age, gender, smoking status and body mass index. Extracted data included study design, patient characteristics, outcome measure and results.

RESULTS:

In the five publications that satisfied the inclusion criteria, significant direct associations with artificial consumption were found for laryngeal (odds ratio, OR 2.34, 95% CI: 1.20-4.55), urinary tract tumours (OR 2.12, 95% CI: 1.22-3.89), non-Hodgkin lymphoma in men (RR 1.31, 95% CI: 1.01-1.72), multiple myeloma in men (RR 2.02, 95% CI: 1.20-3.40) and leukaemia (RR 1.42, 95% CI: 1.00-2.02). Inverse relationships were found in breast (OR 0.70, 95% CI: 0.54-0.91, p trend = 0.015) and ovarian (OR 0.56, 95% CI: 0.38-0.81, p trend < 0.001) cancers.

CONCLUSION:

The statistical value of this review is limited by the heterogeneity and observational designs of the included studies. Although there is limited evidence to suggest that heavy consumption may increase the risk of certain cancers, overall the data presented are inconclusive as to any relationship between artificial sweeteners and cancer.

Intraoperative Adverse Events: Risk Adjustment for Procedure Complexity and Presence of Adhesions Is Crucial

abstract

Purchase $35.95

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Background

Benchmarking the quality of intraoperative care by comparing the rates of intraoperative adverse events (iAEs) necessitates adequate risk adjustment. We sought to identify the patient- and procedure-related risk factors for iAEs.

Study Design

Our 2007 to 2012 institutional American College of Surgeons NSQIP and administrative databases were linked and then screened for iAEs using the Patient Safety Indicator “Accidental Puncture/Laceration.” Intraoperative adverse events were confirmed by systematic review of medical records. Comorbidities were assessed using American College of Surgeons NSQIP variables. Adhesiolysis was determined using CPT codes for lysis of adhesions. Operative complexity was determined using relative value units. Multivariable models were constructed to identify independent predictors of iAEs. Sensitivity analyses were performed in uniform samples of operations.

Results

Of 9,292 patients, 218 iAEs were confirmed in 183 patients. Median patient age was 56 years old and 54% were female. Compared with patients without iAEs, iAE patients were older (median 61 vs 56 years; p < 0.001), more functionally dependent (9% vs 5%; p = 0.028), and had higher American Society of Anesthesiologists class (≥3 in 45% vs 35%; p = 0.004); their procedures were more complex (median relative value units 29 vs 23; p < 0.001), more likely open (48% vs 21%; p < 0.001), and more often required adhesiolysis (44% vs 18%; p < 0.001). In multivariable analyses, adhesiolysis (odds ratio = 2.34; 95% CI, 1.71–3.21; p < 0.001), higher operative complexity (third vs first relative value units quartile: odds ratio = 3.36; 95% CI, 1.66–6.78; p < 0.001; fourth vs first quartile: odds ratio = 5.97; 95% CI, 3.01–11.86; p < 0.001), and open surgical approach (odds ratio = 2.04; 95% CI, 1.39–3.01; p < 0.001) independently predicted iAEs. Sensitivity analyses confirmed adhesiolysis and higher operative complexity as independent iAE predictors.

Conclusions

Adhesiolysis and higher operative complexity predict an increased risk for iAE. Attempts to benchmark the quality of intraoperative care need to adequately risk adjust for these factors.

Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening + comments

 original article - open access


New Articles -- EvidenceUpdates - now includes comments

Abstract

PURPOSE: Cancer screening strategies have commonly adopted single-biomarker thresholds to identify abnormality. We investigated the impact of serial biomarker change interpreted through a risk algorithm on cancer detection rates. PATIENTS AND METHODS: In the United Kingdom Collaborative Trial of Ovarian Cancer Screening, 46,237 women, age 50 years or older underwent incidence screening by using the multimodal strategy (MMS) in which annual serum cancer antigen 125 (CA-125) was interpreted with the risk of ovarian cancer algorithm (ROCA). Women were triaged by the ROCA: normal risk, returned to annual screening; intermediate risk, repeat CA-125; and elevated risk, repeat CA-125 and transvaginal ultrasound. Women with persistently increased risk were clinically evaluated. All participants were followed through national cancer and/or death registries. Performance characteristics of a single-threshold rule and the ROCA were compared by using receiver operating characteristic curves. RESULTS: After 296,911 women-years of annual incidence screening, 640 women underwent surgery. Of those, 133 had primary invasive epithelial ovarian or tubal cancers (iEOCs). In all, 22 interval iEOCs occurred within 1 year of screening, of which one was detected by ROCA but was managed conservatively after clinical assessment. The sensitivity and specificity of MMS for detection of iEOCs were 85.8% (95% CI, 79.3% to 90.9%) and 99.8% (95% CI, 99.8% to 99.8%), respectively, with 4.8 surgeries per iEOC. ROCA alone detected 87.1% (135 of 155) of the iEOCs. Using fixed CA-125 cutoffs at the last annual screen of more than 35, more than 30, and more than 22 U/mL would have identified 41.3% (64 of 155), 48.4% (75 of 155), and 66.5% (103 of 155), respectively. The area under the curve for ROCA (0.915) was significantly (P = .0027) higher than that for a single-threshold rule (0.869). CONCLUSION: Screening by using ROCA doubled the number of screen-detected iEOCs compared with a fixed cutoff. In the context of cancer screening, reliance on predefined single-threshold rules may result in biomarkers of value being discarded.

Comments from Clinical Raters
Gynecology This is an important finding but it is secondary analysis/hypothesis generating and testing. It needs further investigating before it is used in clinical practice.
Oncology - Gynecology This is a preliminary analysis. The core study remains ongoing, to answer the critical question of whether screening saves lives with an acceptable morbidity.

(+video) Advances in Ovarian Cancer Research: Exploiting Vulnerabilities

Meetings Notice AACR
  

Advances in Ovarian Cancer Research: Exploiting Vulnerabilities

October 17 - 20, 2015

Hyatt Regency Orlando

Orlando, Florida, USA

Abstract submission deadline: Monday, August 3

Advance registration deadline: Friday, September 4

Financial Distress and Its Associations With Physical and Emotional Symptoms and Quality of Life Among Advanced Cancer Patients

open access

Implications for Practice:
Financial distress is an important and common factor contributing to the suffering of advanced cancer patients and their caregivers. It should be suspected in patients with persistent, refractory symptom expression. Early identification, measurement, and documentation will allow clinical teams to develop interventions to improve financial distress and its impact on quality of life of advanced cancer patients

Tumor Genetic Screening Programs: A Call to Action

open access

...... Perhaps the most important question raised by the study by Meric-Bernstam et al³ is whether enrollment onto a genotype-matched protocol is really the metric by which these important profiling efforts should be judged. We would instead argue that the standard should be whether these programs identify sufficient patients with specific alterations to allow researchers to design and conduct previously impractical, but potentially transformative, precision medicine studies. Meric-Bernstam et al found that mutations in only three actionable genes (PIK3CA, KRAS, and BRAF) were present in > 5% of the patients tested. Moreover, far lower rates of actionable alterations in many other genes, including AKT, EGFR, and ERBB2, were observed across a wide variety of tumor types. These findings clearly demonstrate the necessity of uncoupling highly multiplexed next-generation genomic screening from the therapeutic studies that seek to enroll these rare genetic subpopulations. To be certain, this type of outcome is much more difficult to measure but ultimately far more clinically meaningful. In sum, despite the challenges highlighted, we feel that the type of genomic screening initiative undertaken by Meric-Bernstam et al will be an increasingly critical part of a robust clinical trials program, and the authors should be applauded for their efforts.

REFERENCES