EMA recommends granting a marketing authorisation for pegylated liposomal formulation of Irinotecan for metastatic pancreatic adenocarcinoma

On 21 July 2016, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the medicinal product Onivyde (pegylated liposomal formulation of irinotecan), intended for the treatment of metastatic adenocarcinoma of the pancreas.

Onivyde contains irinotecan in a pegylated liposomal formulation.

When added to 5-fluorouracil (5-FU) 2,400 mg/m2 and leucovorin (LV) 400 mg/m2, Onivyde improved survival compared with 5-FU 2,000 mg/m2 and LV 200 mg/m2.

Read more here.

Nephrectomy for RCC may result in significant declines in renal function

Despite having better baseline kidney function and overall health status, patients with renal cell carcinoma (RCC) had greater postsurgical decreases in kidney function after undergoing a radical nephrectomy compared with patients undergoing a radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC).

These results were published recently in Urology. According to the study, surgical management of both RCC and UTUC involves radical removal of a renal unit, with the additional removal of the ureter in patients with UTUC. With this study, the researchers hoped to identify risk factors that predict a decline in renal function after radical nephrectomy for RCC or RNU for UTUC.

Read more from CancerNetwork.

Delirium common in cancer patients visiting emergency departments

According to a study conducted at the University of Texas MD Anderson Cancer Center, delirium is a condition that may be present yet overlooked by emergency department physicians.  Study lead Dr. Knox Todd stated that there is evidence "of delirium on one of every ten patients with advanced cancer who are treated in the emergency department."

To read more about this study, click here.

Scans not worthwhile for most thyroid cancers

According to a new study conducted at the University of Michigan, undergoing scans after treatment does not improve survival changes of thyroid cancer patients.  According to study researcher Dr. Megan Haymart, this study, conducted on more than 28,000 thyroid cancer patients between 1998-2011, shows that "for the most part, this imaging isn't affecting survival."  Further, while a small number of thyroid cancers are aggressive and likely to return, overall, 96% of patients with thyroid cancer continue to live more than 10 years after first being diagnosed.

To read more about this study, click here.

Omega-3s in fish tied to better colon cancer outcomes

A new study conducted at the Massachusetts General Hospital in Boston has shown that colon cancer patients who consume higher levels of omega-3 fatty acids, primarily from fish oil, have better rates of survival.  According the study team led by Dr. Andrew Chan, "patients who consumed at least 0.3 grams of omega-3 fatty acids from oily fish per day...were 41% less likely to die from colon cancer then those who consumed less than 0.1 grams per day."

To read more about this study, click here.

Radiologists do not face higher risk of radiation-related death

A study led by the U.S. National Cancer Institute has determined that radiologists are not a greater risk of death due to chronic exposure to low levels of radiation.  The study, comparing nearly 44,000 radiologists with 65,000 psychiatrists (who are unlikely to be exposed to radiation on the job) found that radiologists graduating after 1940 "fared better than the psychiatrists [with] no evidence of increased radiation-related deaths".

To read more about this study, click here.

In vitro fertilization does not raise risk for breast cancer

Researchers at the Netherlands Cancer Institute in Amsterdam have discovered that women undergoing in vitro fertilization (IVF) are not at increased risk of developing breast cancer. Findings from the Dutch study conducted on more than 25,000 women found that "the cumulative rate of breast cancer was 3% for the IVF group, compared to 2.9% for the non-IVF group."

To read more about this study, click here.

Analytical studies branch research paper series – health and work in the family: evidence from spouses’ cancer diagnoses

Changes in health status may affect not just the individuals who experience such changes, but also their family members. For example, if the main earner in a family loses his or her ability to generate income due to a health shock, it invariably affects the financial situation of the spouse and other dependants. This study analyzes how one spouse’s cancer diagnosis affects the employment and earnings of the other spouse and (before-tax) total family income using administrative data from Canada.

Read the full report from Stats Canada.

Targeted therapy for advanced squamous cell lung cancer

Squamous cell cancer offers distinct therapeutic challenges by virtue of presentation in older patients, its physical location in the chest, pattern of metastasis and association with comorbidities that can compromise treatment delivery and exacerbate toxicity.

Recently, molecular genotyping has led to the application of targeted agents for mutations prevalent in SqCC.9 This overview of the targeted treatments of squamous cell lung carcinoma highlights these recent molecular advances and discusses the potential role of newer molecular agents currently being evaluated for the treatment of advanced SqCC.

Read more here.

PET-CT–guided surveillance may reduce need for surgery in some patients with advanced head and neck cancer

Patients with advanced squamous cell carcinoma of the head and neck who underwent PET-CT imaging after chemoradiation to determine if they still needed to have surgery had overall survival rates similar to those of patients who underwent planned neck dissection and chemoradiation. PET-CT imaging also resulted in fewer operations and was more cost-effective.

Read more from National Cancer Institute.

New England Journal of Medicine, April 14, 2016 (see the journal abstract).

Study forecasts ‘Silver Tsunami’ of cancer survivors

The number of long-term cancer survivors has continued to grow over the past several decades. With this growth has come the recognition that many cancer survivors have unique health care needs as a consequence of their cancer or the treatments they received.

To better understand the composition of the cancer survivor population and their other medical conditions, or comorbidities, the researchers made projections based on data from NCI’s Surveillance, Epidemiology, and End Results (SEER) program, including the SEER-Medicare linked database, and the U.S. Census Bureau.

A unique aspect of the study, published July 1 in Cancer Epidemiology, Biomarkers & Prevention, was that the researchers were able to assess specific cancer burden by age groups of older survivors.

Read more here.

How much does cancer prevention cost?

There are many indicators used in health care to assess the value of a public health intervention, and one frequently-used metric is cost effectiveness. This indicator involves calculating a ratio that measures the balance between cost and health benefits that are not monetized (typically, lives saved).

Read more from Centre of Excellence in Cancer Prevention on Cost effectiveness of cancer prevention interventions.

Recent advances in treating ovarian cancer

A pair of studies published recently in the AACR’s journal Clinical Cancer Research report on some interesting observations and developments in treating ovarian cancer, a difficult-to-diagnose and difficult-to-treat disease.

Research that reported in these two studies to identify new methods and opportunities to improve the treatment of ovarian cancer is much needed.

- Can presurgery chemotherapy make advanced ovarian cancers responsive to immunotherapy?
- An imaging system that can guide surgeons to remove more ovarian cancer

Read more from Cancer Research Catalyst.

Euthanasia and physician-assisted suicide increasingly being legalized, although still relatively uncommon

Euthanasia and physician-assisted suicide in the United States, Canada, and Europe are increasingly being legalized, but they remain relatively rare, and primarily involve patients with cancer, according to a study appearing in the July 5 issue of JAMA.

The authors found that between 0.3 percent to 4.6 percent of all deaths are reported as euthanasia or PAS in jurisdictions where they are legal. The frequency of these deaths increases after legalization. More than 70 percent of cases involved patients with cancer. Typical patients are older, white, and well-educated.

Read more from July 4 JAMA News Release.

Study mentioned:
Emanuel EJ, Onwuteaka-Philipsen BD, Urwin JW, Cohen J. Attitudes and Practices of Euthanasia and Physician-Assisted Suicide in the United States, Canada, and Europe. JAMA. 2016;316(1):79-90.

Cancer patients, doctors often disagree about prognosis

Those with advanced disease are likely to be more optimistic than their doctor, study shows.

Cancer patients and their doctors often hold different opinions about the patient's chances for survival and how long he or she might live, according to a new study published July 14 in the journal JAMA Oncology. The study found that 68 percent of patients rated their odds for survival differently from their doctors. Almost all patients were more optimistic than their doctor. Of the 68 percent, only 10 percent understood that their views and their doctor's differed.

Source: JAMA Oncology, news release, July 14, 2016

Read more here.

Risks for breast, ovarian cancers could be found with multigene panel testing

In nearly 100,000 patients who were clinically tested for hereditary cancer risk, utilization of multigene panel sequencing was found to detect ovarian cancer-associated mutations in 11 genes, according to results of a study presented at the 2016 ASCO Annual Meeting.

A second study, also presented at the meeting2, examined the potential harms of multiplex testing for cancer risk, such as unwarranted surgery or adverse psychological effects. However, results showed that, at a 3-month follow-up after genetic testing, the rates of patient distress, intrusive thoughts, or regret of testing were found to be low.


Studies mentioned:
Kurian AW, Hughes E, Handorf E, et al. Association of ovarian cancer (OC) risk with mutations detected by multiple-gene germline sequencing in 95,561 women. J Clin Oncol. 2016;34 (suppl; abstr 5510).
Kurian AW, Idos G, Culver J, et al. Safety of multiplex gene testing for inherited cancer risk: Interim analysis of a clinical trial. J Clin Oncol. 2016;34 (suppl; abstr 1503).

New myeloma guideline expands diagnostic criteria, adds novel agents

Substantial changes were made to the latest version of the NCCN guideline for multiple myeloma to address the multitude of newly approved agents for patients with this disease.

In newly diagnosed patients, primary therapy now includes lenalidomide plus dexamethasone in combination with bortezomib (preferred) or the ixazomib. Additionally, the “active” myeloma category was expanded through an adjustment in the diagnostic criteria, to make more patients eligible for therapy.

Read more here.

Abstracts and titles are now available for Palliative Care In Oncology Symposium

A team approach to palliative care can, and should, include everyone in an oncology setting: physicians, palliative care specialists, nurses, hospice professionals, social workers, and others. The 2016 Palliative Care in Oncology Symposium will provide information that is vital to the entire cancer care continuum, from laboratory research regarding biologic mechanisms of symptoms to caring for patients’ psychosocial and spiritual needs during cancer treatment and at end of life.

Abstract titles are released now - view more info about the Symposium here.

The unbearably slow adoption of genetic cancer tests

Over the past 20 years, Nazneen Rahman, professor and Head of the Division of Genetics and Epidemiology at the Institute of Cancer Research, has identified a steady stream of genes that influence the risk of breast, ovarian, and childhood cancers. But her latest accomplishment, and one of her proudest, is very different. Rahman has created a shortcut in the British healthcare system that will give women with ovarian cancer access to a critical genetic test. The new pathway is cost-efficient, saving time and money as well as lives.

The Clinical Pathway mentioned:
A discrete event simulation to evaluate the cost effectiveness of germline BRCA1 and BRCA2 testing in UK women with ovarian cancer
Anthony Eccleston, Anthony Bentley, Matthew Dyer, Ann Strydom, Wim Vereecken, Angela George, Nazneen Rahman
bioRxiv 060418; doi: http://dx.doi.org/10.1101/060418

Read more here.

Regulations issued by FDA for next-generation sequencing use

The utilization of next-generation sequencing (NGS)—which can examine millions of DNA variants at one time—is now being regulated. The FDA has released 2 draft guidances regarding the use of these NGS-based tests, which can be used to inform risk and treatment decisions across multiple tumor types.

The first draft guidance, titled, “Use of Standards in FDA’s Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” provides recommendations for designing, developing, and validating NGS-based tests for rare hereditary disease.

The second draft guidance, titled, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” describes an approach wherein test developers may rely on clinical evidence from FDA-recognized public genome databases to support clinical claims for their tests and provide assurance of accurate clinical interpretation of genomic test results.

The guidances are part of the of the FDA’s engagement in the Precision Medicine Initiative (PMI), created by the White House in early 2015.

“Targeting the right treatments to the right patients at the right time is the goal of the President’s Precision Medicine Initiative,” said FDA commissioner Robert Califf, MD, in a statement. “Soon, patients will have a much more complete picture of their health than in the past, informed by their genetic and genomic makeup.

Read more here.

Statin treatment linked to fewer cancer deaths

Being treated for high cholesterol with statins is being linked with a reduced risk of death and better survival from four common cancers. The results come from a study of 14 years of UK data that included nearly a million people.

Data on deaths from cancers came from the Office for National Statistics. When researchers from several UK centres analysed the data, they found that people diagnosed with high cholesterol and one of the four cancers were less likely to die from cancer.
However, being diagnosed with high cholesterol usually lead to treatment, often with statins.

The study could only find a link between high cholesterol and a lower death risk, rather than establishing any cause-and-effect.

Read more here.

Study mentioned:
European Society of Cardiology Frontiers in CardioVascular Biology (FCVB) 2016, Florence, Italy. Abstract: Hyperlipidaemia reduces mortality in breast, prostate, lung and bowel cancer.

Acupressure may ease fatigue after breast cancer

The targeted massage therapy known as acupressure may help breast cancer patients overcome fatigue, according to a new study.

As reported online July 7 in JAMA Oncology, the researchers randomly assigned 288 breast cancer survivors to one of three groups. One group was told to continue their usual care. A second group received acupressure that targets relaxation points. The final group received stimulating acupressure, intended to increase energy.

Study mentioned:
Zick SM, Sen A, Wyatt GK, Murphy SL, Arnedt J, Harris RE. Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. Published online July 07, 2016. doi:10.1001/jamaoncol.2016.1867.

Read more here.

Doxorubicin/Sorafenib combo fails in frontline phase III study

Upfront treatment with the combination of doxorubicin and sorafenib (Nexavar) did not improve overall survival (OS) compared with sorafenib alone for patients with advanced hepatocellular carcinoma (HCC). Additionally, the combination was associated with increased toxicity, according to results from the phase III CALGB 80802 trial presented at the 2016 ASCO Annual Meeting.

Read more here.

Reference:
Abou-Alfa GK, Niedzwieski D, Knox JJ, et al. Phase III randomized study of sorafenib plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC): CALGB 80802 (Alliance). J Clin Oncol. 2016;34 (suppl; abstr 4003).

Promising initial trial of immunotherapy agent in anal cancer

A study of nivolumab (Opdivo) in patients with squamous cell carcinoma of the anal canal (SCCA), which recently presented findings at the 2016 World Congress on Gastrointestinal (GI) Cancer, is the first prospective trial to examine immunotherapy agents in the treatment of SCCA.

Approximately 80% to 95% of cases are linked to human papillomavirus (HPV) infection. "The role of HPV in the tumorigenesis of SCCA provides rationale for the use of immune checkpoint agents as a novel therapy for patients with a virally driven disease." noted lead author Cathy Eng, MD, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center and co-leader of MD Anderson's HPV-related Cancer Moon Shot.

Please read more here.

New trial alert: Topical Brimonidine Tartrate on intraocular pressure of patients undergoing robot-assisted laparoscopic prostatectomy

A new clinical trial sponsored by the University Health Network in Toronto is presently recruiting patients with prostate cancer for a prospective study aimed at evaluating the effect of preoperative treatment with topical Brimonidine Tartrate on ontraocular pressure.  For patients undergoing robot-assisted laparoscopic prostatectomy, the goal of this trial is to prevent "intraocular pressure spike thereby reducing risk of postperative vision loss."

To read more about this trial, click here.