ASCO Calls for Cancer Trials to Include More Seniors

“In a position statement published online July 20 in the Journal of Clinical Oncology, the American Society of Clinical Oncology has called on the U.S. government and the cancer research community to broaden clinical trials to include older adults.

” ‘Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,’ Julie Vose, M.D., M.B.A., society president, said in a news release from the group. ‘As we age, for example, the risk of adverse reactions from treatment significantly increases. Older adults must be involved in clinical trials so we can learn the best way to treat older cancer patients, resulting in improved outcomes and manageable toxicity,’ she explained.

“More than 60 percent of cancers in the United States occur in people aged 65 and older, the statement authors say, noting the number of seniors will increase in coming years. However, there is a lack of evidence about cancer treatments for the elderly because too few are included in clinical trials, and clinical trials designed specifically for seniors are rare.”

Emergency Department Febrile Neutropenia Pathway for Patients With Cancer Reduces Time to Antibiotic Administration

“In a study reported in the Journal of Oncology Practice, Keng et al at Cleveland Clinic found that institution of an emergency department febrile neutropenia pathway for patients with cancer reduced the time to antibiotic administration compared with historical and direct admission cohorts.

“The study included all adult patients with cancer who presented with fever to the Cleveland Clinic Emergency Department between June 2012 and June 2013. The febrile neutropenia pathway interventions included providing patients with febrile neutropenia alert cards, standardizing the definition of febrile neutropenia and recognizing it as a distinct chief complaint, revising the emergency department triage level for febrile neutropenia, creating electronic febrile neutropenia order sets, administering empiric antibiotics before neutrophil count result, and relocating febrile neutropenia antibiotics to the emergency department. The primary outcome was time to antibiotic administration, with a target of 90 minutes after emergency department presentation. (The study was initiated prior to release of ASCO and Surviving Sepsis Campaign recommendations of a target of 60 minutes.)

“Outcomes were compared with those in a historical cohort of patients presenting to the emergency department between February 2010 and May 2012 and a cohort of patients directly admitted to the inpatient oncology service with a presumptive diagnosis of febrile neutropenia between June 2012 and June 2013. Directly admitted patients are judged to be clinically stable, with sicker patients being sent directly to the emergency department.”

Benefit of End-Stage Chemotherapy Is Questioned

“It is an excruciating question for cancer patients with a prognosis of only months to live. Should they try another round of chemotherapy?

“Guidelines for oncologists say no for very sick patients, those who are often bedridden and cannot handle most daily needs themselves. But for patients who are more self-sufficient, chemotherapy is considered a reasonable option. Despite its well-known toxic side effects, many end-stage patients and their doctors have considered chemotherapy worth trying, believing it may ease discomfort or buy time.

“Now, a study suggests that even those stronger patients may not benefit from end-of-life chemotherapy — and that for many their quality of life may worsen in their final weeks compared with patients who forego last-ditch treatment.

“ ‘It worsened quality of life for those that are relatively healthy, and those are the ones that the guidelines support treating,’ said Dr. Charles Blanke, a medical oncologist at Oregon Health and Science University, who was not involved in the study. ‘Chemotherapy is supposed to either help people live better or help them live longer, and this study showed that chemotherapy did neither.’ “

Top Oncologists Push Back On ‘Outrageous’ Costs Of Cancer Drugs

“More than 110 doctors from cancer centers around the country called on drug makers to justify their soaring prices and for the government to put regulatory curbs in place. They noted that every new drug approved by the Food and Drug Administration in 2014 was priced at more than $120,000 per year.

The New York Times: Drug Companies Pushed From Far And Wide To Explain High Prices
As complaints grow about exorbitant drug prices, pharmaceutical companies are coming under pressure to disclose the development costs and profits of those medicines and the rationale for charging what they do. So-called pharmaceutical cost transparency bills have been introduced in at least six state legislatures in the last year, aiming to make drug companies justify their prices, which are often attributed to high research and development costs. (Pollack, 7/23)

The Wall Street Journal: Doctors Object To High Cancer-Drug Prices
More than 100 oncologists from top cancer hospitals around the U.S. have issued a harsh rebuke over soaring cancer-drug prices and called for new regulations to control them. The physicians are the latest in a growing roster of objectors to drug prices. Critics from doctors to insurers to state Medicaid officials have voiced alarm about prescription drug prices, which rose more than 12% last year in the U.S., the biggest annual increase in a decade, according to the nation’s largest pharmacy-benefit manager. (Whalen, 7/23)”

The CAR T-Cell Treatment: Will It Work for Solid Tumors?

Chimeric antigen receptor (CAR) T-cell therapy is a new, immune system-based cancer treatment that has garnered recent media attention. In a clinical trial, CAR T-cell treatment left no signs of tumors in 70% to 90% of children and adults with the aggressive blood cancer acute lymphocytic leukemia (ALL). ALL is almost always fatal, and the results observed with CAR T-cell treatment are nothing short of spectacular. Continue reading…

Team Links Gene Expression, Immune System with Cancer Survival Rates

“Physicians have long sought a way to accurately predict cancer patients’ survival outcomes by looking at biological details of the specific cancers they have. But despite concerted efforts, no such clinical crystal ball exists for the majority of cancers.

“Now, researchers at the Stanford University School of Medicine have compiled a database that integrates gene expression patterns of 39 types of cancer from nearly 18,000 patients with data about how long those patients lived.

“Combining the data from so many people and cancers allowed the researchers to overcome reproducibility issues inherent in smaller studies. As a result, the researchers were able to clearly see broad patterns that correlate with poor or good survival outcomes. This information could help them pinpoint potential therapeutic targets.

“ ‘We were able to identify key pathways that can dramatically stratify survival across diverse cancer types,’ said Ash Alizadeh, MD, PhD, an assistant professor of medicine and a member of the Stanford Cancer Institute. ‘The patterns were very striking, especially because few such examples are currently available for the use of genes or immune cells for cancer prognosis.’ ”

Trial Availability, Patient Eligibility Barriers to Enrollment onto Genomically Matched Trials

“Only a small percentage of patients with actionable gene alterations are eventually enrolled onto genotype-matched trials targeting these alterations, according to study results.

“With the influx of targeted molecular therapies for the treatment of cancer, genomic profiling and matching patients to targeted therapies are imperative, according to study background.

“ ‘However, implementation of genomically informed therapy requires not only access to genomic profiling, but also the availability of molecularly targeted therapies matched to the genomic testing results,’ Funda Meric-Bernstam, MD, chair of the department of investigational cancer therapeutics, at The University of Texas MD Anderson Cancer Center, and colleagues wrote. ‘Availability of clinical trials may not only differ from institution to institution, but may also differ between tumor types. Enrollment onto clinical trials is also limited by trial eligibility criteria, as well as availability of slots.’ ”

Implantable Devices at Risk During During Cancer Radiotherapy

Cancer patients with cardiovascular implantable electronic devices (CIEDs) who require radiotherapy may be at increased risk of a single-event upset malfunction when higher energy neutron-producing radiotherapy is used, a study now shows.

“The retrospective analysis, one of the largest cohorts in which contemporary CIEDs were exposed to photon- and electron-based radiotherapy, demonstrated that more than 10 MV of neutron-producing radiotherapy resulted in a device compromise rate of 21%.

“In 178 courses of non-neutron-producing radiotherapy, however, the device compromise rate was 0%, Jonathan D. Grant, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston, and colleagues said in an online report in JAMA Oncology.

“Single-event upsets also occurred during neutron-producing radiotherapy at a rate of 10% in pacemakers and 34% in implantable cardioverter-defibrillators per course, Grant said.

“Based on these findings, the investigators recommend that non-neutron-producing radiotherapy be used whenever possible. In cases where higher radiotherapy energies are of clinical benefit, however, they emphasized that ‘error rates and outcomes that we report will aid clinicians in weighing the risks of using neutron-producing radiotherapy.’ “

'Skin in the Game' and Importing Cancer Drugs

” ‘Skin in the game’ is a phrase that has gained popularity in the healthcare market. It implies that if patients have a personal financial stake in a decision, such as higher out-of-pocket expenses, they will be more prudent and act more responsibly.

“Skin in the game can work to some degree, note Hagop Kantarjian, MD, chair of the Department of Leukemia, the University of Texas MD Anderson Cancer Center, Houston, and colleagues in a viewpoint article published online July 2 in JAMA Oncology.

“However, for many cancer patients, it has become ‘life in the game,’ they add.”